Controlled phase 3 clinical trial. Medical search. Frequent questions

Amylyx's application is based on a single study, the multicenter, two-phase CENTAUR trial. (medscape.com)
Injection Site Reaction: 98% of subjects experienced at least one injection site reaction during FUZEON treatment in randomized, controlled, open-label, multicenter trials. (nih.gov)

Washington D.C. 4 May 2023 (PAHO) - As cases of chikungunya in the region of the Americas reach over 210,000 in the first months of 2023, experts reviewed in a webinar this week methods to control the disease vector, factors that facilitate its spread and support to countries to tackle a growing number of cases. (paho.org)
NEEDHAM, Mass., March 30, 2023 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing and commercializing viral immunotherapies to help patients fight cancer, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update. (tmcnet.com)
Over the next few quarters of 2023, we anticipate multiple additional clinical data readouts as well as topline data in the fourth quarter of 2024 from our phase 3 clinical trial in early localized prostate cancer. (tmcnet.com)
PETACH TIKVA, Israel, May 22, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the U.S. Food and Drug Administration (FDA) agreed to Company's SHIELD II Phase 3 trial design evaluating D-PLEX 100 for the prevention of abdominal colorectal surgical site infections (SSIs). (globenewswire.com)
Our pivotal Phase 2B/3 study with dipraglurant for the treatment of Parkinson's disease levodopa induced dyskinesia, or PD-LID, remains on track to report data in the first half of 2023. (addexpharma.com)
The clinical trial is expected to enroll approximately 140 patients at 50 sites in the US, with topline results schedule for the first half of 2023. (addexpharma.com)
VANCOUVER, BC , Sept. 19, 2023 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies congratulates the Multidisciplinary Association of Psychedelics Studies ("MAPS") on the results of their phase 3 results. (mystateline.com)
Br J Surg 2023 Feb 15;110(3):344-352. (cancercentrum.se)
2023;15(3). (cancercentrum.se)

CERTAIN-1 (Cefepime Rescue with Taniborbactam in cUTI) was a global, randomized, double-blind, active-controlled non-inferiority Phase 3 study evaluating the efficacy, safety, and tolerability of cefepime-taniborbactam compared to meropenem in adults with cUTI, including acute pyelonephritis. (businesswire.com)

More than 50 percent of adult participants involved in the Phase 1/2 human trials of Pfizer and BioNTech's experimental messenger RNA (ribonucleic acid) COVID-19 vaccine reported adverse reactions. (nvic.org)
In the trials, 12 adults received a 10-microgram dose of the BNT162b1 vaccine, 12 adults were injected with a 30-µg dose, 12 received a 100-µg dose, while nine adults were given an inert saline placebo. (nvic.org)
Three weeks after the initial vaccination with the Pfizer-BioNTech experimental vaccine, all clinical trial participants were given a second dose of the vaccine at the same dosage. (nvic.org)
After the second vaccine dose, 36 percent of trial participants between the ages of 18 and 64 reported fatigue, while 28 percent reported a headache and 18 percent reported muscle pain. (nvic.org)
The development of the COVID-19 vaccine AZD1222 has expanded into a phase 3 trial that is enrolling 30,000 adults aged 18 years or older to assess its safety, efficacy, and immunogenicity. (pharmacytimes.com)
AstraZeneca had received 1 billion dollars from BARDA for the development, production, and delivery of the vaccine in May 2020, and the current phase 3 trial is a part of that original funding agreement. (pharmacytimes.com)
Should clinical trials demonstrate the vaccine protects against COVID-19 disease and is approved for use, we will work hard to make it globally available in a fair and equitable manner as rapidly as possible," said Mene Pangalos, PhD, executive vice president of BioPharmaceuticals R&D, in a press release. (pharmacytimes.com)
In response to the national increase in MenW cases in England, an emergency immunization program with meningococcal ACWY conjugate vaccine (MenACWY) for adolescents was started in August 2015 ( 3 ). (cdc.gov)
Although there are seven chikungunya vaccines under development - three in Phase-3 clinical trials -currently there is no approved vaccine or specific treatment for the disease. (paho.org)
Prof. S.S. Vasan led the pre-clinical trials testing two COVID-19 vaccine candidates. (www.csiro.au)
DOR's ricin toxin vaccine, RiVax™, has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. (biospace.com)
EUAs and have been used for post-vaccine serology determinations for clinical trials and research studies, as noted in published or preprint articles. (cdc.gov)
KL: We got the license to import it, but what we needed were manufacturing documents from the Center for Molecular Immunology that described how the vaccine was manufactured, what quality control measures were taken, etc. (vox.com)
Methods: A randomized, double-blind, active-controlled, phase III clinical trial was conducted to compare a modified Omicron-adapted vaccine (Omicron vaccine) with the authorized prototype vaccine (CoronaVac®) as a booster dose. (bvsalud.org)
Healthy adults aged ≥18 years, who have previously received 2 or 3 doses of CoronaVac (2C or 3C cohort) at least 6 months before, were enrolled to get a booster dose of Omicron vaccine or CoronaVac in a ratio of 2:1 (2C/3C+1O/1C). (bvsalud.org)

Through locally administered, controlled, prolonged-release therapeutics, PolyPid's proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. (globenewswire.com)
Geneva, Switzerland, May 27, 2022 - Addex Therapeutics Ltd (SIX: ADXN, Nasdaq: ADXN), a clinical-stage pharmaceutical company pioneering allosteric modulation-based drug discovery and development, announced today that the outcome of a small Phase 2a feasibility study of dipraglurant in patients with blepharospasm was inconclusive and did not meet all of its objectives. (addexpharma.com)
Addex Therapeutics is a clinical-stage pharmaceutical company focused on the development and commercialization of an emerging class of novel orally available small molecule drugs known as allosteric modulators for neurological disorders. (addexpharma.com)

Centers for Disease Control and Prevention. (cdc.gov)
In the United States, trial centers have begun to enroll adults of diverse racial, ethnic, and geographic backgrounds who are healthy or have stable underlying medical conditions, such as HIV, as well as those who are at an increased risk of SARS-CoV-2 due to their medical conditions. (pharmacytimes.com)
The trial will enroll patients in centers in the United States, Europe and Israel. (globenewswire.com)
I'm Commander Ibad Khan, and I'm representing the Clinician Outreach and Communication Activity COCA with the Emergency Risk Communication Branch at the Centers for Disease Control and Prevention. (cdc.gov)

Based on these results, and ANAVEX®3-71 pre-clinical profile, the Company intends to advance ANAVEX®3-71 into a biomarker-driven clinical development dementia program for the treatment of FTD, schizophrenias and Alzheimer's disease, evaluating longitudinal effect of treatment with ANAVEX®3-71 initiating in 2022. (anavex.com)
On December 6, 2022, Candel hosted its R&D Day during which the Company's leadership team and renowned external experts in oncology provided an in-depth review of the Company's viral immunotherapy platforms and clinical pipeline. (tmcnet.com)
In December 2022, the Company announced updated data from its open-label phase 2 clinical trial evaluating CAN-2409 and valacyclovir in combination with continued PD-1/PD-L1 agents in patients with late-stage NSCLC at the Company's R&D Day. (tmcnet.com)
A Phase 2 study of ADX71149 in epilepsy being conducted by our partner Janssen is expected to report data in Q4 2022," said Tim Dyer, CEO of Addex. (addexpharma.com)
October 3, 2022. (bvsalud.org)

Results Between 3 May 2020 and 13 November 2021, 2930 people were screened for eligibility, with 393 randomly assigned to angiotensin receptor blockers (of which 388 (98.7%) to telmisartan 40 mg/day) and 394 to the control group. (bmj.com)
In September 2021, the Company completed enrollment of 711 evaluable patients in its pivotal, placebo-controlled, randomized phase 3 clinical trial of CAN-2409 in combination with valacyclovir in localized intermediate/high-risk prostate cancer. (tmcnet.com)
Addex has been conducting a placebo-controlled Phase 2b/3 pivotal clinical trial of dipraglurant in PD-LID patients since June 2021. (addexpharma.com)

A 12-month, phase 2 trial, completed by Richeldi and colleagues, assessed the efficacy and safety of four different oral doses of the tyrosine kinase inhibitor nintedanib (formerly BIBF 1120) compared with placebo in patients with idiopathic pulmonary fibrosis. (medscape.com)
The contribution of pharmacogenetics (PG) will be evaluated in a large population subset from a phase III clinical trial with respect to patient efficacy and safety outcomes by incorporating PG data into population pharmacokinetic (PK) models for six major TB drugs and risk algorithms for unfavorable treatment outcomes and to develop and evaluate PG-based dosing algorithms for novel high-dose rifapentine-based regimens. (cdc.gov)
The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection. (merck.com)
A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. (globenewswire.com)
SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is a prospective, multinational, randomized, double blind Phase 3 trial designed to assess the efficacy and safety of D-PLEX 100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in the prevention of post abdominal-surgery incisional infection in patients undergoing surgeries with incisions greater than 20 cm. (globenewswire.com)
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of MDMA-assisted therapy ("MDMA-AT") compared to placebo, with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). (mystateline.com)

Objective To determine whether disrupting the renin angiotensin system with angiotensin receptor blockers will improve clinical outcomes in people with covid-19. (bmj.com)
The effects on the severity and frequency of blepharospasm signs and symptoms using objective measures, clinical ratings and patient reported outcomes were also evaluated as secondary endpoints. (addexpharma.com)
Conclusions: Standardized methodologies, such as our PPTR approach, could facilitate unbiased efficacy outcome determinations, improve discrimination between outcomes that are related and unrelated to regimen efficacy, and enhance the ability to conduct pooled analyses of contemporary trials. (cdc.gov)
Sometimes, 'real-world' outcomes don't reflect what is seen in the well-controlled setting of a clinical trial that resulted in regulatory approval," Dr. Kiss noted. (medscape.com)
Currently, there is no evidence of benefit in critical outcomes (i.e. reduction in mortality) from any therapeutic option (though remdesivir is revealing promise as one option based on 2 randomized controlled trials) and that conclusively allows for safe and effective use to mitigate or eliminate the causative agent of COVID-19. (bvsalud.org)
Annex 3 contains the outcomes of the working group on case management and Annex 4 contains the plan of action for the regional leishmaniasis programme in the Eastern Mediterranean Region 2010 (by months). (who.int)

