NCT03176966

Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Muscle Cramp
• Cirrhosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-09-02
• Primary completion: 2021-10-22
• Completion: 2021-10-22
• First posted: 2017-06-06
• Last updated: 2022-10-31
• Results posted: 2022-10-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study