MedTrace Logo

Arimoclomol in Sporadic Inclusion Body Myositis - Open Label Extension Trial

NCT04049097 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2023-09-15

Study results available
· View outcomes & findings →

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)

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

Sponsors & Collaborators

  • University of Kansas Medical Center

    collaborator OTHER

  • University College, London

    collaborator OTHER

  • ZevraDenmark

    lead INDUSTRY

Principal Investigators

  • Mazen M Dimachkie · University of Kansas Medical Center

  • Michael Hanna · University College, London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-20
Primary Completion
2021-11-15
Completion
2021-11-15
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 NCT04049097 on ClinicalTrials.gov