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Completed

NCT Number: NCT02298868

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

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.

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Key information

Conditions

Muscle Cramps Cirrhosis Fibrosis Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Baclofen

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Nov 24, 2014
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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