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New migraine shot shows promise for children in Long-Term study

NCT ID NCT04530110

Disease control Sponsor: Teva Branded Pharmaceutical Products R&D LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested the long-term safety of a monthly injection called fremanezumab to prevent migraines in children aged 6 to 17. Over 500 participants received the shot for up to 84 months. Researchers tracked side effects, changes in migraine days, and overall safety to see if this treatment is a good option for young people.

What this could mean

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

Active substance
fremanezumab (a monthly injection)
What this could lead to
If successful, this could provide a safe, long-term option to prevent migraines in children and teenagers, reducing the frequency of painful attacks.
What could go wrong
This is an open-label study without a placebo group, so results may be less reliable. Side effects like injection site pain or allergic reactions are possible, and long-term benefits are not guaranteed.

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

499 people

The number who actually took part.

Started

Sep 2020

Finished

Dec 2025

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: Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 or TV48125-CNS-30083): * Participants have completed the pivotal efficacy study and, in the opinion of the Investigator or the Sponsor, are able to complete the study in a safe and compliant way. * Participants may continue with a stable dose/regimen of the preventive medication they were taking during the pivotal efficacy studies. * The participant continues to meet appropriate criteria carried forward from the pivotal efficacy study/ * The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule. * The participant weighs at least 17.0 kg on the day of study enrollment. NOTE: Additional criteria apply; please contact the investigator for more information. Inclusion Criteria for Participants Rolling Over from the Phase 1 Pediatric Pharmacokinetic Study (Study TV48125-CNS-10141): * The participant/caregiver has demonstrated compliance with the electronic headache diary during the 28-day baseline period by entry of headache data on a minimum of 21 out of 28 days (approximately 75% diary compliance). * The participant has received all recommended age-appropriate vaccines according to local standard of care and schedule. * The participant weighs at least 17.0 kg on the day of study enrollment. * The participant has a body mass index ranging from the 5th to 120% of the 95th percentile, inclusive, on the day of study enrollment. * Not using preventive medications or using no more than 2 preventive medications for migraine or other medical condition, as long as the dose and regimen have been stable for at least 2 months prior to screening (visit 1). NOTE: Additional criteria apply; please contact the investigator for more information. Inclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment Only: • Participants may be included in this study if they sign and date the informed consent document or upon consent of a parent or guardian, if the participant is younger than the age of consent, accompanied by assent of the participant. Exclusion Criteria: Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 or TV48125-CNS-30083): * In the judgment of the investigator, the participant has a clinically significant abnormal finding on study entry, including hematology, blood chemistry, coagulation tests, or urinalysis values/findings (abnormal tests may be repeated for confirmation). * 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 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 is pregnant or nursing. * In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant. * The participant has a current or past medical history of hemiplegic migraine. NOTE: Additional criteria apply; please contact the investigator for more information. Exclusion Criteria for Participants Rolling Over from the Phase 1 Pharmacokinetic Study (TV48125-CNS-10141): * The participant has any clinically significant cardiovascular (including congenital cardiac anomalies or thromboembolic events), endocrine, gastrointestinal, genitourinary, hematologic, hepatic, immunologic, neurologic, ophthalmic, pulmonary, renal disease, or complications of an infection, at the discretion of the investigator. * The participant has a current history of a clinically significant psychiatric condition, any prior history of a suicide attempt, or a history of suicidal ideation with a specific plan within the past 2 years, at the discretion of the investigator. * 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 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 is pregnant or nursing. * In the judgment of the investigator, the participant has an abnormal finding on the baseline 12-lead ECG considered clinically significant. * The participant has a current or past medical history of hemiplegic migraine. NOTE: Additional criteria apply; please contact the investigator for more information. Exclusion Criteria for Participants Rolling Over from the Pivotal Efficacy Studies (TV48125-CNS-30082 and TV48125-CNS-30083) for Safety and antidrug antibody (ADA) Assessment Only: Not Applicable

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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 11181

    Montreal, Quebec, H3H 2R9, Canada

  • Teva Investigational Site 11182

    Ottawa, Ontario, K1H 8L1, Canada

  • 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 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 14276

    Amherst, New York, 14226, United States

  • Teva Investigational Site 14319

    Aurora, Colorado, 80045, 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 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 14367

    Dallas, Texas, 75235-7701, United States

  • Teva Investigational Site 14368

    Colorado Springs, Colorado, 80907, 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 31270

    Valencia, 46026, Spain

  • Teva Investigational Site 31271

    Barcelona, 08035, Spain

  • 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, 3104802, 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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