drugset / Trial / NCT05458011
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
RandomizedParallel-groupDouble-blindTreatment
Summary
Primary Objective: To demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult Chinese participants with migraine. Secondary Objectives: * To further demonstrate the efficacy of fremanezumab administered as monthly and quarterly sc injections. * To evaluate the safety and tolerability of fremanezumab administered as monthly and quarterly sc injections.
Timeline
- Start
- 2022-09-30
- Primary completion
- 2024-01-31
- Completion
- 2024-06-13
Outcome
Met primary endpoint
registry analysis (other test); Placebo vs Fremanezumab Monthly/Quarterly; p <0.0001; LS Mean Difference -1.8 (95% CI -2.66 to -0.95); ANCOVA NCT05458011 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fremanezumab | Monoclonal antibody | — | Subcutaneous |