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Could a monthly shot prevent migraines in kids?

NCT ID NCT04458857

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 fremanezumab, a monthly injection, can prevent episodic migraine in children aged 6 to 17. Participants receive either the drug or a placebo for 12 weeks, and researchers track changes in monthly migraine days. The goal is to see if fremanezumab is safe and effective for pediatric migraine prevention.

What this could mean

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

Active substance
fremanezumab
What this could lead to
If it works, this could offer a new preventive treatment option for children with episodic migraine, reducing the number of migraine days.
What could go wrong
This is a Phase 3 trial, but results may not apply to all children. Side effects are possible, and the drug may not prove more effective than placebo.

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

235 people

The number who actually took part.

Started

Jul 2020

Finished

Mar 2024

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: * The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14 headache days per month in each of the 3 months prior to screening (visit 1). * The participant or parent/caregiver maintain a prospectively collected headache diary * The participant does not have chronic daily headache. For the purposes of this study, chronic daily headache is operationally defined as \<4 headache-free days during the 28-day baseline period. NOTE: Additional criteria apply; please contact the investigator for more information. Exclusion Criteria: * The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit. * The participant or parent/caregiver maintain a prospectively collected headache diary * The participant has used an intervention/device (eg, scheduled nerve block or transcranial magnetic stimulation) for the treatment of migraine or in the head or neck area for any condition during the 2 months prior to the day of the screening visit. * The participant has a current history of a clinically significant psychiatric condition, at the discretion of the investigator. Any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, must be excluded. * The participant has an ongoing infection or a known history of human immunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis B or C, or a known active infection of coronavirus disease 2019 (COVID-19). * The participant has a past or current history of cancer. * The participant is pregnant or nursing. * The participant has a history of hypersensitivity reactions to injected proteins, including mAbs, or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or the participant is concomitantly using lamotrigine. * The participant received a live attenuated vaccine (eg, intranasal flu vaccine, and measles, mumps, and rubella vaccine) within the 12-week period prior to screening. Note: If a medical need arises during the study, the participant may receive a live attenuated vaccine. * The participant has a current or past medical history of hemiplegic migraine. NOTE: Additional criteria apply; please contact the investigator for more information.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

