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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298868
• Other study ID #: 16306
• Status: Completed
• Phase: Phase 2
• First received: November 12, 2014
• Last updated: February 4, 2015
• Start date: October 2012
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis
• Muscle Cramp
• Muscle Cramps
• Spasm

Intervention

Drug:
• Baclofen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No