Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Overview
- Phase
- Phase 2
- Intervention
- Baclofen
- Conditions
- Muscle Cramps
- Sponsor
- University of Virginia
- Enrollment
- 10
- Primary Endpoint
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Zachary Henry, MD
Fellow Physician
University of Virginia
Eligibility 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
Arms & Interventions
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.
Intervention: Baclofen
Outcomes
Primary Outcomes
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
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
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
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
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
Secondary Outcomes
- 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)
- 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)
- Change in Frequency of Muscle Cramps After Washout Period(End of treatment (week 4) to end of washout (week 7))
- Change in Severity of Muscle Cramps After Washout Period(End of treatment (week 4) to end of washout (week 7))