Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
NCT03373968 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Givinostat
Study Locations (20)
Other
- University Hospitals Leuven, Neuromuscular Reference Centre, Child Neurology — Leuven
- Hospital de La Citadelle, Centre de Référence des Maladies Neuromuscolaires (CRMN) — Liège
- CHU de Nantes - Hotel-Dieu - Hopital Nord Laennec, rez-de-chausse haut ail Ouest — Nantes
- Hôpital Armand Trousseau I-Motion - Plateforme d'essais cliniques pédiatriques Bâtiment Lemariey - Porte 20 * 2ème étage 26 Avenue du Dr Arnold Nette — Paris
- Universitätsklinikum Essen - Kinder-und Jugendmedizin Neuropadiatrie — Essen
- Klinik- und Poliklinik fur Kinder- und Jugendmedizin, Universitatsklinikum HamburgEppendorf, Martinistr. 52 — Hamburg
- Klinikum der Universitat Munchen, Campus Innenstadt, Lindwurmstr. 4 — München
California
- University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation — Sacramento
- Rady Children's Hospital center - UCSD Department of Neuroscience — San Diego
Connecticut
- Connecticut Children's Medical Center, Neurology Division — Hartford
Florida
- Child Health Research Institute — Gainesville
Georgia
- MD Rare Disease Research, LLC — Atlanta
Iowa
- University of Iowa Children's Hospital — Iowa City
Missouri
- Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111 — St Louis
Oregon
- Shriners Hospitals for Children — Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2017-10-24 |
| Est. Completion | 2029-12 |
| Phase | Phase 2 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03373968
The ClinicalTrials.gov registry entry for NCT03373968 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 206 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Italfarma, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Duchenne Muscular Dystrophy appearing as the primary indexed condition, and to 1 intervention — of which Givinostat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03373968 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03373968 about?
NCT03373968 is a clinical study titled "Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study". 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.
What is the current status of trial NCT03373968?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 206 participants. The study started on 2017-10-24. Estimated completion is 2029-12.
What conditions does trial NCT03373968 study?
This clinical trial studies the following conditions: Duchenne Muscular Dystrophy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03373968?
The interventions under investigation include: Givinostat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03373968?
This trial is sponsored by Italfarma, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03373968 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.