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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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

Full criteria on ClinicalTrials.gov

Sites (74)

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

SiteCityCountrySite status
Praxis Dr. Astrid Gendolla
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EssenGermanyUnknown status
Sanos A/S
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GandrupDenmarkActive, not recruiting
Herlev Hospital
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HerlevDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Hospital Clínico Universitario de Valladolid
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ValladolidSpainActive, not recruiting
Mangala Hospital & Mangala Kidney Foundation
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MangaloreIndiaUnknown status
Central India Cardiology and Research Institute
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NagpurIndiaUnknown status
All India Institute of Medical Sciences (AIIMS) - Nagpur
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NagpurIndiaUnknown status
Getwell Hospital and Research Institute
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NagpurIndiaUnknown status
Sir Ganga Ram Hospital
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New DelhiIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
G.B. Pant Institute of Postgraduate Medical Education & Research
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New DelhiIndiaUnknown status
Medipoint Hospitals Pvt. Ltd.
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PuneIndiaUnknown status
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyActive, not recruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I
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RomeItalyActive, not recruiting
Bambino Gesu Childrens Hospital
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RomeItalyActive, not recruiting
Konan Hospital
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KobeJapanUnknown status
Umenotsuji Clinic
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KochiJapanUnknown status
Tatsuoka Neurology Clinic
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KyotoJapanUnknown status
Yamaguchi Clinic
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NishinomiyaJapanUnknown status
Tominaga Hospital
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OsakaJapanUnknown status
Sendai Headache and Neurology Clinic
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SendaiJapanUnknown status
Tokyo Medical University Hospital
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Shinjuku-kuJapanUnknown status
Tokyo Headache Clinic
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TokyoJapanUnknown status
Centro de Investigación Médica Aguascalientes (CIMA),
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AguascalientesMexicoUnknown status
Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V.
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Chihuahua CityMexicoUnknown status
Hospital Civil Fray Antonio Alcalde
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GuadalajaraMexicoUnknown status
PanAmerican Clinical Research - Guadalajara
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GuadalajaraMexicoUnknown status
Clinica De Enfermedades Cronicas y Procedimientos Especiales
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MoreliaMexicoUnknown status
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Dr. Samuel Sanchez PSC
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CaguasPuerto RicoUnknown status
Ponce Medical School Foundation Inc.
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PoncePuerto RicoUnknown status
Dent Neurologic Institute
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AmherstUnited StatesUnknown status
Medical Research Partners
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AmmonUnited StatesUnknown status
Clinical Integrative Research Center of Atlanta, LLC
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AtlantaUnited StatesUnknown status
Children's Hospital Colorado
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AuroraUnited StatesUnknown status
Pharmasite Research, Inc.
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BaltimoreUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Elite Clinical Trials
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BlackfootUnited StatesUnknown status
Northwest Clinical Trials
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BoiseUnited StatesUnknown status
Boston Clinical Trials
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BostonUnited StatesUnknown status
Minneapolis Clinic of Neurology - Burnsville Office
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BurnsvilleUnited StatesUnknown status
Cincinnati Children's Hospital Medical Center
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CincinnatiUnited StatesUnknown status
Velocity Clinical Research, Providence
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East GreenwichUnited StatesUnknown status
Tribe Clinical Research LLC
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GreenvilleUnited StatesUnknown status
Inpatient Pharmacy
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Hoffman EstatesUnited StatesUnknown status
Pain and Headache Centers of Texas
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HoustonUnited StatesUnknown status
Rehabilitation & Neurological Services
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HuntsvilleUnited StatesUnknown status
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
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JacksonvilleUnited StatesUnknown status
Children Mercy Pediatric Clinical Research Unit
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Kansas CityUnited StatesUnknown status
University of Kentucky Chandler Medical Center
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LexingtonUnited StatesUnknown status
Miller Children's & Women's Hospital Long Beach
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Long BeachUnited StatesUnknown status
University of Miami Don Suffer Clinical Research Building
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MiamiUnited StatesUnknown status
Ezy Medical Research
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Miami LakesUnited StatesUnknown status
Cohen Children's Northwell Health Physician Partners - Pediatric Neurology
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New Hyde ParkUnited StatesUnknown status
Clinical Neuroscience Solutions
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OrlandoUnited StatesUnknown status
Avanza Medical Research Center
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PensacolaUnited StatesUnknown status
21st Century Neurology, a Division of Xenoscience, Inc.
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PhoenixUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
Office 18
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PittsburghUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
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PittsburghUnited StatesUnknown status
Providence Health & Services
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PortlandUnited StatesUnknown status
Velocity Clinical Research at Raleigh Neurology
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RaleighUnited StatesUnknown status
Wr-McCr, Llc
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San DiegoUnited StatesUnknown status
Meridian Clinical Research, LLC
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SavannahUnited StatesUnknown status
Seattle Children's Hospital
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SeattleUnited StatesUnknown status
USF Health
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TampaUnited StatesUnknown status
Center for Neurosciences
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TucsonUnited StatesUnknown status
MedVadis Research Corporation
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WalthamUnited StatesUnknown status
Premiere Research Institute at Palm Beach Neurology
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West Palm BeachUnited StatesUnknown status

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