Posted on 10/16/2015 12:08:57 PM PDT by Red Badger
This study is currently recruiting participants!
FOUR RINGY DINGIES!.................Same drug as used in the UK trials.......................AND THE NEED VOLUNTEERS!.................
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02345031
Contacts
Contact: Peter Harris, MD peter.harris@autifony.com
Contact: Jeannette Watson jeannette.watson@autifony.com
Locations
United States, California
Sacramento ENT Recruiting
Sacramento, California, United States, 95815
Contact: Kevin McKennan, ENT
United States, Colorado
Colorado ENT and Allergy Recruiting
Colorado Springs, Colorado, United States, 80909
Contact: James Romett, MD
United States, Florida
ENT Associates of South Florida Recruiting
Boca Raton, Florida, United States, 33487
Contact: Mark Widick, MD MWIDICK@MAC.COM
University of South Florida Recruiting
Tampa, Florida, United States, 33620
Contact: Robert Frisina, PhD rfrisina@usf.edu
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Jill Preminger, PhD jill.preminger@louisville.edu
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55095
Contact: Douglas Sladen, PhD sladen.douglas@mayo.edu
United States, Mississippi
The University of Mississippi Medical Center Not yet recruiting
Jackson, Mississippi, United States, 39216
Contact: Victoria Gonzalez, Au.D., PhD vgonzalez@umc.edu
United States, New York
Long Island Jewish Medical Center Recruiting
New Hyde Park, New York, United States, 11042
Contact: Andrea Vambutas, MD vambutas@nshs.edu
United States, North Carolina
Piedmont Ear, Nose, & Throat Associates Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Joseph Inman, MD
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Robert Labadie, MD, PhD Robert.labadie@vanderbilt.edu
United States, Utah
Jean Brown Research Recruiting
Murray, Utah, United States, 84107
Contact: Justin Gull, MD jgull@jbrutah.com
Sponsors and Collaborators
Autifony Therapeutics Limited
Investigators
Principal Investigator: Robert Frisina, PhD Director Global Center for Hearing and Speech Research
More Information
No publications provided
Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02345031 History of Changes
Other Study ID Numbers: AUT022063
Study First Received: January 19, 2015
Last Updated: August 17, 2015
Health Authority: United States: Food and Drug Administration
Keywords provided by Autifony Therapeutics Limited:
hearing loss
speech-in-noise
Additional relevant MeSH terms:
Deafness
Hearing Loss
Presbycusis
Ear Diseases
Hearing Disorders
Hearing Loss, Sensorineural
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
ClinicalTrials.gov processed this record on October 16, 2015
Oh well....
I’m 60. Us Boomers are getting ooooolllllddddd.........................
LOL. I’m 51. Eventually they’ll look into it for we “younger” folk.
Are you in any of the areas included on the trial?
No, the nearest to me is Jackson, MS, 289 miles..................
Estimated Study Completion Date: March 2016
I’ll keep tabs on it for everyone!.......................
Closest to me is 400+ miles. Damn.
I noticed that they have two in South Florida: Boca Raton and Tampa, both have large elderly populations of retirees...............
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.
If you experience an erection lasting more than 12 hours, please get to an emergency room..........or a brothel................
Likely dead by then, knowing the FDA and the glacial pace they approve stuff at.
Thanks for the link and this posting.
Some Freepers lucky enough to live near the clinics that get on the trial should keep us updated.
Guess Texas didn’t have a clinic...........
viagra for the ears???
Closest one to me, >2500 miles away:
United States, California
Sacramento ENT Recruiting
Sacramento, California, United States, 95815
Contact: Kevin McKennan, ENT
I have contacted by email the Doctor doing the study in my area, I seem to fit all the criteria, I’ll let you know when I hear back if I’m selected.
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