A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age

Last updated: March 31, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Overall Status: Completed

Phase

3

Condition

Oral Facial Pain

Pain (Pediatric)

Headaches

Treatment

Fremanezumab

Placebo

Clinical Study ID

NCT04458857
TV48125-CNS-30083
2019-002055-42
  • Ages 6-17
  • All Genders

Study Summary

The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).

Secondary objectives are to further demonstrate the efficacy of fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of fremanezumab in the preventive treatment of EM 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 up to 51 months.

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

Total Participants: 235
Treatment Group(s): 2
Primary Treatment: Fremanezumab
Phase: 3
Study Start date:
July 15, 2020
Estimated Completion Date:
March 13, 2024

Connect with a study center

  • Teva Investigational Site 11180

    Ajax, Ontario L1Z 0M1
    Canada

    Site Not Available

  • Teva Investigational Site 11179

    Nepean, Ontario K2G 1W2
    Canada

    Site Not Available

  • Teva Investigational Site 11179

    Ottawa, Ontario K2G 1W2
    Canada

    Site Not Available

  • Teva Investigational Site 11182

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Teva Investigational Site 11181

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • Teva Investigational Site 40053

    Helsinki, 00380
    Finland

    Site Not Available

  • Teva Investigational Site 40049

    Kuopio, 70210
    Finland

    Site Not Available

  • Teva Investigational Site 40054

    Oulu, 90100
    Finland

    Site Not Available

  • Teva Investigational Site 40052

    Tampere, 33521
    Finland

    Site Not Available

  • Teva Investigational Site 32728

    Bad Homburg, 61350
    Germany

    Site Not Available

  • Teva Investigational Site 32729

    Berlin, 13353
    Germany

    Site Not Available

  • Teva Investigational Site 32725

    Dresden, 01307
    Germany

    Site Not Available

  • Teva Investigational Site 32724

    Essen, 45133
    Germany

    Site Not Available

  • Teva Investigational Site 32726

    Leipzig, 04177
    Germany

    Site Not Available

  • Teva Investigational Site 80170

    Be'er Ya'akov, 7033001
    Israel

    Site Not Available

  • Teva Investigational Site 80166

    Haifa, 3339419
    Israel

    Site Not Available

  • Teva Investigational Site 80168

    Holon, 58100
    Israel

    Site Not Available

  • Teva Investigational Site 80169

    Jerusalem, 9124001
    Israel

    Site Not Available

  • Teva Investigational Site 80167

    Ramat Gan, 5265601
    Israel

    Site Not Available

  • Teva Investigational Site 80164

    Safed, 1311001
    Israel

    Site Not Available

  • Teva Investigational Site 80165

    Tel-Aviv, 6423906
    Israel

    Site Not Available

  • Teva Investigational Site 80170

    Zerifin, 70300
    Israel

    Site Not Available

  • Teva Investigational Site 30230

    Firenze, 50139
    Italy

    Site Not Available

  • Teva Investigational Site 30228

    Milan, 20133
    Italy

    Site Not Available

  • Teva Investigational Site 30226

    Milano, 20148
    Italy

    Site Not Available

  • Teva Investigational Site 30228

    Milano, 20133
    Italy

    Site Not Available

  • Teva Investigational Site 30239

    Milano, 20132
    Italy

    Site Not Available

  • Teva Investigational Site 30238

    Padua, 35128
    Italy

    Site Not Available

  • Teva Investigational Site 30227

    Pavia, 27100
    Italy

    Site Not Available

  • Teva Investigational Site 30225

    Rome, 00163
    Italy

    Site Not Available

  • Teva Investigational Site 38138

    Doetinchem, 7009 BL
    Netherlands

    Site Not Available

  • Teva Investigational Site 38135

    Nijmegen, 6532 SZ
    Netherlands

    Site Not Available

  • Teva Investigational Site 38136

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Teva Investigational Site 53441

