An Open Label Phase 3 Trial to Evaluate the Safety of ALD403 Administered Intravenously in Patients With Chronic Migraines
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 23
- 主要终点
- Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)
研究概览
简要总结
An evaluation of long term safety of repeat ALD403 doses in Chronic Migraine
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
排除标准
- •Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
- •Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
- •Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
- •History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
结局指标
主要结局
Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior on Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: 104 Weeks
Baseline responses are collected at screening and assess suicidal ideation in the past 6 months. Post baseline reports the worst assessment of suicidal ideation since the last visit for all post baseline visits.
Number of Participants With Any Clinically Significant (CS) Changes in Vital Signs
时间窗: 104 Weeks
Changes in vital signs that were considered clinically meaningful or clinically significant (CS) by the Investigator
Number of Participants With Any Treatment Emergent Adverse Events (TEAEs)
时间窗: 104 Weeks
Treatment emergent adverse events were defined as adverse events with start date and time on or after the date and time of the initial study drug infusion.
Number of Participants With a Clinically Significant Electrocardiogram
时间窗: Baseline, Day 0 Postdose, Week 12, 24, 36, 48 60, 72 and 84 (Predose and Postdose), and Week 104
Overall investigator interpretation of participant electrocardiogram
Number of Participants With Any Clinically Significant Laboratory Values
时间窗: 104 Weeks
Each of the laboratory values that were reported as abnormal and clinically significant and entered as adverse events in the database.
次要结局
- Patient Global Impression of Change (PGIC) at Week 104(Week 104)
- Summary of Neutralizing Properties of Anti-ALD403 Antibodies by Visit(Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104)
- Change in Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores(Baseline to Week 12)
- Health Related Quality of Life (EQ-5D-5L) at Week 12(Week 12)
- Development of Anti-ALD403 Antibody by Visit(Baseline, Week 2, 4, 8, 12, 24, 36, 48, 72 and 104)
- Change in Most Bothersome Symptom at Week 48(Baseline to Week 48)
- Change in Baseline of Headache Impact Test (HIT-6) Score(Baseline, Week 1-4, Week 9-12)
- Change From Baseline of Migraine Disability Assessment (MIDAS) Total Score(Baseline to Week 12)