AM-101 TACTT1 Results Released

It looks like Auris Medical finally released the results from their Phase 2 trial of AM-101. Here's the link if anyone would like to read it.

http://www.aurismedical.com/p/news/news_40.php?lg=en

 

I would rather see the scientific paper, but I'm not sure what journal it has been posted in. I'll do some research this evening into that.

 

After some long hard work from auris medical and INSERM montpellier, france this is good news

as most scientists still aren't sure what's the difference between acute, post acute, chronic or blahblah tinnitus, let's just hope this gets released, test it on more than 12 months sufferers and helps a lot of people suffering from this ailment !

 

http://www.reddit.com/r/tinnitus/comments/1m1kiy/follow_up_on_am101_study_i_participated_in/

A poster on Reddit posted his experience in this trial. I felt it was relevant to this since he was contacted and informed he received the active drug.

 

Yes, good to see progress is being made. But like James said, hope they expand the scope beyond acute patients. I believe, but could be wrong, that University of Florida-Gainesville may be a phase III site -- but will only take patients within three months of onset.

 

@James White and @LadyDi At one point, I recall Auris also wanted to consider tinnitus within 12 months of onset, the subacute phase. I don't know if this is still being considered. But it makes sense Auris would focus on acute sufferers, for this offers them the greatest likelihood of success. And medical trials are expensive. But once they get approval for acute tinnitus, the company will either conduct trials with people whose tinnitus is longer than three months, or else doctors will offer the medicine "off label." Either way, I'm sure this drug will be available for people with chronic tinnitus. The only question will be if it will work.

As a prophalatic treatment, the drug should help people with chronic tinnitus. Everyone with chronic tinnitus worries their noise will get worse. With treatments like AM 101, if someone's tinnitus does worsen, they will probably get a shot to stop additional damage. The shot might not work for age-related tinnitus, but it should work for trauma-induced tinnitus.

 

In my opinion its a very important step in the right direction regardless.
It will be amazing to see a doctor actually being able to prescribe a drug for tinnitus - albeit acute.
I think doctors will then be more educated on tinnitus because they need to know how exactly the drug
acts on the body when they administer a drug.
Let us hope this drug comes out to the market specifically for tinnitus.

 

So far I've heard mostly good news from the AM101 trials, and only a few cases where it didn't help at all. This is very exciting stuff.

 

http://clinicaltrials.gov/ct2/show/NCT01934010?term=tinnitus&recr=Open&rank=22

FYI here is the study that Auris will be conducting on the post-acute effectiveness of AM-101.

It seems they will only be recruiting patients who participated in their earlier trials though?

 

@Hudson You're right. From my read, it looks like they are interested in trial participants whose hearing continued to decrease after receiving the treatment. How this affects tinnitus is unclear. It's also unclear if any former participant is eligible, or if Auris is targeting those whose hearing initially improved, then declined later. So many questions.

But hey this is great information nevertheless! Thanks for posting!!

 

Here is an automatic translation of a french article in the switzerland press about Thomas Meyer :

http://translate.google.fr/translat...medical-marche-dans-les-pas-dactelion&act=url

Don't read "they failed the animal model of tinnitus in rats" but "they succeeded in an animal model"

 

hi guys

if i ve understood well:

he has only used an existing anesthesic + a gel to make a new product wich can go thru ears to cochlea.

so basically it s not a new product but a new application for an existing medic

does anyone know the name of the anesthesic tey are using?

thanks

 

I've read that it's based on ketamine but other than that I'd have no idea if it is ketamine or a derivative of it.

 

I've been in contact with M. Meyer and i may be participating in the phase3 clinical trial. The compound seems safe and as it's a phase3, it should not be risky. I'll keep you all posted.

 

Have you had T for less than 3 months? If not, how would you qualify to participate?

 

They may qualify people up to 12 Months since onset in a separate trial. They didn't see a reduction of the effect near the end of the 3 months so it seems positive.

 

Hi James White,
Could you please tell us that how can we join phase 3 clinical trial? Thanks.
Are trails only be available in US ?Thanks

 

Trials will be held in Europe for Phase3, trials will be published on http://clinicaltrials.gov

 

I just called them and asked i I could participate in the phase 3 trials. At first she said no because I am from Norway, but then she said they will put out contact information on their web site. Does this mean recruitment hasnt started?

