Status:
COMPLETED
Arimoclomol in Sporadic Inclusion Body Myositis
Lead Sponsor:
Richard Barohn, MD
Conditions:
Inclusion Body Myositis
Eligibility:
All Genders
50+ years
Phase:
PHASE2
PHASE3
Brief Summary
Inclusion body myositis (IBM) is the most common progressive and debilitating muscle disease beginning in persons over 50 years of age. This study will assess the safety and tolerability of Arimoclomo...
Detailed Description
IBM is a chronic disorder in which muscles become inflamed (swollen) and cause muscle weakening. The cause is unknown. There is new evidence to suggest that the pathology in IBM results from cellular ...
Eligibility Criteria
Inclusion
- Meet the diagnostic criteria for definite or probable IBM (Griggs 1995)
- Muscle function adequate for quantitative muscle testing
- Age \> 50 years
- Women must be postmenopausal or status post hysterectomy
- For any patient currently taking medication for IBM, they must remain on current dosage for the extent of the study and last dosage change must be \> 30 days previous to enrollment
Exclusion
- Presence of any one of the following medical conditions: diabetes mellitus or patients taking anti-diabetic medications, chronic infection, chronic renal insufficiency, cancer other than skin cancer less than 5 years previously, multiple sclerosis or prior episode or central nervous system demyelination, or other chronic serious medical illnesses
- Presence of any of the following on routine blood screening: WBC \< 3000, platelets \< 100,000, hematocrit \< 30%, BUN \> 30 mg%, creatine \> 1.5 mg%, symptomatic liver disease with serum albumin \< 3 g/dl, PT or PTT \> upper range of control values
- Women who are pregnant or lactating
- History of non-compliance with other therapies
- Coexistence of other neuromuscular disease
- Drug or alcohol abuse within the last 3 months
- Inability to give informed consent
- Known bleeding disorder
- Use of potentially renal toxic drugs
- Prior difficulties with local anesthetic
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00769860
Start Date
September 1 2008
End Date
September 1 2012
Last Update
January 19 2017
Active Locations (2)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
2
University College London, MRC Centre for Neuromuscular Disease
London, United Kingdom