A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
NCT ID: NCT04530110
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
506 participants
INTERVENTIONAL
2020-09-16
2025-12-22
Brief Summary
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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.
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Detailed Description
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* 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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fremanezumab
The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Fremanezumab
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly.
Participants weighing \< threshold will receive Dose B subcutaneously monthly.
Subcutaneously monthly, confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Interventions
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Fremanezumab
Participants weighing ≥ threshold will receive Dose A subcutaneously monthly.
Participants weighing \< threshold will receive Dose B subcutaneously monthly.
Subcutaneously monthly, confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
• 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
* 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.
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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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
Teva Investigational Site 14327
Louisville, Kentucky, United States
Teva Investigational Site 14360
Covington, Louisiana, United States
Teva Investigational Site 14365
Baltimore, Maryland, United States
Teva Investigational Site 14246
Waltham, Massachusetts, United States
Teva Investigational Site 14251
Ann Arbor, Michigan, United States
Teva Investigational Site 14270
Minneapolis, Minnesota, United States
Teva Investigational Site 14376
Ridgeland, Mississippi, United States
Teva Investigational Site 14256
Bridgeton, Missouri, United States
Teva Investigational Site 14371
New Brunswick, New Jersey, United States
Teva Investigational Site 14276
Amherst, New York, United States
Teva Investigational Site 14377
Durham, North Carolina, United States
Teva Investigational Site 14248
Raleigh, North Carolina, United States
Teva Investigational Site 14264
Cincinnati, Ohio, United States
Teva Investigational Site 14257
Oklahoma City, Oklahoma, United States
Teva Investigational Site 14363
Tulsa, Oklahoma, United States
Teva Investigational Site 14364
Philadelphia, Pennsylvania, United States
Teva Investigational Site 14374
Bristol, Tennessee, United States
Teva Investigational Site 14252
Austin, Texas, United States
Teva Investigational Site 14273
Austin, Texas, United States
Teva Investigational Site 14367
Dallas, Texas, United States
Teva Investigational Site 14375
Salt Lake City, Utah, United States
Teva Investigational Site 14323
Norfolk, Virginia, United States
Teva Investigational Site 11182
Ottawa, Ontario, Canada
Teva Investigational Site 11179
Ottawa, Ontario, Canada
Teva Investigational Site 11181
Montreal, Quebec, Canada
Teva Investigational Site 40053
Helsinki, , Finland
Teva Investigational Site 40049
Kuopio, , Finland
Teva Investigational Site 40054
Oulu, , Finland
Teva Investigational Site 40052
Tampere, , Finland
Teva Investigational Site 32728
Bad Homburg, , Germany
Teva Investigational Site 32729
Berlin, , Germany
Teva Investigational Site 32726
Leipzig, , Germany
Teva Investigational Site 80170
Be’er Ya‘aqov, , Israel
Teva Investigational Site 80166
Haifa, , Israel
Teva Investigational Site 80168
Holon, , Israel
Teva Investigational Site 80169
Jerusalem, , Israel
Teva Investigational Site 80167
Ramat Gan, , Israel
Teva Investigational Site 80164
Safed, , Israel
Teva Investigational Site 80165
Tel Aviv, , Israel
Teva Investigational Site 30230
Florence, , Italy
Teva Investigational Site 30239
Milan, , Italy
Teva Investigational Site 30228
Milan, , Italy
Teva Investigational Site 30226
Milan, , Italy
Teva Investigational Site 30238
Padua, , Italy
Teva Investigational Site 30227
Pavia, , Italy
Teva Investigational Site 30225
Rome, , Italy
Teva Investigational Site 38138
Doetinchem, , Netherlands
Teva Investigational Site 38135
Nijmegen, , Netherlands
Teva Investigational Site 38136
Rotterdam, , Netherlands
Teva Investigational Site 53441
Gdansk, , Poland
Teva Investigational Site 53437
Kielce, , Poland
Teva Investigational Site 53443
Krakow, , Poland
Teva Investigational Site 53452
Krakow, , Poland
Teva Investigational Site 53440
Lublin, , Poland
Teva Investigational Site 53439
Poznan, , Poland
Teva Investigational Site 53451
Poznan, , Poland
Teva Investigational Site 53442
Szczecin, , Poland
Teva Investigational Site 31271
Barcelona, , Spain
Teva Investigational Site 31270
Valencia, , Spain
Teva Investigational Site 31265
Valladolid, , Spain
Countries
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Other Identifiers
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TV48125-CNS-30084
Identifier Type: -
Identifier Source: org_study_id
2019-002056-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-512837-34-00
Identifier Type: CTIS
Identifier Source: secondary_id
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