drugset / Trial / NCT04049097
Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial
Phase 3
Terminated
121 enrolled
ZevraDenmark
University College, London · collabUniversity of Kansas Medical Center · collab
NaSingle-groupOpen-labelTreatment
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)
Timeline
- Start
- 2019-05-20
- Primary completion
- 2021-11-15
- Completion
- 2021-11-15
Outcome
Outcome not reported
Stopped: “As a consequence of the results of IBM4809 which did not meet any of its efficacy endpoints. The planned duration of open-label treatment was 40 months. After termination, the actual mean duration of treatment was approx. 28 weeks.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Arimoclomol | Small molecule | 248 mg | — |