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

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.

Timeline

Start

2010-07

Primary completion

2013-09

Completion

2013-09

Outcome

Outcome not reported

Stopped: “Study was never initiated under new location/provider group. Contract to continue was never signed between TEVA and Kennedy Headache Center”

Drugs

Indications