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Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Primary Purpose

Muscle Cramp, Cirrhosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin E
Ropinirole
Muscle cramp survey
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Muscle Cramp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vitamin E then Ropinirole

Ropinirole then Vitamin E

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 2, 2017
Last Updated
September 30, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03176966
Brief Title
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Official Title
Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2016 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Cramp, Cirrhosis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin E then Ropinirole
Arm Type
Active Comparator
Arm 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.
Arm Title
Ropinirole then Vitamin E
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Description
Patients will take 400 IU vitamin E nightly for 3 months.
Intervention Type
Drug
Intervention Name(s)
Ropinirole
Other Intervention Name(s)
Requip
Intervention Description
Patients will take 0.5mg ropinirole nightly for 3 months.
Intervention Type
Other
Intervention Name(s)
Muscle cramp survey
Intervention Description
Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
Primary Outcome Measure Information:
Title
Frequency of Muscle Cramps as Assessed by Patient Survey
Description
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 Outcome Measure Information:
Title
Muscle Cramp Severity as Assessed by Patient Survey
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Scanga, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

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