A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study
概览
- 阶段
- 3 期
- 干预措施
- Galcanezumab
- 疾病 / 适应症
- Chronic Migraine
- 发起方
- Eli Lilly and Company
- 入组人数
- 312
- 试验地点
- 88
- 主要终点
- Change from Baseline in the Number of Monthly Migraine Headache Days
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. 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 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. Enrollment in the European Union may also include participants 6 to 11 years of age.
研究者
入排标准
入选标准
- •Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3 according to ICHD-3 \[2018\]), that is, a headache occurring on 15 or more days per month for at least the last 3 months, which has the features of migraine headache on at least 8 days per month.
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, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
- •Known hypersensitivity 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
- •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
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
Placebo
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
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
- Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia(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)
- Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase(16 Months)
- Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting(Baseline, 3 Months)
- Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days(3 Months)
- Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken(Baseline, 3 Months)
- Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms(Baseline, 3 Months)
- Change from Baseline in the Severity of Remaining Migraine Headaches per Month(Baseline, 3 Months)
- Patient Global Impression-Improvement (PGI-I) Rating(Month 1 to Month 3)
- Change from Baseline in the Number of Monthly Headache Days(Baseline, 3 Months)
- Pharmacokinetics (PK): Serum Concentration of Galcanezumab(Baseline through 3 Months)
- Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)(Baseline through 3 Months)
- Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score(Baseline, 3 Months)
- Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score(Baseline, 3 Months)
- Percentage of Participants Developing Anti-Drug Antibodies(Baseline through 3 Months)