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NCT01839656 · ClinicalTrials.gov registry record · Phase 2
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01839656 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 21 participants.
The verdict
NCT01839656, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of multiple doses of nusinersen administered intrathecally to participants with infantile-onset SMA.
Interventions
- DRUG nusinersen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2013-05-08 |
| Est. Completion | 2017-08-21 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01839656
The ClinicalTrials.gov registry entry for NCT01839656 describes a study currently listed as completed, 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 1 intervention - of which nusinersen is the first listed.
NCT01839656 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01839656 about?
NCT01839656 is a clinical study titled "A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)". The primary objective is to examine the clinical efficacy of multiple doses of nusinersen (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of multiple doses of nusinersen a...
What is the current status of trial NCT01839656?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2013-05-08. Estimated completion is 2017-08-21.
What interventions are being tested in trial NCT01839656?
The interventions under investigation include: nusinersen (DRUG).
Who is sponsoring clinical trial NCT01839656?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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