NCT03965091

A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of the Efficacy and Safety of Fremanezumab for Treatment of Patients With Fibromyalgia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fibromyalgia

Interventions

Type	Name	Description
DRUG	Fremanezumab	Fremanezumab will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to fremanezumab will be administered per schedule specified in the arm description.

Timeline

• Start date: 2019-07-31
• Primary completion: 2022-01-19
• Completion: 2022-01-19
• First posted: 2019-05-28
• Last updated: 2023-03-30
• Results posted: 2023-03-30

Locations

49 sites across 1 country: United States

Regulatory

• FDA-regulated drug study