Comparative Study of Oral Atogepant Versus Oral Topiramate to Assess Adverse Events in Adult Participants With Migraine
3期
已完成
NCT05748483
| 适应症 | Migraine |
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| 分期 | 3期 |
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| 申办方 | AbbVie |
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| 状态 | 已完成 |
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| 受试者人数 | 545 人 |
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| 干预(药物) | Atogepant, Placebo for Atogepant, Topiramate, Placebo for Topiramate |
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| 开始日期 | 2023年10月7日 |
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| 完成日期 | 2025年4月28日 |
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| 结果公布日 | 2026年7月2日 |
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摘要
A migraine is a moderate to severe headache on one side of the head that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The main goal of the study is to evaluate the tolerability (how patients handle the study treatment) and safety of atogepant compared to topiramate in participants with migraine. Atogepant is a medicine currently approved for the preventive treatment of adult patients with episodic migraine (0 to 14 migraine days per month) and is being studied for the preventative treatment of migraine globally. Topiramate is an approved medication for migraine prevention. This study is conducted in 2 periods. In Period 1, participants will be randomly put into 1 of 2 groups at the start of the study to receive atogepant or topiramate. In Period 2, eligible participants will receive atogepant. Approximately 520 participants aged 18 and older will be enrolled in this study in approximately 85 sites across the world. Participants will receive atogepant (and placebo for topiramate) or topiramate (and placebo for atogepant) for 24 weeks in Period 1. Both atogepant and placebo for atogepant are given as a tablet to take by mouth w
Percentage of Participants Who Discontinued Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Week 24 · percentage of participants
| Topiramate | 29.6 percentage of participants |
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| Atogepant | 12.1 percentage of participants |
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| p-value | <0.0001 |
| Relative Risk | 0.41 (95% CI 0.28–0.59) |
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