Cirrhosis, Muscle Cramp
Conditions
Brief summary
The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.
Detailed description
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.
Interventions
DRUGVitamin E
Patients will take 400 IU vitamin E nightly for 3 months.
DRUGRopinirole
Patients will take 0.5mg ropinirole nightly for 3 months.
OTHERMuscle cramp survey
Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice * diagnosis of cirrhosis * Self report regular muscle cramping
Exclusion criteria
* Patients without cirrhosis * Patients under the age of 18 * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Muscle Cramps as Assessed by Patient Survey | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Cramp Severity as Assessed by Patient Survey | 3 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 16 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month to 6 Months (2nd Intervention) | Death | 0 | 1 |
| 3 Month to 6 Months (2nd Intervention) | Lost to Follow-up | 3 | 4 |
| 3 Month to 6 Months (2nd Intervention) | Physician Decision | 1 | 0 |
| 3 Month to 6 Months (2nd Intervention) | Withdrawal by Subject | 2 | 0 |
| Baseline to 3 Months (1st Intervention) | Death | 2 | 1 |
| Baseline to 3 Months (1st Intervention) | Lost to Follow-up | 1 | 2 |
| Baseline to 3 Months (1st Intervention) | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Vitamin E Then Ropinirole | Total | Ropinirole Then Vitamin E |
|---|---|---|---|
| Age, Continuous | 53.6 years STANDARD_DEVIATION 8.8 | 58.0 years STANDARD_DEVIATION 8.7 | 61.8 years STANDARD_DEVIATION 6.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 28 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 14 Participants | 28 Participants | 14 Participants |
| Region of Enrollment United States | 14 participants | 30 participants | 16 participants |
| Sex: Female, Male Female | 4 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Male | 10 Participants | 17 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 23 | 1 / 26 |
| other Total, other adverse events | 1 / 23 | 3 / 26 |
| serious Total, serious adverse events | 1 / 23 | 0 / 26 |
Outcome results
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.
Time frame: 3 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin E Taken Nightly for 3 Months | Frequency of Muscle Cramps as Assessed by Patient Survey | 1.14 score on a scale | Standard Deviation 0.99 |
| Ropinirole Taken Nightly for 3 Months | Frequency of Muscle Cramps as Assessed by Patient Survey | 1.23 score on a scale | Standard Deviation 1.42 |
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.
Time frame: 3 months
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin E Taken Nightly for 3 Months | Muscle Cramp Severity as Assessed by Patient Survey | 6.57 score on a scale | Standard Deviation 3.79 |
| Ropinirole Taken Nightly for 3 Months | Muscle Cramp Severity as Assessed by Patient Survey | 6.00 score on a scale | Standard Deviation 3.53 |