This time, two panelists who previously voted no were swayed by the drugmaker's new analysis of previously presented research, more than 1300 public comments in support of the drug, supportive testimony from ALS patients and clinicians, and assurances from company executives that Amylyx would pull the drug from the market if results of an ongoing phase 3 clinical trial show the drug doesn't work. (medscape.com)
Pfizer reported early U.S. Phase 3 clinical trials results in mid-September. (nvic.org)
Clarity AD: Full results from the Phase 3 confirmatory Clarity AD clinical trial of lecanemab in patients with early AD will be presented in a scientific session on November 29 at 4:50 p.m. (eisai.com)
The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab. (eisai.com)
Efficacy of Leqembi was evaluated using the results of Study 301 (CLARITY AD), a Phase 3 randomized, controlled clinical trial. (fda.gov)
All committee members voted affirmatively that the results of the study verified the clinical benefit of Leqembi for the indicated use. (fda.gov)
As a human cell-based technology, thepre-clinical trial results will more accurately mimic many of our own responsesto infections. (www.csiro.au)
This decision came after the FDA review of positive results from a Phase 3 randomized, controlled clinical trial that confirmed lecanemab's clinical benefit. (massgeneral.org)
An experimental drug appears to slow the progression of Niemann-Pick disease type C1 (NPC1), a fatal neurological disease, according to results of a clinical study led by researchers at the National Institutes of Health. (scienceblog.com)
The results are very encouraging and support continued development of VTS-270 for treating NPC1," said Forbes D. Porter, M.D., Ph.D., clinical director at NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the study's senior author. (scienceblog.com)
The trial is sponsored by Sucampo, and its results will help determine which symptoms are most responsive to the drug and provide information for refining the dose and dosing frequency. (scienceblog.com)
The trial results were recently published in the Journal of Investigative Dermatology . (sciencedaily.com)
This type of study also helps researchers to better find and control for such features as age, sex, and other factors that can affect the results of the study. (cancer.net)
We are pleased with the Phase 1 trial results for ANAVEX®3-71 and are eager to advance ANAVEX®3-71 into Phase 2," said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. (anavex.com)
ET to discuss the top-line results from the Phase 1 clinical trial of ANAVEX®3-71 in healthy volunteers. (anavex.com)
On June 9, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee affirmatively voted that the results of the study verified the clinical benefit for the indicated use of lecanemab. (pharmacytimes.com)
SSE: 688180) and Coherus BioSciences, Inc. ("Coherus", Nasdaq: CHRS) today announced positive interim results from the pivotal study "JUPITER-06" (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). (globenewswire.com)
Within the clinical trials, the dose levels based on the results in the non-clinical tests, were confirmed and a minimum effective dose in humans established. (europa.eu)
For example, the Company is using forward-looking statements when it discusses the expected resumption of recruitment for the SHIELD II Phase 3 trial and the timing of top-line results therefrom. (globenewswire.com)
As largely expected, the results of the confirmatory phase 3 study, named MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial indicated 71.2% of participants in the MDMA-AT group no longer met the criteria for PTSD after receiving three dosing sessions, together with therapy, delivered approximately one month apart - further underscoring the importance and potential effectiveness of MDMA for the treatment of PTSD. (mystateline.com)
The move toward precision psychiatry is bolstered by the study's results , which validated 26 candidate biomarkers for tracking mood states in independent cohorts of people with clinically severe depression or mania, and for predicting clinical course, including future hospitalizations for depression or mania. (medscape.com)
Elsewhere, results of two phase 3, randomized, placebo-controlled trials show that an investigational, orally dissolving film formulation of dexmedetomidine may offer rapid relief from acute agitation related to bipolar disorder or schizophrenia. (medscape.com)
3-week centered moving averages of percentage of RSV-positive PCR results nationwide. (cdc.gov)
The black dotted line represents the threshold for a seasonal epidemic (3% RSV-positive laboratory PCR results). (cdc.gov)
These real-world data from patients with refractory disease mirror the results from recent VISUAL-1 and VISUAL-2 clinical trials, suggesting that inflammatory activity at the time of adalimumab commencement may play a key role in determining long-term treatment success," Dr. Lyndell L. Lim of the University of Melbourne, Australia, and colleagues write in the British Journal of Ophthalmology, online February 19. (medscape.com)
A recent release by Glenmark announced promising results from a Phase 3 Clinical Trial of favipiravir in patients with mild to moderate COVID-19. (bvsalud.org)
He recognized further challenges and called for enhanced efforts to control the disease which still posed a major public health threat, traditional and classical methods of control and prevention were not yielding the expected results and they strongly needed to be revised. (who.int)

Additionally, other important research from the lecanemab clinical development program and Eisai's AD pipeline, including the company's investigational anti-microtubule binding region (MTBR) tau antibody (E2814), will be presented in four oral and ten poster presentations. (eisai.com)
KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced a pause in enrollment for the IMPOWER 22 (MK-8591-022) and IMPOWER 24 (MK-8591-024) Phase 3 clinical studies evaluating investigational, once-monthly, oral islatravir (ISL), a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis (PrEP) in people at high risk of HIV-1 infection. (merck.com)
The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes. (science20.com)
Our investigational viral immunotherapies have shown early clinical promise, including a persistent immune response and have been generally well tolerated," said W. Garrett Nichols, MD, MS, Chief Medical Officer of Candel. (tmcnet.com)

Addex's lead drug candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM), is in a pivotal registration clinical trial for Parkinson's disease levodopa induced dyskinesia (PD-LID). (addexpharma.com)

