Back to resultsTreatment of Muscle Cramps in Patients With Liver Cirrhosis
Primary Purpose
Liver Cirrhosis, Muscle Cramps
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hydroxychloroquine
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Cirrhosis focused on measuring liver cirrhosis, muscle cramps
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hydroxychloroquine
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01495403
Brief Title
Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Official Title
A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis, Muscle Cramps
Keywords
liver cirrhosis, muscle cramps
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hydroxychloroquine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Other Intervention Name(s)
Plaquenil
Intervention Description
daily dosing
Primary Outcome Measure Information:
Title
frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
Description
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.
Time Frame
1 month after completion of questionnaire
Secondary Outcome Measure Information:
Title
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.
Description
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.
Time Frame
28 days after first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Kamath, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Muscle Cramps in Patients With Liver Cirrhosis
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