Treatment of Muscle Cramps in Patients With Liver Cirrhosis

May 2, 2023 updated by: Patrick Kamath, Mayo Clinic

A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis

This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • previous diagnosis of cirrhosis
  • adult (>21 years)
  • able to complete a written questionnaire in English
  • stable and ambulatory
  • MELD score < 25, Platelet count >25,000

Exclusion Criteria:

  • people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation
  • previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone
  • previous diagnosis of porphyria
  • previous diagnosis of psoriasis
  • fulminant hepatic failure
  • pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hydroxychloroquine
Drug: Hydroxychloroquine
daily dosing
Other Names:
  • Plaquenil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
Time Frame: 1 month after completion of questionnaire
Patients will be given the mMCQ and SF-12 to complete. These instruments will be scored according to established algorithms. Data analysis will include descriptive statistics (frequency, duration and severity of muscle cramps) and correlation between overall quality of life and the mMCQ summary score.
1 month after completion of questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.
Time Frame: 28 days after first dose
The study intervention will include open label HCQ daily, which will be provided for the patients for two weeks. A designated coordinator will contact the patient 2 and 7 days of the study to ask of adverse events and fill out the AE inventory. At the end of the dosing, patients will be asked to return to the clinic for post-intervention assessment, which will include the mMCQ, SF-12, systemic AE inventory, CBC and EKG. Designated coordinator will contact patient again on day 28 of the study to ask mMCQ, SF-12, AE inventory.
28 days after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Patrick Kamath, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 19, 2011

First Posted (Estimate)

December 20, 2011

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-002743

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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