Arimoclomol in Sporadic Inclusion Body Myositis
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Inclusion Body Myositis
In brief
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 Arimoclomol in IBM as compared to placebo over 4 months of treatment.
Key facts
- Study ID
- NCT00769860
- Run by
- Richard Barohn, MD
- People needed
- 24
- Starts
- 2008-09-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2017-01-19
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Kansas Medical Center — Kansas City, Kansas, United States
- University College London, MRC Centre for Neuromuscular Disease — London, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.