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New hope for teens with chronic migraine?

NCT ID NCT04616326

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether galcanezumab, a monthly injection, can prevent chronic migraine in 312 adolescents aged 12 to 17. Participants receive either the drug or a placebo for 3 months. The main goal is to see if the drug reduces the number of migraine days per month.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
galcanezumab
What this could lead to
If it works, this could give teens with chronic migraine a new preventive option to reduce headache days.
What could go wrong
This is a single phase 3 trial; results may not confirm benefit. Side effects or lack of efficacy are possible.

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

312 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Mar 2027

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

12 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 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. 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, 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.

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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.

Chronic migraine

Contacts and locations

Locations

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

    Phoenix, Arizona, 85004, United States

  • Access Clinical Trials - Nashville

    Nashville, Tennessee, 37203, United States

  • Allied Biomedical Research Institute

    Miami, Florida, 33155, United States

  • Apollo Hospitals Ahmedabad

    Ahmedabad, 382428, India

  • Artemis hospital

    Gurugram, 122003, India

  • Ascension Via Christi Research

    Wichita, Kansas, 67214, United States

  • Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

    Marseille, 13385, France

  • Atmaram Child Care

    Kanpur, 208011, India

  • Avanza Medical Research Center

    Pensacola, Florida, 32503, United States

  • Bio-Medical Research LLC

    Miami, Florida, 33144, United States

  • Bordeaux University Hospital - Pellegrin

    Bordeaux, 33076, France

  • CHU d'Amiens-Picardie - Hôpital Sud

    Amiens, 80054, France

  • Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Central India Cardiology and Research Institute

    Nagpur, 440015, India

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010, France

  • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

    Lille, 59037, France

  • 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 Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256, United States

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414, United States

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

    New Hyde Park, New York, 11042, United States

  • D&H Tamarac Research Center

    Tamarac, Florida, 33321, United States

  • Dent Neurologic Institute

    Amherst, New York, 14226, United States

  • Department of Pediatrics

    Nagpur, 441108, India

  • EMDA Clinical Research

    Miami, Florida, 33126, 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

  • Headache Center of Hope

    Cincinnati, Ohio, 45236, United States

  • 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 Infantil de Mexico Federico Gomez

    Mexico City, 6720, Mexico

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041, Spain

  • Hôpital Armand Trousseau

    Paris, 75571, France

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133, Italy

  • Infinity Life Research Group

    Tamarac, Florida, 33321, 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

  • Medical Research Partners - Logan

    Logan, Utah, 84341, United States

  • Medipoint Hospitals Pvt. Ltd.

    Pune, 411007, India

  • 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

  • Neuroscience

    Roma, 165, Italy

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007, United States

  • Northwest Clinical Trials

    Boise, Idaho, 83704, United States

  • Northwest Florida Clinical Research Group

    Gulf Breeze, Florida, 32561, United States

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

    Chihuahua City, 31203, Mexico

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409, 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

  • Precise Research Centers

    Flowood, Mississippi, 39232, United States

  • Prime Clinical Research - Lewisville

    Lewisville, Texas, 75067, United States

  • Proven Endpoints

    Ridgeland, Mississippi, 39157, United States

  • Providence Health & Services

    Portland, Oregon, 97225, United States

  • Rehabilitation & Neurological Services

    Huntsville, Alabama, 35805, United States

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Sanos Clinic - Nordjylland

    Aalborg, 9362, Denmark

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Sir Ganga Ram Hospital

    New Delhi, 110060, India

  • St. Alexius Medical Center

    Hoffman Estates, Illinois, 60169, United States

  • Tanaka Neurosurgery&Headache Clinic

    Kagoshima, 892-0844, Japan

  • 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

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

  • USF Health

    Tampa, Florida, 33612, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75235, United States

  • Umenotsuji Clinic

    Kochi, 780-8011, Japan

  • University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536, United States

  • Velocity Clinical Research at Raleigh Neurology

    Raleigh, North Carolina, 27607, United States

  • Vitaly Clinical Research

    Miami, Florida, 33125, United States

  • Wellness Clinical Research

    Miami Lakes, Florida, 33016, United States

  • Yamaguchi Clinic

    Nishinomiya, 663-8204, Japan

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Other studies related to the condition(s) this trial covers.