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The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.
Muscle cramps are common in liver disease, especially in patients with cirrhosis. Despite the association of muscle cramps with liver disease, there is a paucity of information regarding treatment in these patients. Many treatment options have been reported in the literature but no standard of treatment has been established.
Oral vitamin E replacement has been used successfully in the management of nocturnal muscle cramps in cirrhotic patients. Ropinirole is primarily used for treatment of restless leg syndrome. An off label trial of low dose Ropinirole in clinical practice has shown some success in providing relief of muscle cramps in patients with cirrhosis. This study will compare Ropinirole to vitamin E treatment in a prospective cross-over study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin E then Ropinirole | Active Comparator | Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. |
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| Ropinirole then Vitamin E | Active Comparator | Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin E | Drug | Patients will take 400 IU vitamin E nightly for 3 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Muscle Cramps as Assessed by Patient Survey | Compare the incidence of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses the frequency of muscle cramps from once weekly or less to multiple episodes per day. Frequency scale is 0 to 3 with 0 being once weekly or less and 3 being multiple episodes a day. Survey is completed at the end of 3 months on study intervention. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle Cramp Severity as Assessed by Patient Survey | Compare the severity of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses muscle cramp pain on a scale from 0 to 10 with 0 being no pain and 10 being hurts worst. Survey is completed at the end of 3 months of study intervention. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Scanga, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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31 subjects were consented and randomized. 1 subject became ill after randomization and was unable to participate so only 30 subjects took a first dose of assigned drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin E Then Ropinirole | Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months. |
| FG001 | Ropinirole Then Vitamin E | Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to 3 Months (1st Intervention) |
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| 3 Month to 6 Months (2nd Intervention) |
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One subject was consented and randomized to Ropinirole then Vitamin E but became ill and withdrew prior to first dose of drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin E Then Ropinirole | Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to Ropinirole. Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Frequency of Muscle Cramps as Assessed by Patient Survey | Compare the incidence of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses the frequency of muscle cramps from once weekly or less to multiple episodes per day. Frequency scale is 0 to 3 with 0 being once weekly or less and 3 being multiple episodes a day. Survey is completed at the end of 3 months on study intervention. | Of the 23 participants who received Vitamin E, data was analyzed for those who completed the survey at the end of each specific crossover period (n=14). Of the 26 participants who received Ropinirole, data was analyzed for those who completed the survey at the end of each specific crossover period (n=13). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
Adverse event data was collected for each patient while they remained on study for a maximum of 6 months participation.
All cause mortality deaths were unrelated to any study intervention. These are not designated as SAEs.
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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 | Vitamin E | Patients will be provided with vitamin E, 400 international units (IU), at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. . Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hepatic encephalopathy | Hepatobiliary disorders | Non-systematic Assessment | Subject admitted to hospital with altered mental status.Note suggests subject not compliant with prescribed lactulose. Subject discharged after one day. This event is not thought by the PI to be related to study IP or study related procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| chest pressure | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael McGill | Vanderbilt University Medical Center | 615-322-4643 | michael.g.mcgill@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 11, 2016 | Aug 10, 2022 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D014810 | Vitamin E |
| C046649 | ropinirole |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ropinirole | Drug | Patients will take 0.5mg ropinirole nightly for 3 months. |
|
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| Muscle cramp survey | Other | Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months. |
|
| Lost to Follow-up |
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| NOT COMPLETED |
|
|
| BG001 | Ropinirole Then Vitamin E | Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. After 3 months, patients will be switched to vitamin E, 400 international units (IU). Surveys measuring muscle cramp frequency and intensity will be collected at baseline, 3 months, and 6 months. Vitamin E: Patients will take 400 IU vitamin E nightly for 3 months. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. Muscle cramp survey: Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Ropinirole Taken Nightly for 3 Months | Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. |
|
|
| Secondary | Muscle Cramp Severity as Assessed by Patient Survey | Compare the severity of muscle cramps in patients using vitamin E versus ropinirole. Patients complete a survey that assesses muscle cramp pain on a scale from 0 to 10 with 0 being no pain and 10 being hurts worst. Survey is completed at the end of 3 months of study intervention. | Of the 23 participants who received Vitamin E, data was analyzed for those who completed the survey at the end of each specific crossover period (n=14). Of the 26 participants who received Ropinirole, data was analyzed for those who completed the survey at the end of each specific crossover period (n=13). | Posted | Mean | Standard Deviation | score on a scale | 3 months |
|
|
|
| 3 |
| 23 |
| 1 |
| 23 |
| 1 |
| 23 |
| EG001 | Ropinirole | Patients will be prescribed ropinirole at baseline. Patient demographics will be collected along with baseline lab data including magnesium, potassium, albumin, and total bilirubin levels. Ropinirole: Patients will take 0.5mg ropinirole nightly for 3 months. | 1 | 26 | 0 | 26 | 3 | 26 |
|
| Increased muscle cramps | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nausea and vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| bruising | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |