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Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03176966
First Posted: June 6, 2017
Last Update Posted: July 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael K. Porayko, M.D., Vanderbilt University Medical Center
  Purpose
The investigator's aim is to compare the efficacy of Ropinirole (Requip) to vitamin E in the treatment of muscle cramps in cirrhotic patients.

Condition Intervention Phase
Muscle Cramp Cirrhosis Drug: Vitamin E Drug: Ropinirole Other: Muscle cramp survey Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

Resource links provided by NLM:


Further study details as provided by Michael K. Porayko, M.D., Vanderbilt University Medical Center:

Primary Outcome Measures:
  • Frequency of muscle cramps as assessed by patient survey [ Time Frame: baseline to 6 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.


Secondary Outcome Measures:
  • Muscle cramp severity as assessed by patient survey [ Time Frame: baseline to 6 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 5 with 0 being no pain and 5 being hurts worst.


Estimated Enrollment: 60
Actual Study Start Date: September 2, 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin E then Ropinirole
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.
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 Name: Requip
Other: Muscle cramp survey
Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
Active Comparator: Ropinirole then Vitamin E
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.
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 Name: Requip
Other: Muscle cramp survey
Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176966


Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Michael Porayko, MD Vanderbilt University Medical Center
  More Information

Responsible Party: Michael K. Porayko, M.D., Principal Investigator, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03176966     History of Changes
Other Study ID Numbers: 160960
First Submitted: June 2, 2017
First Posted: June 6, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Muscle Cramp
Spasm
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Ropinirole
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents