Last updated 11 days ago
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
325 patients around the world
Available in Puerto Rico, Mexico, United States
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 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.
- The study addendum is a stand-alone study of galcanezumab pharmacokinetics and
safety in a group of participants separate from those in the main study. The study
addendum includes a 5-month evaluation period after a single injection of
galcanezumab, followed by a 9-month open-label extension.
Eli Lilly and Company
6Research sites
325Patients around the world
This study is for people with
Migraine
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.History of IHS ICHD-3 diagnosis of new daily persistent headache, cluster headache or migraine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.
Sites
Centro de Investigación Médica Aguascalientes - CIMA
Recruiting
Unidad de Investigación en Salud
Recruiting
Hospital Infantil de México Federico Gómez
Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
Panamerican Clinical Research S.A. de C.V
Recruiting
Clínica de Enfermedades Crónicas y de Procedimientos Especiales - CECYPE
Recruiting
StudyREBUILD-1
SponsorEli Lilly and Company
Study typeInterventional
Conditions
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT03432286
