Back to resultsSafety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Primary Purpose
Muscle Cramps, Cirrhosis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Baclofen
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Cramps
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
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).
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).
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)
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)
Full Information
NCT ID
NCT02298868
First Posted
November 12, 2014
Last Updated
February 4, 2015
Sponsor
University of Virginia
1. Study Identification
Unique Protocol Identification Number
NCT02298868
Brief Title
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Official Title
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramps, Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Baclofen
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)
Description
Proportion of patients with headache at any time during the 4 weeks of therapy
Time Frame
4 weeks of active therapy
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)
Description
Proportion of patients with nausea at any time during the 4 weeks of therapy
Time Frame
4 weeks of active therapy
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)
Description
Proportion of patients with dizziness at any time during the 4 weeks of therapy
Time Frame
4 weeks of active therapy
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)
Description
Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
Time Frame
4 weeks of active therapy
Title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)
Description
Proportion of patients with somnolence at any time during the 4 weeks of therapy
Time Frame
4 weeks of active therapy
Secondary Outcome Measure Information:
Title
Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy
Description
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
Title
Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy
Description
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
Title
Change in Frequency of Muscle Cramps After Washout Period
Description
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)
Title
Change in Severity of Muscle Cramps After Washout Period
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zachary Henry, M.D.
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
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