International research ethics guidelines prevalence and factors associated with already participating in 10 different have specified the essential require- therapeutic misconception in the devel- therapeutic clinical trials being con- ments for a valid informed consent: oped world have been explored ( 10 , 11 ), ducted at the Centre (Table 1). (who.int)
better understanding of the prevalence clinical trial at the Centre and willing to In the last decade, local and inter- and the underlying factors associated participate in this study. (who.int)

Leqembi demonstrated a statistically significant and clinically meaningful reduction of decline from baseline to 18 months on the primary endpoint, the Clinical Dementia Rating Scale Sum of Boxes score, compared to placebo. (fda.gov)
Main outcome measures The primary endpoint was covid-19 disease severity using a modified World Health Organization Clinical Progression Scale (WHO scale) at day 14. (bmj.com)
The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery. (globenewswire.com)

Solanezumab was safely used in combination with approved Alzheimer's disease treatment, such as acetylcholinesterase inhibitors or memantine, in the clinical trials. (wikipedia.org)
In a single-dose, placebo-controlled study (H8A-LC-LZAH) in 19 patients with mild-to-moderate Alzheimer's disease, solanezumab was well tolerated over the whole dose range. (wikipedia.org)
52 patients with mild-to-moderate Alzheimer's disease underwent a parallel group, double-blind, randomized, placebo controlled phase 2 trial. (wikipedia.org)
As in March, today we have to have an internal dialogue between our scientific scrutiny and clinical compassion," said Liana G. Apostolova, MD, Distinguished Professor in Neurology and the Barbara and Peer Baekgaard Chair in Alzheimer's Disease Research at the Indiana University School of Medicine, who originally voted against the application. (medscape.com)
They also provided new information on a biomarker data from a phase 2 study of AMX0035 to treat Alzheimer's disease. (medscape.com)
Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. (fda.gov)
Today's action is the first verification that a drug targeting the underlying disease process of Alzheimer's disease has shown clinical benefit in this devastating disease," said Teresa Buracchio, acting director of the Office of Neuroscience in the FDA's Center for Drug Evaluation and Research. (fda.gov)
On June 9 , the FDA convened the Peripheral and Central Nervous System Drugs Advisory Committee to discuss whether Study 301 provided evidence of clinical benefit of Leqembi for the treatment of Alzheimer's disease. (fda.gov)
ANAVEX®3-71 demonstrated disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, as well as beneficial effects on mitochondrial dysfunction and neuroinflammation. (anavex.com)

The multinational miR-AGE ABX464 phase 2b/3 clinical trial (ABX464-401), has already recruited 500 high-risk Covid-19 patients out of the planned 1,034 and has been declared "Research National Priority" by the French government in December 2020. (pharmiweb.com)
The trial was conducted in May and June 2020, and involved 45 healthy adults between the ages of 18 and 55 years. (nvic.org)

In line with our plans we have been able to demonstrate the safety and clinical efficacy of rhLAMAN as an effective therapeutic agent for treatment of the human disease alpha-Mannosidosis in clinical trial Phases 1 and 2. (europa.eu)
More than 200 therapeutic options or their combinations are being investigated in more than 1,700 clinical trials. (bvsalud.org)
This study aimed to evaluate the informed consent process, therapeutic misconception and motivation for participation among Egyptians participating in clinical trials. (who.int)
Investigators need to emphasize the distinction between research and clinical care to address the high rate of therapeutic misconception. (who.int)

This pathway allows the FDA to approve drugs for serious conditions where there is an unmet medical need, based on clinical data demonstrating the drug's effect on a surrogate endpoint-in the case of Leqembi, reducing amyloid plaques in the brain-that is reasonably likely to predict a clinical benefit to patients. (fda.gov)
The drug is approved under the accelerated approval pathway, under which FDA may approve drugs for serious conditions where there is an unmet medical need and a drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. (sflorg.com)
The primary efficacy endpoint evaluated the composite clinical and microbiologic response (i.e., bacterial eradication) at the Test of Cure (TOC) visit (Day 19-23) in the microbiological intent-to-treat (microITT) population. (businesswire.com)

The study has a robust randomized, double-blind and placebo-controlled design to test whether ABX464 could prevent the development of severe Covid-19 disease in the participants. (pharmiweb.com)
In D8110C00001, participants will receive 2 doses of either AZD1222 or a saline control. (pharmacytimes.com)
With late-stage clinical trials assessing AZD1222 underway in the United Kingdom, Brazil, and South Africa, as well as trials set to begin in Japan and Russia, the total number of participants in trials assessing AZD1222 globally is planned to be 50,000. (pharmacytimes.com)
Over longer time frames, some participants experienced a stabilization of muscle strength and control. (sflorg.com)
At the end of the placebo-controlled part of the study, participants were offered the option to receive tofersen as part of an open-label extension that will last up to 4½ years. (sflorg.com)
Participants already enrolled in the trials will continue to receive the study medicine. (merck.com)
Overall, investigators found that only 16% of participants responded to iTBS during the double-blind period of the trial, and the proportion of patients who responded to iTBS was the same as the proportion who responded to sham treatment. (medscape.com)
Agree to actively stay in contact with the trial site for the duration of the trial for the participants own safety. (who.int)
In a cross-sectional qualitative pilot study 103 participants in 10 clinical trials responded to a questionnaire. (who.int)
RÉSUMÉ Les études ayant examiné le processus du consentement éclairé chez les participants à des études de recherche dans les pays en développement sont peu nombreuses. (who.int)
guided important aspects of research the risk associated with clinical trials, Participants enrolment and participation, particu- thus further undermining the validity of larly the process of informed consent. (who.int)

