QUIET-1: AUT00063 (Kv3 modulator) Phase 2a — stopped early for futility
Record details
- Authors: Hall DA, Ray J, Watson J, et al.
- Journal / source: Hearing Research (2019)
- Design: Randomized placebo-controlled Phase 2a
- Sample: 91
- Primary endpoint: TFI
- Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No
What this research found
Stopped early for futility after a planned interim analysis (91 of a planned 152 randomised; 76 in the primary analysis). TFI change −1.6 points in the AUT00063 arm vs −5.8 with placebo (p = 0.98) — no benefit despite drug exposure in the expected therapeutic range.
Limitations and conflicts of interest
—
Funding / conflicts: Sponsor-run (Autifony).
Corrections to this record
- 2026-09-04: Citation-hygiene fix: year: 2018 → 2019; pmid: None → '30939361'; doi: None → '10.1016/j.heares.2019.03.018'; n: '—' → '91'
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.