Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02345031 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
A Phase 2 study of Age-Related Hearing Loss, sponsored by Autifony Therapeutics Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 78
- Enrollment target
- 13
- Study locations
NCT02345031: Completed Phase 2 study of Age-Related Hearing Loss, sponsored by Autifony Therapeutics Limited.
NCT02345031 is a Phase 2 study of Age-Related Hearing Loss that has completed, run by Autifony Therapeutics Limited. The registered enrollment target is 78 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02345031, a Phase 2 study of Age-Related Hearing Loss, has completed, sponsored by Autifony Therapeutics Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 78 participants
- Enrollment target
- 13
- Study locations
Study Summary
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.
Primary Outcome
To compare the change in hearing using the QuickSIN test (speech in noise performance) from baseline (Day 1 to Day 28) between AUT00063 and placebo. The QuickSIN test measures the level of signal compared to the noise that is required to achieve 50% recognition. The test is administered in a sound booth at 70-dB HL binaurally via insert-ear phones. Three lists are administered to each individual subject and the threshold or 50% signal-to-noise ratio (SNR) is calculated as the mean of the three l
Conditions Studied
Interventions
- DRUG Placebo
- DRUG AUT00063
Study Locations (13)
Florida
- ENT Associates of South Florida - Boca Raton
- QPS MRA (Miami Research Associates) - Miami
- University of South Florida - Tampa
North Carolina
- PMG Research Inc. - Wilmington
- Piedmont Ear, Nose, & Throat Associates - Winston-Salem
California
- Sacramento ENT - Sacramento
Colorado
- Colorado ENT and Allergy - Colorado Springs
Kentucky
- University of Louisville - Louisville
Minnesota
- Mayo Clinic - Rochester
Mississippi
- The University of Mississippi Medical Center - Jackson
New York
- Long Island Jewish Medical Center - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2015-01 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT02345031 record still lists
NCT02345031 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).
The record links to 1 condition, with Age-Related Hearing Loss appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02345031 lists 13 locations in 10 states (Florida, North Carolina, California).
Frequently Asked Questions
What is clinical trial NCT02345031 about?
NCT02345031 is a clinical study titled "Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss". This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.
What is the current status of trial NCT02345031?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 78 participants. The study started on 2015-01. Estimated completion is 2016-06.
What conditions does trial NCT02345031 study?
This clinical trial studies the following conditions: Age-Related Hearing Loss.
What interventions are being tested in trial NCT02345031?
The interventions under investigation include: Placebo (DRUG), AUT00063 (DRUG).
Who is sponsoring clinical trial NCT02345031?
This trial is sponsored by Autifony Therapeutics Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02345031 being conducted?
This trial has 13 study locations across California, Colorado, Florida, Kentucky, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02345031's enrollment target sits among peer trials
78 884th of 2000 higher than 1,110 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02397668 · 78 participants · NA
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
- NCT03321656 · 78 participants · Phase 2
Impact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile
- NCT03687814 · 78 participants · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
- NCT04018872 · 78 participants · Phase 2
Evaluating the Effect of Itraconazole on Pathologic Complete Response Rates in Esophageal Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia