Overview

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

Status:
Recruiting
Trial end date:
2024-03-08
Target enrollment:
0
Participant gender:
All
Summary
The main purpose of this study is to evaluate the efficacy and safety of galcanezumab for the preventive treatment of chronic migraine in participants 12 to 17 years of age. 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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Criteria
Inclusion Criteria:

- Have a diagnosis of chronic migraine as defined by the IHS ICHD-3 guidelines (1.3
according to ICHD-3 [2018]), that is, a headache occurring on 15 or more days per
month for at least the last 3 months, which has the features of migraine headache on
at least 8 days per month.

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, other than antibodies to calcitonin gene-related
peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior
to baseline.

- Known hypersensitivity to multiple drugs, 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antibody, including those who have previously completed or withdrawn from this study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 persistent daily headache, cluster headache or migraine subtypes including
hemiplegic (sporadic or familial) migraine and migraine with brainstem aura
(previously basilar-type migraine) as defined by IHS ICHD-3.

- 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.