Ropinirole for the Treatment of Muscle Cramps in Patients With Cirrhosis

NCT03176966 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 160960
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Muscle Cramp; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle Cramp Severity as Assessed by Patient Survey

  3 months

Study Arms (2)

Vitamin E then Ropinirole

ACTIVE COMPARATOR

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; Drug: Ropinirole; Other: Muscle cramp survey

Ropinirole then Vitamin E

ACTIVE COMPARATOR

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; Drug: Ropinirole; Other: Muscle cramp survey

Interventions

Vitamin E DRUG

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

Ropinirole then Vitamin E; Vitamin E then Ropinirole

Ropinirole DRUG

Patients will take 0.5mg ropinirole nightly for 3 months.

Also known as: Requip

Ropinirole then Vitamin E; Vitamin E then Ropinirole

Muscle cramp survey OTHER

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

Ropinirole then Vitamin E; Vitamin E then Ropinirole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age in the Vanderbilt Medical Center Hepatology Practice
• diagnosis of cirrhosis
• Self report regular muscle cramping

You may not qualify if:

• Patients without cirrhosis
• Patients under the age of 18
• Pregnant women

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Muscle Cramp; Fibrosis

Interventions

Vitamin E; ropinirole

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Michael McGill
• Organization: Vanderbilt University Medical Center

michael.g.mcgill@vumc.org

615-322-4643

Study Officials

• Andrew Scanga, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 6, 2017
• Study Start: September 2, 2016
• Primary Completion: October 22, 2021
• Study Completion: October 22, 2021
• Last Updated: October 31, 2022
• Results First Posted: October 31, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)