A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Tolerability of Atogepant in Pediatric Subjects 6 to 17 years of age with Migraine
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 38
- 主要终点
- The endpoints of Study M21-199 are the safety and tolerability of atogepant, including: Adverse event (AE) monitoring for severity and incidence including adverse event of special interests (AESIs)
研究概览
简要总结
To evaluate the long-term safety and tolerability of atogepant treatment for the prevention of migraine in pediatric participants 6 to 17 years of age.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must be between 6 and 17 years of age (inclusive), with a history of episodic or chronic migraine.
- •Participant must have completed the lead-in Study M21-201, or the pharmacokinetic (PK) substudy in Study M21-201 or the lead-in Study M23-
- •Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- •A history of 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.
排除标准
- •History of migraine with brainstem aura, hemiplegic migraine, or retinal 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).
- •Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.
结局指标
主要结局
The endpoints of Study M21-199 are the safety and tolerability of atogepant, including: Adverse event (AE) monitoring for severity and incidence including adverse event of special interests (AESIs)
The endpoints of Study M21-199 are the safety and tolerability of atogepant, including: Adverse event (AE) monitoring for severity and incidence including adverse event of special interests (AESIs)
Clinical laboratory testing (hematology, chemistry, and urinalysis)
Clinical laboratory testing (hematology, chemistry, and urinalysis)
Electrocardiogram (ECG) variables
Electrocardiogram (ECG) variables
Vital sign measurements
Vital sign measurements
Treatment-emergent suicidal ideations with intent, with or without a plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]) or any suicidal behaviors
Treatment-emergent suicidal ideations with intent, with or without a plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]) or any suicidal behaviors
Menstrual cycle assessments (female subject only)
Menstrual cycle assessments (female subject only)
Tanner Stage scale
Tanner Stage scale
Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2)
Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF2)
次要结局
未报告次要终点
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG