Overview

Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine

Status:
Terminated
Trial end date:
2013-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to evaluate the effectiveness and safety of cyclobenzaprine hydrochloride extended release (Amrix 15mg/day) for the prophylaxis of chronic migraine compared to a placebo medication. A second objective, is to find out whether there is an improvement in quality of sleep and self-reported depression in patients taking Amrix 15mg daily. The hypothesis is that the number of migraine days per month of patients treated with Amrix 15mg daily will be significantly lower than those patients treated with placebo.
Phase:
Phase 3
Details
Lead Sponsor:
Kennedy Medical Group
Collaborator:
Teva Pharmaceuticals USA
Treatments:
Amitriptyline
Cyclobenzaprine