Trial · NCT03439670
A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
NCT03439670, Phase 2, Completed, ReveraGen BioPharma, Inc.; results first posted 2022-07-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD). Trials, record NCT03439670. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03439670
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Assess the Efficacy and Safety of Vamorolone in Boys With Duchenne Muscular Dystrophy (DMD)
- NCT number
- NCT03439670
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 121 participants, actual
- Lead sponsor
- ReveraGen BioPharma, Inc.
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- Vamorolone, Prednisone, Placebo, Vamorolone, Prednisone, Placebo, Vamorolone, Vamorolone
- First posted
- 2018-02-20
- Last updated
- 2023-03-09
- Results first posted
- 2022-07-13
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline | 24 weeks | Vamorolone at 6.0mg/kg/day vs. placebo group in change from baseline to the Week 24 assessment |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline | 24 weeks | Per the protocol, the primary clinical efficacy endpoint was comparison of the vamorolone 6.0 mg/kg/day dose level group versus the placebo group in change from baseline to the Week 24 assessment. | Rises/Seconds | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline | Treatment Group 1 | -.007 | Standard Deviation 0.0628 | Rises/Seconds | |
| Efficacy Measured by Time to Stand Test (TTSTAND) Velocity in Rises/Second Change From Baseline | Treatment Group 2 | 0.054 | Standard Deviation 0.0666 | Rises/Seconds |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group 1 | 30 | |
| Overall Study | STARTED | Treatment Group 2 | 30 | |
| Overall Study | STARTED | Treatment Group 3 | 15 | |
| Overall Study | STARTED | Treatment Group 4 | 16 | |
| Overall Study | STARTED | Treatment Group 5 | 15 | |
| Overall Study | STARTED | Treatment Group 6 | 15 | |
| Overall Study | COMPLETED | Treatment Group 1 | 28 | |
| Overall Study | COMPLETED | Treatment Group 2 | 26 | |
| Overall Study | COMPLETED | Treatment Group 3 | 15 | |
| Overall Study | COMPLETED | Treatment Group 4 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events768
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 1 | 3 | 28 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 2 | 3 | 28 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 3 | 2 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 4 | 1 | 15 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 5 | 2 | 14 | |
| other | Abdominal Pain | Gastrointestinal disorders | Treatment Group 6 | 0 | 14 | |
| other | Abdominal Pain upper | Gastrointestinal disorders | Treatment Group 1 | 1 | 28 | |
| other | Abdominal Pain upper | Gastrointestinal disorders | Treatment Group 2 | 3 | 28 | |
| other | Abdominal Pain upper | Gastrointestinal disorders | Treatment Group 3 | 3 | 15 | |
| other | Abdominal Pain upper | Gastrointestinal disorders | Treatment Group 4 | 2 | 15 |
1 to 10 of 768Source ClinicalTrials.gov
See all 768 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group 1 | 0 | 28 |
| Total, all-cause mortality | Treatment Group 2 | 0 | 28 |
| Total, all-cause mortality | Treatment Group 3 | 0 | 15 |
| Total, all-cause mortality | Treatment Group 4 | 0 | 15 |
| Total, all-cause mortality | Treatment Group 5 | 0 | 14 |
| Total, all-cause mortality | Treatment Group 6 | 0 | 14 |
| Total, other adverse events | Treatment Group 1 | 26 | 28 |
| Total, other adverse events | Treatment Group 2 | 26 | 28 |
| Total, other adverse events | Treatment Group 3 | 15 | 15 |
| Total, other adverse events | Treatment Group 4 | 13 | 15 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers47
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03439670
GET https://conductscience.org/api/trials/v1/NCT03439670/events?page=2