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NCT01780246 · ClinicalTrials.gov registry record · Phase 1
An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT01780246 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 18 participants.
The verdict
NCT01780246, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 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-CS1 (NCT02865109). The secondary objective was to examine the plasma pharmacokinetics of a single dose of ISIS 396443 administered intrathecally to participants with SMA who previously participated in ISIS 396443-CS1.
Interventions
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2013-01-31 |
| Est. Completion | 2014-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01780246
The ClinicalTrials.gov registry entry for NCT01780246 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 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.
NCT01780246 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01780246 about?
NCT01780246 is a clinical study titled "An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)". 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-CS1 (NCT02865109). The secondary objective was to examine the plasma phar...
What is the current status of trial NCT01780246?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2013-01-31. Estimated completion is 2014-02-28.
What interventions are being tested in trial NCT01780246?
The interventions under investigation include: nusinersen (DRUG).
Who is sponsoring clinical trial NCT01780246?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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