A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 120
- 主要终点
- Number of Participants Experiencing Adverse Events (AEs)
研究概览
简要总结
Migraine is a disease that most often causes 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. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.
Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.
Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.
Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit
- •During the last 28 days of the screening/baseline period, and as per eDiary:
- •Participant must have completed the eDiary for a minimum of 20 out of 28 days.
- •Participant has >= 15 headache days.
- •Participant has >= 8 migraine days.
排除标准
- •Clinically significant hypertension per investigator's judgment.
- •History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
研究组 & 干预措施
Atogepant
Participants will receive atogepant once daily for 12 weeks.
干预措施: Atogepant (Drug)
Placebo for Atogepant
Participants will receive placebo for atogepant once daily for 12 weeks.
干预措施: Placebo for Atogepant (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 16 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.
Change From Baseline in Mean Monthly Migraine Days
时间窗: Baseline (Week 0) through Week 12
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 From Baseline in Mean Monthly Headache Days(Baseline (Week 0) through Week 12)
- Change From Baseline in Mean Monthly Acute Medication Use Days(Baseline (Week 0) through Week 12)
- Percentage of Participants who Achieve at Least a 50% Reduction in 3-month Average of Monthly Migraine Days(Baseline (Week 0) through Week 12)
- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score(Baseline (Week 0) through Week 12)
- Change From Baseline in the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score(Baseline (Week 0) through Week 12)