A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 496
- 试验地点
- 212
- 主要终点
- Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
研究概览
简要总结
A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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
- •At least a 1-year history of migraine with or without aura.
- •Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.
- •Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.
- •Have regular menstrual cycles of between 21-35 days in length.
- •Less than 15 headache days per month.
- •At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.
排除标准
- •History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.
- •Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.
- •Clinically significant abnormalities in the physical examination as determined by the investigator.
- •Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.
- •Acute headache medication overuse.
研究组 & 干预措施
Double-Blind Period: Placebo for Ubrogepant
Participants will receive placebo during the double-blind period.
干预措施: Placebo for Ubrogepant (Drug)
Open-Label Extension Period: Ubrogepant
Eligible participants from Double-Blind period may continue to receive ubrogepant during the open-label extension period.
干预措施: Ubrogepant (Drug)
Double-Blind Period: Ubrogepant
Participants will receive ubrogepant during the double-blind period.
干预措施: Ubrogepant (Drug)
结局指标
主要结局
Change From Baseline in Number of Migraine Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period
时间窗: Up to approximately 16 Weeks
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed in the protocol as per eDiary.
Number of Participants With Adverse Events (AEs)
时间窗: Up to approximately 68 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
- Change From Baseline in Number of Headache Days Occurring During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period(Up to approximately 16 Weeks)
- Change From Baseline in Number of Moderate or Severe Headache Days During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period(Up to approximately 16 Weeks)
- Change From Baseline in Number of Migraine Days With Moderate or Severe Headache During Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period(Up to approximately 16 Weeks)
- Percentage of Participants With No Disability/ Mild Impairment for most (>= 65%) of PMP Days(Up to approximately 16 Weeks)
- Change From Baseline in Acute Medication Use Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period(Up to approximately 16 Weeks)
- Percentage of Participants Achieving >= 50% Reduction in Number of Migraine Days During the Perimenstrual Periods (PMPs) Across the Double-Blind Treatment Period(Up to approximately 16 Weeks)
- Percentage of Participants Achieving "Not at all limited" or "A little limited" Daily Activity Level for Most (>= 65%) of PMP Days(Up to approximately 16 Weeks)