We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial. (science20.com)

As a postmarketing requirement of the accelerated approval, the FDA required the applicant to conduct a clinical trial, often referred to as a confirmatory study, to verify the anticipated clinical benefit of Leqembi. (fda.gov)

The call will feature presentations by Key Opinion Leader (KOL) Maria Fleseriu, MD, FACE, lead investigator of the MPOWERED study, who will discuss the topline data from Chiasma's Phase 3 MPOWERED study as well as the unmet medical need in acromegaly and the treatment burden that patients experience with monthly somatostatin analog injections. (biospace.com)
Chiasma's management team will also provide an overview of the MPOWERED Phase 3 topline data, which were announced on November 18th. (biospace.com)
Jason A. Amello, Chief Financial Officer of Candel, added, "I am pleased that the prudent and disciplined management of our expenditures and programs has enabled us to extend our cash runway into the second quarter of 2024, bringing us another quarter closer to our anticipated phase 3 topline data readout for prostate cancer in 2024. (tmcnet.com)

Prospective, Randomized, Blinded Phase 2 Pharmacokinetic/Pharmacodynamic Study of the Efficacy and Tolerability of Levofloxacin in Combination with Optimized Background Regimen (OBR) for the treatment of MDR-TB. (cdc.gov)
Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis: A randomized, open-label, controlled phase 3 clinical trial. (cdc.gov)
Randomized, Phase II clinical trial assessing the antimicrobial activity and safety of substitution of rifapentine for rifampin in standard intensive phase TB treatment regimen. (cdc.gov)
Randomized, double-blind, Phase II clinical trial assessing impact on 2-month sputum conversion rate of substitution of moxifloxacin for isoniazid in standard intensive phase TB treatment regimen. (cdc.gov)
Randomized, open-label Phase III clinical trial of ultra short-course treatment of latent TB infection among contacts of active cases, using a 3-month once-weekly regimen of isoniazid and rifapentine, compared to standard 9-month daily therapy with isoniazid. (cdc.gov)
This is a phase 3 open label, multi-center, randomized, active-controlled non-inferiority trial that compares the safety and effectiveness of a 6-week regimen of daily rifapentine against the current standard of 12-16 weeks of rifamycin-based treatment for latent TB infection (LTBI). (gwdocs.com)
Our innovative project will develop a novel screening tool to rapidly screen existing drugs and advance those that can be used for COVID-19 treatment to phase 2-3 clinical trials. (www.csiro.au)
DOR expects to begin a confirmatory Phase 3 clinical trial of orBec® for the treatment of GI GVHD in 1H 2009. (biospace.com)
In May, a long-awaited randomized, double-blind, placebo-controlled, Phase 3 clinical trial testing MDMA-assisted therapy for the treatment of PTSD was published in Nature Medicine . (forbes.com)
Dr. Fleseriu has a long-standing clinical and research interest in the pathophysiology and treatment of pituitary and adrenal disorders. (biospace.com)
She is a frequent plenary guest speaker at national and international meetings on treatment of Cushing's, acromegaly and growth hormone deficiency, is global principal investigator in clinical trials, and has authored over 170 manuscripts in prestigious journals, including guidelines, consensus papers and book chapters. (biospace.com)
Anavex is developing ANAVEX®3-71 initially for the treatment of Frontotemporal Dementia (FTD), for which ANAVEX®3-71 was previously granted orphan drug designation by the FDA. (anavex.com)
We continue to apply learnings from our HIV program as we move forward with the development of islatravir in both treatment and PrEP," said Dr. Joan Butterton, vice president, infectious diseases, Global Clinical Development, Merck Research Laboratories. (merck.com)
The data demonstrated evidence of local and systemic anti-tumor activity in patients with inadequate response to previous immune checkpoint inhibitor (ICI) treatment and showed a disease control rate of 77 percent (20/26) in patients entering the trial with disease progression despite ICI treatment. (tmcnet.com)
In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. (mayo.edu)
Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. (mayo.edu)
Addex's second clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc., is in a Phase 2a proof of concept clinical trial for the treatment of epilepsy. (addexpharma.com)
The marketing authorisation of rilpivirine is based on the 48-week analyses of ECHO and THRIVE, two randomised, double blind, active controlled, global Phase 3 clinical trials which evaluated the efficacy, safety and tolerability of rilpivirine compared to efavirenz in more than 1,350 treatment-naïve HIV-1 adult patients in over 20 countries. (jnj.com)
From the role of calcium homeostasis to studies on emerging treatment options, increased discussion about bipolar disorder resulted in this week's top trending clinical topic. (medscape.com)
Rationale: We developed a standardized method, possible poor treatment response (PPTR), to help ascertain efficacy endpoints in Study S31/A5349 (NCT02410772), an open-label trial comparing two 4-month rifapentine-based regimens with a standard 6-month regimen for the treatment of pulmonary tuberculosis (TB). (cdc.gov)
A Phase 3 RCT demonstrates statistically significant faster time to clinical improvement with favipiravir treatment compared to control (n=150 patients). (bvsalud.org)

