Treatment of Muscle Cramps in Patients With Liver Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495403
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : July 30, 2015
Information provided by (Responsible Party):
Patrick Kamath, Mayo Clinic

December 16, 2011
December 20, 2011
July 30, 2015
December 2011
April 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01495403 on Archive Site
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory. [ Time Frame: 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.
Same as current
Not Provided
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Treatment of Muscle Cramps in Patients With Liver Cirrhosis
A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
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.
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.
Early Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Liver Cirrhosis
  • Muscle Cramps
Drug: Hydroxychloroquine
daily dosing
Other Name: Plaquenil
Experimental: hydroxychloroquine
Intervention: Drug: Hydroxychloroquine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Patrick Kamath, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Patrick Kamath, MD Mayo Clinic
Mayo Clinic
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP