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

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

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 60 months.

Detailed Description:
The study population will be composed of 3 subgroups of participants as follows:
- Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083)
- Participants rolling over from the Phase 1 pediatric pharmacokinetic study (Study TV48125-CNS-10141)
- Participants rolling over from the pivotal Phase 3 pediatric efficacy studies (Studies TV48125-CNS-30082 and TV48125-CNS-30083) for safety follow-up and antidrug antibody (ADA) evaluation only


Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 550 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date: September 16, 2020
Estimated Primary Completion Date: June 20, 2027
Estimated Study Completion Date: November 7, 2027

Arm:
- Experimental: Fremanezumab

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