Treatment of Muscle Cramps in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495403
• Other study ID #: 11-002743
• Status: Completed
• Phase: Early Phase 1
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: May 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Muscle Cramp
• Muscle Cramps
• Spasm

Intervention

Drug:
• Hydroxychloroquine
daily dosing

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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