Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Muscle Cramps in Patients With Liver Cirrhosis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Patrick Kamath, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01495403
First received: December 16, 2011
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495403

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

No publications provided

Responsible Party: Patrick Kamath, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01495403     History of Changes
Other Study ID Numbers: 11-002743
Study First Received: December 16, 2011
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
liver cirrhosis
muscle cramps

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

ClinicalTrials.gov processed this record on November 27, 2014