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Chronic MigrainePhase 3REBUILD-2NCT04616326

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

A Phase 3 study testing Galcanezumab in people with Chronic Migraine, run by Eli Lilly and Company at 88 sites in 11 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Chronic Migraine
What is being tested?
Galcanezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
312 participants
Where
88 sitesin 11 countries
Study dates
25 Nov 2020to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Known hypersensitivity 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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody. 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.
  • Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.

Trial locations and contacts

88 sites in 11 countries.

88 sites in 11 countries

United States45 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Medical Research Partners

    Ammon, Idaho, 83406

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota, 55337

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Headache Center of Hope

    Cincinnati, Ohio, 45236

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

  • Precise Research Centers

    Flowood, Mississippi, 39232

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida, 32561

  • St. Alexius Medical Center

    Hoffman Estates, Illinois, 60169

  • Rehabilitation & Neurological Services

    Huntsville, Alabama, 35805

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Children Mercy Pediatric Clinical Research Unit

    Kansas City, Missouri, 64108

  • Prime Clinical Research - Lewisville

    Lewisville, Texas, 75067

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

  • Medical Research Partners - Logan

    Logan, Utah, 84341

  • Miller Children's & Women's Hospital Long Beach

    Long Beach, California, 90806

  • Vitaly Clinical Research

    Miami, Florida, 33125

  • EMDA Clinical Research

    Miami, Florida, 33126

  • Bio-Medical Research LLC

    Miami, Florida, 33144

  • Allied Biomedical Research Institute

    Miami, Florida, 33155

  • Ezy Medical Research

    Miami Lakes, Florida, 33015

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016

  • Access Clinical Trials - Nashville

    Nashville, Tennessee, 37203

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

  • Cohen Children's Northwell Health Physician Partners - Pediatric Neurology

    New Hyde Park, New York, 11042

  • Avanza Medical Research Center

    Pensacola, Florida, 32503

  • 21st Century Neurology, a Division of Xenoscience, Inc.

    Phoenix, Arizona, 85004

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

  • Providence Health & Services

    Portland, Oregon, 97225

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina, 27607

  • Proven Endpoints

    Ridgeland, Mississippi, 39157

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • D&H Tamarac Research Center

    Tamarac, Florida, 33321

  • Infinity Life Research Group

    Tamarac, Florida, 33321

  • USF Health

    Tampa, Florida, 33612

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Ascension Via Christi Research

    Wichita, Kansas, 67214

Other trials in United States

India10 sites

  • Apollo Hospitals Ahmedabad

    Ahmedabad, 382428

  • Artemis hospital

    Gurugram, 122003

  • Atmaram Child Care

    Kanpur, 208011

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, 575003

  • Getwell Hospital and Research Institute

    Nagpur, 440012

  • Central India Cardiology and Research Institute

    Nagpur, 440015

  • Department of Pediatrics

    Nagpur, 441108

  • G.B. Pant Institute of Postgraduate Medical Education & Research

    New Delhi, 110002

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

Other trials in India

Japan8 sites

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 892-0844

  • Konan Hospital

    Kobe, 658-0064

  • Umenotsuji Clinic

    Kochi, 780-8011

  • Tatsuoka Neurology Clinic

    Kyoto, 600-8811

  • Yamaguchi Clinic

    Nishinomiya, 663-8204

  • Tominaga Hospital

    Osaka, 556-0017

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Tokyo Headache Clinic

    Tokyo, 151-0051

Other trials in Japan

France6 sites

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, 80054

  • Bordeaux University Hospital - Pellegrin

    Bordeaux, 33076

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

    Lille, 59037

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, 13385

  • Hôpital Armand Trousseau

    Paris, 75571

Other trials in France

Mexico6 sites

  • Centro de Investigacion Medica Aguascalientes (CIMA)

    Aguascalientes, 20116

  • Operadora Unidad de Investigación en Salud de Chihuahua S.A. de C.V.

