NCT06641466招募中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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 723
- 试验地点
- 221
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has regular menstrual cycles ≥24 days and ≤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
研究组 & 干预措施
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing
Experimental
干预措施: Rimegepant (Drug)
Standard of Care
Active Comparator
干预措施: Standard of Care (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Comparator (Drug)
Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing
Experimental
干预措施: Rimegepant (Drug)
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 (5 menstrual cycles)
Change from Observation Period in the number of migraine days per the 5-day perimenstrual period
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 (5 menstrual cycles))
- Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder)(5 months (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 Phase(5 months (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
- 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 (5 menstrual cycles))
研究者
研究点 (221)
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