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Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial

Inclusion Body Myositis Clinical Trial

Official title:
An Open-label, Non-randomized Trial to Investigate the Efficacy and Safety of Early Versus Delayed Start of Arimoclomol in Patients With Sporadic Inclusion Body Myositis Who Have Completed the IBM4809 Trial

Clinical Trial Summary

A multicenter, nonrandomized, open-label, uncontrolled clinical extension trial designed to compare the efficacy and safety of early versus delayed start of arimoclomol in the treatment of Inclusion Body Myositis (IBM)

Clinical Trial Description

This was planned to be a 40-month open-label extension trial of the 20-month randomized, double-blind, placebo-controlled IBM4809 trial. The open-label trial was terminated early by the sponsor as a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. Therefore, the actual average duration of open-label treatment was approximately 28 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04049097
Study type Interventional
Source ZevraDenmark
Contact
Status Terminated
Phase Phase 3
Start date May 20, 2019
Completion date November 15, 2021
View Details
See also
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