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NCT01703988 · ClinicalTrials.gov registry record · Phase 1
An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT01703988 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 34 participants.
The verdict
NCT01703988, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA). Four dose levels will be evaluated sequentially. Each dose level will be studied in a cohort of approximately 8 participants, where all participants will receive active drug.
Interventions
- DRUG Nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2012-10-31 |
| Est. Completion | 2015-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01703988
The ClinicalTrials.gov registry entry for NCT01703988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 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.
NCT01703988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01703988 about?
NCT01703988 is a clinical study titled "An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy". This study will test the safety, tolerability, and pharmacokinetics of escalating doses of nusinersen (ISIS 396443) administered into the spinal fluid either two or three times over the duration of the trial, in participants with spinal muscular atrophy (SMA). Four dose levels will be evaluated seq...
What is the current status of trial NCT01703988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2012-10-31. Estimated completion is 2015-01-31.
What interventions are being tested in trial NCT01703988?
The interventions under investigation include: Nusinersen (DRUG).
Who is sponsoring clinical trial NCT01703988?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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