CTRI/2026/01/101202尚未招募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
Eli Lilly and Company India Pvt Ltd4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月9日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 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 evaluate 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 6.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
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 the last 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, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
- •Known hypersensitivity to multiple drugs, 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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 persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-
- •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.
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
次要结局
- 1. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting(2. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia)
- Patient Global Impression-Improvement (PGI-I) Rating(Month 1 to Month 3)
- 1. Change from Baseline in the Severity of Remaining Migraine Headaches per Month(2. Change from Baseline in the Number of Monthly Headache Days)
- Percentage of Participants with Reduction from Baseline greater than or equal to 50%, greater than or equal to 75% and 100% in Monthly Migraine Headache Days(3 months)
- 1. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score(2. Pharmacokinetics (PK): Serum Concentration of Galcanezumab)
- Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase(16 months)
研究者
Dr Manish Mistry
Eli Lilly and Company(India) pvt.Ltd
研究点 (4)
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