Study AB09004 was a randomized, double-blind, two parallel-group (four-arm), placebo-controlled trial. (biomedcentral.com)
orBec® is also currently the subject of an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. (biospace.com)

The participation of clinical research teams across Brazil within this multinational trial was a very enriching experience that will be valuable for future clinical studies. (pharmiweb.com)

These diverse populations are historically underrepresented in clinical trials. (mystateline.com)
Hovén E , Flynn KE, Weinfurt KP, Eriksson LE, Wttergren L. Psychometric evaluation of the Swedish version of the PROMIS Sexual Function and Satisfaction Measures in clinical and nonclinical young adult populations. (cancercentrum.se)

Tumor stem cell-targeted immunotherapy for metastatic melanoma -a randomized phase 3 clinical trial. (ca.gov)

As reported in March by Medscape Medical News , the panel previously voted 6-4 to reject the drug, ruling that data provided by Amylyx had failed to demonstrate that the survival benefit reported in the only clinical trial of AMX0035 so far was a direct result of the drug. (medscape.com)
The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. (globenewswire.com)

ALS is a devastating and deadly disease," said Timothy M. Miller, MD, PhD, the David Clayson Professor of Neurology at Washington University and the principal investigator of the tofersen clinical trials. (sflorg.com)

Both were randomized, double-blind and placebo-controlled. (wikipedia.org)

A second, independent parallel group (distinct for statistical analysis and control arm), randomized patients (2:1) to masitinib at an initial dose of 4.5 mg/kg/day for 12 weeks that was then titrated to 6.0 mg/kg/day, or equivalent placebo. (biomedcentral.com)
AHA should be administered orally, one tablet 3-4 times a day in a total daily dose of 10-15 mg/kg/day. (rxlist.com)
furthermore, a double-blinded clinical trial in 2005 by Demets et al (IFIGENIA Study) on 182 patients with the diagnosis of idiopathic pulmonary fibrosis concluded that a therapy with acetylcysteine at a dose of 600 mg three times daily, added to prednisone and azathioprine, preserves vital capacity and diffusion capacity of carbon monoxide (DL CO ) in patients with idiopathic pulmonary fibrosis. (medscape.com)
Participant QTcF measures were normal across all dose groups with no difference between ANAVEX®3-71 and Placebo. (anavex.com)
In non-clinical studies we also found the optimal rhLAMAN dose for a maximal correction of visceral and central nervous system pathology following injection in immune-tolerant alpha Mannosidosis mice. (europa.eu)
Adults: Four adult strength tablets as a single daily dose for 3 days. (nih.gov)
This study enrolled volunteers who first received two full-dose CoronaVac vaccinations before receiving heterologous boosters with DNA- and/or mRNA-vaccines for an additional 2 doses (n = 40) or an additional 3 doses (n = 16). (bvsalud.org)

High doses of vitamin D taken one hour after sunburn significantly reduce skin redness, swelling, and inflammation, according to double-blinded, placebo-controlled clinical trial. (sciencedaily.com)
High doses of vitamin D taken one hour after sunburn significantly reduce skin redness, swelling, and inflammation, according to double-blinded, placebo-controlled clinical trial out of Case Western Reserve University School of Medicine and University Hospitals Cleveland Medical Center. (sciencedaily.com)
The study may have people flocking to vitamin supplement aisles, but Lu stresses that the trial tested very high doses of vitamin D that far exceed daily allowances. (sciencedaily.com)
The study was a double-blind, randomized, placebo-controlled, Phase 1 trial to evaluate safety and tolerability, and pharmacokinetics (PK) of oral escalating doses of ANAVEX®3-71 including effects of food and gender in healthy volunteers. (anavex.com)
ANAVEX®3-71 was well tolerated in all cohorts receiving ANAVEX®3-71 in single doses ranging from 5 mg to 200 mg daily with no serious adverse events (SAEs) and no significant lab abnormalities in any subject. (anavex.com)
Single escalating doses of ANAVEX®3-71 were administered in order to evaluate the safety, tolerability, and pharmacokinetics (PK) of ANAVEX®3-71 and the effects of food and gender on its PK in healthy volunteers. (anavex.com)
Findings from the RECOVERY Trial showed that low doses of dexamethasone (6 mg of oral or intravenous preparation once daily for 10 days) significantly reduced mortality by one-third in ventilated patients and by one fifth in patients receiving oxygen only. (bvsalud.org)
Children should avoid taking niacinamide doses above the daily upper limits, which are 10 mg for children 1-3 years of age, 15 mg for children 4-8 years of age, 20 mg for children 9-13 years of age, and 30 mg for children 14-18 years of age. (medlineplus.gov)

NICHD researchers led the design, data collection and analysis of the phase 1/2a clinical trial. (scienceblog.com)
Researchers are now working on a randomized, controlled phase 2b/3 clinical trial (NCT02534844) that has been approved by the FDA and the European Medicines Agency. (scienceblog.com)
In addition to NICHD researchers, the study includes authors from NIH's National Center for Advancing Translational Sciences (NCATS), the National Institute on Deafness and Other Communication Disorders, the National Institute of Neurological Disorders and Stroke, the National Institute of Mental Health, the Mark O. Hatfield Clinical Research Center, and the National Human Genome Research Institute. (scienceblog.com)
Experimental studies and clinical trials help researchers learn more about how cancer starts or spreads. (cancer.net)
Researchers do clinical trials in segments called phases. (cancer.net)
Researchers can prevent bias in a clinical trial by keeping those people and themselves, or just those people, from knowing who is in each group. (cancer.net)
The people in the study and the researchers do not know who belongs to the intervention group or control group. (cancer.net)
Most researchers feel this type of clinical trial produces the best study data. (cancer.net)
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. (mayo.edu)
Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. (mayo.edu)
The researchers concluded in large part that the findings could be considered hypothesis testing and urged the conduct of large sample sized RCTs to assess any clinical benefit. (bvsalud.org)

