Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 14-009814
NCT ID: NCT02345031
Sponsor Protocol Number: AUT022063
About this study
This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.See eligibility criteria
- Be between ages 50-89 years old
- American-English speaking
- Have difficulty hearing speech in a noisy environment
- No recent history of middle ear disease
- No severe insomnia, major depressive disorders, severe anxiety or post-traumatic stress disorder
- Not a current or previous user of hearing aids. You are eligible if you were noncompliant and stopped wearing a hearing aid device >6 months earlier for intermittent use or >3 years if you were a full-time consistent user of hearing aid devices
- Not be dependent on alcohol or drugs
- Have not participated in another research study within 30-days
- If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)
- If male, you must confirm to use a barrier method (condom)
- Not be a professional musician
- No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor
While you are in the study, you must:
- Follow the instructions you are given
- Come to the study centre for all visits with the study doctor or study staff
- Answer the telephone at the scheduled date and time for the 2 telephone calls
- Tell the study doctor or study staff about any changes in your health or the way you feel
- Tell the study doctor or study staff if you want to stop being in the study at any time
- Bring your Diary to each visit
- Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study
- Use sun screen if you plan to sunbathe
- Not use headphones or headsets at high volume
- Not use hearing aids or devices at any time during the study
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Douglas Sladen, Ph.D.
Closed for enrollment