Fremanezumab in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Study Title
- A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
Teva Identifier
- TV48125-CNS-30083 | 2019-002055-42
ClinicalTrials.gov Identifier
- NCT04458857
Study Status
- Recruiting
Trial Condition(s)
- Migraine
Interventions
- Drug: Fremanezumab | Drug: Placebo
EudractCT Number
- 2019-002055-42
Study Description
The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM 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 up to 36 months.
Key Participation Requirements
Gender
- Female, Male
Age Range
- 6 Years to 17 Years
Trial Duration
- July 16, 2020 - April 11, 2022
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.
