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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03176966
Other study ID # 160960
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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