Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Liver Cirrhosis, Muscle Cramps

Intervention / Treatment
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* Drug: Hydroxychloroquine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hydroxychloroquine<br> | Drug: Hydroxychloroquine<br>* daily dosing<br>* Other names: Plaquenil;|

What is the study measuring?
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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) | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, muscle cramps