A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents

NCT04530110 | Completed Phase 3 Results FDA Drug

• 4 other identifiers: TV48125-CNS-300842019-002056-162024-512837-34-00EMEA-001877-PIP01-15
• Study Type: interventional
• Target: 499
• Locations: 9 countries
• Sites: 70

Brief Summary

The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). 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.

Conditions

Migraine

Keywords

episodic migraine; chronic migraine

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in the Reported AE section.

  Day 1 up to Day 393

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

  Serum chemistry tests with clinically significant abnormal findings included: alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase ≥2\*upper limit of normal (ULN); gamma glutamyl transferase ≥3\* ULN; bilirubin ≥34.2 micromole/liter (umol/L); and urea nitrogen ≥9 umol/L. Hematology tests with clinically significant abnormal findings included: hemoglobin ≤100 grams (g)/L (female) or ≤100 g/L (male), hematocrit \<0.32 L/L (male), leukocytes ≤3\*10\^9 cells/L or ≥20\*10\^9 cells/L, neutrophils ≤1\*10\^9 cells/L, eosinophils/leukocytes ≥10%, and platelets ≤75x10\^9/L. Coagulation parameter test with clinically significant abnormal findings included: prothrombin international normalized ratio (INR) \>1.5. Urinalysis laboratory tests with clinically significant abnormal findings included: urine protein and urine glucose ≥2 units (U) increase from baseline. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Day 1 up to Day 253

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

  The number of participants with a shift from Baseline (Normal, Abnormal CS \[Clinically Significant\], or Abnormal NCS \[Not Clinically Significant\]) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), and QT interval corrected using the Fridericia formula (QTcF). Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline to last assessment (up to Day 253)

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

  The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following ECG parameters is reported by treatment group: Heart rate, PR interval, QRS interval, RR interval, QT interval, QTcB, and QTcF. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline to last assessment (up to Day 253)

• Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

  Potentially clinically significant abnormal vital signs findings included any one of the following: Pulse rate ≥120 beats per minute (bpm) and increase from baseline of ≥15 bpm, or ≤50 bpm and decrease from baseline of ≥15 bpm, or ≤60 bpm and decrease from baseline of ≥15 bpm; systolic blood pressure ≤80 millimeters of mercury (mmHg) and decrease of ≥20 mmHg, or ≤85 mmHg and decrease of ≥20 mmHg, or ≥150 mmHg and increase of ≥20 mmHg; diastolic blood pressure ≤37 mmHg and decrease of ≥15 mmHg, or ≤44 mmHg and decrease of ≥15 mmHg, or ≥100 mmHg and increase of ≥15 mmHg, or ≥93 mmHg and increase of ≥15 mmHg; respiratory rate \<15 or \<10 breaths/minute; and body temperature ≥38.3 degrees Celsius and change ≥1.1 degrees Celsius. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Day 1 up to Day 253

• Number of Participants With Shift From Baseline to Last Assessment in Physical Examination Findings

  The number of participants with a shift from Baseline (Normal or Abnormal) in any of the following organ systems examination is reported by treatment group: general appearance; head, eyes, ears, nose, and throat (HEENT); chest and lungs; cardiovascular; abdomen; musculoskeletal; skin; lymph nodes; neurological, and extremities/back. Last assessment was defined as the last observed postbaseline interpretation. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Baseline to last assessment (up to Day 393)

• Number of Participants With Suicidal Ideation or Behavior, as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

  C-SSRS is a questionnaire to assess suicidal ideation and suicidal behavior. Suicidal behavior was defined as a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation was defined as a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent, any self-injurious behavior with no suicidal intent.

  Day 1 up to Day 393

Secondary Outcomes (7)

• Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity

  Baseline, Months 1, 5, and 9

• Mean Change From Baseline in the Monthly Average Number of Migraine Days

  Baseline, Months 1, 5, and 9

• Percentage of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Migraine Days

  Months 1, 5, and 9

• Percentage of Participants Reaching at Least 50% Reduction From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity

  Months 1, 5, and 9

• Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications

  Baseline, Months 1, 5, and 9

Study Arms (1)

Fremanezumab

EXPERIMENTAL

The dose of Fremanezumab to be administered will be confirmed or adjusted, as appropriate, based on the participant's weight every 3 months.

Drug: Fremanezumab

Interventions

Fremanezumab DRUG

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.

Fremanezumab

Eligibility Criteria

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

You may qualify if:

• Participants have completed the pivotal efficacy study and, in the opinion of the Investigator or the Sponsor, are able to complete the study in a safe and compliant way.
• 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.

You may not qualify if:

• In the judgment of the investigator, the participant has a clinically significant abnormal finding on study entry, including hematology, blood chemistry, coagulation tests, or urinalysis values/findings (abnormal tests may be repeated for confirmation).
• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (70)

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 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 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 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 14375

Salt Lake City, Utah, 84109, United States

Location

Teva Investigational Site 14323

Norfolk, Virginia, 23510, United States

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, H3H 2R9, 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, 61350, Germany

Location

Teva Investigational Site 32729

Berlin, 13353, 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, 3104802, 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

Location

Teva Investigational Site 30226

Milan, 20148, Italy

Location

Teva Investigational Site 30238

Padua, 35128, Italy

Location

Teva Investigational Site 30227

Pavia, 27100, Italy

Location

Teva Investigational Site 30225

Rome, 00163, 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 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 LLC

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: September 16, 2020
• Primary Completion: August 15, 2025
• Study Completion: December 22, 2025
• Last Updated: July 24, 2026
• Results First Posted: July 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

NL (3); US (32); ES (3); IL (7); CA (3); FI (4); IT (7); DE (3); PL (8)