A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age
NCT ID: NCT04464707
Last Updated: 2025-12-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
292 participants
INTERVENTIONAL
2020-09-24
2024-11-29
Brief Summary
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Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab
The total duration of the study is planned to be 75 months.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Fremanezumab Dose A
Participants weighing \< threshold will receive Dose A subcutaneously monthly for 3 months.
Fremanezumab
Dose A or Dose B subcutaneous
Fremanezumab Dose B
Participants weighing ≥ threshold will receive Dose B subcutaneously monthly for 3 months.
Fremanezumab
Dose A or Dose B subcutaneous
Placebo
Matching placebo
Placebo
Matching placebo
Interventions
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Fremanezumab
Dose A or Dose B subcutaneous
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* The participant or parent/caregiver maintain a prospectively collected headache diary
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion Criteria
* 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.
6 Years
17 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
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 14281
Little Rock, Arkansas, United States
Teva Investigational Site 14253
Banning, California, United States
Teva Investigational Site 14370
Loma Linda, California, United States
Teva Investigational Site 14322
Los Angeles, California, United States
Teva Investigational Site 14361
Sacramento, California, United States
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 14283
Park Ridge, 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 14317
Silver Spring, 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 14275
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 14274
Houston, Texas, United States
Teva Investigational Site 14312
Houston, Texas, United States
Teva Investigational Site 14366
San Antonio, Texas, United States
Teva Investigational Site 14241
San Antonio, Texas, United States
Teva Investigational Site 14375
Salt Lake City, Utah, United States
Teva Investigational Site 14323
Norfolk, Virginia, United States
Teva Investigational Site 14277
Tacoma, Washington, United States
Teva Investigational Site 11180
Ajax, Ontario, Canada
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 32725
Dresden, , Germany
Teva Investigational Site 32724
Essen, , 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 31266
Elda, , Spain
Teva Investigational Site 31268
Madrid, , Spain
Teva Investigational Site 31267
Madrid, , Spain
Teva Investigational Site 31270
Valencia, , Spain
Teva Investigational Site 31265
Valladolid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2019-002053-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
TV48125-CNS-30082
Identifier Type: -
Identifier Source: org_study_id