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

[MadG]

I completely agree with PhilB. Publicity likely has a lot to do with the challenge in finding candidates. I'm sure there are a number of sufferers who would meet the criteria, who have no idea this trail exists. Obviously they're not testing it in the US, for T anyway, but the American T Association doesn't have a word about Aut's existence of their website or mailings. One would think they would at least make people aware of it?

Why don't people write to the ATA?

 

[swc5150]

It'd be great if you could have him come on here and share his Expierience.

That would be great, as long as some members would just let him disclose his results, and not borderline accuse him of lying or attempt to punch holes in his story. Dannyboy, Corrine and I all had our share of negative feedback after reporting some positive results from various treatments. I know I'll never report any personal positive news on the forum again. Dannyboy really got shredded, and he's been awesome reporting his treatment plan and results.

 

[swc5150]

Why don't people write to the ATA?

I suppose someone could, but I don't know how anyone involved in T research wouldn't be aware of Aut? It appears they're funding is wrapped up in TRT and AM101.

 

[Eltel]

I was told that there is a high failure rate to get on the trial when I spoke to the hospital , also the trial will be open to the end of the yr .

 

[Nucleo]

I was told that there is a high failure rate to get on the trial when I spoke to the hospital , also the trial will be open to the end of the yr .

Do you mean high rejection rate? Because we have reports here on people who seemingly fit all the criteria and got turned down for dubious reasons.

 

[Eltel]

Yes I was told "there is a high screen test failure rate " .Those were the specific words .
I am waiting to hear back but I think my hearing loss too great .
I tried to get a feeling of how things looked for those already on trial but I quote " I cannot comment " was the reply.
I guess that its the official line from Autifony and we just have too wait

 

[Silvio Sabo]

As I stated previously: It's a good thing they're picky about their candidates. Also, if I was running the trial I wouldn't take any trailees that are members of any forums like this. I'm sorry to say this but sharing stories and results can effect the outcome of the trial.

Just let them do their thing and hope for the best!

 

[Neilpk]

Do they do blood or urine tests before allowing you to participate in the trial?

Thanks

 

[Bertman]

Well I think if Aut63 makes it to phase 3 there is a pretty good chance it comes to market. Not only do I say this because I have hope but because RTG did it and this seems to be working with similar parts of the brain. I know they are not exactly the same and RTG is not available in all countries anymore because of the side effects but from my understanding, drugs like aut63 and sf34 are more selective, thus lowering these side effects in theory. Also from what I hear the few patients we know of have had good results with minor side effects, if any. And there is a chance that anyone who it didn't work for could have gotten a placebo. I sure hope they expand the trial to other countries like Canada and the US so that maybe we can get the trial done sooner with more available participants (and so I can give it a try )

 

[Bertman]

Do they do blood or urine tests before allowing you to participate in the trial?

Thanks

Not sure about either of those but this page includes the inclusion and exclusion criteria:
https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85​

From this you should be able to figure out if the reason you would like to know about the tests affects whether your able to participate.
The page also includes contact info for the trial so it may be worth asking them directly, although who knows how long it will take for a response.

Best of luck,,

 

[Neilpk]

Not sure about either of those but this page includes the inclusion and exclusion criteria:
https://clinicaltrials.gov/ct2/show/NCT02315508?term=tinnitus&rank=85

From this you should be able to figure out if the reason you would like to know about the tests affects whether your able to participate.
The page also includes contact info for the trial so it may be worth asking them directly, although who knows how long it will take for a response.

Best of luck,,

Thanks so much!

I am thinking about giving it a shot. It's doesn't say whether your T has to be bilateral or unilateral in nature though. I am also curious as to whether or not it can be somatic in nature, not to mention if hearing loss is required or not, although I had seen somewhere that some hearing loss is required.

I am guessing also periodic use of Xanax may preclude you from the study, unless you just stopped taking it a few weeks before going for the trial so it's undetectable in any urine or blood tests.

