A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
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.
The 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. Enrollment in the European Union may also include
 participants 6 to 11 years of age.
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 antibody, including those who have previously completed or withdrawn from this study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.