Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Early Phase 1

Completed

• Conditions: Muscle Cramps; Liver Cirrhosis
• Interventions: Drug: Hydroxychloroquine

• Registration Number: NCT01495403
• Lead Sponsor: Mayo Clinic

Brief Summary

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

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-16
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-20
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hydroxychloroquine	Hydroxychloroquine	-

Primary Outcome Measures

Name	Time	Method
frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)	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.

Secondary Outcome Measures

Name	Time	Method
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States