Study to Test the Effectiveness and Safety of Fremanezumab in Fibromyalgia
- Study Title
- A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia
- Teva Identifier
- TV48125-PN-20028
- ClinicalTrials.gov Identifier
- NCT03965091
- Study Status
- Terminated
- Trial Condition(s)
- Fibromyalgia
- Interventions
- Drug: Fremanezumab - Dose A | Drug: Fremanezumab - Dose B | Drug: Placebo
- Study Description
- Primary objectives: The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously in reducing pain in adult patients with FM. Secondary objectives: A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality of life, sleep, fatigue, improvement in health, physical functioning, and mood. Another secondary objective is to evaluate the safety and tolerability of fremanezumab administered subcutaneously in adult patients with FM. The total duration of patient participation in the study is planned to be 21 weeks, consisting of a screening period of up to 5 weeks (ranging from 17 to 35 days), and a double-blind treatment period of 16 weeks.
Key Participation Requirements
- Gender
- Female, Male
- Age group
- Adult, Older Adult
- Age Range
- 18 Years to 75 Years
- Trial Duration
- May 31, 2019 - January 19, 2022
- Phase
- Phase 2
