Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
Public ClinicalTrials.gov record NCT03703882. 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
A Randomized, Double-Blind, Placebo-Controlled, Global Phase 3 Study of Edasalonexent in Pediatric Patients With Duchenne Muscular Dystrophy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male patients from 4-7 years of age (up to 8th birthday) will be enrolled. Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key link between loss of dystrophin and disease pathology and plays a fundamental role in the initiation and progression of skeletal and cardiac muscle disease in DMD.
Study identification
- NCT ID
- NCT03703882
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 131 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 7 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
- Oct 2, 2018 (Actual)
- Primary completion
- Sep 22, 2020 (Actual)
- Completion
- Sep 22, 2020 (Actual)
- Last update posted
- Jun 21, 2022
2018 – 2020
United States locations
- U.S. sites
- 24
- U.S. states
- 19
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| UC Davis | Sacramento | California | 95817 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Rare Disease Research, LLC | Atlanta | Georgia | 30318 | — |
| Rush University Children's Hospital | Chicago | Illinois | 60612 | — |
| University of Iowa Children's Hospital | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Fairway | Kansas | 66205 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Las Vegas Clinic | Las Vegas | Nevada | 89145 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| Shriners Hospitals for Children | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23510 | — |
| Children's Hospital of Richmond at VCU | 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 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03703882, 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 Jun 21, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03703882 live on ClinicalTrials.gov.