We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. (nih.gov)

Prior to joining DOR, Dr. Schaber served from 1998 to 2006 as Executive Vice President and Chief Operating Officer of Discovery Laboratories, Inc., where he was responsible for overall pipeline development and key areas of commercial operations, including regulatory affairs, quality control and assurance, manufacturing and distribution, preclinical and clinical research, and medical affairs, as well as coordination of commercial launch preparation activities. (biospace.com)
In addition to these clinical-stage projects, Addex has multiple preclinical programs advancing rapidly through clinical candidate selection phase toward IND enabling studies which are expected to start within the next 12 months. (addexpharma.com)

Each trial showed a statistically significant improvement in FVC compared with placebo ( P = .001). (medscape.com)

Patients aged ≥50 years, with clinical diagnosis of mild-to-moderate probable AD and a Mini-Mental State Examination (MMSE) score of 12-25 were randomized (1:1) to receive masitinib 4.5 mg/kg/day (administered orally as two intakes) or placebo. (biomedcentral.com)
Abivax (Euronext Paris: FR0012333284 - ABVX), a clinical-stage biotechnology company modulating the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, announces today that it is halting the miR-AGE phase 2b/3 clinical trial in high-risk Covid-19 patients after the independent Data Safety and Monitoring Board (DSMB) recommendation for lack of efficacy. (pharmiweb.com)
The miR-AGE trial was set up based on a scientifically sound rationale and it was robustly designed with the input of a highly experienced steering committee in order to evaluate the safety and efficacy of ABX464 in preventing severe Covid-19 disease and death in high-risk patients. (pharmiweb.com)
Abivax, a clinical stage biotechnology company, is modulating the body's natural immune machinery to treat patients with chronic inflammatory diseases, viral infections, and cancer. (pharmiweb.com)
At Mass General, the brightest minds in medicine collaborate on behalf of our patients to bridge innovation science with state-of-the-art clinical medicine. (massgeneral.org)
MPOWERED (Maintenance of acromegaly Patients with Octreotide capsules compared with injections - Evaluation of REsponse Durability), was a global, randomized, non-inferiority, open-label, and active-controlled 15-month trial that was designed to support a potential marketing application of MYCAPSSA ® in the European Union. (biospace.com)
The phase 1 trial in patients with SOD1 ALS demonstrated that an antisense oligonucleotide could be safely delivered directly into the cerebrospinal fluid that bathes the brain and spinal cord. (sflorg.com)
The trial enrolled 661 adult patients who were randomized 2:1 to receive cefepime-taniborbactam 2.5g q8h or meropenem 1g q8h for 7 days (up to 14 days for patients with bacteremia). (businesswire.com)
Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial. (science20.com)
If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control. (science20.com)
Final Report Summary - ALPHA-MAN (Clinical development of Enzyme Replacement Therapy in alpha-Mannosidosis patients using recombinant human enzyme. (europa.eu)
More specifically, data from our CAN-2409 clinical trial demonstrated robust evidence of local and systemic anti-tumor activity in patients with non-small cell lung cancer who had an inadequate response to immune checkpoint inhibitors. (tmcnet.com)
Recruitment into the trial will resume imminently with the enrollment of an estimated 550 additional patients beyond the 40 patients already recruited into SHIELD II. (globenewswire.com)
And it's still a long way from clinical trials to being widely available for patients. (vox.com)
They've been developing it since the late 1990s and have done a lot of interesting clinical trials, including a large phase 3 randomized controlled trial in 405 patients in Cuba. (vox.com)
A total of 15 patients were enrolled into this double-blind, placebo controlled Phase 2a feasibility study. (addexpharma.com)
Methods Patients on stable methotrexate and with inadequate response to one or more TNF inhibitors were randomised to placebo (n=35), 30 mg tabalumab (n=35) or 80 mg tabalumab (n=30) given intravenously at 0, 3 and 6 weeks. (bmj.com)
The findings also highlight the importance of routinely assessing PTH, vitamin D, and calcium levels in patients with bipolar disorder as a marker of clinical severity, Palummo added. (medscape.com)
Within this group, epilepsy is refractory in up to 40 % of patients, who have shown para el control de síntomas refractarios en a decrease in the frequency of seizures with the concomitant use of cannabidiol and conventional antiepileptics, with mild síndromes convulsivos side effects such as diarrhea and drowsiness. (bvsalud.org)
This narrative article aims to determine the use of cannabidiol for the control of Current therapy for advanced diseases is refractory neurological symptoms in patients oriented towards symptom control rather with seizure syndromes and neurode- than halting their progression. (bvsalud.org)

