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

Part of paid clinical trials in Sacramento, California.

Sponsor
Italfarmaco
Study ID
NCT03373968
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Givinostat — DRUG
    suspension of givinostat (10 mg/mL)

Study Details

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.

Key Dates

Start date
Oct 24, 2017
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
206 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: givinostat
    Givinostat oral suspension (10 mg/mL) twice daily in a fed state

Primary Outcome Measure

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California - Davis Medical Center - Devis Physical Medicine & RehabilitationSacramentoCalifornia95817-
Rady Children's Hospital center - UCSD Department of NeuroscienceSan DiegoCalifornia92123-
Connecticut Children's Medical Center, Neurology DivisionHartfordConnecticut06106-
Child Health Research InstituteGainesvilleFlorida32610-
MD Rare Disease Research, LLCAtlantaGeorgia30318-
University of Iowa Children's HospitalIowa CityIowa52242-
Washington University School of Medicine in St Louis Department of Neurology 660 S.Euclid Avenue, Campus Box 8111St LouisMissouri63110-
Shriners Hospitals for ChildrenPortlandOregon97239-
The Children's Hospital of Philadelphia Colket Translational Research BuildingPhiladelphiaPennsylvania19104-
Virginia Commonwealth University Childrens Hospital of Richmond atRichmondVirginia23298-

Find similar trials in Sacramento, CA

By condition
Duchenne muscular dystrophy
By specialty
Pediatrics
By research site
University of California - Davis Medical Center - Devis Physical Medicine & Rehabilitation· Sacramento, CARady Children's Hospital center - UCSD Department of Neuroscience· San Diego, CAConnecticut Children's Medical Center, Neurology Division· Hartford, CTChild Health Research Institute· Gainesville, FLMD Rare Disease Research, LLC· Atlanta, GAUniversity of Iowa Children's Hospital· Iowa City, IA

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