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

NCT04464707 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: TV48125-CNS-300822019-002053-33
• Study Type: interventional
• Target: 292
• Locations: 9 countries
• Sites: 89

Brief Summary

The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). 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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Monthly Average Number of Migraine Days During 12-Week Period After the First Dose of Study Drug

  A migraine day was defined as a day with any of the following: A day (0:00 to 23:59) with at least 2 hours of headache with ≥2 migraine symptom(s) or day (0:00 to 23:59) demonstrating a headache treated with migraine medications (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\], paracetamol etc.), or a headache associated with aura. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in electronic diary (e-diary) for 12-week period) \* 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).

  Baseline (Day -28 to Day -1), up to Week 12

Secondary Outcomes (13)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  Baseline up to Month 3

• Number of Participants With Shift From Baseline to Last Assessment in Electrocardiogram (ECG) Findings (Assessed by Investigator)

  Baseline to last assessment (up to Month 3)

• Number of Participants With Shift From Baseline to Last Assessment in ECG Findings (Assessed by Cardiologist)

  Baseline to last assessment (up to Month 3)

• Number of Participants With Any One or More Potentially Clinically Significant Vital Sign Abnormalities

  Baseline up to Month 3

• Number of Participants With Potentially Clinically Significant Abnormal Laboratory (Serum Chemistry, Hematology, Coagulation, and Urinalysis) Results

  Baseline up to Month 3

Study Arms (3)

Fremanezumab Dose A

EXPERIMENTAL

Participants weighing \< threshold will receive Dose A subcutaneously monthly for 3 months.

Drug: Fremanezumab

Fremanezumab Dose B

EXPERIMENTAL

Participants weighing ≥ threshold will receive Dose B subcutaneously monthly for 3 months.

Drug: Fremanezumab

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Interventions

Placebo DRUG

Matching placebo

Placebo

Fremanezumab DRUG

Dose A or Dose B subcutaneous

Fremanezumab Dose A; Fremanezumab Dose B

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participant has a clinical history of recurrent headache consistent with the diagnosis of migraine for at least 6 months before screening, consistent with ICHD-3 criteria (Headache Classification Committee of the IHS 2013), and a history of ≥15 headache days per month on average during the 3 months prior to screening (visit 1).
• The participant or parent/caregiver maintain a prospectively collected headache diary
• NOTE: Additional criteria apply; please contact the investigator for more information.

You may not qualify if:

• The participant is using medications containing opioids (including codeine) or barbiturates (including Fiorinal®, Fioricet®, or any other combination containing butalbital) for the treatment of migraine during the 3 months prior to the day of the screening visit.
• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (89)