She also said a product or treatment would be available om the market in "3 years or less"

 

http://clinicaltrials.gov/ct2/show/NCT01934010?term=tinnitus+am101&rank=3

'not yet recruiting'.

Really? That's a lot to promise.

 

Looks like you must have completed one of their previous trials to participate?
http://clinicaltrials.gov/ct2/show/NCT01934010?term=am101&rank=2


And in the other one your tinnitus can't be older than 3 months..
http://clinicaltrials.gov/ct2/show/NCT01803646?term=am101&rank=4

 

Hopefully someone with a more chronic Tinnitus, like 3 years or longer sneaks in the trials and gets the medicin... I`d love to hear his/her story a couple of months after that. I`ll try to get in when I get the chance, I don`t mind to lie

 

I wouldn't try that, it's best if people comply with their requirements if everyone wants the drug to come out.

 

@James White

What did they tell you regarding participation in the trials?

 

Nothing about my personal condition, just that they will be doing a trial and France, then, i may not qualify if they stick to the 3 months window!

 

I said I was willing to travel to anywhere in Europe. Hope I can join.

 

I could travel to Canada and US too, not because I am desperate (although I am, hehe) but I have family in Canada, and a friend in New York

 

I think we should be as truthful as possible regarding any and all trials. I understand tinnitus desperation, I really do. However, if the trial is flooded by people who do not fit the criteria, the drug could possibly fail. That would be another disappointing set back for tinnitus research and a prolonging of more meaningful treatments. I want a company to have a tinnitus treatment that is effective. I want them to make money. If they do, more money will be funneled into research.

 

I'm very frustrated with the pace of tinnitus research. That is why I am looking at graduate school for tinnitus research myself.

I got tinnitus when I was 17. I was scared as hell, because there was even less information then than now. Basically, they told you that you had damaged your ears somehow and you had to live with it. There was little or no belief that it was a brain issue back then. I understand the panic, the desperation. The thoughts that your life are over, that you won't be able to to live a normal life and participate in normal activities, like going to a dance with a girl, or being in a bar with loud music. I remember scared to go hunting with my own dad because I was concerned about the blast from the gun, so much so that I did not go with him. It hurt him very much and he could not understand why a son would not want to hunt with his father. I have been dumped by girls for other men because they were tired of my worry/obsession about tinnitus, or wearing ear plugs when we went to movies and I got weird stares. Nothing is more emasculating than to have people stare at you in public when your girlfriend is there, and to have her ashamed. I have had to quit jobs that were good paying opportunities because of noise levels. I've cried out of desperation on my mom's shoulder, which is frustrating for a mother that can't help in ways I can't imagine. I've looked at that shotgun leaning against my wall. How easy it would be to pop a buckshot round in it, drive up into the mountains out in the middle of nowhere, hike somewhere with a gorgeous view and end it. That wouldn't be beating tinnitus, it would be giving in. I've come to terms with that. I want to study tinnitus, and beat it like the piece of crap it is. I want to contribute in a way so that others' lives won't be profoundly impacted the way mine has.

What am I getting at here? I am just saying I know all about tinnitus. I don't remember what silence is like. I want it gone. I don't want others to have to go through what I have gone through. If that means counting myself out of a trial that COULD have a possibility of helping me, I'll accept that. I want treatments available for that scared 17 year old I was. I want a doctor to be able to give that scared teenager some kind of meaningful treatment, instead of saying "Go home and live with it. No one really knows much about it."

At the end of the day, we all make decisions about our treatment. I want to ensure that a drug like AM-101 has all the possibility of making it through regulatory trials. If it does, maybe then the doc could squirt some of that crap in my ear drum and it could help.

EDIT - My purpose of this message was not to convey fear, desperation or to make anyone worried. I am just saying that I know what all of you face every day. Just be careful that we don't shoot ourselves in the foot when there is real opportunity here.

 

I agree. ESPECIALLY if you've had it for like 3 or 4 years. Because if that's the case, then it's not gonna matter whether you get treatment now or in 3 years.

In my situation it's different though. Because if the case is that it could help you early on, and I'm JUST too late, it COULD have worked, but won't when the treatment is available.