2024-512946-41-00招募中3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study with an Open-Label Extension to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Preventive Treatment of Menstrual Migraine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 247
- 试验地点
- 61
- 主要终点
- The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.
研究概览
简要总结
The primary objective is to evaluate the efficacy of atogepant taken consecutively for 7 days compared to placebo for the preventive treatment of MM.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult individuals, at least 18 years old, who by history and eDiary confirmation have regular menstrual cycles within the range of 21 to 35 days in length (Note: menstrual cycle length is calculated as onset of menses until the day before the next onset of menses).
- •History of migraine (with or without aura) according to the ICHD-3 for ≥ 12 months prior to Visit 1/Screening.
- •Migraine onset before age 50 years.
- •By history at Visit 1/Screening, subject meets ICHD-3 criteria for pure menstrual migraine with or without aura, or menstrually-related migraine with or without aura, i.e., in at least 2 out of 3 cycles, experiences migraine attacks starting during the PMP (Day –2 to Day +3 relative to menses onset) in the opinion of the investigator.
- •Subject records 3 PMPs in the eDiary during the screening period, and in at least 2 of 3 PMPs the subject experiences and records a migraine attack in the eDiary with at least 1 migraine day.
排除标准
- •History of an average of 15 or more headache days per month during the 3 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-
- •An average of 15 or more headache days per month recorded in the eDiary during the screening period.
- •History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-
- •Current diagnosis of new persistent daily headache, trigeminal autonomic cephalalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-
- •Subject required hospital/emergency room treatment for migraine attacks 3 or more times within 6 months prior to Visit 1/Screening.
- •Presence of other confounding pain syndromes, confounding psychiatric conditions, dementia, epilepsy, or significant neurological disorders other than migraine per investigator judgment.
- •Subject has a condition or situation, which the investigator feels will compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
结局指标
主要结局
The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.
The primary endpoint is the change from baseline (CFB) in number of migraine days occurring during the perimenstrual period (PMP) averaged across 3 menstrual cycles during the double-blind (DB) period.
次要结局
- CFB in number of migraine days (with moderate or severe headache) during the PMP averaged across 3 menstrual cycles during the DB period
- 50% or above reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period
- CFB in number of acute medication use days during the PMP averaged across 3 menstrual cycles during the DB period
- CFB in number of moderate or severe headache days during the PMP averaged across 3 menstrual cycles during the DB period
- 100% reduction from baseline in the number of migraine days averaged across 3 PMPs during the DB period
- No disability/mild impairment for 100% of PMP days (assessed by FDS) across 3 menstrual cycles during the DB period
- CFB in number of headache days during the PMP averaged across 3 menstrual cycles during the DB period
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (61)
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