Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
3상
완료
NCT05861427
| 대상 질환 | Migraine |
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| 임상 단계 | 3상 |
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| 스폰서 | AbbVie |
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| 상태 | 완료 |
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| 참여자 수 | 524 명 |
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| 중재(약물) | Atogepant, Placebo for Atogepant |
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| 시작일 | 2023년 7월 12일 |
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| 완료일 | 2025년 3월 1일 |
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| 결과 공개일 | 2026년 6월 11일 |
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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 |
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| Atogepant 10 mg | -2.80 migraine days per month |
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| Atogepant 30 mg | -3.14 migraine days per month |
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| Atogepant 60 mg | -3.34 migraine days per month |
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| 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
| Placebo | 62 Participants |
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| Atogepant 10 mg | 57 Participants |
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| Atogepant 30 mg | 51 Participants |
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| Atogepant 60 mg | 57 Participants |
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BENITIONS에서 보기
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