AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
Hi all,
I'm new here but heard about this AM101 for tinnitus. It would be gr8 if this would work
I got tinnitus from loud music days last year April.
I see the criteria on the AM101 site says you have to have had tinnitus between 3 and 12 months. Why? I don't see what the difference is. Is it to be safe or for it to work?
Would someone past the 12 months, going on the trial, would put themselves at risk or would it just not work? Or are they improving their chances of success starting with the new tinnitus sufferers first? Are they planning to progress it past the 12 months?
What if you tell them you got tinnitus only 6 months ago? Is that irresponsible to the rest of you or all of us looking for a cure?
What way can they tell that?
Thanks
Jo
I'm new here but heard about this AM101 for tinnitus. It would be gr8 if this would work
I got tinnitus from loud music days last year April.I see the criteria on the AM101 site says you have to have had tinnitus between 3 and 12 months. Why? I don't see what the difference is. Is it to be safe or for it to work?
Would someone past the 12 months, going on the trial, would put themselves at risk or would it just not work? Or are they improving their chances of success starting with the new tinnitus sufferers first? Are they planning to progress it past the 12 months?
What if you tell them you got tinnitus only 6 months ago? Is that irresponsible to the rest of you or all of us looking for a cure?
What way can they tell that?
Thanks
Jo
MemberHi all,
I'm new here but heard about this AM101 for tinnitus. It would be gr8 if this would work
I see the criteria on the AM101 site says you have to have had tinnitus between 3 and 12 months. Why? I don't see what the difference is. Is it to be safe or for it to work?
Would someone past the 12 months, going on the trial, would put themselves at risk or would it just not work? Or are they improving their chances of success starting with the new tinnitus sufferers first? Are they planning to progress it past the 12 months?
What if you tell them you got tinnitus only 6 months ago? Is that irresponsible to the rest of you or all of us looking for a cure?
What way can they tell that?
Thanks
Jo
They will ask for papers from Doctors. In your case to be short, T fairly bothersome -> go and be happy
(plus read complete thread is filled with people thinking like you, people like me)
@attheedgeofscience please PM me as I would like to talk with you about something, thanks
Well the main idea is that we don`t want to mess with the data - imagine it would not work past 12 months but it would before 9 ... than if people lie about the time of onset and don`t get any benefit the scientists and FDA might decide not to put it in the market. So the people that lied screwed the whole world ... one point of view.Hi all,
I'm new here but heard about this AM101 for tinnitus. It would be gr8 if this would work
I see the criteria on the AM101 site says you have to have had tinnitus between 3 and 12 months. Why? I don't see what the difference is. Is it to be safe or for it to work?
Would someone past the 12 months, going on the trial, would put themselves at risk or would it just not work? Or are they improving their chances of success starting with the new tinnitus sufferers first? Are they planning to progress it past the 12 months?
What if you tell them you got tinnitus only 6 months ago? Is that irresponsible to the rest of you or all of us looking for a cure?
What way can they tell that?
Thanks
Jo
Received my 3rd and final round of shots today. I have to say my tinnitus is much louder, though I will add, my ears (7 hours later) are still clogged with fluid so I'm figuring that has something to do with it.
As I mentioned before, if I received the drug, I should notice it's effects in the next two weeks.
I'll post updates as the days go by.
A few notes about the procedure. It doesn't exactly hurt, but it does has it's moments of discomfort. It is a very strange sensation feeling a needle in your ear and fluid filling it up. The drug needs to be hand warmed, but on my final round it was warmed a bit much and I had vertigo for about a minute. While the other shots I either had no vertigo or just of a few seconds of it. My ears did ache for a number of hours after, though I'm sure that's also to be expected from getting a shot in the ear. Though for the most part, for me at least, it seemed a lot scarier than it actually was.
As I mentioned before, if I received the drug, I should notice it's effects in the next two weeks.
I'll post updates as the days go by.
A few notes about the procedure. It doesn't exactly hurt, but it does has it's moments of discomfort. It is a very strange sensation feeling a needle in your ear and fluid filling it up. The drug needs to be hand warmed, but on my final round it was warmed a bit much and I had vertigo for about a minute. While the other shots I either had no vertigo or just of a few seconds of it. My ears did ache for a number of hours after, though I'm sure that's also to be expected from getting a shot in the ear. Though for the most part, for me at least, it seemed a lot scarier than it actually was.
I had same after third round wow not nice T level.. it will subside, the rough edge goes of it in say 2 days
Ken219
Member
I believe first DO NO HARM! I have T for 24 years. Several relapses. In one now(8th week). I have habituated to all relapses. I expect to it this time too. I hope there is many doing research of T and H and of course hearing loss. God bless all and keep the conversation going.
@nills - yes, but if the window of opportunity is gone for us sufferers between 1 and 2 years, what is to say that if they prove it works for 3 to 12 months, then it could also work for past that. Phase 4 maybe? It is a trial after all and they don't really know yet what timeframes divide acute and chronic. It's a thumb suck.
My feeling is that it is being tested on recent sufferers because according to the trial, it is subjective. A person with 2 months of T has a better subjective view than a person with 15 months of it. I think that is the only reason, they are taking newbies. I don't think it is because it does not work past 12 months.
My feeling is that it is being tested on recent sufferers because according to the trial, it is subjective. A person with 2 months of T has a better subjective view than a person with 15 months of it. I think that is the only reason, they are taking newbies. I don't think it is because it does not work past 12 months.
@Robb - Not all of us have papers so would they allow you to take part on your word? Btw - my T is more than fairly bothersome. Like the rest of you, it has ruined my life.
I just wish like the rest of us that it would be extended and we get a cure for this damn thing!
Btw: I have been talking to a lot of people here and some people have had what they are calling relapses. It sounds very bad. He has had it 15 years ago but got it better through meditation and changing his lifestyle so that he habituated it. But then 6 months ago he had this bad relapse. So before then he did not notice his T. I said he must try for the AM101 becase he was exposed to loud sound again 6 months ago. Maybe AM101 would take away his most recent relapse from the noise. Because that is what he company are saying that it is the onset of T. He would then not skew the results for 3 - 12 months T sufferers because he is effectively a one of those guys. If he sees that it takes away his most recent acoustic trauma, then this would still be noted as a positive in the research and not skew it.
This T is a very subjective thing and we all relate to it very differently. It is cursing those days of listening to way too much loud music
They require documentation from your doctor. They will not let you in the trial without it. This is a medical trial and the they have to get accurate data to show if the drug works or doesn't work. If they let anyone in the trial based on their word, a lot of people would lie about their situation in hopes of relief. This would skew the results and potentially eliminate the drug from making it to market.
There is a concurrent trial being done for tinnitus sufferers 3-12 months. Unfortunately they're only letting people who participated in the acute phase trial partake. It was explained to me that this is to both find out if people need more than one treatment and if it works on chronic tinnitus.
My understanding is this drug is being fast tracked through the FDA. If it works as described, it will be available in 2016.
Actually depending on your location it could be available a bit earlier, I know as example that the approval process can be much faster in some asian or middle east country. In europe you can also have it through your doctor under certain conditions after the phase 3 while it's being aproved.
I am not sure about NA, if someone has more info, I would be glad to hear what you think.
I wasn`t saying anything about efficiency of the product, I really don`t know and can only hope it works. We just can not lie about our time frames of onset because it messes with data and the bureaucratic system does n`t give anything about our feelings or what we want. They need facts and money and maybe than we can have a cure (hopefully)
ps my T is very bothersome too, it has changed my life dramatically to the point it has ended a 9 year relationship with a woman I still carry close in my heart ... still i`m hanging in there and hope this product will be out soon so I can try it ... messing with data might be good for you but it will suck for me so better not do it cause like i said before, you screw the whole world. We are not scientists so we really do not know if it wrks or not before or beyond 12 months. It`s just hope that makes you say it.. and good on you that you still have hope.
I'm in North America, and the 2016 date is what I was told, as I was also told it was being fast tracked by the FDA. I'm sure they'll work as hard as they can to bring to market as soon as possible if it passes phase III.
I do believe part of the reason it is going to take that long is it takes time for recruit patients. While a lot of people may have acute tinnitus, I don't think very many people go to their ENT during the acute phase, then there's the problem of their ENT even knowing about the study. I found out about the study by visiting this site. The 3 ENTs I went to on the onset of my tinnitus didn't even know about this trial. I brought it to their attention when I asked if they knew anything about it and could give me any advice on taking part.
Hi Nills. I am sorry to hear about your relationship. That is tragic. I think we can all relate how this T has messed up our lives. Unfortunately, even if the drug gets passed, no doctor would administer it to us anyway, as we are out of the 12 month onset anyway. By 2016, it will be 2 years or more. So double whammy. Unless of course you lied to your doctor that you got T yesterday just to try it. But again, they would need doctors papers so unless someone starts a Dallas Buyers Guide for +12 month T sufferers. I guess that is just our bad luck.
No not quite. This guy got on the phase 2 for 3 to 12 months who had not been on phase 1.
Don`t jump to conclusions because officially we don`t know anything yet. if they discover during the trials it does work up to 12 months, why wouldn`t we get the drug? Also it might be able to stop newly acquired hearing loss from turning into louder or different tinnitus. yeah, the relationship is a bummer, I wasn`t the happiest person for the last years, bloody T get`s to you ... it`s good she left and found her own happiness.
In the US, according to the trial requirements, you have to have completed the acute trial first. If someone found a way around that, I'd be curious to know how they did that.
http://clinicaltrials.gov/ct2/show/NCT02040207?term=am-101&rank=3
http://clinicaltrials.gov/ct2/show/NCT01934010?term=am-101&rank=4
Hi earsnothappy. It was someone in the EU that got that right so I can't comment on the US system.
Hi @nills. That is very big of you to have that attitude. I'd have a very different attitude. You are a bigger man than me! I think what I meant about the trials was that if they realised it works up to 12 months, they would have to do some further trials to see if it effective past 12 months. Then again, they might just say, if it is effective pre 12 months, then lets just give post 12 month T sufferers the injections, if they want to try it. Without having to go through the FDA approval. And then if it worked for chronic T sufferers, then they could extend their patent to that. It really would be a win / win. However, I am just guessing. It would just be really crap for T sufferers that missed the window to have to wait even longer when pre-12 month people were getting relief. I guess that is just our bad luck. Keep on keeping on. All the best man!
Well, I am now on the AM-101 path. My evaluation appointment is scheduled for July 23rd.
I still would be interested to hear how folks who received the AM-101 treatment in the recent past are feeling in general, as well as how their T is doing.
I still would be interested to hear how folks who received the AM-101 treatment in the recent past are feeling in general, as well as how their T is doing.
"Gel stops constant buzzing", "Early results from clinical trials suggest it can halve the volume level of tinnitus in about 40 per cent of sufferers. But as it is likely to work only in the early stages of the condition."
Gives one a percentage of reality presented on the news lol.
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