    Gdansk, 80-389
    Poland

    Site Not Available

  • Teva Investigational Site 53437

    Kielce, 25-316
    Poland

    Site Not Available

  • Teva Investigational Site 53443

    Krakow, 30-363
    Poland

    Site Not Available

  • Teva Investigational Site 53452

    Krakow, 30-539
    Poland

    Site Not Available

  • Teva Investigational Site 53440

    Lublin, 20-582
    Poland

    Site Not Available

  • Teva Investigational Site 53439

    Poznan, 60-355
    Poland

    Site Not Available

  • Teva Investigational Site 53451

    Poznan, 61-731
    Poland

    Site Not Available

  • Teva Investigational Site 53442

    Szczecin, 70-111
    Poland

    Site Not Available

  • Teva Investigational Site 31271

    Barcelona, 08035
    Spain

    Site Not Available

  • Teva Investigational Site 31266

    Elda, 03600
    Spain

    Site Not Available

  • Teva Investigational Site 31267

    Madrid, 28046
    Spain

    Site Not Available

  • Teva Investigational Site 31268

    Madrid, 28007
    Spain

    Site Not Available

  • Teva Investigational Site 31270

    Valencia, 46026
    Spain

    Site Not Available

  • Teva Investigational Site 31265

    Valladolid, 47010
    Spain

    Site Not Available

  • Teva Investigational Site 14358

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Teva Investigational Site 14281

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Teva Investigational Site 14253

    Banning, California 92220
    United States

    Site Not Available

  • Teva Investigational Site 14370

    Loma Linda, California 92354
    United States

    Site Not Available

  • Teva Investigational Site 14322

    Los Angeles, California 90027
    United States

    Site Not Available

  • Teva Investigational Site 14277

    Oceanside, California 92056
    United States

    Site Not Available

  • Teva Investigational Site 14361

    Sacramento, California 95815
    United States

    Site Not Available

  • Teva Investigational Site 14319

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Teva Investigational Site 14368

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • Teva Investigational Site 14244

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Teva Investigational Site 14325

    Miami, Florida 33155
    United States

    Site Not Available

  • Teva Investigational Site 14250

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Teva Investigational Site 14255

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Teva Investigational Site 14243

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Teva Investigational Site 14258

    Savannah, Georgia 31406
    United States

    Site Not Available

  • Teva Investigational Site 14263

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Teva Investigational Site 14263

    Hoffman Estates, Illinois 60169
    United States

    Site Not Available

  • Teva Investigational Site 14283

    Park Ridge, Illinois 60068
    United States

    Site Not Available

  • Teva Investigational Site 14245

    Wichita, Kansas 67206
    United States

    Site Not Available

  • Teva Investigational Site 14327

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Teva Investigational Site 14360

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Teva Investigational Site 14365

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Teva Investigational Site 14317

    Silver Spring, Maryland 26505
    United States

    Site Not Available

  • Teva Investigational Site 14246

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Teva Investigational Site 14251

    Ann Arbor, Michigan 48104
    United States

    Site Not Available

  • Teva Investigational Site 14270

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Teva Investigational Site 14376

    Ridgeland, Mississippi 39157
    United States

    Site Not Available

  • Teva Investigational Site 14256

    Bridgeton, Missouri 63044-2513
    United States

    Site Not Available

  • Teva Investigational Site 14371

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Teva Investigational Site 14276

    Amherst, New York 14226
    United States

    Site Not Available

  • Teva Investigational Site 14377

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Teva Investigational Site 14248

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • Teva Investigational Site 14264

    Cincinnati, Ohio 45229-3039
    United States

    Site Not Available

  • Teva Investigational Site 14257

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Teva Investigational Site 14275

    Oklahoma City, Oklahoma 73116
    United States

    Site Not Available

  • Teva Investigational Site 14363

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Teva Investigational Site 14364

    Philadelphia, Pennsylvania 19104-4318
    United States

    Site Not Available

  • Teva Investigational Site 14374

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Teva Investigational Site 14252

    Austin, Texas 78731
    United States

    Site Not Available

  • Teva Investigational Site 14273

    Austin, Texas 78759
    United States

    Site Not Available

  • Teva Investigational Site 14274

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Teva Investigational Site 14367

    Dallas, Texas 75235-7701
    United States

    Site Not Available

  • Teva Investigational Site 14274

    Houston, Texas 77004
    United States

    Completed

  • Teva Investigational Site 14312

    Houston, Texas 77087
    United States

    Site Not Available

  • Teva Investigational Site 14241

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Teva Investigational Site 14366

    San Antonio, Texas 78207
    United States

    Site Not Available

  • Teva Investigational Site 14375

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • Teva Investigational Site 14323

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • Teva Investigational Site 14277

    Tacoma, Washington 98405
    United States

    Site Not Available

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