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NCT06517888 · ClinicalTrials.gov registry record · Phase 1
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
A Phase 1 study of Vestibular Schwannoma, sponsored by Akouos.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 4
- Study locations
NCT06517888: Recruiting Phase 1 study of Vestibular Schwannoma, sponsored by Akouos.
NCT06517888 is a Phase 1 study of Vestibular Schwannoma that is actively recruiting participants, run by Akouos. The registered enrollment target is 27 participants, below the 49-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (45% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06517888, a Phase 1 study of Vestibular Schwannoma, is actively recruiting participants, sponsored by Akouos.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 4
- Study locations
Study Summary
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
Primary Outcome
AEs with relationship to the investigational medicinal product and/or to the administration procedure (including the delivery device)
Conditions Studied
Interventions
- COMBINATION_PRODUCT AAVAnc80-antiVEGF via Akouos Delivery Device
Study Locations (4)
Maryland
- Johns Hopkins Hospital - Baltimore
Minnesota
- Mayo Clinic - Rochester
Tennessee
- Vanderbilt Bill Wilkerson Center - Nashville
Texas
- University of Texas Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-01-17 |
| Est. Completion | 2029-08 |
| Phase | Phase 1 |
What NCT06517888 shows while recruiting
NCT06517888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 49-participant average among 7 other Vestibular Schwannoma trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Vestibular Schwannoma appearing as the primary indexed condition, and to 1 intervention - of which AAVAnc80-antiVEGF via Akouos Delivery Device is the first listed.
NCT06517888 reports a single indexed study location in Maryland, Minnesota, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06517888 about?
NCT06517888 is a clinical study titled "Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma". This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
What is the current status of trial NCT06517888?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2025-01-17. Estimated completion is 2029-08.
What conditions does trial NCT06517888 study?
This clinical trial studies the following conditions: Vestibular Schwannoma.
What interventions are being tested in trial NCT06517888?
The interventions under investigation include: AAVAnc80-antiVEGF via Akouos Delivery Device (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06517888?
This trial is sponsored by Akouos, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06517888 being conducted?
This trial has 4 study locations across Maryland, Minnesota, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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