A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia
Status:
Recruiting
Trial end date:
2022-03-12
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to estimate the treatment effect of fremanezumab
administered subcutaneously in reducing pain in adult patients with 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
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.
Phase:
Phase 2
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Branded Pharmaceutical Products, R&D Inc.