Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-02

Study Completion Date

2021-10-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Muscle Cramp Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DRUG

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

Ropinirole

Intervention Type DRUG

Patients will take 0.5mg ropinirole nightly for 3 months.

Muscle cramp survey

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Vitamin E

Intervention Type DRUG

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

Ropinirole

Intervention Type DRUG

Patients will take 0.5mg ropinirole nightly for 3 months.

Muscle cramp survey

Intervention Type OTHER

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

Interventions

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Vitamin E

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

Intervention Type DRUG

Ropinirole

Patients will take 0.5mg ropinirole nightly for 3 months.

Intervention Type DRUG

Muscle cramp survey

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

Intervention Type OTHER

Other Intervention Names

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Requip

Eligibility Criteria

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Inclusion Criteria

* Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice
* diagnosis of cirrhosis
* Self report regular muscle cramping