Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia
• Treatments: Baclofen

Criteria

Inclusion Criteria:

• Cirrhosis

• Presence of muscle cramps on a regular basis

Exclusion Criteria:

• Allergy or hypersensitivity to Baclofen

• Active or untreated Portosystemic encephalopathy

• Active alcohol or substance abuse

• Age less than 18

• Pregnancy

• Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent

• Concomitant use of Tricyclic Antidepressant due to drug interaction

• History of chronic kidney disease defined by GFR < 30 (using MDRD equation)

• Subject is institutionalized or a prisoner

• Inability or unwillingness to give informed consent

• Expected lifespan less than 3 months

• Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols