Treatment of Muscle Cramps in Patients With Liver Cirrhosis
A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Dec 2011
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 16, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 3, 2023
May 1, 2023
3.3 years
December 16, 2011
May 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month after completion of questionnaire
Secondary Outcomes (1)
safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.
28 days after first dose
Study Arms (1)
hydroxychloroquine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Kamath, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 16, 2011
First Posted
December 20, 2011
Study Start
December 1, 2011
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
May 3, 2023
Record last verified: 2023-05