A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study

Conditions
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Episodic Migraine

Intervention / Treatment
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* Drug: Galcanezumab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Galcanezumab<br>Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period. | Drug: Galcanezumab<br>* Administered SQ<br>* Other names: LY2951742;|
| Placebo Comparator: Placebo<br>Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period. | Drug: Placebo<br>* Administered SQ<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Number of Monthly Migraine Headache Days | Change from baseline in the number of monthly migraine headache days | Baseline, 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days | 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 | 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 | 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 | 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 | Change from baseline in the number of migraine headache days on which acute headache medication is taken | Baseline, 3 Months | 
| Patient Global Impression-Improvement (PGI-I) Rating | PGI-I rating | Month 1 to Month 3 | 
| Change from Baseline in the Severity of Remaining Migraine Headaches per Month | 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 | 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 | Change from Baseline on the PedsQL total score | Baseline, 3 Months | 
| Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score | Change from baseline on the 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 | Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score | Baseline through 3 Months | 
| Pharmacokinetics (PK): Serum Concentration of Galcanezumab | PK: Serum concentration of galcanezumab | Baseline through 3 Months | 
| Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP) | Plasma concentration of CGRP | Baseline through 3 Months | 
| Percentage of Participants Developing Anti-Drug Antibodies | 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 | Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase | 16 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, children, prevention, prophylaxis, headache, pediatric migraine