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NCT02193074 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
A Phase 3 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 122
- Enrollment target
NCT02193074 is a Phase 3 study that was terminated before completion, run by Biogen. The registered enrollment target is 122 participants.
The verdict
NCT02193074, a Phase 3 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 122 participants
- Enrollment target
Study Summary
The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability of nusinersen administered intrathecally to participants with infantile-onset SMA.
Interventions
- PROCEDURE Sham procedure
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2014-08-19 |
| Est. Completion | 2016-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02193074
The ClinicalTrials.gov registry entry for NCT02193074 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham procedure is the first listed.
NCT02193074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02193074 about?
NCT02193074 is a clinical study titled "A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy". The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA). The secondary objective of the study is to examine the safety and tolerability o...
What is the current status of trial NCT02193074?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 122 participants. The study started on 2014-08-19. Estimated completion is 2016-11-21.
What interventions are being tested in trial NCT02193074?
The interventions under investigation include: Sham procedure (PROCEDURE), nusinersen (DRUG).
Who is sponsoring clinical trial NCT02193074?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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