Fact CheckerSign in

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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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

Full criteria on ClinicalTrials.gov

Sites (90)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Praxis Dr. Astrid Gendolla
Coordinator of this site? Confirm its status
EssenGermanyUnknown status
Sanos A/S
Coordinator of this site? Confirm its status
GandrupDenmarkActive, not recruiting
Herlev Hospital
Coordinator of this site? Confirm its status
HerlevDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
Coordinator of this site? Confirm its status
ValenciaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
Coordinator of this site? Confirm its status
ValladolidSpainActive, not recruiting
Centre Hospitalier Universitaire Amiens Picardie
Coordinator of this site? Confirm its status
Amiens Cedex 1FranceActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceActive, not recruiting
University Hospital Of Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceActive, not recruiting
Centre Hospitalier Intercommunal Creteil
Coordinator of this site? Confirm its status
Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire De Lille
Coordinator of this site? Confirm its status
Lille CedexFranceActive, not recruiting
Assistance Publique Hôpitaux de Marseille
Coordinator of this site? Confirm its status
MarseilleFranceActive, not recruiting
Trousseau Hospital
Coordinator of this site? Confirm its status
ParisFranceActive, not recruiting
Apollo Hospitals Ahmedabad
Coordinator of this site? Confirm its status
AhmedabadIndiaUnknown status
Artemis Hospital
Coordinator of this site? Confirm its status
GurugramIndiaUnknown status
Atmaram Child Care
Coordinator of this site? Confirm its status
KanpurIndiaUnknown status
Mangala Hospital & Mangala Kidney Foundation
Coordinator of this site? Confirm its status
MangaloreIndiaUnknown status
Department of Pediatrics
Coordinator of this site? Confirm its status
NagpurIndiaUnknown status
Central India Cardiology and Research Institute
Coordinator of this site? Confirm its status
NagpurIndiaUnknown status
Getwell Hospital and Research Institute
Coordinator of this site? Confirm its status
NagpurIndiaUnknown status
G.B. Pant Institute of Postgraduate Medical Education & Research
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Sir Ganga Ram Hospital
Coordinator of this site? Confirm its status
New DelhiIndiaUnknown status
Medipoint Hospitals Pvt. Ltd.
Coordinator of this site? Confirm its status
PuneIndiaUnknown status
IRCCS Foundation Istituto Neurologico Carlo Besta
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyActive, not recruiting
Bambino Gesu Childrens Hospital
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Coordinator of this site? Confirm its status
RomeItalyActive, not recruiting
Tanaka Neurosurgery & Headache Clinic
Coordinator of this site? Confirm its status
KagoshimaJapanUnknown status
Konan Hospital
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Umenotsuji Clinic
Coordinator of this site? Confirm its status
KochiJapanUnknown status
Tatsuoka Neurology Clinic
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Yamaguchi Clinic
Coordinator of this site? Confirm its status
NishinomiyaJapanUnknown status
Tominaga Hospital
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Tokyo Medical University Hospital
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Tokyo Headache Clinic
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
Centro de Investigación Médica Aguascalientes (CIMA),
Coordinator of this site? Confirm its status
AguascalientesMexicoUnknown status
Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V.
Coordinator of this site? Confirm its status
Chihuahua CityMexicoUnknown status
PanAmerican Clinical Research - Guadalajara
Coordinator of this site? Confirm its status
GuadalajaraMexicoUnknown status
Hospital Civil Fray Antonio Alcalde
Coordinator of this site? Confirm its status
GuadalajaraMexicoUnknown status
Hospital Infantil de Mexico Federico Gomez
Coordinator of this site? Confirm its status
Mexico CityMexicoUnknown status
Clinica De Enfermedades Cronicas y Procedimientos Especiales
Coordinator of this site? Confirm its status
MoreliaMexicoUnknown status
Isala Klinieken Stichting
Coordinator of this site? Confirm its status
ZwolleNetherlandsActive, not recruiting
Ponce Medical School Foundation Inc.
Coordinator of this site? Confirm its status
PoncePuerto RicoUnknown status
Dent Neurologic Institute
Coordinator of this site? Confirm its status
AmherstUnited StatesUnknown status
Medical Research Partners
Coordinator of this site? Confirm its status
AmmonUnited StatesUnknown status
Children's Hospital Colorado
Coordinator of this site? Confirm its status
AuroraUnited StatesUnknown status
Pharmasite Research, Inc.
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Northwest Clinical Research Center
Coordinator of this site? Confirm its status
BellevueUnited StatesUnknown status
Northwest Clinical Trials
Coordinator of this site? Confirm its status
BoiseUnited StatesUnknown status
Minneapolis Clinic of Neurology - Burnsville Office
Coordinator of this site? Confirm its status
BurnsvilleUnited StatesUnknown status
Coastal Pediatric Research
Coordinator of this site? Confirm its status
CharlestonUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Headache Center of Hope
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Precise Research Centers
Coordinator of this site? Confirm its status
FlowoodUnited StatesUnknown status
Northwest Florida Clinical Research Group
Coordinator of this site? Confirm its status
Gulf BreezeUnited StatesUnknown status
St. Alexius Medical Center
Coordinator of this site? Confirm its status
Hoffman EstatesUnited StatesUnknown status
Rehabilitation & Neurological Services
Coordinator of this site? Confirm its status
HuntsvilleUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Children Mercy Pediatric Clinical Research Unit
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Prime Clinical Research - Lewisville
Coordinator of this site? Confirm its status
LewisvilleUnited StatesUnknown status
University of Kentucky Chandler Medical Center
Coordinator of this site? Confirm its status
LexingtonUnited StatesUnknown status
Medical Research Partners - Logan
Coordinator of this site? Confirm its status
LoganUnited StatesUnknown status
Miller Children's & Women's Hospital Long Beach
Coordinator of this site? Confirm its status
Long BeachUnited StatesUnknown status
EMDA Clinical Research
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Allied Biomedical Research Institute
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Bio-Medical Research LLC
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Vitaly Clinical Research
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Ezy Medical Research
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Wellness Clinical Research
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Access Clinical Trials - Nashville
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Saint Peter's University Hospital
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
Coordinator of this site? Confirm its status
New Hyde ParkUnited StatesUnknown status
Avanza Medical Research Center
Coordinator of this site? Confirm its status
PensacolaUnited StatesUnknown status
Phoenix Children s Hospital
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
21st Century Neurology, a Division of Xenoscience, Inc.
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
Providence Health & Services
Coordinator of this site? Confirm its status
PortlandUnited StatesUnknown status
Velocity Clinical Research at Raleigh Neurology
Coordinator of this site? Confirm its status
RaleighUnited StatesUnknown status
Proven Endpoints
Coordinator of this site? Confirm its status
RidgelandUnited StatesUnknown status
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status
Infinity Life Research Group
Coordinator of this site? Confirm its status
TamaracUnited StatesUnknown status
D&H Tamarac Research Center
Coordinator of this site? Confirm its status
TamaracUnited StatesUnknown status
USF Health
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Center for Neurosciences
Coordinator of this site? Confirm its status
TucsonUnited StatesUnknown status
MedVadis Research Corporation
Coordinator of this site? Confirm its status
WalthamUnited StatesUnknown status
Palm Beach Research Center
Coordinator of this site? Confirm its status
West Palm BeachUnited StatesUnknown status
Ascension via Christi Research
Coordinator of this site? Confirm its status
WichitaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.