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NCT04089566 · ClinicalTrials.gov registry record · Phase 3
Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
NCT04089566 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 145 participants.
The verdict
NCT04089566, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
Study Summary
The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C). The secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B).
Interventions
- DRUG Nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2020-03-26 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04089566
The ClinicalTrials.gov registry entry for NCT04089566 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 145 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 1 intervention - of which Nusinersen is the first listed.
NCT04089566 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04089566 about?
NCT04089566 is a clinical study titled "Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy". The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) tot...
What is the current status of trial NCT04089566?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2020-03-26. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT04089566?
The interventions under investigation include: Nusinersen (DRUG).
Who is sponsoring clinical trial NCT04089566?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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