A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 202
- 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. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.
Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.
Placebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.
There may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- •History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
- •Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
- •To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 [2018]) and per investigator judgment is appropriate to receive preventive treatment for migraine.
排除标准
- •History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- •Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
- •Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
研究组 & 干预措施
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
干预措施: Atogepant (Drug)
Double-Blind Treatment Period: Placebo (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
干预措施: Placebo-Matching Atogepant (Drug)
Double-Blind Treatment Period: Placebo (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
干预措施: Placebo-Matching Atogepant (Drug)
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
干预措施: Atogepant (Drug)
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
干预措施: Atogepant (Drug)
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
干预措施: Atogepant (Drug)
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
干预措施: Atogepant (Drug)
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day 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: Baseline (Week 0) through Week 12
A migraine day is defined as any calendar day on which a migraine occurs as per participant eDiary. Calendar days begin at midnight and last until 11:59 PM.
Number of Participants Experiencing Adverse Events
时间窗: Baseline (Week 0) through Week 16
An 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 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)
- 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 Average of Monthly Migraine Days(Baseline (Week 0) to 3 Months)
- Change from Baseline in Mean Monthly Headache Days of at Least Moderate Severity(Baseline (Week 0) through Week 12)