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

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Muscle Cramps Drug: Hydroxychloroquine Early Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Start Date : December 2011
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: hydroxychloroquine Drug: Hydroxychloroquine
daily dosing
Other Name: Plaquenil

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495403

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Patrick Kamath, MD Mayo Clinic

Responsible Party: Patrick Kamath, PI, Mayo Clinic Identifier: NCT01495403     History of Changes
Other Study ID Numbers: 11-002743
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Patrick Kamath, Mayo Clinic:
liver cirrhosis
muscle cramps

Additional relevant MeSH terms:
Liver Cirrhosis
Muscle Cramp
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents