Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Mayo Clinic

Status and phase: Completed; Early Phase 1

Conditions: Muscle Cramps; Liver Cirrhosis

Treatments: Drug: Hydroxychloroquine

Study type: Interventional

Funder types: Other

Identifiers

NCT01495403

11-002743

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

hydroxychloroquine

Experimental group

Treatment:

Drug: Hydroxychloroquine