NCT00769860

Arimoclomol in Sporadic Inclusion Body Myositis

Safety and Tolerability Trial of Arimoclomol for Sporadic Inclusion Body Myositis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Richard Barohn, MD · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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 changes induced by a variety of stressful events and diseases. In response to these stressful events the body's normal response is to increase the levels of Heat Shock Proteins (HSP) to help counteract and stop these cellular changes. In people with IBM this increase does not appear sufficient enough to reverse these toxic cellular changes. Arimoclomol causes the body to make more of this HSP protein. By increasing HSP levels in IBM patients we hope to reverse the toxic cellular changes that might be responsible for the pathology of IBM.

Conditions

• Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	Arimoclomol	Arimoclomol 100 mg TID for 4 months
OTHER	Placebo	Placebo for 4 months

Timeline

• Start date: 2008-09-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2008-10-09
• Last updated: 2017-01-19
• Results posted: 2017-01-19

Locations

2 sites across 2 countries: United States, United Kingdom