A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age
A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age
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 48 months.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Chronic Migraine in Pediatric Patients 6 to 17 Years of Age
Actual Study Start Date: July 30, 2020
Estimated Primary Completion Date: October 6, 2026
Estimated Study Completion Date: October 6, 2026
Arms:
- Experimental: Fremanezumab
- Placebo Comparator: Placebo
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 418 |
| Study start date | 30 July 2020 |
| Estimated study completion date | 06 October 2026 |