AM-101 TACTT1 Results Released

The idea is that it is permanent, although you can't say that with any certainty because there have been no long term studies of it done.

 

The real question I have about this: are they still treating only one ear per patient in the Phase III trial? I think they might achieve better efficacy if they actually treat both ears... I think they've established the safety profile already (the original point of treating only one ear) so why not go for both?

 

Does it say where in EU it will take place? not very competent at guineapig sites
Great being in an acute phase knowing it's out there and that you'll most likely miss out on it

 

Alcohol is a big no no for us t victims, so today my friend skyped me as it´s her b/day and we have always celebrated her birthday for the last 10 yrs by going for a liquid lunch, and then a little get together at her house with family etc, and lots of alcohol. This day i had to say NO i can´t have a drink as my T was ringing off its head, and i was at my witts end, after about an hour of watching her so happy and me so unhappy, i thought f this i´m having a drink... to my surprise after about two drinks my T just went so far to the back of my brain i could only hear it if i tried to listen for it which of course i did not!!!!! now don´t get me wrong i know i will pay for this happy afternoon that i have spent with my dearest friend laughing and joking, and talking about the old days, it was worth it just to be normal again, but i can´t help thinking WHY has the alcohol dulled my T down, obviously to do with clouding the brain, also stimulating my brain with the alcohol will be unbearable in a few hours when i´m no longer happy and dulled by alcohol, well i´ve had a great few hours, it was so worth being able to join in and just have some fun for a change... here´s to a spiked evening!!!! damn you tinnitus, just damn you!!!

 

What´s one of them???? as a new T victim i have no idea what all this abbreviation means, it does make this new forum very difficult to understand.

 

AM101 is a codename or something for a gel-like drug they inject into your ear, that hopefully reduces or stops tinnitus. after a little while. it has been developed for many years already, and it currently tested in clinical trials, and is expected to be available within 4 years or so.

if that was what you were asking hehe

 

Woah, permanent - sounds almost too good to be true! Drool!!!

 

Auris Medical presents positive results from phase IIb study with AM-101 to treat acute inner ear tinnitus at international conference

And as far as I know this could be somewhat dependent on the dose they use, and it would make sense to use small doses when you're unsure of the safety of it.

Am-101 is what I'm hoping for, and I think it will help a lot of people at least until a complete cure is made in 20 years or whatever.

 

I see now. This is TACTT2, Treatment of Acute Peripheral Tinnitus Following Traumatic Cochlear Injury or Otitis Media

and this AMPACT1 "AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1" follows from TACTT2

I guess they expect people to go from TACTT2 which you either get the placebo or drug to the post acute where every one gets the drug.

What's interesting is that one trial was in New Jersey which is 2.5 hrs away from me. It would be cool, if it was in a similar location.

 

I wonder if doubling the dose doubles the effect

 

when this drug hits the market, we will all be chronic T sufferers. do you guys personally think this drug will help us? what are your thoughts

 

Thanks. I looked at that site, and there was no button for me to send an application for the trial.

Do I need to personally make the call or email the experimenter and apply that way?

 

btw, has this drug passed the threshold for it to come out to the market? or, is it the case that it still may not make it to the market?

 

If phase III-trial(s) goes well, hopefully AM-101 will hit market within 3-4 years at best, to my understanding. I sure hope it will pass and sell sooner though!

 

yes, when I participated in phase II, I first contacted Auris Medical directly and they forwarded me to one of the clinics where study was going to take place. There should be a list of contacts in the clinicaltrials.gov study page.

 

You participated? Did it help you?

never mind

The whole truth about my Tinnitus and how I treated it | Tinnitus Talk Support Forum

You jumped off and still it helped you, I think that's a good sign..

Also, maybe when it hits the market, you can get a new injection?

 

Hi all,

Been reading this forum for about 2 months and this is my first post (Yay for me!).
yesterday i went to the UZA hospital(Antwerp, Belgium) for another checkup for my tinnitus and i got the option to participate in the upcoming phase III trials. I still have some doubt but i think i will join the trial.
The trial itself should start very soon (should get a call this week with the set date)

anyway i'll keep everyone here informed.

 

Good for you Bart. Are you going to the St Augustinus hospital at Antwerp too afterwards ? It is the sequel of the BRAI2N clinic De Ridder founded. Brai2n

 

Going to St Augustinus tomorow at 11pm. Been looking forward to that for over a month.
It's going to be a first meeting to see what my options are.
Seems that i am extremly lucky with where i live. Both hospitals are 15 mins away from me by car.

 

Where can you see which countries and hospitals participate in the trials?

 

Thats great! Please stick around in the following months with some updates on possible progress!

 

what you can consider luckily in the first place !

Anyway good luck and indeed keep us posted.

Fingers crossed you will have some positive results which will open the gates for...

 

@Bart Marien
Big yay for you! = )
Might I inquire about your first hospital visit? Was it like the first step visit any of us pay a regular ENT & audiologist, outside a hospital? And what lies within a checkup of your tinnitus? The private GPs and ENTs kicked me out rather not wanting to see me again and checkup.
That doubt is natural, for many in here I'm sure they'd chose it straight away so there's a lot to weight. Have you gotten any info of potential side effects?

It's so troublesome knowing it's out there but you might not make it in time

 

I´d sooo do it, so I really think you should take the opportunity!

 

When my tinnitus first started i went to the local ENT right away. I was in full panic cause i knew what tinnitus was (my dad has had it for over 6 years and my grandfather had it as well).
The ENT told me that water behind my ears was the cause (i had a bad cold) and that i had to wait it out. After a week i went back with the same ringing still going on. The water was gone but the ringing was still there.
Did several treatments since then. (nootropil infuse, hyperbolic oxygen, tons of other meds) but nothing worked.
About a month ago the ENT just told me to deal with it and it wasn't gonna go away .

I refused to just "deal with it" and made an appointment with 2 other institutions:
1) UZA antwerp: ( ENT for a second opinion)
2) Brai2n: read about them online and they are all about neuro stimulation

Anyway by luck i got the ENT who is leading the AM101 research in UZA who was looking for locals with tinnitus for less then 3 months for the third phase of this new drug. (this was yesterday). Chatted with him for about 40 minutes and did some hearing tests as well. He said that 33% is getting the placebo and the others the real stuff. We will never know which one we got. Not even after the research is done. If the first treatment did not work for whatever reason i am getting the real treatment for sure after another 3 months.

And the Brai2n clinic appointment is tomorrow. Hoping that something will work out for me

ps: hoping that my english is not too bad. Been a long while since i have written anything in English

 

Thank you Bart, please do keep us updated ! Best wishes.

 

update: got a phone call today that the research has been delayed by a month. Meaning i will be passed the 90 days limit.
They said that there will also be a 3-12month trial early next year and that they will keep me updated.

Needless to say i was down when i got the news. Part of my hope for a cure was kind of crushed into the ground.

 

this is ridiculous, I'm sorry Bart Marien

 

Well they haven't even indicated that there should be a reason it won't work for chronic sufferers, quite the opposite.

I think that when they get this approved, the doses will be higher, and so will the effect. So this should NOT crush any hope for a treatment/cure!

But it sucks that you will have to wait of course.

 

Sorry to hear that, Bart.