NCT03432286Active, not recruitingPhase 3
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study
Source: ClinicalTrials.gov · Last updated 26 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 533 (actual)
- First submitted
- 8 Feb 2018
- Start date
- 14 Mar 2018
- Primary completion date
- 14 Nov 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Migraine
- NCT number
- NCT03432286
- EU CT number
- 2023-505836-36-00
- EudraCT number
- 2017-004351-23
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 533
- From 14 Mar 2018 to the primary completion date, 14 Nov 2025
- 74 sites in 10 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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.
Other illness
- Known hypersensitivity to monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
- Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
Who the study is looking for
- 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.
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (74)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Praxis Dr. Astrid Gendolla Coordinator of this site? Confirm its status | Essen | Germany | Unknown status |
| Sanos A/S Coordinator of this site? Confirm its status | Gandrup | Denmark | Active, not recruiting |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Active, not recruiting |
| Mangala Hospital & Mangala Kidney Foundation Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Central India Cardiology and Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| All India Institute of Medical Sciences (AIIMS) - Nagpur Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Getwell Hospital and Research Institute Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Sir Ganga Ram Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| G.B. Pant Institute of Postgraduate Medical Education & Research Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Medipoint Hospitals Pvt. Ltd. Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Konan Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Umenotsuji Clinic Coordinator of this site? Confirm its status | Kochi | Japan | Unknown status |
| Tatsuoka Neurology Clinic Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Yamaguchi Clinic Coordinator of this site? Confirm its status | Nishinomiya | Japan | Unknown status |
| Tominaga Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Sendai Headache and Neurology Clinic Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Tokyo Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Unknown status |
| Tokyo Headache Clinic Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Centro de Investigación Médica Aguascalientes (CIMA), Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Unknown status |
| Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Hospital Civil Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| PanAmerican Clinical Research - Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Clinica De Enfermedades Cronicas y Procedimientos Especiales Coordinator of this site? Confirm its status | Morelia | Mexico | Unknown status |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Active, not recruiting |
| Dr. Samuel Sanchez PSC Coordinator of this site? Confirm its status | Caguas | Puerto Rico | Unknown status |
| Ponce Medical School Foundation Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| Dent Neurologic Institute Coordinator of this site? Confirm its status | Amherst | United States | Unknown status |
| Medical Research Partners Coordinator of this site? Confirm its status | Ammon | United States | Unknown status |
| Clinical Integrative Research Center of Atlanta, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Pharmasite Research, Inc. Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Elite Clinical Trials Coordinator of this site? Confirm its status | Blackfoot | United States | Unknown status |
| Northwest Clinical Trials Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Minneapolis Clinic of Neurology - Burnsville Office Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Velocity Clinical Research, Providence Coordinator of this site? Confirm its status | East Greenwich | United States | Unknown status |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Inpatient Pharmacy Coordinator of this site? Confirm its status | Hoffman Estates | United States | Unknown status |
| Pain and Headache Centers of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Rehabilitation & Neurological Services Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. dba CNS Healthcare Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Children Mercy Pediatric Clinical Research Unit Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| University of Kentucky Chandler Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Miller Children's & Women's Hospital Long Beach Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| University of Miami Don Suffer Clinical Research Building Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Ezy Medical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Cohen Children's Northwell Health Physician Partners - Pediatric Neurology Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Avanza Medical Research Center Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| 21st Century Neurology, a Division of Xenoscience, Inc. Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Office 18 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Providence Health & Services Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Velocity Clinical Research at Raleigh Neurology Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Wr-McCr, Llc Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Meridian Clinical Research, LLC Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| USF Health Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Center for Neurosciences Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| MedVadis Research Corporation Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
| Premiere Research Institute at Palm Beach Neurology Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.