A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
Overview
- Phase
- Early Phase 1
- Intervention
- Hydroxychloroquine
- Conditions
- Liver Cirrhosis
- Sponsor
- Mayo Clinic
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Patrick Kamath
PI
Mayo Clinic
Eligibility Criteria
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
Arms & Interventions
hydroxychloroquine
Intervention: Hydroxychloroquine
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.(28 days after first dose)