Trial · NCT04419233
Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
NCT04419233, Completed, Biogen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection. Trials, record NCT04419233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04419233
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium Injection
- NCT number
- NCT04419233
- Status
- Completed
- Enrollment
- 50 participants, actual
- Lead sponsor
- Biogen
- Conditions
- Muscular Atrophy, Spinal
- Interventions
- Nusinersen Sodium Injection
- First posted
- 2020-06-05
- Last updated
- 2023-12-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 0 up to End of Treatment (2 Years) | An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event. |
| Secondary | Percentage of Participants who Achieved World Health Organization (WHO) Motor Milestone | Baseline, Day 63 and Every 4 Months Up to End of Treatment (2 years) | WHO Multicentre Growth Reference Study (MGRS), a component to assess gross motor development and is usually assessed in terms of age of achievement of motor milestones. Six distinct gross motor milestones criteria are as follows: sitting without support, hands-and-knees crawling, standing with assistance, walking with assistance, standing alone, and walking alone. |
| Secondary | Hammersmith Infant Neurological Examination (HINE) Section 2 Scores | Baseline, Day 63 and Every 4 Months Up to End of Treatment (2 years) | Section 2 of the HINE is used to assess motor milestones of the participants. It is composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. |
| Secondary | Number of Participants with Ventilatory Support | Baseline, Day 63 and Every 4 Months Up to End of Treatment (2 years) | |
| Secondary | Plasma Concentrations of Nusinersen Sodium Injection | Pre-dose and multiple time points post-dose on Day 0, post-dose on Day 28 and pre-dose every 4 months up to end of treatment (2 years) | |
| Secondary | Cerebrospinal Fluid (CSF) Concentrations of Nusinersen Sodium Injection | pre-dose on Day 0, Day 63, and Every 4 Months Up to End of Treatment (2 years) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38722537 | DERIVED |
Source PubMed
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/NCT04419233
GET https://conductscience.org/api/trials/v1/NCT04419233/registered