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

Migraine

Contacts and locations

Locations

  • Teva Investigational Site 11179

    Ottawa, Ontario, K2G 1W2, Canada

  • Teva Investigational Site 11180

    Ajax, Ontario, L1Z 0M1, Canada

  • Teva Investigational Site 11181

    Montreal, Quebec, H4A 3J1, Canada

  • Teva Investigational Site 11182

    Ottawa, Ontario, K1H 8L1, Canada

  • Teva Investigational Site 14241

    San Antonio, Texas, 78240, United States

  • Teva Investigational Site 14243

    Atlanta, Georgia, 30328, United States

  • Teva Investigational Site 14244

    Jacksonville, Florida, 32256, United States

  • Teva Investigational Site 14245

    Wichita, Kansas, 67206, United States

  • Teva Investigational Site 14246

    Waltham, Massachusetts, 02451, United States

  • Teva Investigational Site 14248

    Raleigh, North Carolina, 27607, United States

  • Teva Investigational Site 14250

    West Palm Beach, Florida, 33407, United States

  • Teva Investigational Site 14251

    Ann Arbor, Michigan, 48104, United States

  • Teva Investigational Site 14252

    Austin, Texas, 78731, United States

  • Teva Investigational Site 14253

    Banning, California, 92220, United States

  • Teva Investigational Site 14255

    West Palm Beach, Florida, 33409, United States

  • Teva Investigational Site 14256

    Bridgeton, Missouri, 63044-2513, United States

  • Teva Investigational Site 14257

    Oklahoma City, Oklahoma, 73112, United States

  • Teva Investigational Site 14258

    Savannah, Georgia, 31406, United States

  • Teva Investigational Site 14263

    Hoffman Estates, Illinois, 60169, United States

  • Teva Investigational Site 14264

    Cincinnati, Ohio, 45229-3039, United States

  • Teva Investigational Site 14270

    Minneapolis, Minnesota, 55402, United States

  • Teva Investigational Site 14273

    Austin, Texas, 78759, United States

  • Teva Investigational Site 14274

    Bellaire, Texas, 77401, United States

  • Teva Investigational Site 14275

    Oklahoma City, Oklahoma, 73116, United States

  • Teva Investigational Site 14276

    Amherst, New York, 14226, United States

  • Teva Investigational Site 14277

    Tacoma, Washington, 98405, United States

  • Teva Investigational Site 14281

    Little Rock, Arkansas, 72202, United States

  • Teva Investigational Site 14283

    Park Ridge, Illinois, 60068, United States

  • Teva Investigational Site 14312

    Houston, Texas, 77087, United States

  • Teva Investigational Site 14317

    Silver Spring, Maryland, 26505, United States

  • Teva Investigational Site 14319

    Aurora, Colorado, 80045, United States

  • Teva Investigational Site 14322

    Los Angeles, California, 90027, United States

  • Teva Investigational Site 14323

    Norfolk, Virginia, 23510, United States

  • Teva Investigational Site 14325

    Miami, Florida, 33155, United States

  • Teva Investigational Site 14327

    Louisville, Kentucky, 40202, United States

  • Teva Investigational Site 14360

    Covington, Louisiana, 70433, United States

  • Teva Investigational Site 14361

    Sacramento, California, 95815, United States

  • Teva Investigational Site 14363

    Tulsa, Oklahoma, 74136, United States

  • Teva Investigational Site 14364

    Philadelphia, Pennsylvania, 19104-4318, United States

  • Teva Investigational Site 14365

    Baltimore, Maryland, 21201, United States

  • Teva Investigational Site 14366

    San Antonio, Texas, 78207, United States

  • Teva Investigational Site 14367

    Dallas, Texas, 75235-7701, United States

  • Teva Investigational Site 14368

    Colorado Springs, Colorado, 80907, United States

  • Teva Investigational Site 14370

    Loma Linda, California, 92354, United States

  • Teva Investigational Site 14371

    New Brunswick, New Jersey, 08901, United States

  • Teva Investigational Site 14374

    Bristol, Tennessee, 37620, United States

  • Teva Investigational Site 14375

    Salt Lake City, Utah, 84109, United States

  • Teva Investigational Site 14376

    Ridgeland, Mississippi, 39157, United States

  • Teva Investigational Site 14377

    Durham, North Carolina, 27710, United States

  • Teva Investigational Site 30225

    Rome, 00163, Italy

  • Teva Investigational Site 30226

    Milan, 20148, Italy

  • Teva Investigational Site 30227

    Pavia, 27100, Italy

  • Teva Investigational Site 30228

    Milan, 20133, Italy

  • Teva Investigational Site 30230

    Florence, 50139, Italy

  • Teva Investigational Site 30238

    Padua, 35128, Italy

  • Teva Investigational Site 30239

    Milan, 20132, Italy

  • Teva Investigational Site 31265

    Valladolid, 47010, Spain

  • Teva Investigational Site 31266

    Elda, 03600, Spain

  • Teva Investigational Site 31267

    Madrid, 28046, Spain

  • Teva Investigational Site 31268

    Madrid, 28007, Spain

  • Teva Investigational Site 31270

    Valencia, 46026, Spain

  • Teva Investigational Site 31271

    Barcelona, 08035, Spain

  • Teva Investigational Site 32724

    Essen, 45133, Germany

  • Teva Investigational Site 32725

    Dresden, 01307, Germany

  • Teva Investigational Site 32726

    Leipzig, 04177, Germany

  • Teva Investigational Site 32728

    Bad Homburg, 61350, Germany

  • Teva Investigational Site 32729

    Berlin, 13353, Germany

  • Teva Investigational Site 38135

    Nijmegen, 6532 SZ, Netherlands

  • Teva Investigational Site 38136

    Rotterdam, 3015 GD, Netherlands

  • Teva Investigational Site 38138

    Doetinchem, 7009 BL, Netherlands

  • Teva Investigational Site 40049

    Kuopio, 70210, Finland

  • Teva Investigational Site 40052

    Tampere, 33521, Finland

  • Teva Investigational Site 40053

    Helsinki, 00380, Finland

  • Teva Investigational Site 40054

    Oulu, 90100, Finland

  • Teva Investigational Site 53437

    Kielce, 25-316, Poland

  • Teva Investigational Site 53439

    Poznan, 60-355, Poland

  • Teva Investigational Site 53440

    Lublin, 20-582, Poland

  • Teva Investigational Site 53441

    Gdansk, 80-389, Poland

  • Teva Investigational Site 53442

    Szczecin, 70-111, Poland

  • Teva Investigational Site 53443

    Krakow, 30-363, Poland

  • Teva Investigational Site 53451

    Poznan, 61-731, Poland

  • Teva Investigational Site 53452

    Krakow, 30-539, Poland

  • Teva Investigational Site 80164

    Safed, 1311001, Israel

  • Teva Investigational Site 80165

    Tel Aviv, 6423906, Israel

  • Teva Investigational Site 80166

    Haifa, 3339419, Israel

  • Teva Investigational Site 80167

    Ramat Gan, 5265601, Israel

  • Teva Investigational Site 80168

    Holon, 58100, Israel

  • Teva Investigational Site 80169

    Jerusalem, 9124001, Israel

  • Teva Investigational Site 80170

    Be’er Ya‘aqov, 7033001, Israel

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