Placebo-controlled study

LB Pharmaceuticals To Participate in the B. Riley Securities’ Neuroscience Conference

Retrieved on: 
Monday, April 26, 2021
Research, Technology, Other Technology, Clinical trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Psychoactive drugs, Chemical compounds, Atypical antipsychotics, Receptor antagonists, Pyrrolidines, Amisulpride, Antidepressants, Antiemetics, Sulpiride, Placebo-controlled study

Following the presentation, Mr. Prensky will participate in a question-and-answer session.

Key Points: 
  • Following the presentation, Mr. Prensky will participate in a question-and-answer session.
  • Our approach is to create a research-focused organization dedicated to generating novel intellectual property around improved versions of these former best-selling drugs.
  • LB-102 has the potential to offer schizophrenia patients the benefits of amisulpride at a lower dose than amisulpride.
  • A first-in-human, double-blind placebo-controlled Phase 1 study designed to test the safety and pharmacokinetics of LB-102 was completed over the summer of 2020.

LivaNova and Verily Announce First Patient Enrolled in Study to Evaluate Treatment Effectiveness for Patients Living with Depression

Retrieved on: 
Monday, April 26, 2021
Medical Supplies, Medical devices, Health, Hospitals, Pharmaceutical, Biotechnology, Clinical research, Health sciences, Medical research, Design of experiments, Health, Clinical trials, Pharmaceutical industry, Placebo-controlled study, Placebo, the RECOVER Study and UNCOVER Sub-study, VNS Therapy for Depression, LivaNova, Verily, THE RECOVER STUDY AND UNCOVER SUB-STUDY, VNS THERAPY FOR DEPRESSION, LIVANOVA, VERILY

The Verily tools measure passive and active data, such as the participant\xe2\x80\x99s pulse rate, activity levels and sleep quality.

Key Points: 
  • The Verily tools measure passive and active data, such as the participant\xe2\x80\x99s pulse rate, activity levels and sleep quality.
  • The double-blind, randomized, placebo-controlled study is assessing how VNS Therapy can offer patients relief from their DTD symptoms and improve quality of life.
  • Symmetry\xc2\xae, the LivaNova VNS Therapy System for depression, is the first and only FDA-approved implantable device specifically designed for DTD.
  • LivaNova and Verily announced their collaboration on UNCOVER in February 2020.\nFor more information on the RECOVER clinical study, please visit www.RecoverVNS.com .

Retrotope Announces Completion of Enrollment in Phase 2 Study of RT001 in Patients with Amyotrophic Lateral Sclerosis (ALS)

Retrieved on: 
Wednesday, April 21, 2021
Clinical research, Chemistry, Biochemistry, Di-deuterated linoleic acid ethyl ester, Medical research, Clinical trials, Health sciences, Placebo-controlled study, Placebo, Retrotope

"This trial enrolled very rapidly due to the enthusiasm of ALS patients for a new potential treatment with a unique mechanism for combatting this disease.

Key Points: 
  • "This trial enrolled very rapidly due to the enthusiasm of ALS patients for a new potential treatment with a unique mechanism for combatting this disease.
  • "\nThe Phase 2 trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of RT001 in patients with ALS.
  • Study participants have been randomized to receive either RT001 or placebo daily for 24 weeks.
  • The primary endpoint of the trial is change from baseline in the revised ALS Functional Rating Scale (ALSFRS-R) at 24 weeks.

180 Life Sciences Corp. Announces Collection of All Patient Data for Phase 2b Dupuytren’s Disease Trial

Retrieved on: 
Tuesday, April 20, 2021
Clinical research, Design of experiments, Clinical trials, Methodology, Research, Experiments, Randomized controlled trial, Placebo-controlled study, Knowledge

In this double-blind placebo-controlled trial, 181 patients were randomized across 3 sites, two in the UK and one in the Netherlands.

Key Points: 
  • In this double-blind placebo-controlled trial, 181 patients were randomized across 3 sites, two in the UK and one in the Netherlands.
  • The data is currently being analyzed and is planned to be published in a peer-reviewed journal in an open access format.
  • The data is being reviewed and validated, which is not an easy task under current conditions.
  • 180 Life Sciences is leading the research into solving one of the world\xe2\x80\x99s biggest drivers of disease \xe2\x80\x93 inflammation.

LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021

Retrieved on: 
Friday, April 23, 2021
Biotechnology, General Health, Health, Pharmaceutical, Managed care, Type I hypersensitivity, Monoclonal antibodies, Tralokinumab, Medical specialties, Immunology, Atopic dermatitis, Dermatitis, Atopy, Placebo-controlled study, Clinical medicine

LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries.

Key Points: 
  • LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries.
  • Long-term Safety, Efficacy, and Adherence to Tralokinumab Treatment in Moderate-to-severe Atopic Dermatitis for up to 3 Years: Interim Readout of ECZTEND, a Phase 3, Long-term Extension Trial.
  • Tralokinumab for moderate\xe2\x80\x90to\xe2\x80\x90severe atopic dermatitis: results from two 52\xe2\x80\x90week, randomized, double\xe2\x80\x90blind, multicentre, placebo\xe2\x80\x90controlled phase III trials (ECZTRA 1 and ECZTRA 2).
  • Tralokinumab Does Not Impact Vaccine-induced Immune Responses: Results From a 30-week, Randomized, Placebo-controlled Trial in Adults With Moderate-to-severe Atopic Dermatitis.

