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NCT05386680 · ClinicalTrials.gov registry record · Phase 3
Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT05386680 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 27 participants.
The verdict
NCT05386680, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study Summary
This was a Phase IIIb open-label, single arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101B in participants with SMA aged 2 to \<18 years after the discontinuation of treatment with nusinersen or risdiplam. The study aimed to enroll approximately 28 participants across each of 2 age brackets (2 to \<6 years, and 6 to \<18 years).
Interventions
- GENETIC OAV101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2023-01-12 |
| Est. Completion | 2024-11-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386680
The ClinicalTrials.gov registry entry for NCT05386680 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 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 1 intervention - of which OAV101 is the first listed.
NCT05386680 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05386680 about?
NCT05386680 is a clinical study titled "Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam". This was a Phase IIIb open-label, single arm, multi-center study to evaluate the safety, tolerability and efficacy of OAV101B in participants with SMA aged 2 to \<18 years after the discontinuation of treatment with nusinersen or risdiplam. The study aimed to enroll approximately 28 participants acr...
What is the current status of trial NCT05386680?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2023-01-12. Estimated completion is 2024-11-29.
What interventions are being tested in trial NCT05386680?
The interventions under investigation include: OAV101 (GENETIC).
Who is sponsoring clinical trial NCT05386680?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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