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

Phase 3Active Not RecruitingNCT03432286

Eli Lilly and Company533 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

533

Conditions

Episodic Migraine

Interventions

GalcanezumabDRUG

Administered SQ

PlaceboDRUG

Administered SQ

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.

Locations (73)

Outcomes

Primary Outcomes

Change from Baseline in the Number of Monthly Migraine Headache Days

Change from baseline in the number of monthly migraine headache days

Time frame: Baseline, 3 Months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, 3 Months

Patient Global Impression-Improvement (PGI-I) Rating

Data from ClinicalTrials.gov

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