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

NCT04530110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 506

Last updated 2026-02-13

No results posted yet for this study

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

Interventions

DRUG

Fremanezumab

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.

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D LLC

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-16
Primary Completion
2025-08-15
Completion
2025-12-22
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Finland
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04530110 on ClinicalTrials.gov