Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the... Drug AUT00063

ClinicalTrials.gov ^ | Last updated: October 13, 2015 | Autifony Therapeutics Limited & University of Nottingham (UK)

[Red Badger]

This study is ongoing, but not recruiting participants.

Change in subjective Tinnitus after 4 weeks treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo.

To further investigate the safety and tolerability profile of repeat administration of AUT00063 (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 Change in Tinnitus Loudness matching after 4 weeks of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] Changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching (LM). Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels) [ Time Frame: at day 28 ] [ Designated as safety issue: No ] Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels at Day 28

Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo Official Title ICMJE A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus Brief Summary

This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus. 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 has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.

The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). 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.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.

It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK. 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 Tinnitus, Subjective Intervention ICMJE

Drug: AUT00063 800 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)

Experimental: AUT00063 4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks. Intervention: Drug: AUT00063 Placebo Comparator: Placebo 4 capsules of placebo, to take orally with food for 4 weeks. Intervention: Drug: Placebo

[aimhigh]

What about broccoli?................p>Haven't watched for that connection. I will watch for it now. Thanks.

[Red Badger]

Also check out apricots, ripe or dried, avocados, acorn squash, artichokes, bamboo shoots, and worst of all: CHOCOLATE......B^(

[Red Badger]

You have been added.............8^)

[FourtySeven]

I will post this to you publicly in the hopes it will help not just you but others. I’m not in the habit of sharing my prescriptions online.

I’ve had our mutual “friend” in my head for the last year and a half. Nothing helped at all until last November I visited an ENT (the last one after five) who suggested I try “Nortriptyline”, an anti-depressant (now no longer used for that purpose) that some recent studies at NIH had shown could decrease or eliminate tinnitus. 30% of the participants saw a decrease, 30% saw elimination and the rest saw no decrease but came to a point where they were no longer bothered by the “noise”.

I experienced some decrease and also have reached a point where I’m not “as” bothered by what remains. It’s not a promise of a cure for you or anyone but it’s at least better than all the herbal junk out there that I’m sure you’ve tried already like I did.

Anyway it’s been the best for me I thought I’d share. You take much lower doses than were previously prescribed for depression so you don’t get any of the nasty side effects. Take the name to your doctor and see what he thinks. Again just a suggestion; because I “know”.

I think it’s fair to say at least half the burden is how much it bothers. Some may not think a high pitched whine constant for every hour of the day can be too bothersome. Those people never had it though.

[FourtySeven]

Thank you.

[X-spurt]

Ooops, sorry for my mistake.

From all I have heard/read on it, it is not something they can tune out like background noise. Seems to be a brain thing instead of ear thing.

[aimhigh]

Also check out apricots, ripe or dried, avocados, acorn squash, artichokes, bamboo shoots, and worst of all: CHOCOLATE......B^(

CHOCOLATE! Hold on, there are limits . .

[Red Badger]

Chocolate (dark) has 165mg of potassium per 1.5 oz.
Your banana has 425mg, average.......................

http://www.drugs.com/cg/potassium-content-of-foods-list.html

[Red Badger]

1 medium baked potato, with skin (925)...................

[Stevenc131]

For me it’s fairly severe. High(er) frequency sounds start merging with the ringing in my ears at about 7500hz - 8000hz and I can’t hear anything above that. Of course I’m old anyway!

[Red Badger]

http://www.freerepublic.com/focus/f-chat/3349512/posts

[mlizzy]

Without a doubt, I’d love to be on the tinnitus list. Thanks so much for pinging me FourtySeven, and I feel for you; I’m sorry you have to suffer with this malady too.

And, by the way, a FReeper suggested Bromelain capsules [the enzyme from pineapple], and I think it has helped me to a minor degree, but everything is appreciated so I’ve been taking them ever since he mentioned it many months ago.

Now I’m going to go read the article. Thank you again! .. =)

[Red Badger]

This particular study is in the UK.

Here’s the one for the US:

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

[Red Badger]

You are on the list!......................

[right way right]

You didn’t make a mistake.
I’m the one who embarrassed myself.
I’m good at it.
No harm.

Red please put me on your list.

[Vinnie]

Put me on your list if I’m not there already.
And answer the phone :^)

[TheOldLady]

I was sitting here FReeping and listening to my ears ringing when my husband got out his
drill and made holes over the dining room windows in preparation for installing blinds.

A few minutes after he was done drilling the mounting holes, I realized that my ringing
ears were no longer ringing.

Weird...

[Red Badger]

You’re ON!...........................