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NCT05089656 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT05089656 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 126 participants.
The verdict
NCT05089656, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This was a Phase III multi-center, single dose (1.2 x 10\^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never ambulatory SMA patients 2 to \<18 years of age.
Interventions
- GENETIC OAV101
- PROCEDURE Sham control
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2022-02-01 |
| Est. Completion | 2025-04-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05089656
The ClinicalTrials.gov registry entry for NCT05089656 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 126 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which OAV101 is the first listed.
NCT05089656 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05089656 about?
NCT05089656 is a clinical study titled "Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)". This was a Phase III multi-center, single dose (1.2 x 10\^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never ambulatory SMA patients 2 to \<18 years of age.
What is the current status of trial NCT05089656?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2022-02-01. Estimated completion is 2025-04-29.
What interventions are being tested in trial NCT05089656?
The interventions under investigation include: OAV101 (GENETIC), Sham control (PROCEDURE).
Who is sponsoring clinical trial NCT05089656?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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