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

University of Virginia

Status and phase: Completed; Phase 2

Conditions: Muscle Cramps; Cirrhosis

Treatments: Drug: Baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT02298868

16306

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.

Treatment:

Drug: Baclofen