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

Fibromyalgia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03965091
Study type Interventional
Source Teva Branded Pharmaceutical Products R&D, Inc.
Contact
Status Terminated
Phase Phase 2
Start date July 31, 2019
Completion date January 19, 2022
View Details
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