    Chihuahua City, 31203

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, 44280

  • PanAmerican Clinical Research - Guadalajara

    Guadalajara, 44670

  • Hospital Infantil de Mexico Federico Gomez

    Mexico City, 6720

  • Clinica De Enfermedades Cronicas y Procedimientos Especiales

    Morelia, 58249

Other trials in Mexico

Spain5 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitari Vall d'Hebron

    Barcelona

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Clinico de Valencia

    Valencia, 46010

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005

Other trials in Spain

Italy3 sites

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Policlinico Umberto I

    Roma, 161

  • Neuroscience

    Roma, 165

Other trials in Italy

Denmark2 sites

  • Sanos Clinic - Nordjylland

    Aalborg, 9362

  • Herlev and Gentofte Hospital

    Copenhagen, 2730

Other trials in Denmark

Germany1 site

  • Praxis Dr. Astrid Gendolla

    Essen, 45133

Other trials in Germany

Netherlands1 site

  • Isala, locatie Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

Puerto Rico1 site

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

Other trials in Puerto Rico

About this study

Official title: 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

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.

Read the detailed description

The 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. Enrollment in the European Union may also include participants 6 to 11 years of age.

Being tested
Galcanezumab, Placebo
Keywords
pediatric, children, prevention, prophylaxis, headache, pediatric migraine
Medical subject headings
Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalcanezumabDrug

    Also called LY2951742

    Administered SQ

  • PlaceboDrug

    Administered SQ

Study groups in NCT04616326
Study groupRoleWhat they receive
GalcanezumabExperimentalGalcanezumab administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Receives: Drug: Galcanezumab
PlaceboPlacebo comparatorPlacebo administered by SQ injection. Participants may be eligible for optional open-label extension at the end of the double-blind period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Number of Monthly Migraine Headache Days

    Change from Baseline in the Number of Monthly Migraine Headache Days

    Measured: Baseline, 3 Months

Secondary outcomes (15)

  1. Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

    Percentage of Participants with Reduction from Baseline ≥30%, ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

    Measured: 3 Months

  2. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting

    Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting

    Measured: Baseline, 3 Months

  3. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia

    Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia

    Measured: Baseline, 3 Months

  4. Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms

    Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms

    Measured: Baseline, 3 Months

  5. Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken

    Change from Baseline in the Number of Monthly Migraine Headache Days on Which Acute Headache Medication is Taken

    Measured: Baseline, 3 Months

  6. Patient Global Impression-Improvement (PGI-I) Rating

    PGI-I Rating

    Measured: Month 1 to Month 3

  7. Change from Baseline in the Severity of Remaining Migraine Headaches per Month

    Change from Baseline in the Severity of Remaining Migraine Headaches per Month

    Measured: Baseline, 3 Months

  8. Change from Baseline in the Number of Monthly Headache Days

    Change from Baseline in the Number of Monthly Headache Days

    Measured: Baseline, 3 Months

  9. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score

    Change from Baseline on the PedsQL Total Score

    Measured: Baseline, 3 Months

  10. Change from Baseline on the Pediatric Migraine Disability Assessment test (PedMIDAS) Total Score

    Change from Baseline on the PedMIDAS Total Score

    Measured: Baseline, 3 Months

  11. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the C-SSRS Score

    Measured: Baseline through 3 Months

  12. Pharmacokinetics (PK): Serum Concentration of Galcanezumab

    PK: Serum Concentration of Galcanezumab

    Measured: Baseline through 3 Months

  13. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)

    Plasma Concentration of CGRP

    Measured: Baseline through 3 Months

  14. Percentage of Participants Developing Anti-Drug Antibodies

    Percentage of Participants Developing Anti-Drug Antibodies

    Measured: Baseline through 3 Months

  15. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase

    Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase

    Measured: 16 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2020
  2. Study start25 Nov 2020
  3. Primary completion10 Dec 2025
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
312 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04616326
Sponsor's protocol ID
16353
Other IDs
2018-004622-28, I5Q-MC-CGAT, 2018
Acronym
REBUILD-2
Status last verified
Feb 2026
First submitted
3 Nov 2020
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galcanezumab in people with Chronic Migraine, run by Eli Lilly and Company at 88 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 88 sites in United States, India, Japan, France, Mexico and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Number of Monthly Migraine Headache Days (time frame: Baseline, 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04616326.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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