jRCT2031250041尚未招募不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 723
- 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
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 45age old under（—）
- 性别
- Female
入选标准
- •Inclusion Criteria:
- •1.Participant has regular menstrual cycles >=24 days and <=34 days
- •2.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
- •3.A history of menstrual migraine attacks of at least 3 months
- •4.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.
- •5.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
- •Exclusion Criteria:
- •1.Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
- •2.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
- •3.History of retinal migraine, basilar migraine or hemiplegic migraine
- •4.Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
- •5.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 (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
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