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
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 468
- 试验地点
- 194
- 主要终点
- Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)
研究概览
简要总结
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often throbbing or pulsating. The headache is often accompanied by sensitivity to light, sensitivity to sound, nausea, or other symptoms. Menstrual migraine (MM) attacks are migraine attacks that occur in individuals before or during their menstrual period. The main goals of the study are to evaluate the efficacy (how well the medicine works), safety, and tolerability (the degree to which any adverse symptoms can be handled by the patients during the study) of atogepant, compared to placebo (looks like the study treatment but has no medicine in it), for the prevention of MM.
Atogepant is an investigational drug being developed for the preventive treatment of menstrual migraine. Participants are randomly assigned to one of the 2 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 2 chance for the participant to receive placebo. 468 adult female participants with menstrual migraine are enrolled in approximately 92 sites across the world.
Participants will receive oral atogepant or matching placebo for 3 menstrual cycles during the double-blind period. During the open-label treatment period, participants will receive atogepant during each menstrual cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 International Classification of Headache Disorders, 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
- •Migraine onset before age 50 years.
- •By history at Visit 1/Screening, participant 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.
- •Participant records 3 perimenstrual periods (PMP) in the eDiary during the screening period, and in at least 2 of 3 PMPs the participant 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 International Classification of Headache Disorders, 3rd Edition (ICHD-3).
- •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-
- •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.
- •Has a condition or situation, which the investigator feels will compromise the safety of the participant or the quality of the data and renders the subject an unsuitable candidate for the study.
研究组 & 干预措施
Atogepant
Participant will receive atogepant during Double-Blind period and Open-Label period.
干预措施: Atogepant (Drug)
Placebo for Atogepant
Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
干预措施: Atogepant (Drug)
Placebo for Atogepant
Participant will receive placebo during Double-Blind period and atogepant during the Open-Label period.
干预措施: Placebo for Atogepant (Drug)
结局指标
主要结局
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP)
时间窗: Up to approximately 120 days
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Change in Number of Migraine Days Occurring During the Perimenstrual Period (PMP) Averaged Across 3 Menstrual Cycles During the Double-Blind Period
时间窗: Up to approximately 120 days
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
次要结局
- Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP(Up to approximately 120 days)
- Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs(Up to approximately 120 days)
- Change in Number of Acute Medication Use Days During PMP(Up to approximately 120 days)
- Change in Number of Moderate or Severe Headache Days During PMP(Up to approximately 120 days)
- Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs(Up to approximately 120 days)
- Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS)(Up to approximately 120 days)
- Change in Number of Headache Days During PMP(Up to approximately 120 days)
- Change in Number of Migraine Days (With Moderate or Severe Headache) During the PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)
- Change in Number of Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)
- Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period(Up to approximately 120 days)
- Change in Number of Acute Medication Use Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)
- Change in Number of Moderate or Severe Headache Days During PMP Averaged Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)
- Percentage of Participants Achieving 100% Reduction From Baseline in Number of Migraine Days Averaged Across 3 PMPs During the Double-Blind Period(Up to approximately 120 days)
- Percentage of Participants With No Disability/Mild Impairment for 100% of PMP Days As Assessed by Functional Disability Scale (FDS) Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)
- Percentage of Participants With No Difficult At All/Little Difficult in Thinking Clearly for 100% of PMP Days As Assessed by Cognitive Function Scale (CFS) Across 3 Menstrual Cycles During the Double-Blind Period(Up to approximately 120 days)