I have some relatives in gerymany, can i just lie and tell i live in germany? (I live in sweden)
Very happy for you Bart!
I contacted Auris with the question if am-101 is proven to be/not to be helpful in chronic Tinnitus and if they completely thrown out the idea, I also stated that i have had my Tinnitus for 5 years now.
reply;
We will evaluate efficacy in a post-acute stage as part of our phase III clinical trial in Europe.
Kind regards,
Thomas Meyer
not much information though it seems they keep the possibility open. So they must have concluded that the effect of the drug does n`t diminish when reaching 3 months post onset. fingers crossed.
Sure you can but they probably ask for your documents and secondly, when complications appear and you are in Sweden at the time then its really your loss. Therefore wouldn't advise you to do that. Also, your profile says that you have had tinnitus since 2005 so you dont qualify anyway?
Yes i got tinnitus 2005, but it got worse this summer, like much worse due loud noise trauma. Maby AM-101 can help me treat the damage i got this summer.
How would the know when I got my tinnitus ;P ............ I am desprate, tinnitus has ruined my life in so many ways. I couldent care less if I got tinnitus when i reach 40+ age, cuz by than iv probably lived my life, but i got it when i was 10 years old and im 19 now, not fun having tinnitus in this age..........
I understand your frustration. But unfortunately if you decide to participate then that will make the results of the survey inaccurate. For scientific plausibility I would not advise to lie and mess with the results. If smth goes wrong then that could mean that the drug will never reach the market.
Also, you are not going to live with tinnitus for decades. If the trials of AM101 are successful, it will probably be on the market in 4-5 years from now and as you said yourself, it could help with "spikes". In addition to this, yes Am101 is probably the 1st drug to be on the market. But many studies are held for chronic tinnitus as well. Not much of a consolation, but its the best we have.
Given the length of time these trials will be run, my own familiarity with FDA regulatory approvals and whatnot, I don't think it will take 4-5 years to get to market (this is from a US point of view, of course). It is the only drug that treats a given condition, literally. That could speed along it's approval. Most of these Phase III trials are set to be completed in 2015. Auris is hurrying to get this to market (as fast as they can). I think that if the results are good, we are looking at a 2.5 year time window for market approval (at worst). Then again, that's my guess.
I understand your frustration. But unfortunately if you decide to participate then that will make the results of the survey inaccurate. For scientific plausibility I would not advise to lie and mess with the results. If smth goes wrong then that could mean that the drug will never reach the market.
Also, you are not going to live with tinnitus for decades. If the trials of AM101 are successful, it will probably be on the market in 4-5 years from now and as you said yourself, it could help with "spikes". In addition to this, yes Am101 is probably the 1st drug to be on the market. But many studies are held for chronic tinnitus as well. Not much of a consolation, but its the best we have.
...and if there is no cure for chronic tinnitus by the time i finish my studies, than im gonna find it!
It has been confirmed that my first appointment for the AM-101 trial is on the 20th, where I will be evaluated by an audiologist. I will keep all of you updated throughout the procedure.
That's great news, I'm looking forward to hearing about your experience. Thanks for taking the plunge for all of us! Is it TACTT 2 or TACTT 3 you'll be participating in?
I think the whole acute vs chronic is still an assumed condition because there isn`t any cure or treatment yet that can make a division between these two. Like adhd is an assumed condition, there is no way to prove it, it is accepted as such. So I feel that am-101 will mark a new era because this will pin point to certain degrees when it stops helping someone and thus prove this person has reached a state of `chronic` tinnitus.What does he mean with post-acute stage?
I do understand that the brain rememebr the tinnitus and the treatment would not help because it solves only the core problem in the ear (ore am I wrong?). But, if you cure the core "problem", than treating tinnitus might be easier done by just training the brain to ignore/forget the sound (like with vns). I mean, if you would combine vns with AM-101 i belive chronic tinnitus is curable.
This might be a stupid question, but i understood that in this treatment you get some injections to the ear where tinnitus is, how about then when both ears are ringing? Does it cost more than when you have injections just in one ear?
These are Phase III clinical trials. Participation in the trial will not cost you anything, as it is experiment (albeit the last stage before a product goes commercial). That means a safety profile has generally been established, but not tested in large numbers of people. The product at this stage should be safe. To my knowledge they are treating both ears (if needed) in patients for these Phase III clinical trials.
I am curious, how expensive will be this treatment in commercial stage. I estimate it around $1000 for one ear.
I am curious, how expensive will be this treatment in commercial stage. I estimate it around $1000 for one ear.
You'd have to deal with Phantom Limb then.I wonder if they will trade me for a kidney ...and maybe an arm.. and a leg,maybe a few toes as well ?
I wonder about insurance coverage though. I think insurance companies would cover acute and post acute, but chronic people might not get covered.I am curious, how expensive will be this treatment in commercial stage. I estimate it around $1000 for one ear.
I wonder about insurance coverage though. I think insurance companies would cover acute and post acute, but chronic people might not get covered.
I was thinking the same thing... When this comes out on the market how would they be able to say only for accute or covers only accute T... Think they would be smarter to not do that cause they know there gonna get overloaded with tons of chronic T people that say theres is accute.. And no way to prove either!And they can prove your "chronic" condition how?