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Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss (CLARITY-1)
ClinicalTrials.gov ^ | Last updated: August 17, 2015 | Autifony Therapeutics Limited

Posted on 10/16/2015 12:08:57 PM PDT by Red Badger

This study is currently recruiting participants!

First Received Date ICMJE January 19, 2015 Last Updated Date August 17, 2015 Start Date ICMJE January 2015 Estimated Primary Completion Date December 2015 (final data collection date for primary outcome measure) Current Primary Outcome Measures ICMJE (submitted: January 22, 2015) Change in hearing loss after 4 weeks of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] To compare the change from baseline (Day 1 to Day 28) between AUT00063 and placebo, on a speech-in-noise deficit Original Primary Outcome Measures ICMJE Same as current Change History Complete list of historical versions of study NCT02345031 on ClinicalTrials.gov Archive Site Current Secondary Outcome Measures ICMJE (submitted: January 22, 2015)

Change in parameters of hearing performance from baseline to day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ] Changes in hearing tests To further investigate the safety and tolerability profile of repeat administration of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG Pharmacokinetic of AUT00063, plasma levels [ Time Frame: 28 days ] [ Designated as safety issue: No ] Exposure of AUT00063 ng/ml, in plasma levels at Day 28

Brief Title ICMJE Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss Official Title ICMJE A Balanced, Randomized, Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss [CLARITY-1 Study] Brief Summary

This study aims to demonstrate that the investigational drug AUT00063 is effective and safe in the treatment of age-related hearing loss. Detailed Description

Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).

AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.

Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).

The amount of drug in the blood will also be measured. It is expected that up to 100 people with age-related hearing loss may take part in the study. The study participants will be recruited at around 10-12 sites in the USA. Study Type ICMJE Interventional Study Phase Phase 2 Study Design ICMJE Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Condition ICMJE Age-Related Hearing Loss Intervention ICMJE

Drug: AUT00063 600 mg, orally, once a day, for 4 weeks Other Name: Experimental Drug: Placebo orally, once a day, for 4 weeks Other Name: Comparator

Study Arm (s)

Active Comparator: AUT00063 (600 mg capsules) 3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks Intervention: Drug: AUT00063 Placebo Comparator: (AUT00063 placebo capsules) 3 capsules of placebo, to take orally once daily with food for 4 weeks Intervention: Drug: Placebo


TOPICS: Business/Economy; Health/Medicine; Science; Society
KEYWORDS: aut00063; ear; hearing; tinnitus
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THIS IS THE SAME DRUG THAT WAS IN THE EARLIER POST FROM THE UK.

This study is currently recruiting participants!

1 posted on 10/16/2015 12:08:57 PM PDT by Red Badger
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To: joe fonebone; SamiGirl; gitmogrunt; Freee-dame; ROCKLOBSTER; ryderann; Red_Devil 232; ...

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


2 posted on 10/16/2015 12:10:08 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: All

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


3 posted on 10/16/2015 12:12:21 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: All

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


4 posted on 10/16/2015 12:14:17 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger
Ages Eligible for Study:   60 Years to 89 Years

Oh well....

5 posted on 10/16/2015 12:17:26 PM PDT by FourPeas ("Maladjusted and wigging out is no way to go through life, son." -hg)
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To: FourPeas

I’m 60. Us Boomers are getting ooooolllllddddd.........................


6 posted on 10/16/2015 12:18:12 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger

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?


7 posted on 10/16/2015 12:20:38 PM PDT by FourPeas ("Maladjusted and wigging out is no way to go through life, son." -hg)
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To: Red Badger

https://clinicaltrials.gov/ct2/show/study/NCT02345031?term=clarity-1&rank=2#contacts


8 posted on 10/16/2015 12:21:03 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: FourPeas

No, the nearest to me is Jackson, MS, 289 miles..................


9 posted on 10/16/2015 12:21:40 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: FourPeas

Estimated Study Completion Date: March 2016

I’ll keep tabs on it for everyone!.......................


10 posted on 10/16/2015 12:22:42 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger

Closest to me is 400+ miles. Damn.


11 posted on 10/16/2015 12:28:53 PM PDT by oh8eleven (RVN '67-'68)
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To: oh8eleven

I noticed that they have two in South Florida: Boca Raton and Tampa, both have large elderly populations of retirees...............


12 posted on 10/16/2015 12:30:52 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger

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.


13 posted on 10/16/2015 12:31:33 PM PDT by aMorePerfectUnion ( "Forward lies the crown, and onward is the goal.")
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To: aMorePerfectUnion

If you experience an erection lasting more than 12 hours, please get to an emergency room..........or a brothel................


14 posted on 10/16/2015 12:32:19 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger
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.

15 posted on 10/16/2015 12:36:14 PM PDT by doorgunner69
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To: doorgunner69

https://clinicaltrials.gov/ct2/show/study/NCT02345031?term=clarity-1&rank=2#contacts


16 posted on 10/16/2015 12:52:09 PM PDT by Red Badger (READ MY LIPS: NO MORE BUSHES!...............)
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To: Red Badger

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...........


17 posted on 10/16/2015 12:54:10 PM PDT by X-spurt (CRUZ missile - armed and ready.)
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To: aMorePerfectUnion

viagra for the ears???


18 posted on 10/16/2015 1:00:12 PM PDT by HiTech RedNeck (Embrace the Lion of Judah and He will roar for you and teach you to roar too. See my page.)
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To: Red Badger
Come to the study centre for all visits with the study doctor or study staff

Closest one to me, >2500 miles away:

United States, California

Sacramento ENT Recruiting
Sacramento, California, United States, 95815

Contact: Kevin McKennan, ENT

19 posted on 10/16/2015 1:04:14 PM PDT by doorgunner69
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To: Red Badger

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.


20 posted on 10/16/2015 1:16:16 PM PDT by PoloSec ( Believe the Gospel: how that Christ died for our sins, was buried and rose again)
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