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

NCT01151787 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2014-07-25

No results posted yet for this study

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

DRUG

cyclobenzaprine hydrochloride

15mg daily for 3 months

DRUG

placebo

placebo

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • Kennedy Medical Group

    lead OTHER

Principal Investigators

  • Loretta Mueller, DO · Kennedy Medical Group dba The Headache Center at Kennedy Health Alliance

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01151787 on ClinicalTrials.gov