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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Muscle Cramps
• Intervention / Treatment: Drug: Baclofen

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Baclofen

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 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).	Baseline to 4 weeks of therapy
Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 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).	Baseline to end of 4 weeks of therapy
Change in Frequency of Muscle Cramps After Washout Period	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)	End of treatment (week 4) to end of washout (week 7)
Change in Severity of Muscle Cramps After Washout Period	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)	End of treatment (week 4) to end of washout (week 7)

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Zachary Henry, M.D., University of Virginia

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 5, 2015
• Last Update Submitted That Met QC Criteria: February 4, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Liver Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Fibrosis; Liver Cirrhosis; Spasm; Muscle Cramp; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: 16306