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

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

ClinicalTrials.gov ID

NCT04530110

Acronym / sponsor ID

TV48125-CNS-30084

Conditions

Migraine

Keywords

episodic migraine, chronic migraine

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

499 participants (actual)

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)

Study start

16 Sep 2020 (actual)

Primary completion

15 Aug 2025 (actual)

Study completion

22 Dec 2025 (actual)

First posted

28 Aug 2020 (actual)

Results

Posted 24 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

6 to 17 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events (AEs)

   Time frame: Day 1 up to Day 393

   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.

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

   Time frame: Day 1 up to Day 253

   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.

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

   Time frame: Baseline to last assessment (up to Day 253)

   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.

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

   Time frame: Baseline to last assessment (up to Day 253)

   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.

5. Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

   Time frame: Day 1 up to Day 253

   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.

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

   Time frame: Baseline to last assessment (up to Day 393)

   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.

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

   Time frame: Day 1 up to Day 393

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

70 sites in 9 countries: see every site and its status.