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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4 weeks of active therapy
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).
Time frame: Baseline to 4 weeks of therapy
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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).
Time frame: 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)
Time frame: 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)
Time frame: End of treatment (week 4) to end of washout (week 7)