[Red Badger]

THIS IS THE SAME DRUG THAT WAS IN THE EARLIER POST FROM THE UK.

This study is currently recruiting participants!

[Red Badger]

FOUR RINGY DINGIES!.................Same drug as used in the UK trials.......................AND THE NEED VOLUNTEERS!.................

[Red Badger]

Eligibility Criteria ICMJE

Be between ages 60-89 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

[FourPeas]

Ages Eligible for Study:   60 Years to 89 Years

Oh well....

[aMorePerfectUnion]

AUT00063

WARNINGS:

AUT00063 May lead to loss of sight, touch, taste and smell.
AUT00063 Has led to skin rashes on ears and big toes.
If you experience an erection lasting more than 12 hours, please get to an emergency room.

[doorgunner69]

I'd be happy to join the trials and would qualify, but cannot afford flying to Calif for the thing. Wonder if they will expand the scope and area or just wait until legal.

Likely dead by then, knowing the FDA and the glacial pace they approve stuff at.