Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years
Study Title
- A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Patients 6 to 17 Years of Age
Teva Identifier
- TV48125-CNS-30082 | 2019-002053-33
ClinicalTrials.gov Identifier
- NCT04464707
Study Status
- Recruiting
Trial Condition(s)
- Migraine
Interventions
- Drug: Fremanezumab | Drug: Placebo
EudractCT Number
- 2019-002053-33
Study Description
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.
Key Participation Requirements
Gender
- Female, Male
Age Range
- 6 Years to 17 Years
Trial Duration
- July 30, 2020 - April 25, 2023
Phase
- Phase 3
Study Type
Interventional
Location - Where to Participate
You may contact 1-888-483-8279 or email USMedInfo@tevapharm.com to obtain more information about study locations.
