Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity in Adult Participants With Migraine - Trial NCT06241313
Access comprehensive clinical trial information for NCT06241313 through Pure Global AI's free database. This Phase 3 trial is sponsored by AbbVie and is currently Recruiting. The study focuses on Migraine. Target enrollment is 1300 participants.
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Study Focus
Sponsor & Location
AbbVie
Timeline & Enrollment
Phase 3
Apr 30, 2024
Nov 30, 2025
Primary Outcome
Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Summary
A migraine attack is a moderate or severe headache that usually occurs on one side of the
 head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound,
 nausea, or other symptoms. The main goal of the study is to see if atogepant is effective,
 safe, and well-tolerated in treating migraine attacks quickly.
 
 Atogepant is a medicine currently approved for the preventive treatment of migraine in adults
 and has been shown to be effective and well tolerated when taken daily to prevent migraine
 attacks. This study includes double-blind phase means that neither the participants nor the
 study doctors know who is given which study treatment (atogepant or placebo) followed by an
 open-label phase meaning that both participants and study doctors know which study treatment
 is given. All participants will receive atogepant during the open-label part of the study.
 This study will include 1300 participants aged 18-75 years with a history of migraine at
 approximately 160 sites across the world.
 
 All participants will receive both atogepant and placebo to treat qualifying migraines. At
 the start of the study, participants will be randomized to 1 of 4 dosing sequences to
 determine when they will receive atogepant and when they will receive placebo during the
 study. After treating 4 qualifying migraine attacks, participants will receive open-label
 atogepant for any additional migraine attacks they have until the end of the study (Week 24).
 
 There may be a bigger responsibility for participants in this study than there would be in
 participants receiving standard of care treatment. participants will attend regular visits
 during the study at a hospital or clinic, as well as telephone visits, and the effects of
 treatment will be checked by completion of questionnaires in an electronic diary, medical
 assessments, blood tests, and checking for side effects.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06241313
Non-Device Trial