Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Study Overview
=================
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.

Official Title
-----------------
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Conditions
-----------------
Muscle Cramp, Cirrhosis

Intervention / Treatment
-----------------
* Drug: Vitamin E
* Drug: Ropinirole
* Other: Muscle cramp survey


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vitamin E then Ropinirole<br>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. | Drug: Vitamin E<br>* Patients will take 400 IU vitamin E nightly for 3 months.<br>Drug: Ropinirole<br>* Patients will take 0.5mg ropinirole nightly for 3 months.<br>* Other names: Requip;Other: Muscle cramp survey<br>* Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.<br>|
| Active Comparator: Ropinirole then Vitamin E<br>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. | Drug: Vitamin E<br>* Patients will take 400 IU vitamin E nightly for 3 months.<br>Drug: Ropinirole<br>* Patients will take 0.5mg ropinirole nightly for 3 months.<br>* Other names: Requip;Other: Muscle cramp survey<br>* Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |