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NCT01494701 · ClinicalTrials.gov registry record · Phase 1
An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT01494701 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 28 participants.
The verdict
NCT01494701, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).
Interventions
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2011-11-30 |
| Est. Completion | 2013-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01494701
The ClinicalTrials.gov registry entry for NCT01494701 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 28 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.
NCT01494701 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01494701 about?
NCT01494701 is a clinical study titled "An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)". This objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics of a single dose of nusinersen (ISIS 396443) administered intrathecally to participants with Spinal Muscular Atrophy (SMA).
What is the current status of trial NCT01494701?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2011-11-30. Estimated completion is 2013-01-31.
What interventions are being tested in trial NCT01494701?
The interventions under investigation include: nusinersen (DRUG).
Who is sponsoring clinical trial NCT01494701?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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