Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Phase 4

Completed

Conditions: Muscle Cramp
Cirrhosis

Interventions: Drug: Vitamin E
Drug: Ropinirole
Other: Muscle cramp survey

Registration Number: NCT03176966

Lead Sponsor: Vanderbilt University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vitamin E then Ropinirole	Muscle cramp survey	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.
Ropinirole then Vitamin E	Muscle cramp survey	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 then Ropinirole	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. 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 then Ropinirole	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.
Ropinirole then Vitamin E	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.
Ropinirole then Vitamin E	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. 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.