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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baclofen | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 4 weeks of active therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zachary Henry, M.D. | University of Virginia | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 4 weeks of active therapy |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Zachary Henry | University of Virginia | 434-243-2718 | zhenry@virginia.edu |
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| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D001418 | Baclofen |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| 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). | 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) | 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) | End of treatment (week 4) to end of washout (week 7) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | days/week | Baseline to 4 weeks of therapy |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline to end of 4 weeks of therapy |
|
|
|
| Primary | 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 | Posted | Number | participants | 4 weeks of active therapy |
|
|
|
| Primary | 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 | Posted | Number | participants | 4 weeks of active therapy |
|
|
|
| Primary | 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 | Posted | Number | participants | 4 weeks of active therapy |
|
|
|
| Primary | 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 | Posted | Number | participants | 4 weeks of active therapy |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | days/week | End of treatment (week 4) to end of washout (week 7) |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | units on a scale | End of treatment (week 4) to end of washout (week 7) |
|
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|
| 0 |
| 10 |
| 6 |
| 10 |
| Nausea | Gastrointestinal disorders |
|
| Dizziness | Nervous system disorders |
|
| Somnolence | Nervous system disorders |
|
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |