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NCT02462759 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).
A Phase 2 study, sponsored by Biogen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT02462759 is a Phase 2 study that was terminated before completion, run by Biogen. The registered enrollment target is 21 participants.
The verdict
NCT02462759, a Phase 2 study, was terminated before completion, sponsored by Biogen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS 396443-CS4 (NCT02292537). The secondary objective of Part 1 of this study is to examine the pharmacokinetics (PK) of Nusinersen in participants with SMA. The primary objective of Part 2 of this study is to assess the long-term safety and tolerability of Nusinersen in participants with SMA who participated in Part 1 and completed their End of Part 1 Evaluation assessments. The secondary objective of Part 2 of this study is to examine the PK of Nusinersen in participants with SMA who participated in Part 1 and completed their End of Part 1 Evaluation assessments.
Interventions
- PROCEDURE Sham Procedure
- DRUG Nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2015-08-19 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02462759
The ClinicalTrials.gov registry entry for NCT02462759 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 21 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.
NCT02462759 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02462759 about?
NCT02462759 is a clinical study titled "A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).". The primary objective of Part 1 of this study is to assess the safety and tolerability of Nusinersen in participants with SMA who are not eligible to participate in the clinical studies ISIS 396443-CS3B (NCT02193074) or ISIS 396443-CS4 (NCT02292537). The secondary objective of Part 1 of this study i...
What is the current status of trial NCT02462759?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2015-08-19. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT02462759?
The interventions under investigation include: Sham Procedure (PROCEDURE), Nusinersen (DRUG).
Who is sponsoring clinical trial NCT02462759?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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