Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy
Public ClinicalTrials.gov record NCT02851797. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Primary Objective The primary objective of the study was to establish the effects of givinostat versus placebo administered chronically over 18 months to slow disease progression in ambulant DMD subjects. Secondary Objectives The secondary objectives of this study were: * To assess the safety and tolerability of givinostat versus placebo administered chronically in DMD subjects * To evaluate the PK profile of givinostat administered chronically in DMD subjects * To evaluate the impact on quality of life (QoL) and activities of daily living of givinostat versus placebo administered chronically.
Study identification
- NCT ID
- NCT02851797
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 179 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 17 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2017 (Actual)
- Primary completion
- Feb 22, 2022 (Actual)
- Completion
- Feb 22, 2022 (Actual)
- Last update posted
- Feb 2, 2023
2017 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular Research Center UC Davis Department of Physical Medicine and Rehabilitation | Davis | California | 95817 | — |
| Rady Children's Hospital center - UCSD Department of Neuroscience | San Diego | California | 92123 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Connecticut Children's Medical Center - Division Neurology | Hartford | Connecticut | 06106 | — |
| Child Health Research Institute - Department of Pediatrics | Gainesville | Florida | 32610 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| MD Rare Disease Research, LLC | Atlanta | Georgia | 30318 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | — |
| University of Minnesota - Department of Neurology | Minneapolis | Minnesota | 55455 | — |
| Washington University School of Medicine in St Louis - Department of Neurology | St Louis | Missouri | 63110 | — |
| Shriners Hospitals for Children | Portland | Oregon | 97239 | — |
| The Children's Hospital of Philadelphia Colket Translational Research Building | Philadelphia | Pennsylvania | 19104 | — |
| Virginia Commonwealth University Childrens Hospital of Richmond at Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02851797, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 2, 2023 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02851797 live on ClinicalTrials.gov.