In other words, our findings are more reflective of clinical practice in general, rather than the more artificial constraints of a clinical trial. (medscape.com)
It was important to do this study to validate the findings of the larger Phase 3 clinical trials. (medscape.com)
Trial findings and WHO's SOLIDARITY Trial findings both show no benefit via use of hydroxychloroquine and lopinavir/ritonavir in terms of reducing 28-day mortality or reduced time to clinical improvement or reduced adverse events. (bvsalud.org)

The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data. (science20.com)

The trial was conducted by MAPS Public Benefit Corporation , a for-profit subsidiary launched by the registered non-profit in 2014, with the goal of conducting the necessary research to make MDMA a legally available medicine. (forbes.com)
Los efectos del cannabidiol lo convierten en una alternativa, of the title and research adicional a la terapéutica convencional, para el control de síntomas en trastornos neurológicos, disminuyendo de forma objectives, exhaustive sostenida el número total de episodios con un perfil de seguridad aceptable. (bvsalud.org)

At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies. (merck.com)
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. (who.int)

We report the safety, tolerability, pharmacokinetics, and pharmacodynamics (turnover of plasma/serum ARGS-aggrecan neoepitope fragments [ARGS]) of GLPG1972 in 3 randomized, double-blind, placebo-controlled phase 1 trials. (lu.se)

Help us make reference on Medscape the best clinical resource possible. (medscape.com)

From biomarkers to therapies, a wide variety of new information about bipolar disorder led to the condition becoming this week's top trending clinical topic. (medscape.com)
As part of the alternative therapies for the control of refractory symptoms in advanced diseases, the use of cannabidiol stands out. (bvsalud.org)
new therapies are rapidly emerging but still in the clinical trial phase. (msdmanuals.com)

Randomized, placebo-controlled, double-blind Phase I/II clinical trial assessing the safety and microbiological activity of Linezolid added to Optimized Background Therapy (OBT) for MDR TB or XDR TB. (cdc.gov)
The study was a phase 1/2a clinical trial designed to test the drug's safety and effectiveness. (scienceblog.com)
The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis. (science20.com)
The safety and efficacy of molnupiravir in children and adolescents have not been established in clinical studies. (who.int)

2. Have been on antiretroviral therapy (ART) for at least 3 consecutive months at screening and agree to remain on ART throughout the trial. (who.int)

Experimental studies, called clinical trials. (cancer.net)
This is because people in these studies are placed in the intervention group or control group, usually at random. (cancer.net)
After antisense oligonucleotides showed promise in animal studies of SOD1 ALS, Miller - along with Merit Cudkowicz, MD, the director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital - co-led the first clinical trial of an antisense oligonucleotide in the central nervous system. (sflorg.com)

R, Flisberg P, Hedlund L, Östlund I, Bergkvist L. Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane. (cancercentrum.se)

ALS is a progressive, fatal neurodegenerative disease affecting nerve cells in the brain and spinal cord that causes loss of motor control. (medscape.com)
Identification of individuals with risk factors for the development of severe alcoholic hepatitis may provide insight to the diverse clinical spectrum and prognosis of the disease. (wjgnet.com)
In the phase 3 clinical trial, the drug reduced molecular signs of disease and curbed neurodegeneration in the first six months of use. (sflorg.com)
However, Hurler syndrome is a severe form of the same heavy mucopolysaccharidosis, with affected children dying after several years, whereas Scheie disease has a mild clinical phenotype. (medscape.com)

It is important to understand the mechanisms of action and the pharmacokinetics of antiepileptic drugs (AEDs) so that these agents can be used effectively in clinical practice, especially in multidrug regimens (see the image below). (medscape.com)

Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. (gwdocs.com)
The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. (globenewswire.com)
1,2] There were approximately half the incidence of grade 2-4 overall adverse events in the rilpivirine arm vs. the efavirenz arm (16% vs. 31%) including significantly lower incidence of rash, dizziness, abnormal dreams/nightmares, and lower incidence of grade 3-4 lipid abnormalities. (jnj.com)

International clinical trials of tofersen, developed by the global biotechnology company Biogen Inc., were led by a neurologist at Washington University School of Medicine in St. Louis. (sflorg.com)

Grade 3 - Considered a severe or medically significant adverse event but not one that is considered immediately life-threatening. (nvic.org)
Four main clinical variables for bipolar disorder were correlated with reduced HRV: illness duration, lifetime number of depressive episodes, duration of the most severe manic or hypomanic episode, and family history of suicide. (medscape.com)

Anatomy1

Diseases30

Chemicals and Drugs42

Analytical, Diagnostic and Therapeutic Techniques and Equipment106

Psychiatry and Psychology11

Phenomena and Processes16

Disciplines and Occupations14

Anthropology, Education, Sociology and Social Phenomena12

Technology, Industry, Agriculture4

Humanities7

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Named Groups4

Health Care94

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20239

Evaluating the efficacy1

Vaccine15

Therapeutics3

Centers4

20225

20213

Efficacy and Safety6

Outcomes6

Results27

Investigational4

Pivotal1

Centre2

Primary endpoint3

Alzheimer's9

20202

Therapeutic4

Endpoint3

Participants11

Investigators1

Confirmatory study1

Topline data3

Treatment21

Placebo-controlled trial2

Participation1

Populations2

Melanoma1

Demonstrate2

Principal investigator1

Double-blind and placebo-controlled1

Dose7

Doses8

Researchers11

Assess1

Preclinical2

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Patients20

Findings3

Measures1

Research2

Data2

Tolerability1

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