A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
Summary
The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (FM). 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 SC in adult participants with FM. The total duration of participant 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.
Timeline
- Start
- 2019-07-31
- Primary completion
- 2022-01-19
- Completion
- 2022-01-19
Outcome
Missed primary endpoint
Stopped: “Met pre-specified criteria for futility at interim analysis”
registry analysis (other test); Placebo vs Fremanezumab Dose A; p = 0.7963; Least square (LS) mean difference 0.1 (95% CI -0.46 to 0.60); Mixed Models Analysis NCT03965091 ↗
registry analysis (other test); Placebo vs Fremanezumab Dose B; p = 0.8629; LS mean difference 0.0 (95% CI -0.48 to 0.58); Mixed Models Analysis NCT03965091 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fremanezumab | Monoclonal antibody | — | Subcutaneous |