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A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

NCT04530110•Teva Branded Pharmaceutical Products R&D LLC

View on ClinicalTrials.gov

Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab. The total duration of the study is planned to be up to 84 months.

Detailed Description

The study population will be composed of 3 subgroups of participants as follows: * Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) * Participants rolling over from the Phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141) * Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) for safety follow-up and antidrug antibody (ADA) evaluation only

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•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.
+3 more criteria

Exclusion Criteria

•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.
•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.
+8 more criteria

Locations (70)

Teva Investigational Site 14319

Aurora, Colorado, United States

Teva Investigational Site 14368

Colorado Springs, Colorado, United States

Teva Investigational Site 14244

Jacksonville, Florida, United States

Teva Investigational Site 14325

Miami, Florida, United States

Teva Investigational Site 14250

West Palm Beach, Florida, United States

Teva Investigational Site 14255

West Palm Beach, Florida, United States

Teva Investigational Site 14243

Atlanta, Georgia, United States

Teva Investigational Site 14258

Savannah, Georgia, United States

Teva Investigational Site 14263

Hoffman Estates, Illinois, United States

Teva Investigational Site 14245

Wichita, Kansas, United States

Key Dates

Start Date

September 16, 2020

Primary Completion Date

August 15, 2025

Completion Date

December 22, 2025

Last Updated

February 13, 2026

Enrollment

506

ACTUAL participants

Conditions

Migraine

Interventions

Fremanezumab

DRUG

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

NCT07018713

Chronic Migraine

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RECRUITINGPHASE3

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

NCT06641466

Menstrual Migraine

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RECRUITINGNA

Mind Body Balance for Pediatric Migraine

NCT04715685

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

Inclusion Criteria

Exclusion Criteria

A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine

A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

Mind Body Balance for Pediatric Migraine

Light Exposure, Migraine Outcomes, and Sleep Quality

A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

Prophylactic Treatment With Atorvastatin for Episodic Migraine.