A Phase 3, Multicenter, Open-Label, 12-Week Study to Evaluate the Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Chinese Participants With Chronic Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
Migraine is characterized by attacks of throbbing, moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The main objective of the study is to evaluate how safe and effective the atogepant is in preventing chronic migraine in adult Chinese participants who completed study 3101-303-002. Adverse events will be monitored.
Atogepant is an investigational drug being developed to prevent chronic migraine. All participants will receive the same treatment. Approximately 120 adult participants who completed study 3101-303-002 will be enrolled at approximately 25 centers in China.
All participants will receive atogepant oral tablet once daily for 12 weeks.
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 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
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Eligible participants completed the double-blind treatment period, and the safety follow-up period, if applicable, depending on the timing of study initiation, of Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.
排除标准
- •Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments, that cannot be discontinued or switched to an allowable alternative. Concomitant medications with demonstrated efficacy for the prevention of migraine is exclusionary, except that participants from lead-in study 3101-303-002 taking 1 medication with demonstrated efficacy for the prevention of migraine may participate in the current study provided that the dose was stable prior to the lead-in study and the participant is willing to continue taking that medication.
- •Participants with an electrocardiogram (ECG) indicating clinically significant abnormalities at Visit
- •Participants with hypertension (sitting systolic blood pressure (BP) > 160 mm Hg or sitting diastolic BP > 100 mm Hg) at Visit
- •Participants with a significant risk of self-harm Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others (investigator opinion); participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
- •Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
研究组 & 干预措施
Atogepant
Participants will receive fixed dose of Atogepant once daily for 12 weeks.
干预措施: Atogepant (Drug)
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: Baseline of the study 3101-303-002 to 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. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity.
Number of Participants With a Change in Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Baseline of the study 3101-303-002 to 16 weeks
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 being wish to be dead and 5 being active suicidal ideation with specific plan and intent. Suicidal behavior is classified on a 5-item scale: 0 being no suicidal behavior and 4 being actual attempt.
Number of Participants With Significant Change in Electrocardiogram (ECG) Parameters
时间窗: Baseline of the study 3101-303-002 to 12 weeks
12-lead ECG will be performed.
Number of Participants With Significant Change in Clinical Laboratory Determinations
时间窗: Baseline of the study 3101-303-002 to 16 weeks
Number of participants with clinically significant change from baseline for any detectable clinical laboratory tests like hematology will be reported.
Number of Participants With Significant Change in Vital Sign Measurements
时间窗: Baseline of the study 3101-303-002 to 16 weeks
Number of participants with clinically significant change from baseline for any vital signs like standing BP, sitting and standing pulse rate will be reported.
次要结局
未报告次要终点