Status:
COMPLETED
Lithium in Inclusion Body Myositis (IBM)
Lead Sponsor:
Phoenix Neurological Associates, LTD
Conditions:
Inclusion Body Myositis
Eligibility:
All Genders
30-88 years
Brief Summary
IBM is the most common acquired muscle disease occurring over the age of 50. The underlying cause remains unknown and there is currently no effective treatment. Pathological studies have revealed abno...
Detailed Description
Trial Status Open for Enrollment What is the Purpose of this Study? There is currently no effective treatment for IBM and its pathogenesis remains uncertain. This study is designed to test the hypoth...
Eligibility Criteria
Inclusion
- Age \>30
- Meet diagnostic criteria for definite IBM
- Muscle function adequate for quantitative muscle testing
- Able to give informed consent
- Women of child bearing potential must have a negative pregnancy test
Exclusion
- Presence of uncontrolled diabetes, hypothyroidism, chronic infection, chronic renal insufficiency, congestive heart failure, cancer, or other chronic serious medical conditions
- Significant arrhythmias or conduction defect abnormalities on ECG
- Pregnant or lactating
- Coexistence of other neuromuscular or neurological diseases that would interfere with assessment
- Known bleeding disorder
- On Warfarin
- Contraindications to muscle biopsy: allergy to local anesthetic, skin infection, known bleeding disorder
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00917956
Start Date
June 1 2008
End Date
December 1 2009
Last Update
February 26 2010
Active Locations (1)
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1
Phoenix Neurological Associates, LTD
Phoenix, Arizona, United States, 85018