Long-term Extension Study to Assess Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Public ClinicalTrials.gov record NCT03038399. 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 24-month Phase II Open-label, Multicenter Long-term Extension Study to Assess the Long-Term Safety and Efficacy of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This long-term extension study is an open-label, multiple-dose study to evaluate the long-term safety, tolerability, efficacy and PD of vamorolone administered once daily by liquid oral suspension over a Treatment Period of 24 months to young boys with DMD who participated in the VBP15-002 Phase IIa and VBP15-003 Phase IIa extension core studies.
Study identification
- NCT ID
- NCT03038399
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Interventions
- Vamorolone 0.25 mg/day/day Drug
- Vamorolone 0.75 mg/day/day Drug
- Vamorolone 2.0 mg/day/day Drug
- Vamorolone 6.0 mg/day/day Drug
Drug
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
- Feb 2, 2017 (Actual)
- Primary completion
- Apr 30, 2020 (Actual)
- Completion
- Apr 30, 2020 (Actual)
- Last update posted
- May 20, 2021
2017 – 2020
United States locations
- U.S. sites
- 6
- U.S. states
- 5
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California Davis | Davis | California | 95616 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75207 | — |
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 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03038399, 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 May 20, 2021 · Synced Oct 2, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03038399 live on ClinicalTrials.gov.