Any thoughts/feedback, especially from other trial participants would be highly appreciated.

 

[Dutchy]

Well I think if Aut63 makes it to phase 3 there is a pretty good chance it comes to market. Not only do I say this because I have hope but because RTG did it and this seems to be working with similar parts of the brain. I know they are not exactly the same and RTG is not available in all countries anymore because of the side effects but from my understanding, drugs like aut63 and sf34 are more selective, thus lowering these side effects in theory. Also from what I hear the few patients we know of have had good results with minor side effects, if any. And there is a chance that anyone who it didn't work for could have gotten a placebo. I sure hope they expand the trial to other countries like Canada and the US so that maybe we can get the trial done sooner with more available participants (and so I can give it a try )

Netherlands here send me some ..

 

[markoana]

When Autifony needs to public the molecular and chemical data for AUT63, molecular ingredients etc...

Is that phase III trial obligation, or when?

Tnx if anyone knows the answer.

 

[Bertman]

Thanks so much!

I am thinking about giving it a shot. It's doesn't say whether your T has to be bilateral or unilateral in nature though. I am also curious as to whether or not it can be somatic in nature, not to mention if hearing loss is required or not, although I had seen somewhere that some hearing loss is required.

I am guessing also periodic use of Xanax may preclude you from the study, unless you just stopped taking it a few weeks before going for the trial so it's undetectable in any urine or blood tests.

Any thoughts/feedback, especially from other trial participants would be highly appreciated.

Yeah it seems that those are the baselines for the trial and then once you go to screening or whatever, then they may become more picky about certain situations (i.e. hearing loss, single tones etc) . And I would think that if you stopped xanax like you said a few weeks before you'd be good, but can't say for certain. Either way if I was you I would definitely give it a shot. From what I hear if you get the real drug and have success you will likely go to baseline after the trial period, but at least you would know that it will help you which I think would be a huge stress relief.

 

[Lucero]

Hello everybody, Im new in this forum
I keep optimistic in AUT63 drug, but I have a question.
If phase II is finally successfull, when will phase III starts?
Early 2016 maybe or later? Id like to try it in Spain.
Thank you!

 

[sanjay doodani]

I learn from company it will multi nation trial

 

[Nucleo]

I learn from company it will multi nation trial

They are already running trials in the US and the UK.

 

[Christian78]

Hello everybody, Im new in this forum
I keep optimistic in AUT63 drug, but I have a question.
If phase II is finally successfull, when will phase III starts?
Early 2016 maybe or later? Id like to try it in Spain.
Thank you!

if as they said 2nd quarter 2016 will get results, then minimum 6 months prepare or more until 3rd phase

 

[Christian78]

They are already running trials in the US and the UK.

how do you know about USA?

When Autifony needs to public the molecular and chemical data for AUT63, molecular ingredients etc...

Is that phase III trial obligation, or when?

Tnx if anyone knows the answer.

they said 12/2015 and moved to 6/2016
3rd phase is obligatory but they we hope it will open for public for those who have doctors old document and are patient who surfer for tinnitus and are unable to live

 

[valeri]

if as they said 2nd quarter 2016 will get results, then minimum 6 months prepare or more until 3rd phase

In other words = forever

 

[Nucleo]

how do you know about USA?

There are trials going on right now for AUT00063 in the US. @Zimichael tried to get in for was refused because of hyperacusis.

https://clinicaltrials.gov/ct2/show/NCT02345031

 

[valeri]

US trial is for hearing loss not tinnitus

 

[Robb09]

and for old people only

 

[Guest57247683]

Nucleo wrote: They are already running trials in the US and the UK.

- Are these running trials phase III?

Thanks

 

[amandine]

Are these running trials phase III?

Phase 2

 

[Zimichael]

There are trials going on right now for AUT00063 in the US.

