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Treatment of Muscle Cramps in Patients With Liver Cirrhosis

This study has been completed.
Information provided by (Responsible Party):
Patrick Kamath, Mayo Clinic Identifier:
First received: December 16, 2011
Last updated: July 29, 2015
Last verified: July 2015
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 Intervention Phase
Liver Cirrhosis
Muscle Cramps
Drug: Hydroxychloroquine
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 3
Study Start Date: December 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hydroxychloroquine Drug: Hydroxychloroquine
daily dosing
Other Name: Plaquenil

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01495403

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

Responsible Party: Patrick Kamath, PI, Mayo Clinic Identifier: NCT01495403     History of Changes
Other Study ID Numbers: 11-002743
Study First Received: December 16, 2011
Last Updated: July 29, 2015

Keywords provided by 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 processed this record on April 28, 2017