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Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

Finished my 29 days of AUT00063 on the 4th of August 2015 (3 days ago).

I had the quietest days of T since it started in this last month. Also some of the loudest.

dB requirement is now 25 rather than 40 at the hospital I was at (Royal Ear Nose and Throat, London, UK). My left ear passed, my right did not.

I bought retigabine from China last year and since AUT is meant to act in the same way I imagined I felt a familiar tickle in the brain on the first day. 50% chance I had pills full of nothing and was imagining it.

3 weeks in it was so low I was writing '1'on my form (from 3) and feeling back to my old self. Placebo or not, this made me very happy. At that level I started thinking about who I would visit at the weekend rather than just hanging on until Monday. A bout of flu 7 days ago brought it back to above baseline (4) and has now reduced to (3) again.

Coming out of the AM-101 trial and into this (I turned down the 3rd cycle of AM-101 so the results for both studies would be valid and was transparent to the AUT doctors) I felt that both were helpful. *If* I actually had the drug, I would say AUT helped more, but I regret having to having make a choice between them. AM-101 helped me as well, and I know I got 2 rounds of that after the first blinded injections.

~10 months in I'm down to a tolerable 3 from 9. No longer suicidal and able to read a book and focus on work. "tincture of time?", maybe. Able to live again, within my means? Certainly.

I don't listen to music anymore but flirted with my spotify account on one of the best evenings. Remembered how nice it was.

Something inspiring by John Metcalfe, The Shock of Recognition:


The same, high quality on spotify:


Keep it nice and quiet.

Tom

Edit: trial is now running until the end of the year (at least in R:ENT, London) with results projected to be released at the earliest Q2 2016.

Any side effects or anything while on the drug? Aside from the lowered t of course!
 
Nice try. You misinterpreted what i wrote , tried to put words in my mouth and now youre hurt that you were corrected.
I guess they keep securing funds because they don't have a clue as to what they are doing....yes that makes perfect sense.

It's ok if you want to blindly beleive Autifony is on the right track and that they know what they are doing just because.

As for myself, I'll wait for concrete data before passing judgement. My concern is about them seemingly not following their protocol for patient inclusion/exclusion. It also probably depends on the site too (altough it shouldn't?) as there are about of dozen of them.
 
It's ok if you want to blindly beleive Autifony is on the right track and that they know what they are doing just because.

As for myself, I'll wait for concrete data before passing judgement. My concern is about them seemingly not following their protocol for patient inclusion/exclusion. It also probably depends on the site too (altough it shouldn't?) as there are about of dozen of them.

Maybe you still dont understand my statement. The conversation just before I made my statement revolved around the inclusion criteria. My statement was geared toward my thoughts that they know what they are doing WITH THE TRIALS. I didn't say anything to the effect that they will be successful just because they have experience. I said they have experience conducting trials. Jeez
 
Goodness guys this thread has gone way off track.
Sometimes you've just got to agree to disagree.
The one consistent theme throughout this thread is that we're all in this together. We're all suffering with T to varying degrees - but we have all had our lives affected by this stupid condition and every single one of us want the same thing - to be rid of tinnitus. There are 'arguments' for and against Autifony and the trial and I get that. But whatever side of the fence you're on we should all be thankful that there is a company out there that is trying to help us - and people who are willing to put themselves on the line and be involved in a trial that is at best a 'leap of faith' with their own health in order to help others. All this 'in fighting' is not doing anyone any good at all. What ever we say on here, whatever views we state it is not going to change the outcome of this trial. I respect all the views of everyone on here but ultimately only time will tell if Autifony has the solution to our problem.
 
Hi Bazz, that may well be an endpoint (either primary or secondary) in the Phase 111 trial - we'll just have to wait and see on that.
If efficacy is proven in the 6-18 month criteria of the current phase 11b trial, it is a possibility that they will extend it to a wider timeframe.
 
It's great seeing a second person reporting positive results from the trial. It's sad seeing this thread is still useless.

I have to agree with you that this thread has been drug through the mud.

Onto a positive note, from what we know so far it appears this drug may have some potential. We are only seeing the tip of the iceberg here, but in time we might find an effective treatment for lowering volume. If the drug is showing some benefit then I would assume the drug maker is just as anxious to get the drug to market as we are. That would make its shareholders happy, and it would make me very happy as well.
 
It's great seeing a second person reporting positive results from the trial. It's sad seeing this thread is still useless.

Agree, lost interest in this thread a while back, might be a good idea for @Markku to close it and start a new thread for informative post's only and no opinions without substance or facts!

On a brighter note, AUT00063 is looking very promising and now it's just the wait for it to be available to all!
 
Agree, lost interest in this thread a while back, might be a good idea for @Markku to close it and start a new thread for informative post's only and no opinions without substance or facts!

On a brighter note, AUT00063 is looking very promising and now it's just the wait for it to be available to all!
I really don't understand why you would close the thread with the most activity by far. If you're not enjoying the thread than goto another thread.
 
I really don't understand why you would close the thread with the most activity by far. If you're not enjoying the thread than goto another thread.

Your post, pointing out the obvious, is just another example of posts that really don't need to be posted! (with all due respect @tshapiro )

You obviously haven't read the whole thread and some of the bull#$#t posts it contains, (sorry no other word to describe it!), If you understood my post, you would have noted that I have not visited for some time, and if you have noted my posts on this forum, I have a bit of an issue with nonsensical posts on important threads like this was suppose to be!

I suggested closing the thread and making another but if you didn't understand my original post, I ain't repeating it.

Read every post in this thread and then give me your opinion, this is another example of posts that don't need to be in here and wasted space! you didn't really have to state the obvious to me.
 
Your post, pointing out the obvious, is just another example of posts that really don't need to be posted! (with all due respect @tshapiro )

You obviously haven't read the whole thread and some of the bull#$#t posts it contains, (sorry no other word to describe it!), If you understood my post, you would have noted that I have not visited for some time, and if you have noted my posts on this forum, I have a bit of an issue with nonsensical posts on important threads like this was suppose to be!

I suggested closing the thread and making another but if you didn't understand my original post, I ain't repeating it.

Read every post in this thread and then give me your opinion, this is another example of posts that don't need to be in here and wasted space! you didn't really have to state the obvious to me.
Hey bro, I have read the thread daily since it started. I enjoy it. There is interesting new info on occasion. And, if you think I can't 'hang' with your posts than you obviously have no idea who I am. Anyway, I'll give you the last word and then I'll go back to enjoying the thread.
 
There is interesting new info on occasion

Yep, You said it, and if people would stop posting rubbish that could be posted in a PM or just kept in someones head then the thread would be interesting all the time!

And, if you think I can't 'hang' with your posts than you obviously have no idea who I am.

Huh????, Mate I really have no idea where your going with this, but if I've got the last say, I will say this, 'Stop reading something into stuff that's not there, your right I have no idea who you are because you post under a made up name so is impossible to know who you are, and I don't believe I said anything of the sort!

You reading imagined meanings in my post and seemingly not able to understand them tell's me more than enough of who you are.:rolleyes:

I'll give you the last word and then I'll go back to enjoying the thread.

You just do that and I won't be expecting a responding post from you then huh?

Enjoy and have a great day!:sleep:
 
Do they try to improve the drug in meantime?

No. You can't really ''improve a drug''. You can modify it or make a derivative, but then it becomes a new drug entirely so more trials etc...

They probably are working on other compounds though. But since we don't have any info, it's probably not anywhere close to be ready for other trials.
 
Hi guys, jut wanted to find out where they are at currently with the trials? I meet with all the necessary criteria, am local to one of the trial sites and have the number of the local research team also. But don't want to pester them unless phase II hasn't started yet.

I would be happy to provide you all with feedback if i get accepted.

I also work in the entertainment industry and as such have a considerable understanding of excessive sound levels and related impact to one's hearing.

cheers
 
Hi guys, jut wanted to find out where they are at currently with the trials? I meet with all the necessary criteria, am local to one of the trial sites and have the number of the local research team also. But don't want to pester them unless phase II hasn't started yet.

I would be happy to provide you all with feedback if i get accepted.

I also work in the entertainment industry and as such have a considerable understanding of excessive sound levels and related impact to one's hearing.

cheers

Phase II has been going on for a while now. I say go for it :)
 
Hi guys, jut wanted to find out where they are at currently with the trials? I meet with all the necessary criteria, am local to one of the trial sites and have the number of the local research team also. But don't want to pester them unless phase II hasn't started yet.

I would be happy to provide you all with feedback if i get accepted.

I also work in the entertainment industry and as such have a considerable understanding of excessive sound levels and related impact to one's hearing.

cheers

please try be enrolled and let us know :)
 
I know this was probably already asked and answered but i'm raising the question again - why is the requirement for hearing loss if the pill "modulates specific voltage gated potassium ion channels"?

Because pill is not just for t, it is for hearing loss also. (thats what they say) Why? I suppose tactic- catch all, in phase III they can easily eliminate that requirement if there was no results in improve hearing, and be focused just on t
 
I know this was probably already asked and answered but i'm raising the question again - why is the requirement for hearing loss if the pill "modulates specific voltage gated potassium ion channels"?
Hearing loss can turn into Tinnitus ... they want to see if AUT can stop hearing loss turning into chronic T ... or even reversing the T itself and maybe even influencing the hearing loss.

2 goals in one aim.
 
Because pill is not just for t, it is for hearing loss also. (thats what they say) Why? I suppose tactic- catch all, in phase III they can easily eliminate that requirement if there was no results in improve hearing, and be focused just on t

From their Autifony's website:

http://www.autifonytherapeutics.com/autifony-tinnitus-quiet-study.asp

Q. If I also suffer from hearing loss, can I expect to see an improvement in my audiogram, as I know AUT00063 is being tested also for Age Related Hearing Loss in the USA
A. No, we do not expect AUT00063 to improve the pure tone audiogram as the drug does not work on mechanisms is the cochlea itself. "063" is designed to improve auditory processing in the brain, and of course to reduce the central auditory activity that gives rise to tinnitus. A decline in central auditory processing is an important aspect of age related hearing loss, and gives rise to the difficult people have understanding speech in difficult listening environments, such as in a background of noise. In preclinical models, AUT00063 has been shown to improve central auditory processing.
So it has nothing to do with the hearing organs. All our current standard audiological methods to quantify hearing is based on the general state of cochlear hair cells (pure tone thresholds, otoacoustic emissions). They will only test for speech understanding in noise which I admit I do not know how accurate such tests can be.
 
From their Autifony's website:

http://www.autifonytherapeutics.com/autifony-tinnitus-quiet-study.asp

Q. If I also suffer from hearing loss, can I expect to see an improvement in my audiogram, as I know AUT00063 is being tested also for Age Related Hearing Loss in the USA
A. No, we do not expect AUT00063 to improve the pure tone audiogram as the drug does not work on mechanisms is the cochlea itself. "063" is designed to improve auditory processing in the brain, and of course to reduce the central auditory activity that gives rise to tinnitus. A decline in central auditory processing is an important aspect of age related hearing loss, and gives rise to the difficult people have understanding speech in difficult listening environments, such as in a background of noise. In preclinical models, AUT00063 has been shown to improve central auditory processing.
So it has nothing to do with the hearing organs. All our current standard audiological methods to quantify hearing is based on the general state of cochlear hair cells (pure tone thresholds, otoacoustic emissions). They will only test for speech understanding in noise which I admit I do not know how accurate such tests can be.
I did one of those tests last week. You hear noise and than some sentences being spoken. If you lost the higher freq in hearing it will become very hard to being able to distinguish words ... I scored pretty bad on it ... I think it is quit a solid test with what they aim to find or test. You have to repeat the sentence to the doctor so it`s water proof in that sense.
 
I did one of those tests last week. You hear noise and than some sentences being spoken. If you lost the higher freq in hearing it will become very hard to being able to distinguish words ... I scored pretty bad on it ... I think it is quit a solid test with what they aim to find or test. You have to repeat the sentence to the doctor so it`s water proof in that sense.

I had a test like this done but it was only simple words. I scored 100% on it but I might have cheated. The list of word was quite small and there was multiple repeats. The audiologist also had an accent I think she made sure she was as clear as possible even though in everyday situations no one would speak like this.
 
From their Autifony's website:

http://www.autifonytherapeutics.com/autifony-tinnitus-quiet-study.asp

Q. If I also suffer from hearing loss, can I expect to see an improvement in my audiogram, as I know AUT00063 is being tested also for Age Related Hearing Loss in the USA
A. No, we do not expect AUT00063 to improve the pure tone audiogram as the drug does not work on mechanisms is the cochlea itself. "063" is designed to improve auditory processing in the brain, and of course to reduce the central auditory activity that gives rise to tinnitus. A decline in central auditory processing is an important aspect of age related hearing loss, and gives rise to the difficult people have understanding speech in difficult listening environments, such as in a background of noise. In preclinical models, AUT00063 has been shown to improve central auditory processing.
So it has nothing to do with the hearing organs. All our current standard audiological methods to quantify hearing is based on the general state of cochlear hair cells (pure tone thresholds, otoacoustic emissions). They will only test for speech understanding in noise which I admit I do not know how accurate such tests can be.
Yes that's what i read there which leave this hearing loss criteria unexplained.
 

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