A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

Phase 3

Recruiting

• Conditions: Chronic Migraine

• Registration Number: NCT04616326
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-3
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria:<br><br> - Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3<br> according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per<br> month for at least the last 3 months, which has the features of migraine headache on<br> at least 8 days per month.<br><br>Exclusion Criteria:<br><br> - Participants who are taking, or are expected to take, therapeutic antibodies during<br> the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.).<br> Prior use of therapeutic antibodies is allowed if that use was more than 12 months<br> prior to baseline, except for antibodies to CGRP or its receptor, which are not<br> allowed at any time prior to study entry.<br><br> - Known hypersensitivity monoclonal antibodies or other therapeutic proteins, or to<br> galcanezumab or its excipients.<br><br> - Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP<br> receptor antibody, including those who have previously completed or withdrawn from<br> this study or any other study investigating a CGRP antibody. Participant must also<br> not have prior oral CGRP antagonist use within 30 days prior to baseline.<br><br> - History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache<br> or migraine subtypes including hemiplegic (sporadic or familial) migraine and<br> migraine with brainstem aura (previously basilar-type migraine).<br><br> - History of significant head or neck injury within 6 months prior to screening; or<br> traumatic head injury at any time that is associated with significant change in the<br> quality or frequency of their headaches, including new onset of migraine following<br> traumatic head injury.<br><br> - Participants with a known history of intracranial tumors or developmental<br> malformations including Chiari malformations.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline in the Number of Monthly Migraine Headache Days