CTRI/2025/11/097643尚未招募3 期
An Interventional Efficacy and Safety, Phase 3, Double-Blind, Parallel-Group Study to Investigate Intermittent Prevention of Menstrual Migraine with Rimegepant Compared with Placebo in Women Participants 18 to 45 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer Inc.
- 入组人数
- 470
- 试验地点
- 8
- 主要终点
- Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks. This study supports the continued development of Rimegepant for use as a short-term preventive treatment for migraine attacks associated with specific and predictable triggers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Participant has regular menstrual cycles greater than equal to 24 days and less than equal to 34 days
- •A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
- •A history of menstrual migraine attacks of at least 3 months
- •Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
- •If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study.
排除标准
- •Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
- •A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
- •History of retinal migraine, basilar migraine or hemiplegic migraine
- •Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
- •Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea.
结局指标
主要结局
Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase
时间窗: 5 months
次要结局
- Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase(5 months)
- Percentage of participants with greater than equal to 50 percent reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment PhaseMean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase(5 months)
- Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase(5 months)
研究者
研究点 (8)
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