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NCT02594124 · ClinicalTrials.gov registry record · Phase 3
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 292
- Enrollment target
NCT02594124: Completed Phase 3 study, sponsored by Biogen.
NCT02594124 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02594124, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 292 participants
- Enrollment target
Study Summary
The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine the long-term efficacy of nusinersen administered by IT injection to participants with SMA who previously participated in investigational studies of nusinersen.
Primary Outcome
AE:unfavorable and unintended sign, symptom, or disease temporally associated with study/use of an investigational drug, whether or not it's considered related to investigational drug. SAE:AE that in view of either Investigator/Sponsor, meets any of the following criteria: results in death;is life-threatening:i.e.poses risk of death, hospitalization/it's prolongation;results in a persistent or significant incapacity or substantial disruption of normal life functions;results in congenital anomaly
Interventions
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2015-11-04 |
| Est. Completion | 2023-08-21 |
| Phase | Phase 3 |
What the finished NCT02594124 record still lists
NCT02594124 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which nusinersen is the first listed.
NCT02594124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02594124 about?
NCT02594124 is a clinical study titled "A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational Studies". The primary objective is to evaluate long-term safety and tolerability of nusinersen (ISIS 396443) administered by intrathecal (IT) injection to participants with Spinal Muscular Atrophy (SMA) who previously participated in investigational studies of nusinersen. The secondary objective is to examine...
What is the current status of trial NCT02594124?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2015-11-04. Estimated completion is 2023-08-21.
What interventions are being tested in trial NCT02594124?
The interventions under investigation include: nusinersen (DRUG).
Who is sponsoring clinical trial NCT02594124?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02594124's enrollment target sits among peer trials
292 1166th of 2000 higher than 833 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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