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

Phase 2

Completed

• Conditions: Muscle Cramps; Cirrhosis
• Interventions: Drug: Baclofen

• Registration Number: NCT02298868
• Lead Sponsor: University of Virginia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-11
• Study Completion: 2014-11
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-19
• Study First Posted: 2014-11-24
• Results First Submitted: 2015-01-06
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-04
• Last Update Submitted: 2015-02-04
• Results First Posted: 2015-02-05
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Baclofen	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)	4 weeks of active therapy	Proportion of patients with nausea at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)	4 weeks of active therapy	Proportion of patients with somnolence at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)	4 weeks of active therapy	Proportion of patients with headache at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)	4 weeks of active therapy	Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)	4 weeks of active therapy	Proportion of patients with dizziness at any time during the 4 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy	Baseline to 4 weeks of therapy	Patients undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps. This measures was repeated after 4 weeks of therapy and reported as the mean decrease in frequency of muscle cramps (4 weeks of therapy-Baseline).
Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy	Baseline to end of 4 weeks of therapy	Patients undertook a muscle cramp questionnaire prior to treatment that measured severity in a 0-10 analog scale (0 is no pain and 10 is most severe pain). These measures were repeated after 4 weeks of therapy and the difference was assessed (4 weeks of therapy-Baseline).
Change in Frequency of Muscle Cramps After Washout Period	End of treatment (week 4) to end of washout (week 7)	Subjects undertook a muscle cramp questionnaire prior to treatment that measured frequency in the number of days in a week that a subject experienced muscle cramps and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess frequency of muscle cramps. This was then compared to the end of therapy frequency to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)
Change in Severity of Muscle Cramps After Washout Period	End of treatment (week 4) to end of washout (week 7)	Subjects undertook a muscle cramp questionnaire prior to treatment that measured severity on a 0-10 analog scale (0 is no pain, 10 is most severe pain) and repeated this measure at the end of baclofen therapy (end of week 4). Subjects then underwent a 1 week taper of baclofen and a subsequent two week washout period. At the end of the washout period (end of week 7) the subjects underwent a final muscle cramp questionnaire to reassess severity of muscle cramps. This was then compared to the end of therapy severity to document the increase in muscle cramps after stopping baclofen. (week 7 result - week 4 result)