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Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study

NCT03373968 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2026-01-21

No results posted yet for this study

Summary

This is an open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD (Duchenne's muscular dystrophy) patients who have been previously treated in one of the GIVINOSTAT studies.

Conditions

Interventions

DRUG

Givinostat

suspension of givinostat (10 mg/mL)

Sponsors & Collaborators

  • Cromsource

    collaborator INDUSTRY

  • Italfarmaco

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-24
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT03373968 on ClinicalTrials.gov