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NCT02052791 · ClinicalTrials.gov registry record · Phase 1
An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246)
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT02052791 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 47 participants.
The verdict
NCT02052791, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
The primary objective of this study is to examine the safety and tolerability of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA) who previously participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246). The secondary objective is to examine the plasma and cerebrospinal fluid (CSF) pharmacokinetic(s) (PK) of nusinersen administered intrathecally to participants with SMA who previously participated in ISIS 396443-CS2 or ISIS 396443-CS10.
Interventions
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2014-01-31 |
| Est. Completion | 2017-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02052791
The ClinicalTrials.gov registry entry for NCT02052791 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 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.
NCT02052791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02052791 about?
NCT02052791 is a clinical study titled "An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246)". The primary objective of this study is to examine the safety and tolerability of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA) who previously participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246). The secondary object...
What is the current status of trial NCT02052791?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2014-01-31. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02052791?
The interventions under investigation include: nusinersen (DRUG).
Who is sponsoring clinical trial NCT02052791?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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