Status:
COMPLETED
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Lead Sponsor:
University of Virginia
Conditions:
Muscle Cramps
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- Cirrhosis
- Presence of muscle cramps on a regular basis
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02298868
Start Date
October 1 2012
End Date
November 1 2014
Last Update
February 5 2015
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