Lancet Neurology: The safety, tolerance and effectiveness of oral Atogepant to prevent seizure migraines in adults: a double-blind, randomized phase 2b/3 trial

Migraines are a brain disease that, globally, is the second leading cause of disability.
Atogepant is an oral drug given to small molecules of calcitonin gene-associated peptide (CGRP) peptide antagonists that are currently being studied for the treatment of migraines.
this paper aims to study the safety, toerability and efficacy of preventive treatment of migraines in Atogepant oral doses.
method: In this 2b/3 double-blind trial, adults with a history of migraines (≥1 years) and 4-14 days of migraine days per month (age 18-75 years) were randomly assigned 2:1:2:2:1:1 ratio.
they received a placebo or Atogepant once a day for 10 milligrams, 30 milligrams a day, 60 milligrams once a day, 30 milligrams twice a day, or 60 milligrams twice a day.
all subjects, field personnel and all research sponsors of the study kept the allocation of treatment confidential.
study was conducted at 78 academic and private clinics in the United States.
result was a change in the number of migraine days per month compared to the baseline during 12 weeks of treatment using improved intentional treatments.
the overall type I error rate of multiple comparison of active therapeutic dose was controlled at the level of 0.05 by illustration.
results: Between 6 September 2016 and 23 April 2018, 825 of the 1,772 individuals screened received one or more doses of the study drug: 186 received a placebo and 93 received 10 mg of Ato once a day Gepant, 183 people received 30 mg of Atogepant once a day, 186 people received 60 mg of Atogepant once a day, 86 people received 30 mg of Atogepant twice a day, and 91 people received Atogepant twice a day 60 mg.
overall, 714 (87%) of the 825 participants were women, 628 (76%) were white, the mid-duration of migraines was 17.5 years (IQR 10.0-28.0), and 232 (28%) had used preventive treatment.
analysis included 795 patients: 178 patients were treated with a placebo, 92 patients were given 10 mg Atogepant daily, 182 patients were given 30 mg Atogepant daily, 177 patients were given 60 mg Atogepant daily, 79 patients were given 30 mg Atogepant twice a day, and 87 patients were given 60 mg Atogepant twice a day.
over a 12-week period of treatment, all five Atogepant groups showed significant minimum mean (SE) changes in migraine days per month compared to the placebo group: Atogepant10 Mg is -4.0 per day (0.3; p=0.024), 30 mg is -3.8 (0.2; p=0.0) once a day 39), 60 mg once a day for -3.6 (0.2; p=0.039), 30 mg twice daily -4.2 (0.4, p 0.0034), twice daily 60 mg-4.1 (0.3; p=0.0031); placebo-2.9 (0.2).
adverse reactions (TEAEs) caused by treatment in all groups were nausea.
, the safety and efficacy results of the 2b/3 double-blind, placebo-controlled trial supported the initial efficacy and tolerance of taking Atogepant daily to prevent migraines.
safety and effective will continue to be assessed in a separate Phase 3 clinical trial.
Goadsby, Peter J et al. Safety, tolerability, and efficacy of orally agency atogepant for the prevention of episodic migraine in adults: a double-blind, randomized phase 2b/3 trial. The Lancet Neurology, Volume 19, Issue 9, 727 - 737 MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that indicate "Source: Met Medical" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce by any media, website or individual.
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