A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 524
- 试验地点
- 96
- 主要终点
- Change From Baseline in Mean Monthly Migraine Days
研究概览
简要总结
A migraine is a moderate to severe headache 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. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.
Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan.
Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least a 1-year history of migraine (with or without aura).
- •Less than 50 years of age at the time of migraine onset.
- •History of 4 to 14 migraine days per month in the 3 months prior to screening.
- •4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary.
排除标准
- •Difficulty with distinguishing migraine headaches from tension-type or other headaches.
- •Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
研究组 & 干预措施
Atogepant Dose B
Participants will receive atogepant dose B QD for 24 weeks.
干预措施: Atogepant (Drug)
Atogepant Dose A
Participants will receive atogepant dose A once daily (QD) for 24 weeks.
干预措施: Atogepant (Drug)
Placebo
Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.
干预措施: Placebo for Atogepant (Drug)
Atogepant Dose C
Participants will receive atogepant dose C QD for 24 weeks.
干预措施: Atogepant (Drug)
Placebo
Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.
干预措施: Atogepant (Drug)
结局指标
主要结局
Change From Baseline in Mean Monthly Migraine Days
时间窗: Up to 12 Weeks
A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.
Number of Participants Experiencing With Adverse Events (AEs)
时间窗: Up to approximately 28 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 Mean Monthly Acute Medication Use Days(Up to Week 12)
- Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D)(Up to Week 12)
- Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D(Up to Week 12)
- Change From Baseline in Mean Monthly Headache Days(Up to Week 12)
- Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days(Up to Week 12)
- Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score(Up to Week 12)