Arimoclomol in Sporadic Inclusion Body Myositis

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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 Arimoclomol in IBM as compared to placebo over 4 months of treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Richard Barohn, MD

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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