Status:
RECRUITING
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
Lead Sponsor:
Eli Lilly and Company
Conditions:
Episodic Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
325 Patients enrolled
Trial Details
Trial ID
NCT03432286
Start Date
March 14 2018
End Date
November 1 2026
Last Update
November 5 2025
Active Locations (73)
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1
Rehabilitation & Neurological Services
Huntsville, Alabama, United States, 35805
2
21st Century Neurology, a Division of Xenoscience, Inc.
Phoenix, Arizona, United States, 85004
3
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
4
Center for Neurosciences
Tucson, Arizona, United States, 85718