@Zimichael tried to get in for was refused because of hyperacusis.

https://clinicaltrials.gov/ct2/show/NCT02345031

Uhhhhhhhhhhh...not quite correct, but indeed my Hyperacusis is what screws up my life way more than the astonishingly loud (but stable if not 'reacting' to a 'sound trigger', i.e. getting "zapped" by loud sound, etc.) ringing of my Tinnitus. ***[Details of that interaction with the trial folks repeated below for those interested - and yeah I realize this is not the UK trial and so forth for T, but same drug...and T does not necessarily exclude one from the USA "Clarity-1" trial].

So basically, I 'refused myself' because my "Quality of Life" numbers (in other words = near zero!) were so high on the TFI index, that we decided via phone, that I would not make it into the trial. Question Q kinda knocked me out of the ring. You can see why. Hell I could have scored 30 just on 19 t0 21!!! if really honest about it:

HERE IS FULL EXPLANATION OF THE WHOLE DEALYHICK:

2. AUT00063 in the USA right now...the Clarity-1 Trial for age related hearing loss.

I applied many months ago as fall into the inclusion criteria (am 65 in a few months). However, the nearest site was an air flight away (Portland) and a hassle, until a new one just opened up at an ENT's practice in Sacramento, CA. I contacted Autifony, who contacted them, and I got a response immediately. *[Portland has been asleep at the wheel and still not recruiting yet!]. I had a long chat with a super fellow at that Sacramento ENT's office who is totally into "informed people" in trials like this...so we got on like house on fire. Obviously I asked for more detailed exclusion data to save me a 6 hour round trip drive, as I have tinnitus & hyperacusis and wondered if that was a factor. I got more than enough info...including that the TFI index is integral to the screening (Tinnitus Functional Index - attached). There is no way I can 'hide' the fact that I have T and H as I go everywhere in 'public' with plugs in for protection, until I know if it's "safe" (like that a doc is not a loud talker if I'm waiting in a small examining room; or if a quiet seeming store has loud PA system; etc., etc.).
OK so the trial guy tells me of another applicant who looked super (like me) but was screened out because he scored above 24 on the TFI...That is their threshold level! Twenty four.

So I said: "Look to save us both time let me do the test right now and I will call you back in a few".

Which I did...and scored 31 on the index once "scored" correctly (use the instructions as it is not just a straight addition game). Now, let's be clear here...I scored myself near zero for all the plethora of questions of my T 'affecting' my personal condition within myself. Like ability to think, to sleep, to concentrate and all that stuff. As in general, even though I have incredibly loud central T "EEEEeeeeeeeeeeeeeeeeeee" at all times, I have "adapted" to that pretty well. As I have said before many times (and just for the record this was 'my description' originally, not "You Know Who's")..."my tinnitus is my silence". Hell, after 59 years at same tone, (but 4 volume increases) that can be expected. It's the SRT (sound-reactive-T) and H that is my killer. And that hits squarely at the "quality of life" questions, 19.-22.

"Boom!"...if I was honest, those would all peg at the 9-10 level...Like "completely destroys my social activities, relationships, enjoyment of life, etc." What relationships???!!! People don't like being on alert all the time if I have plugs out, it's boring for them...Oh forget it. I have an axe to grind on the complete lack of understanding most folks have for "invisible illnesses/suffering".

So, that disqualified me for the "Clarity-1" trial right there. Let alone I could easily put some 1's and 2's in some of the other TFI questions of course.

Zimichael

 

[noisebox]

I wonder if it works , if by curing T it will take away H if H symptom is just louder T

 

[amandine]

H symptom is just louder T

no it is not - h is a separate problem

 

[Joan A.]

Hello;

forgive me, i haven't time to read the full thread. I would ask if this drug work even for chronic tinnitus.

Thanks

 

[swc5150]

Hello;

forgive me, i haven't time to read the full thread. I would ask if this drug work even for chronic tinnitus.

Thanks

It's in trials for chronic T, yes.