Phase
Condition
Oral Facial Pain
Pain (Pediatric)
Headaches
Treatment
Fremanezumab
Placebo
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The participant has a clinical history of recurrent headache consistent with thediagnosis of migraine for at least 6 months before screening, consistent with ICHD-3criteria (Headache Classification Committee of the IHS 2013), and a history of ≤=14headache days per month in each of the 3 months prior to screening (visit 1).
The participant or parent/caregiver maintain a prospectively collected headachediary
The participant does not have chronic daily headache. For the purposes of thisstudy, chronic daily headache is operationally defined as <4 headache-free daysduring the 28-day baseline period.
NOTE: Additional criteria apply; please contact the investigator for more information.
Exclusion
Exclusion Criteria:
The participant is using medications containing opioids (including codeine) orbarbiturates (including Fiorinal®, Fioricet®, or any other combination containingbutalbital) for the treatment of migraine during the 3 months prior to the day ofthe screening visit.
The participant or parent/caregiver maintain a prospectively collected headachediary
The participant has used an intervention/device (eg, scheduled nerve block ortranscranial magnetic stimulation) for the treatment of migraine or in the head orneck area for any condition during the 2 months prior to the day of the screeningvisit.
The participant has a current history of a clinically significant psychiatriccondition, at the discretion of the investigator. Any prior history of a suicideattempt, or a history of suicidal ideation with a specific plan within the past 2years, must be excluded.
The participant has an ongoing infection or a known history of humanimmunodeficiency virus infection, tuberculosis, Lyme disease, or chronic hepatitis Bor 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 epidermalnecrolysis syndrome, or the participant is concomitantly using lamotrigine.
The participant received a live attenuated vaccine (eg, intranasal flu vaccine, andmeasles, 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 liveattenuated vaccine.
The participant has a current or past medical history of hemiplegic migraine.
NOTE: Additional criteria apply; please contact the investigator for more information.
Study Design
Connect with a study center
Teva Investigational Site 11180
Ajax, Ontario L1Z 0M1
CanadaSite Not Available
Teva Investigational Site 11179
Nepean, Ontario K2G 1W2
CanadaSite Not Available
Teva Investigational Site 11179
Ottawa, Ontario K2G 1W2
CanadaSite Not Available
Teva Investigational Site 11182
Ottawa, Ontario K1H 8L1
CanadaSite Not Available
Teva Investigational Site 11181
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Teva Investigational Site 40053
Helsinki, 00380
FinlandSite Not Available
Teva Investigational Site 40049
Kuopio, 70210
FinlandSite Not Available
Teva Investigational Site 40054
Oulu, 90100
FinlandSite Not Available
Teva Investigational Site 40052
Tampere, 33521
FinlandSite Not Available
Teva Investigational Site 32728
Bad Homburg, 61350
GermanySite Not Available
Teva Investigational Site 32729
Berlin, 13353
GermanySite Not Available
Teva Investigational Site 32725
Dresden, 01307
GermanySite Not Available
Teva Investigational Site 32724
Essen, 45133
GermanySite Not Available
Teva Investigational Site 32726
Leipzig, 04177
GermanySite Not Available
Teva Investigational Site 80170
Be'er Ya'akov, 7033001
IsraelSite Not Available
Teva Investigational Site 80166
Haifa, 3339419
IsraelSite Not Available
Teva Investigational Site 80168
Holon, 58100
IsraelSite Not Available
Teva Investigational Site 80169
Jerusalem, 9124001
IsraelSite Not Available
Teva Investigational Site 80167
Ramat Gan, 5265601
IsraelSite Not Available
Teva Investigational Site 80164
Safed, 1311001
IsraelSite Not Available
Teva Investigational Site 80165
Tel-Aviv, 6423906
IsraelSite Not Available
Teva Investigational Site 80170
Zerifin, 70300
IsraelSite Not Available
Teva Investigational Site 30230
Firenze, 50139
ItalySite Not Available
Teva Investigational Site 30228
Milan, 20133
ItalySite Not Available
Teva Investigational Site 30226
Milano, 20148
ItalySite Not Available
Teva Investigational Site 30228
Milano, 20133
ItalySite Not Available
Teva Investigational Site 30239
Milano, 20132
ItalySite Not Available
Teva Investigational Site 30238
Padua, 35128
ItalySite Not Available
Teva Investigational Site 30227
Pavia, 27100
ItalySite Not Available
Teva Investigational Site 30225
Rome, 00163
ItalySite Not Available
Teva Investigational Site 38138
Doetinchem, 7009 BL
NetherlandsSite Not Available
Teva Investigational Site 38135
Nijmegen, 6532 SZ
NetherlandsSite Not Available
Teva Investigational Site 38136
Rotterdam, 3015 GD
NetherlandsSite Not Available
Teva Investigational Site 53441
Gdansk, 80-389
PolandSite Not Available
Teva Investigational Site 53437
Kielce, 25-316
PolandSite Not Available
Teva Investigational Site 53443
Krakow, 30-363
PolandSite Not Available
Teva Investigational Site 53452
Krakow, 30-539
PolandSite Not Available
Teva Investigational Site 53440
Lublin, 20-582
PolandSite Not Available
Teva Investigational Site 53439
Poznan, 60-355
PolandSite Not Available
Teva Investigational Site 53451
Poznan, 61-731
PolandSite Not Available
Teva Investigational Site 53442
Szczecin, 70-111
PolandSite Not Available
Teva Investigational Site 31271
Barcelona, 08035
SpainSite Not Available
Teva Investigational Site 31266
Elda, 03600
SpainSite Not Available
Teva Investigational Site 31267
Madrid, 28046
SpainSite Not Available
Teva Investigational Site 31268
Madrid, 28007
SpainSite Not Available
Teva Investigational Site 31270
Valencia, 46026
SpainSite Not Available
Teva Investigational Site 31265
Valladolid, 47010
SpainSite Not Available
Teva Investigational Site 14358
Phoenix, Arizona 85016
United StatesSite Not Available
Teva Investigational Site 14281
Little Rock, Arkansas 72202
United StatesSite Not Available
Teva Investigational Site 14253
Banning, California 92220
United StatesSite Not Available
Teva Investigational Site 14370
Loma Linda, California 92354
United StatesSite Not Available
Teva Investigational Site 14322
Los Angeles, California 90027
United StatesSite Not Available
Teva Investigational Site 14277
Oceanside, California 92056
United StatesSite Not Available
Teva Investigational Site 14361
Sacramento, California 95815
United StatesSite Not Available
Teva Investigational Site 14319
Aurora, Colorado 80045
United StatesSite Not Available
Teva Investigational Site 14368
Colorado Springs, Colorado 80907
United StatesSite Not Available
Teva Investigational Site 14244
Jacksonville, Florida 32256
United StatesSite Not Available
Teva Investigational Site 14325
Miami, Florida 33155
United StatesSite Not Available
Teva Investigational Site 14250
West Palm Beach, Florida 33407
United StatesSite Not Available
Teva Investigational Site 14255
West Palm Beach, Florida 33409
United StatesSite Not Available
Teva Investigational Site 14243
Atlanta, Georgia 30328
United StatesSite Not Available
Teva Investigational Site 14258
Savannah, Georgia 31406
United StatesSite Not Available
Teva Investigational Site 14263
Chicago, Illinois 60637
United StatesSite Not Available
Teva Investigational Site 14263
Hoffman Estates, Illinois 60169
United StatesSite Not Available
Teva Investigational Site 14283
Park Ridge, Illinois 60068
United StatesSite Not Available
Teva Investigational Site 14245
Wichita, Kansas 67206
United StatesSite Not Available
Teva Investigational Site 14327
Louisville, Kentucky 40202
United StatesSite Not Available
Teva Investigational Site 14360
Covington, Louisiana 70433
United StatesSite Not Available
Teva Investigational Site 14365
Baltimore, Maryland 21201
United StatesSite Not Available
Teva Investigational Site 14317
Silver Spring, Maryland 26505
United StatesSite Not Available
Teva Investigational Site 14246
Waltham, Massachusetts 02451
United StatesSite Not Available
Teva Investigational Site 14251
Ann Arbor, Michigan 48104
United StatesSite Not Available
Teva Investigational Site 14270
Minneapolis, Minnesota 55402
United StatesSite Not Available
Teva Investigational Site 14376
Ridgeland, Mississippi 39157
United StatesSite Not Available
Teva Investigational Site 14256
Bridgeton, Missouri 63044-2513
United StatesSite Not Available
Teva Investigational Site 14371
New Brunswick, New Jersey 08901
United StatesSite Not Available
Teva Investigational Site 14276
Amherst, New York 14226
United StatesSite Not Available
Teva Investigational Site 14377
Durham, North Carolina 27710
United StatesSite Not Available
Teva Investigational Site 14248
Raleigh, North Carolina 27607
United StatesSite Not Available
Teva Investigational Site 14264
Cincinnati, Ohio 45229-3039
United StatesSite Not Available
Teva Investigational Site 14257
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Teva Investigational Site 14275
Oklahoma City, Oklahoma 73116
United StatesSite Not Available
Teva Investigational Site 14363
Tulsa, Oklahoma 74136
United StatesSite Not Available
Teva Investigational Site 14364
Philadelphia, Pennsylvania 19104-4318
United StatesSite Not Available
Teva Investigational Site 14374
Bristol, Tennessee 37620
United StatesSite Not Available
Teva Investigational Site 14252
Austin, Texas 78731
United StatesSite Not Available
Teva Investigational Site 14273
Austin, Texas 78759
United StatesSite Not Available
Teva Investigational Site 14274
Bellaire, Texas 77401
United StatesSite Not Available
Teva Investigational Site 14367
Dallas, Texas 75235-7701
United StatesSite Not Available
Teva Investigational Site 14274
Houston, Texas 77004
United StatesCompleted
Teva Investigational Site 14312
Houston, Texas 77087
United StatesSite Not Available
Teva Investigational Site 14241
San Antonio, Texas 78240
United StatesSite Not Available
Teva Investigational Site 14366
San Antonio, Texas 78207
United StatesSite Not Available
Teva Investigational Site 14375
Salt Lake City, Utah 84109
United StatesSite Not Available
Teva Investigational Site 14323
Norfolk, Virginia 23510
United StatesSite Not Available
Teva Investigational Site 14277
Tacoma, Washington 98405
United StatesSite Not Available
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