Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Cirrhosis Clinical Trial

Official title:

Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176966
• Other study ID #: 160960
• Status: Completed
• Phase: Phase 4
• Start date: September 2, 2016
• Est. completion date: October 22, 2021

Study information

• Verified date: September 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 22, 2021
• Est. primary completion date: October 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Muscle Cramp
• Spasm

Intervention

Drug:
• Vitamin E
Patients will take 400 IU vitamin E nightly for 3 months.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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