NCT03432286进行中（未招募）3 期
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 533
- 试验地点
- 141
- 主要终点
- Change from Baseline in the Number of Monthly Migraine Headache Days
研究概览
简要总结
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
详细描述
The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.
- The main study includes a 3-month, randomized, double-blind treatment period in which participants receive either galcanezumab or placebo, followed by a 9-month open-label extension in which all participants receive galcanezumab.
- The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.
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
- Double (Participant, 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
- •Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraine headaches of at least 6 months prior to screening.
排除标准
- •Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies is allowed if that use was more than 12 months prior to baseline.
- •Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
- •Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
- •History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine).
- •History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
- •Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
研究组 & 干预措施
Galcanezumab
Experimental
Galcanezumab administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
干预措施: Galcanezumab (Drug)
Placebo
Placebo Comparator
Placebo administered by SQ injection.
Participants may be eligible for optional open-label extension at the end of the double-blind period.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in the Number of Monthly Migraine Headache Days
时间窗: Baseline, 3 Months
Change from baseline in the number of monthly migraine headache days
次要结局
- Patient Global Impression-Improvement (PGI-I) Rating(Month 1 to Month 3)
- Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days(3 Months)
- Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting(Baseline, 3 Months)
- Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia(Baseline, 3 Months)
- Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms(Baseline, 3 Months)
- Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken(Baseline, 3 Months)
- Change from Baseline in the Severity of Remaining Migraine Headaches per Month(Baseline, 3 Months)
- Change from Baseline in the Number of Monthly Headache Days(Baseline, 3 Months)
- Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score(Baseline, 3 Months)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Baseline through 3 Months)
- Percentage of Participants Developing Anti-Drug Antibodies(Baseline through 3 Months)
- Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase(16 Months)
- Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score(Baseline, 3 Months)
- Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score(Baseline through 3 Months)
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab(Baseline through 3 Months)
研究者
研究点 (141)
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