Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 22, 2021

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.

Interventions

  • Drug: Vitamin E
    • Patients will take 400 IU vitamin E nightly for 3 months.
  • Drug: Ropinirole
    • Patients will take 0.5mg ropinirole nightly for 3 months.
  • Other: Muscle cramp survey
    • Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.

Arms, Groups and Cohorts

  • Active Comparator: 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.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Frequency of Muscle Cramps as Assessed by Patient Survey
    • Time Frame: 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 Measures

  • Muscle Cramp Severity as Assessed by Patient Survey
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andrew Scanga, Principal Investigator – Vanderbilt University Medical Center
  • Overall Official(s)
    • Andrew Scanga, MD, Principal Investigator, Vanderbilt University Medical Center

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