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New hope for young migraine sufferers: drug shows promise in landmark trial

NCT ID NCT03432286

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether galcanezumab, a monthly injection, can prevent migraines in children and teens aged 6 to 17 with episodic migraine. Over 500 participants received either the drug or a placebo for 3 months. The goal is to see if the drug reduces the number of migraine days each month and is safe for young people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

533 people

The number who actually took part.

Started

Mar 2018

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Episodic migraine

Contacts and locations

Locations

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

    Phoenix, Arizona, 85004, United States

  • All India Institute of Medical Sciences

    New Delhi, 110029, India

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

    Nagpur, 441108, India

  • Avanza Medical Research Center

    Pensacola, Florida, 32503, United States

  • Boston Clinical Trials

    Boston, Massachusetts, 02131, United States

  • Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Central India Cardiology and Research Institute

    Nagpur, 440015, India

  • Centro de Investigacion Medica Aguascalientes (CIMA)

    Aguascalientes, 20116, Mexico

  • Children Mercy Pediatric Clinical Research Unit

    Kansas City, Missouri, 64108, United States

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • Clinica De Enfermedades Cronicas y Procedimientos Especiales

    Morelia, 58249, Mexico

  • Clinical Integrative Research Center of Atlanta, LLC

    Atlanta, Georgia, 30328, United States

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32801, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256, United States

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

    New Hyde Park, New York, 11042, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • Dr. Samuel Sanchez PSC

    Caguas, 727, Puerto Rico

  • Elite Clinical Trials

    Blackfoot, Idaho, 83221, United States

  • Ezy Medical Research

    Miami Lakes, Florida, 33015, United States

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

    New Delhi, 110002, India

  • Getwell Hospital and Research Institute

    Nagpur, 440012, India

  • Herlev and Gentofte Hospital

    Copenhagen, 2730, Denmark

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, 44280, Mexico

  • Hospital Clinico de Valencia

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47005, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Inpatient Pharmacy

    Hoffman Estates, Illinois, 60169, United States

  • Isala, locatie Zwolle

    Zwolle, 8025 AB, Netherlands

  • Konan Hospital

    Kobe, 658-0064, Japan

  • Mangala Hospital & Mangala Kidney Foundation

    Mangalore, 575003, India

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451, United States

  • Medical Research Partners

    Ammon, Idaho, 83406, United States

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007, India

  • Meridian Clinical Research, LLC

    Savannah, Georgia, 31406, United States

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

    Long Beach, California, 90806, United States

  • Minneapolis Clinic of Neurology - Burnsville Office

    Burnsville, Minnesota, 55337, United States

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Northwest Clinical Trials

    Boise, Idaho, 83704, United States

  • Office 18

    Pittsburgh, Pennsylvania, 15236, United States

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

    Chihuahua City, 31203, Mexico

  • Ospedale Pediatrico Bambino Gesù

    Roma, 00165, Italy

  • Pain and Headache Centers of Texas

    Houston, Texas, 77054, United States

  • PanAmerican Clinical Research - Guadalajara

    Guadalajara, 44670, Mexico

  • Pharmasite Research, Inc.

    Baltimore, Maryland, 21208, United States

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016, United States

  • Policlinico Umberto I

    Roma, 161, Italy

  • Ponce Medical School Foundation Inc.

    Ponce, 00716, Puerto Rico

  • Praxis Dr. Astrid Gendolla

    Essen, 45133, Germany

  • Premiere Research Institute at Palm Beach Neurology

    West Palm Beach, Florida, 33407, United States

  • Providence Health & Services

    Portland, Oregon, 97225, United States

  • Rehabilitation & Neurological Services

    Huntsville, Alabama, 35805, United States

  • Sanos Clinic - Nordjylland

    Aalborg, 9362, Denmark

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Sendai Headache and Neurology Clinic

    Sendai, 982-0014, Japan

  • Sir Ganga Ram Hospital

    New Delhi, 110060, India

  • Tatsuoka Neurology Clinic

    Kyoto, 600-8811, Japan

  • Tokyo Headache Clinic

    Tokyo, 151-0051, Japan

  • Tokyo Medical University Hospital

    Shinjuku-ku, 160-0023, Japan

  • Tominaga Hospital

    Osaka, 556-0017, Japan

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607, United States

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • USF Health

    Tampa, Florida, 33612, United States

  • Umenotsuji Clinic

    Kochi, 780-8011, Japan

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536, United States

  • University of Miami Don Suffer Clinical Research Building

    Miami, Florida, 33136, United States

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina, 27607, United States

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818, United States

  • Wr-McCr, Llc

    San Diego, California, 92108, United States

  • Yamaguchi Clinic

    Nishinomiya, 663-8204, Japan

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