MedTrace Logo

Study of Arimoclomol in Inclusion Body Myositis (IBM)

NCT02753530 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-05-10

Study results available
· View outcomes & findings →

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.

Conditions

  • Inclusion Body Myositis

Interventions

DRUG

Arimoclomol

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

OTHER

Placebo

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

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • ZevraDenmark

    lead INDUSTRY

Principal Investigators

  • Mazen Dimachkie, MD · University of Kansas Medical Center

  • Michael Hanna, MD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-16
Primary Completion
2021-01-11
Completion
2021-01-11
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02753530 on ClinicalTrials.gov