A Phase 2 interventional study of Baclofen in Muscle Cramps and Cirrhosis, sponsored by University of Virginia. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-05.
Sponsored by University of Virginia · Phase 2, Interventional, and Treatment
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.
95 studies on the registry are indexed under Muscle Cramp; 9 are open to participants now.
This study's enrollment of 10 is below the median of 50 across 85 interventional studies indexed under Muscle Cramp.
Browse Muscle Cramp studies →University of Virginia is the lead sponsor of 653 studies on the registry; 134 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 41 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Baclofen
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
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)
| Milestone | Treatment |
|---|---|
| Started | 10 |
| Completed | 7 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Death | 1 |
| Withdrew: Patient underwent transplant | 1 |
Proportion of patients with headache at any time during the 4 weeks of therapy
| participants | Treatment |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache) | 3 |
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).
| days/week | Treatment |
|---|---|
| Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy | -4.4 ± 3.3 |
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).
| units on a scale | Treatment |
|---|---|
| Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy | -6 ± 2.9 |
Proportion of patients with nausea at any time during the 4 weeks of therapy
| participants | Treatment |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea) | 4 |
Proportion of patients with dizziness at any time during the 4 weeks of therapy
| participants | Treatment |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness) | 2 |
Proportion of patients with endephalopathy at any time during the 4 weeks of therapy
| participants | Treatment |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy) | 0 |
Proportion of patients with somnolence at any time during the 4 weeks of therapy
| participants | Treatment |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence) | 1 |
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)
| days/week | Treatment |
|---|---|
| Change in Frequency of Muscle Cramps After Washout Period | 3.0 ± 3.9 |
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)
| units on a scale | Treatment |
|---|---|
| Change in Severity of Muscle Cramps After Washout Period | 4.0 ± 4.0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | — | 0/10 (0%) | 6/10 (60%) |
| Event | Treatment |
|---|---|
| NauseaGastrointestinal disorders | 4/10 |
| HeadacheNervous system disorders | 3/10 |
| DizzinessNervous system disorders | 2/10 |
| SomnolenceNervous system disorders | 1/10 |
| Age, Categorical(Participants) | Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment |
|---|---|
| Female | 5 |
| Male | 5 |
| Region of Enrollment(participants) | Treatment |
|---|---|
| United States | 10 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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University of Virginia