Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

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 Overview

• Status: Completed
• Conditions: Cirrhosis; Muscle Cramp
• Intervention / Treatment: Drug: Vitamin E; Drug: Ropinirole; Other: Muscle cramp survey

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Requip; Other: Muscle cramp survey; Patients will complete a survey of muscle cramp frequency and severity 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.	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 Names: Requip; Other: Muscle cramp survey; Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2016
• Primary Completion (Actual): October 22, 2021
• Study Completion (Actual): October 22, 2021

Study Registration Dates

• First Submitted: June 2, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Liver Diseases; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Fibrosis; Liver Cirrhosis; Spasm; Muscle Cramp; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Dopamine Agonists; Dopamine Agents; Vitamins; Antioxidants; Antiparkinson Agents; Anti-Dyskinesia Agents; Vitamin E; Ropinirole
• Other Study ID Numbers: 160960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No