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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Muscle Cramps Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

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.

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

Interventions

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Baclofen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No