BENITIONSClinical Trial Intelligence

Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

3상 완료 NCT05861427

대상 질환Migraine
임상 단계3상
스폰서AbbVie
상태완료
참여자 수524 명
중재(약물)Atogepant, Placebo for Atogepant
시작일2023년 7월 12일
완료일2025년 3월 1일
결과 공개일2026년 6월 11일

요약

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to plac

Change From Baseline in Mean Monthly Migraine Days

Up to Week 12 · migraine days per month

Placebo-1.24 migraine days per month
Atogepant 10 mg-2.80 migraine days per month
Atogepant 30 mg-3.14 migraine days per month
Atogepant 60 mg-3.34 migraine days per month
p-value<0.0001
LS Mean-1.57 (95% CI -2.24–-0.89)

Number of Participants Experiencing With Adverse Events (AEs)

Up to Week 12 · Participants

Placebo62 Participants
Atogepant 10 mg57 Participants
Atogepant 30 mg51 Participants
Atogepant 60 mg57 Participants

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