Endourage Begins Human Clinical Trial to Test If Proprietary Hemp-Flower Formulation Eases Symptoms of Post-Acute COVID-19 Syndrome

Retrieved on: 
Tuesday, April 13, 2021
Alternative medicine, Retail, Health, Infectious diseases, Tobacco, Clinical trials, Pharmaceutical, Clinical trials, Clinical research, Design of experiments, Drugs, Health, Medical research, Orphan drugs, Anti-inflammatory agents, Placebo-controlled study, Cannabidiol, Placebo, Open-label trial

It will measure the efficacy and safety of Formula C for people with (PACS).

Key Points: 
  • It will measure the efficacy and safety of Formula C for people with (PACS).
  • The study is a single blind, placebo-controlled trial with an open label arm.
  • Participants will not know if they are receiving the Formula C which includes terpenes and cannabidiol (CBD), or the placebo during the first 28-day arm.
  • Sterling\xe2\x80\x99s mandate is to ensure compliance with federal regulations to protect the rights and welfare of human participants in research studies.\nView source version on businesswire.com: https://www.businesswire.com/news/home/20210413005424/en/\n'

Biohaven Highlights Neuroscience Advancements with 22 Presentations at the 2021 American Academy of Neurology (AAN) Virtual Annual Meeting

Retrieved on: 
Tuesday, April 13, 2021
Clinical research, Design of experiments, Clinical trials, Methodology, Placebo-controlled study, Research, Randomized controlled trial, American Academy of Neurology, Migraine, Knowledge

b'NEW HAVEN, Conn., April 13, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 22 abstracts, including three oral presentations, were accepted at the 2021 American Academy of Neurology (AAN) virtual annual meeting being held from April 17 22.

Key Points: 
  • b'NEW HAVEN, Conn., April 13, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that 22 abstracts, including three oral presentations, were accepted at the 2021 American Academy of Neurology (AAN) virtual annual meeting being held from April 17 22.
  • "\nPhase 2/3 data from the pivotal randomized, placebo-controlled trial assessing rimegepant for the preventive treatment of migraine evaluated 695 patients for efficacy.
  • Patients who had a gap in troriluzole treatment (3 weeks to 12 months) showed a greater than 1 point worsening during the off-treatment period.
  • Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements.

A look back at post hoc analysis

Retrieved on: 
Monday, April 5, 2021
Clinical research, Medical statistics, Design of experiments, Medical research, Health sciences, Health, Multiple comparisons, Clinical trials, Post hoc analysis, Post hoc, Placebo-controlled study

A look back at post hoc analysis People who claim that hindsight is 20/20 probably werent talking about the post hoc evaluation of clinical testing.

Key Points: 

A look back at post hoc analysis

    • People who claim that hindsight is 20/20 probably werent talking about the post hoc evaluation of clinical testing.
    • That was one eye-catching slogan the respondents used to pitch Hepaxa.
    • One notable feature in the marketing was detailed information about clinical testing on the product, including a randomized placebo-controlled clinical trial using Hepaxa.
    • According to the complaint, the respondents subjected the data to post hoc analyses of different subgroups of test subjects.
    • (The complaint describes a post hoc analysis as a statistical analysis conducted after the data have been collected in hopes of discovering statistical relationships that suggest cause and effect.)
    • The FTCs concern is that unplanned, post hoc subgroup analyses pose a high risk of generating spurious findings.
    • That score derives from an algorithm combining subjects waist measurement, body mass index, triglyceride levels and a specific liver enzyme.
    • Once the proposed settlements appearin the Federal Register, the FTC will accept public comments for 30 days.

New England Journal of Medicine Publishes Results of the PULSAR Phase 2 Trial of Sotatercept in Patients with Pulmonary Arterial Hypertension

Retrieved on: 
Thursday, April 1, 2021
Research, Infectious diseases, Clinical trials, Cardiology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Hypertension, Pulmonary hypertension, Placebo-controlled study, Chemical compounds, PAH, Medical research, Chloroarenes, Organic compounds, Riociguat, the PULSAR Trial, Sotatercept, PAH, Acceleron

This is a result that suggests that sotatercept could bring an important new mechanistic approach to the treatment of patients with PAH.

Key Points: 
  • This is a result that suggests that sotatercept could bring an important new mechanistic approach to the treatment of patients with PAH.
  • The PULSAR publication marks the third time that trial results of an Acceleron-discovered therapy have been published in the New England Journal of Medicine in the past 15 months.
  • The PULSAR Phase 2 trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of sotatercept in patients with PAH.
  • In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial.

Corbus Pharmaceuticals Reports Last Subject Visit in DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis

Retrieved on: 
Tuesday, March 30, 2021
Clinical research, Medicine, Health, Clinical medicine, Design of experiments, Orphan drugs, Placebo-controlled study, Placebo, Dermatomyositis, Draft:PPP001, Donnatal

The Phase 3 trial is an international, 176-subject study evaluating the safety and efficacy of lenabasum in adult dermatomyositis patients who are receiving standard treatments, including background immunosuppressive therapies.

Key Points: 
  • The Phase 3 trial is an international, 176-subject study evaluating the safety and efficacy of lenabasum in adult dermatomyositis patients who are receiving standard treatments, including background immunosuppressive therapies.
  • This study is the largest randomized, double-blind, placebo-controlled dermatomyositis study to date.
  • Subjects were randomized 2:1:2 to either receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day.
  • Lenabasum was granted Orphan Drug Designation for the treatment of dermatomyositis from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).