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Episodic MigrainePhase 3REBUILD-1NCT03432286

A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine

A Phase 3 study testing Galcanezumab in people with Episodic Migraine, run by Eli Lilly and Company at 73 sites in 10 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 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… Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Episodic 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
533 participants
Where
73 sitesin 10 countries
Study dates
14 Mar 2018to Nov 2026
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 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

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to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.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

73 sites in 10 countries.

73 sites in 10 countries

United States38 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Medical Research Partners

    Ammon, Idaho, 83406

  • Clinical Integrative Research Center of Atlanta, LLC

    Atlanta, Georgia, 30328

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221

  • Northwest Clinical Trials

    Boise, Idaho, 83704

  • Boston Clinical Trials

    Boston, Massachusetts, 02131

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota, 55337

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Inpatient Pharmacy

    Hoffman Estates, Illinois, 60169

  • Pain and Headache Centers of Texas

    Houston, Texas, 77054

  • 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

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536

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

    Long Beach, California, 90806

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida, 33136

  • Ezy Medical Research

    Miami Lakes, Florida, 33015

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

    New Hyde Park, New York, 11042

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801

  • 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

  • Office 18

    Pittsburgh, Pennsylvania, 15236

  • Providence Health & Services

    Portland, Oregon, 97225

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina, 27607

  • Wr-McCr, Llc

    San Diego, California, 92108

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • USF Health

    Tampa, Florida, 33612

  • Center for Neurosciences

    Tucson, Arizona, 85718

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407

Other trials in United States

India8 sites

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, 575003

  • Getwell Hospital and Research Institute

    Nagpur, 440012

  • Central India Cardiology and Research Institute

    Nagpur, 440015

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, 441108

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

    New Delhi, 110002

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007

Other trials in India

Japan8 sites

  • 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

  • Sendai Headache and Neurology Clinic

    Sendai, 982-0014

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023

  • Tokyo Headache Clinic

    Tokyo, 151-0051

Other trials in Japan

Mexico5 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

  • Clinica De Enfermedades Cronicas y Procedimientos Especiales

    Morelia, 58249

Other trials in Mexico

Spain5 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • 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

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165

  • Policlinico Umberto I

    Roma, 161

Other trials in Italy

Denmark2 sites

  • Sanos Clinic - Nordjylland

    Aalborg, 9362

  • Herlev and Gentofte Hospital

    Copenhagen, 2730

Other trials in Denmark

Puerto Rico2 sites

  • Dr. Samuel Sanchez PSC

    Caguas, 727

  • Ponce Medical School Foundation Inc.

    Ponce, 00716

Other trials in Puerto Rico

Germany1 site

  • Praxis Dr. Astrid Gendolla

    Essen, 45133

Other trials in Germany

Netherlands1 site

  • Isala, locatie Zwolle

    Zwolle, 8025 AB

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine - the REBUILD-1 Study

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.

Read the detailed description

The study has two parts which enroll separately from each other such that participants may choose to participate in either but not both: the main study and a study addendum.

  • The main 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.
  • The study addendum is a stand-alone study of galcanezumab pharmacokinetics and safety in a group of participants separate from those in the main study. The study addendum includes a 5-month evaluation period after a single injection of galcanezumab, followed by a 9-month open-label extension.
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 NCT03432286
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 ≥50%, ≥75% and 100% in Monthly Migraine Headache Days

    Percentage of participants with reduction from baseline ≥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 Migraine Headache Days on which Acute Headache Medication is Taken

    Change from baseline in the number of 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 posted14 Feb 2018
  2. Study start14 Mar 2018
  3. Primary completion14 Nov 2025
  4. Study completionNov 2026 (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
533 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03432286
Sponsor's protocol ID
16352
Other IDs
I5Q-MC-CGAS, 2017-004351-23, 2017
Acronym
REBUILD-1
Status last verified
Jan 2026
First submitted
8 Feb 2018
Last updated
26 Jan 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 Episodic Migraine, run by Eli Lilly and Company at 73 sites in 10 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, India, Japan, Mexico, Spain and 5 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 NCT03432286.

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 26 Jan 2026.

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