NCT01151787

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

Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Kennedy Medical Group · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DRUG	cyclobenzaprine hydrochloride	15mg daily for 3 months
DRUG	placebo	placebo

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2010-06-28
• Last updated: 2014-07-25

Locations

1 site across 1 country: United States