Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Vanderbilt University Medical Center31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Muscle Cramp Cirrhosis

Interventions

Vitamin EDRUG

Patients will take 400 IU vitamin E nightly for 3 months.

RopiniroleDRUG

Patients will take 0.5mg ropinirole nightly for 3 months.

Muscle cramp surveyOTHER

Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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