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Completed

NCT Number: NCT03176966

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.

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Key information

Conditions

Muscle Cramp Cirrhosis Fibrosis Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Drug

Patients will take 400 IU vitamin E nightly for 3 months.

Ropinirole

Drug

Patients will take 0.5mg ropinirole nightly for 3 months.

Other names: Requip

Muscle cramp survey

Other

Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.

Primary outcomes

  1. Frequency of Muscle Cramps as Assessed by Patient Survey

    Time frame: 3 months

    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 outcomes

  1. Muscle Cramp Severity as Assessed by Patient Survey

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 6, 2017
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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