NCT04616326Active, not recruitingPhase 3
A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Adolescent Patients 12 to 17 Years of Age With Chronic Migraine - the REBUILD-2 Study
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 312 (actual)
- First submitted
- 3 Nov 2020
- Start date
- 25 Nov 2020
- Primary completion date
- 10 Dec 2025
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Migraine
- NCT number
- NCT04616326
- EU CT number
- 2023-505835-11-00
- EudraCT number
- 2018-004622-28
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 312
- From 25 Nov 2020 to the primary completion date, 10 Dec 2025
- 90 sites in 11 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, except for antibodies to CGRP or its receptor, which are not allowed at any time prior to study entry.
- 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. Participant must also not have prior oral CGRP antagonist use within 30 days prior to baseline.
- 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 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 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.
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (90)
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 |
| Centre Hospitalier Universitaire Amiens Picardie Coordinator of this site? Confirm its status | Amiens Cedex 1 | France | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Active, not recruiting |
| Centre Hospitalier Intercommunal Creteil Coordinator of this site? Confirm its status | Creteil Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Trousseau Hospital Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Apollo Hospitals Ahmedabad Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Artemis Hospital Coordinator of this site? Confirm its status | Gurugram | India | Unknown status |
| Atmaram Child Care Coordinator of this site? Confirm its status | Kanpur | India | Unknown status |
| Mangala Hospital & Mangala Kidney Foundation Coordinator of this site? Confirm its status | Mangalore | India | Unknown status |
| Department of Pediatrics Coordinator of this site? Confirm its status | Nagpur | India | Unknown status |
| Central India Cardiology and Research Institute 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 |
| G.B. Pant Institute of Postgraduate Medical Education & Research Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Sir Ganga Ram Hospital 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 |
| Bambino Gesu Childrens Hospital Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Tanaka Neurosurgery & Headache Clinic Coordinator of this site? Confirm its status | Kagoshima | Japan | Unknown status |
| 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 |
| 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 |
| PanAmerican Clinical Research - Guadalajara Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Hospital Civil Fray Antonio Alcalde Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Hospital Infantil de Mexico Federico Gomez Coordinator of this site? Confirm its status | Mexico City | 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 |
| 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 |
| 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 |
| Northwest Clinical Trials Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| Minneapolis Clinic of Neurology - Burnsville Office Coordinator of this site? Confirm its status | Burnsville | United States | Unknown status |
| Coastal Pediatric Research Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Headache Center of Hope Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Precise Research Centers Coordinator of this site? Confirm its status | Flowood | United States | Unknown status |
| Northwest Florida Clinical Research Group Coordinator of this site? Confirm its status | Gulf Breeze | United States | Unknown status |
| St. Alexius Medical Center Coordinator of this site? Confirm its status | Hoffman Estates | 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 |
| Prime Clinical Research - Lewisville Coordinator of this site? Confirm its status | Lewisville | United States | Unknown status |
| University of Kentucky Chandler Medical Center Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
| Medical Research Partners - Logan Coordinator of this site? Confirm its status | Logan | 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 |
| EMDA Clinical Research Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Allied Biomedical Research Institute Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Bio-Medical Research LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Vitaly Clinical Research 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 |
| Wellness Clinical Research Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Access Clinical Trials - Nashville Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Saint Peter's University Hospital Coordinator of this site? Confirm its status | New Brunswick | 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 |
| Avanza Medical Research Center Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| 21st Century Neurology, a Division of Xenoscience, Inc. Coordinator of this site? Confirm its status | Phoenix | 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 |
| Proven Endpoints Coordinator of this site? Confirm its status | Ridgeland | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Infinity Life Research Group Coordinator of this site? Confirm its status | Tamarac | United States | Unknown status |
| D&H Tamarac Research Center Coordinator of this site? Confirm its status | Tamarac | 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 |
| Palm Beach Research Center Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Ascension via Christi Research Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.