Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss (CLARITY-1)

ClinicalTrials.gov ^ | Last updated: August 17, 2015 | Autifony Therapeutics Limited

[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

[Red Badger]

THAT’s GREAT! HOPE & PRAY TO HEAR YOU MADE IT IN!.................

[Red Badger]

None closer? Where do you live? Idaho?...........

[Izzy Dunne]

Why must I wear a condom to test a hearing-related drug?

[oldvirginian]

Hope you get in, and get the good stuff!

[doorgunner69]

None closer? Where do you live? Idaho?...........

Big Island, Hawaii. I hate 6 hour flights. Paralyzed at the end of them.

[Red Badger]

I have an Uncle there!.......................(If he’s still alive. I haven’t heard from him in decades)....................

[Red Badger]

[oldvirginian]

Because certain drugs can be transferred through semen and the interaction with whatever medication your partner is taking may not play nice with a new, unknown drug.

Dr House said so, and I checked with my own doctor and he verified it.

[Red Badger]

They don’t know where your head has been......................8^)

[FourPeas]

Very cool. I hope it goes well!

[Chickensoup]

It is not a condom it is a rubber glove.

Why does chickensoup have to point out these obvious things?

[Red Badger]

What’s the difference between a rubber glove and a condom? ............4 fingers..................

[FourtySeven]

Thanks for the ping. Sadly I’m too young (45). It’s a shame I’d qualify by every other requirement. Oh well hopefully it’ll come to be offered to the general public soon.

[Graybeard58]

viagra for the ears???

For the hard of hearing.

[HiTech RedNeck]

But you don’t WANT to be hard of hearing.

[PoloSec]

UPDATE: Clinical Trial: Study Drug AUT00063

I just had a telephone interview with the doctor doing trails in my area, I met all criteria but was rejected for one reason, the severity of my Tinnitis as I described it and the fact it is a constant, I told her I thought Tinnitis was what this trial is specifically about, I told her how I got to her trial by reading about the U.K. trail, she said yes but that trial phase was called “QUIET 1” focused on Tinnitus, the trial phase here in the U.S. is called “Clarity 1” focused on hearing loss, same U.K. based company same drug; different trials, any way she said there will be other phases to the trials so she will keep me on record as my condition may not be an eliminating factor in future trials.

It seems it will be several years before anything comes of this drug, if anything at all, I was looking forward to it; was going to keep ya’ll informed every step of the way but she did not like hearing how bad it is or the fact I’ve had tinnitus for some 35years I was gold until then, I talked to much I guess, intermittent or mild Tinnitus might have been okay.

Thanks for Ping List hopefully someday no more noise, oh side note; they were paying for being in this trial minimum 300 dollars for about 42 days of taking the drug and keeping a diary, 3 maybe 4 visits to the clinic (less than 4 miles from me) and the rest is done by phone, too think I could of been rich.

[Red Badger]

I am truly sorry you did not make the cut. I was hoping you could have given us a day by day progress report. Maybe you will be included with the next phase, if the QUIET-1 version gets to that stage here in the US.............

[Red Badger]

The results of this phase of study will be released in February for the UK and March for the US, so I’ll keep an ‘EAR’ out for it!.......................

[Red Badger]

[FourPeas]

How disappointing. I’m sorry you weren’t accepted for the study. It would have been very interesting to hear about the way in which they conduct the clinical trial.