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RECRUITING
NCT07127978

A Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy

Sponsor: ITF Therapeutics LLC

View on ClinicalTrials.gov

Summary

This is a prospective observational study conducted to evaluate safety, tolerability, and functional outcomes of patients with DMD newly initiating oral givinostat or having started therapy within 6 months as part of routine clinical care in the US. The study has a planned maximum duration of 5 years for the first enrolled patients, including a 24-month enrollment period and a minimum of 2 years of follow-up.

Official title: A Prospective, Observational Study Evaluating the Real-World Experience of Givinostat in Patients With Duchenne Muscular Dystrophy

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-10-23

Completion Date

2030-07-30

Last Updated

2025-10-30

Healthy Volunteers

No

Locations (2)

Ann and Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States