Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Pain Management
Enrollment Eligibility
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antibody, including those who have previously completed or withdrawn from this study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.