CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 152 enrolled
Drug / intervention
Arimoclomol +1 moredrug
Likely dose
Arimoclomol 124 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02753530
NCT02753530Phase 2Completed
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Phase II Study of Arimoclomol for the Treatment of Sporadic Inclusion Body Myositis (IBM)

ZevraDenmark·interventional·Posted Apr 28, 2016·Updated May 10, 2023

In Brief

A Phase 2 clinical trial evaluating Arimoclomol and Placebo for Inclusion Body Myositis. Completed, enrolled 152 participants across 12 sites in 2 countries.

Detailed Summary

Funding Source - FDA Office of Orphan Products Development (OOPD). The purpose of this study is to evaluate the safety and efficacy of the study drug, arimoclomol in IBM patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInclusion Body Myositis
CountriesUnited Kingdom, United States
CollaboratorsUniversity of Kansas Medical Center, University College, London

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedApr 28, 2016
Enrollment StartAug 16, 2017
Primary CompletionJan 11, 2021
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago

Interventions

Arimoclomoldrug

2 capsules (2 x 124 mg arimoclomol base; equivalent to 2 x 200 mg arimoclomol citrate) taken 3 times daily during breakfast, early afternoon, and at bedtime

Placeboother

2 matched placebo capsules taken 3 times daily during breakfast, early afternoon, and at bedtime