Trial · NCT03532542
An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy
NCT03532542, Phase 3, Terminated, Sarepta Therapeutics, Inc.; results first posted 2024-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy. Trials, record NCT03532542. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03532542
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Extension Study to Evaluate Casimersen or Golodirsen in Patients With Duchenne Muscular Dystrophy
- NCT number
- NCT03532542
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 171 participants, actual
- Lead sponsor
- Sarepta Therapeutics, Inc.
- Conditions
- Duchenne Muscular Dystrophy
- Interventions
- Casimersen, Golodirsen
- First posted
- 2018-05-22
- Last updated
- 2024-09-19
- Other registries' IDs
- eudract:2017-004625-32
- Results first posted
- 2024-09-19
- Limitations and caveats
This study was terminated before all participants had reached the last protocol-defined end-of-study visit. Study termination resulted in participants either being transitioned to a post-trial access program, to another study, or they declined further treatment.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Up to 33 days after the last infusion of study drug (up to approximately 149 weeks) | A treatment-emergent adverse event (TEAE) was any untoward medical occurrence in a clinical study participant that did not necessarily have a causal relationship with the study drug. A TEAE could, therefore, be any unfavorable and unintended symptom, sign, disease, condition, or test abnormality that occurred during or after administration of the study drug, whether or not considered related to the study drug. A TESAE was any TEAE that resulted in any of the following outcomes: death, a life-threatening event, required or prolonged inpatient hospitalization, persistent or significant disability/incapacity, or an important medical event (that is, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the previously mentioned outcomes). A summary of serious and all other non-serious TEAEs regardless of causality is located in the Reported Adverse Events module. |
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 | Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Up to 33 days after the last infusion of study drug (up to approximately 149 weeks) | Safety Analysis Set: All enrolled participants who received at least 1 dose of study drug (golodirsen or casimersen). | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Golodirsen | 12 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Casimersen | 22 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Golodirsen | 74 | |
| Overall Study | STARTED | Casimersen | 97 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Golodirsen | 74 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Casimersen | 97 | |
| Overall Study | COMPLETED | Golodirsen | 26 | |
| Overall Study | COMPLETED | Casimersen | 27 | |
| Overall Study | NOT COMPLETED | Golodirsen | 48 | |
| Overall Study | NOT COMPLETED | Casimersen | 70 |
Source ClinicalTrials.gov
Adverse events174
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 | COVID-19 | Infections and infestations | Golodirsen | 10 | 74 | |
| other | COVID-19 | Infections and infestations | Casimersen | 27 | 97 | |
| other | Nasopharyngitis | Infections and infestations | Golodirsen | 26 | 74 | |
| other | Nasopharyngitis | Infections and infestations | Casimersen | 21 | 97 | |
| other | Upper respiratory tract infection | Infections and infestations | Golodirsen | 7 | 74 | |
| other | Upper respiratory tract infection | Infections and infestations | Casimersen | 15 | 97 | |
| other | Influenza | Infections and infestations | Golodirsen | 6 | 74 | |
| other | Influenza | Infections and infestations | Casimersen | 7 | 97 | |
| other | Gastroenteritis | Infections and infestations | Golodirsen | 5 | 74 | |
| other | Gastroenteritis | Infections and infestations | Casimersen | 6 | 97 |
1 to 10 of 174Source ClinicalTrials.gov
See all 174 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Golodirsen | 1 | 74 |
| Total, all-cause mortality | Casimersen | 0 | 97 |
| Total, other adverse events | Golodirsen | 63 | 74 |
| Total, other adverse events | Casimersen | 93 | 97 |
| Total, serious adverse events | Golodirsen | 12 | 74 |
| Total, serious adverse events | Casimersen | 22 | 97 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Golodirsen vs Casimersen: Number of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | Trial comparisons |
| Golodirsen vs Casimersen: deaths from any cause | Trial comparisons |
| Golodirsen vs Casimersen: serious adverse events | Trial comparisons |
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/NCT03532542
GET https://conductscience.org/api/trials/v1/NCT03532542/events?page=2