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

Phase 3

Recruiting

• Conditions: Episodic Migraine
• Interventions: Drug: Galcanezumab; Drug: Placebo

• Registration Number: NCT03432286
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-03-14
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-22
• Last Update Posted: 2025-08-24
• Primary Completion: 2025-11
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 325

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Galcanezumab	Galcanezumab	Galcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Placebo	Placebo	Placebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Number of Monthly Migraine Headache Days	Baseline, 3 Months	Change from baseline in the number of monthly migraine headache days

Secondary Outcome Measures

Name	Time	Method
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 headache days with photophobia and phonophobia
Percentage of Participants with Reduction from Baseline ≥50%, ≥75% and 100% in Monthly Migraine Headache Days	3 Months	Percentage of participants with reduction from baseline ≥50%, ≥75% and 100% in monthly migraine headache days
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 nausea and/or vomiting
Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms	Baseline, 3 Months	Change from baseline in the number of monthly migraine headaches with prodromal symptoms
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 number of migraine headache days on which acute headache medication is taken
Patient Global Impression-Improvement (PGI-I) Rating	Month 1 to Month 3	PGI-I rating
Change from Baseline in the Severity of Remaining Migraine Headaches per Month	Baseline, 3 Months	Change from baseline in the severity of remaining migraine headaches per month
Change from Baseline in the Number of Monthly Headache Days	Baseline, 3 Months	Change from baseline in the number of monthly headache days
Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score	Baseline, 3 Months	Change from Baseline on the PedsQL total score
Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)	Baseline through 3 Months	Plasma concentration of CGRP
Percentage of Participants Developing Anti-Drug Antibodies	Baseline through 3 Months	Percentage of participants developing anti-drug antibodies
Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase	16 Months	Percentage of participants who initiate migraine prevention medication in the post-treatment follow-up phase
Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score	Baseline, 3 Months	Change from baseline on the PedMIDAS total score
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 with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score
Pharmacokinetics (PK): Serum Concentration of Galcanezumab	Baseline through 3 Months	PK: Serum concentration of galcanezumab

Trial Locations

Locations (73)

Rehabilitation & Neurological Services; 🇺🇸 Huntsville, Alabama, United States

21st Century Neurology, a Division of Xenoscience, Inc.; 🇺🇸 Phoenix, Arizona, United States

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States

Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

Miller Children's & Women's Hospital Long Beach; 🇺🇸 Long Beach, California, United States

Wr-McCr, Llc; 🇺🇸 San Diego, California, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare; 🇺🇸 Jacksonville, Florida, United States

University of Miami Don Suffer Clinical Research Building; 🇺🇸 Miami, Florida, United States

Ezy Medical Research; 🇺🇸 Miami, Florida, United States

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