Teva Investigational Site 14281

Little Rock, Arkansas, 72202, United States

Location

Teva Investigational Site 14253

Banning, California, 92220, United States

Location

Teva Investigational Site 14370

Loma Linda, California, 92354, United States

Location

Teva Investigational Site 14322

Los Angeles, California, 90027, United States

Location

Teva Investigational Site 14361

Sacramento, California, 95815, United States

Location

Teva Investigational Site 14319

Aurora, Colorado, 80045, United States

Location

Teva Investigational Site 14368

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 14244

Jacksonville, Florida, 32256, United States

Location

Teva Investigational Site 14325

Miami, Florida, 33155, United States

Location

Teva Investigational Site 14250

West Palm Beach, Florida, 33407, United States

Location

Teva Investigational Site 14255

West Palm Beach, Florida, 33409, United States

Location

Teva Investigational Site 14243

Atlanta, Georgia, 30328, United States

Location

Teva Investigational Site 14258

Savannah, Georgia, 31406, United States

Location

Teva Investigational Site 14263

Hoffman Estates, Illinois, 60169, United States

Location

Teva Investigational Site 14283

Park Ridge, Illinois, 60068, United States

Location

Teva Investigational Site 14245

Wichita, Kansas, 67206, United States

Location

Teva Investigational Site 14327

Louisville, Kentucky, 40202, United States

Location

Teva Investigational Site 14360

Covington, Louisiana, 70433, United States

Location

Teva Investigational Site 14365

Baltimore, Maryland, 21201, United States

Location

Teva Investigational Site 14317

Silver Spring, Maryland, 20910, United States

Location

Teva Investigational Site 14246

Waltham, Massachusetts, 02451, United States

Location

Teva Investigational Site 14251

Ann Arbor, Michigan, 48104, United States

Location

Teva Investigational Site 14270

Minneapolis, Minnesota, 55402, United States

Location

Teva Investigational Site 14376

Ridgeland, Mississippi, 39157, United States

Location

Teva Investigational Site 14256

Bridgeton, Missouri, 63044-2513, United States

Location

Teva Investigational Site 14371

New Brunswick, New Jersey, 08901, United States

Location

Teva Investigational Site 14276

Amherst, New York, 14226, United States

Location

Teva Investigational Site 14377

Durham, North Carolina, 27710, United States

Location

Teva Investigational Site 14248

Raleigh, North Carolina, 27607, United States

Location

Teva Investigational Site 14264

Cincinnati, Ohio, 45229-3039, United States

Location

Teva Investigational Site 14257

Oklahoma City, Oklahoma, 73112, United States

Location

Teva Investigational Site 14275

Oklahoma City, Oklahoma, 73116, United States

Location

Teva Investigational Site 14363

Tulsa, Oklahoma, 74136, United States

Location

Teva Investigational Site 14364

Philadelphia, Pennsylvania, 19104-4318, United States

Location

Teva Investigational Site 14374

Bristol, Tennessee, 37620, United States

Location

Teva Investigational Site 14252

Austin, Texas, 78731, United States

Location

Teva Investigational Site 14273

Austin, Texas, 78759, United States

Location

Teva Investigational Site 14367

Dallas, Texas, 75235-7701, United States

Location

Teva Investigational Site 14274

Houston, Texas, 77024, United States

Location

Teva Investigational Site 14312

Houston, Texas, 77087, United States

Location

Teva Investigational Site 14366

San Antonio, Texas, 78207, United States

Location

Teva Investigational Site 14241

San Antonio, Texas, 78240, United States

Location

Teva Investigational Site 14375

Salt Lake City, Utah, 84109, United States

Location

Teva Investigational Site 14323

Norfolk, Virginia, 23510, United States

Location

Teva Investigational Site 14277

Tacoma, Washington, 98405, United States

Location

Teva Investigational Site 11180

Ajax, Ontario, L1Z 0M1, Canada

Location

Teva Investigational Site 11182

Ottawa, Ontario, K1H 8L1, Canada

Location

Teva Investigational Site 11179

Ottawa, Ontario, K2G 1W2, Canada

Location

Teva Investigational Site 11181

Montreal, Quebec, H4A 3J1, Canada

Location

Teva Investigational Site 40053

Helsinki, 00380, Finland

Location

Teva Investigational Site 40049

Kuopio, 70210, Finland

Location

Teva Investigational Site 40054

Oulu, 90100, Finland

Location

Teva Investigational Site 40052

Tampere, 33521, Finland

Location

Teva Investigational Site 32728

Bad Homburg, 61348, Germany

Location

Teva Investigational Site 32729

Berlin, 13353, Germany

Location

Teva Investigational Site 32725

Dresden, 01307, Germany

Location

Teva Investigational Site 32724

Essen, 452133, Germany

Location

Teva Investigational Site 32726

Leipzig, 04177, Germany

Location

Teva Investigational Site 80170

Be’er Ya‘aqov, 7033001, Israel

Location

Teva Investigational Site 80166

Haifa, 3339419, Israel

Location

Teva Investigational Site 80168

Holon, 58100, Israel

Location

Teva Investigational Site 80169

Jerusalem, 9124001, Israel

Location

Teva Investigational Site 80167

Ramat Gan, 5265601, Israel

Location

Teva Investigational Site 80164

Safed, 1311001, Israel

Location

Teva Investigational Site 80165

Tel Aviv, 6423906, Israel

Location

Teva Investigational Site 30230

Florence, 50139, Italy

Location

Teva Investigational Site 30239

Milan, 20132, Italy

Location

Teva Investigational Site 30228

Milan, 20133, Italy

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Teva Investigational Site 30226

Milan, 20154, Italy

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Teva Investigational Site 30238

Padua, 35128, Italy

Location

Teva Investigational Site 30227

Pavia, 27100, Italy

Location

Teva Investigational Site 30225

Rome, 00166, Italy

Location

Teva Investigational Site 38138

Doetinchem, 7009 BL, Netherlands

Location

Teva Investigational Site 38135

Nijmegen, 6532 SZ, Netherlands

Location

Teva Investigational Site 38136

Rotterdam, 3015 GD, Netherlands

Location

Teva Investigational Site 53441

Gdansk, 80-389, Poland

Location

Teva Investigational Site 53437

Kielce, 25-316, Poland

Location

Teva Investigational Site 53443

Krakow, 30-363, Poland

Location

Teva Investigational Site 53452

Krakow, 30-539, Poland

Location

Teva Investigational Site 53440

Lublin, 20-582, Poland

Location

Teva Investigational Site 53439

Poznan, 60-355, Poland

Location

Teva Investigational Site 53451

Poznan, 61-731, Poland

Location

Teva Investigational Site 53442

Szczecin, 70-111, Poland

Location

Teva Investigational Site 31271

Barcelona, 08035, Spain

Location

Teva Investigational Site 31266

Elda, 03600, Spain

Location

Teva Investigational Site 31268

Madrid, 28007, Spain

Location

Teva Investigational Site 31267

Madrid, 28046, Spain

Location

Teva Investigational Site 31270

Valencia, 46026, Spain

Location

Teva Investigational Site 31265

Valladolid, 47010, Spain

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: July 9, 2020
• Study Start: September 24, 2020
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (5); IT (7); PL (8); FI (4); NL (3); ES (6); IL (7); US (45); CA (4)