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NCT03373968 · ClinicalTrials.gov registry record · Phase 2
Givinostat in Duchenne's Muscular Dystrophy Long-term Safety and Tolerability Study
A Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Italfarma.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 206
- Enrollment target
- 20
- Study locations
NCT03373968: Recruiting Phase 2 study of Duchenne Muscular Dystrophy, sponsored by Italfarma.
NCT03373968 is a Phase 2 study of Duchenne Muscular Dystrophy that is actively recruiting participants, run by Italfarma. The registered enrollment target is 206 participants, below the 408-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (50% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03373968, a Phase 2 study of Duchenne Muscular Dystrophy, is actively recruiting participants, sponsored by Italfarma.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 206 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Type, incidence, and severity of treatment related/not related adverse events(AEs) and serious adverse event (SAEs)
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 |
What NCT03373968 shows while recruiting
NCT03373968 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 408-participant average among 48 other Duchenne Muscular Dystrophy trials with a reported enrollment target (50% lower).
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.
NCT03373968 names 20 study sites across 13 states, led by Other, California, Connecticut.
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.
What interventions are being tested in trial NCT03373968?
The interventions under investigation include: Givinostat (DRUG).
Who is sponsoring clinical trial NCT03373968?
This trial is sponsored by Italfarma, which has 2 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Duchenne Muscular Dystrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03373968's enrollment target sits among peer trials
206 8th of 48 higher than 41 of 48 other Duchenne Muscular Dystrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Duchenne Muscular Dystrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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