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

• ClinicalTrials.gov Identifier: NCT02298868
• Recruitment Status: Completed
• First Posted: November 24, 2014
• Results First Posted: February 5, 2015
• Last Update Posted: February 5, 2015
• Sponsor: University of Virginia
• Information provided by (Responsible Party): Zachary Henry, MD, University of Virginia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Muscle Cramps; Cirrhosis	Drug: Baclofen	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
• Study Start Date: October 2012
• Actual Primary Completion Date: November 2013
• Actual Study Completion Date: November 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) [ Time Frame: 4 weeks of active therapy ]
   Proportion of patients with headache at any time during the 4 weeks of therapy
2. Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) [ Time Frame: 4 weeks of active therapy ]
   Proportion of patients with nausea at any time during the 4 weeks of therapy
3. Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) [ Time Frame: 4 weeks of active therapy ]
   Proportion of patients with dizziness at any time during the 4 weeks of therapy
4. Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) [ Time Frame: 4 weeks of active therapy ]
   Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
5. Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) [ Time Frame: 4 weeks of active therapy ]
   Proportion of patients with somnolence at any time during the 4 weeks of therapy

Secondary Outcome Measures :

1. Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy [ Time Frame: 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).
2. Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy [ Time Frame: 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).
3. Change in Frequency of Muscle Cramps After Washout Period [ Time Frame: 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)
4. Change in Severity of Muscle Cramps After Washout Period [ Time Frame: 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)

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Virginia

Investigators

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

More Information

• Responsible Party: Zachary Henry, MD, Fellow Physician, University of Virginia
• ClinicalTrials.gov Identifier: NCT02298868
• Other Study ID Numbers: 16306
• First Posted: November 24, 2014
• Results First Posted: February 5, 2015
• Last Update Posted: February 5, 2015
• Last Verified: February 2015

Additional relevant MeSH terms:

Muscle Cramp; Liver Cirrhosis; Spasm; Fibrosis; Pathologic Processes; Liver Diseases; Digestive System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Baclofen; Muscle Relaxants, Central; Physiological Effects of Drugs; Neuromuscular Agents; Peripheral Nervous System Agents; GABA-B Receptor Agonists; GABA Agonists; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action