Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Vanderbilt University Medical Center

Status and phase: Completed; Phase 4

Conditions: Cirrhosis; Muscle Cramp

Treatments: Drug: Ropinirole; Other: Muscle cramp survey; Drug: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT03176966

160960

Details and patient eligibility

About

The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Vitamin E then Ropinirole

Active Comparator group

Description:

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.

Treatment:

Other: Muscle cramp survey

Drug: Ropinirole

Drug: Vitamin E

Ropinirole then Vitamin E

Active Comparator group

Description:

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.

Treatment:

Other: Muscle cramp survey

Drug: Ropinirole

Drug: Vitamin E