AM-101 TACTT1 Results Released

#331
GMac14 said:
Hey, thanks for the response. I'm from Edmonton so I definitely wouldn't mind making the commute if they hold trials for onset longer than 3 months. I was wondering how you came across this information?
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Hey GMac, to be able to get into the trial you would have to email Auris Medical. I can send you the link to their contact information. Here's the thing though. They only accept people within a 100 mile radius of the location of the trial, and I don't know whether or not they're accepting applicants with Tinnitus with over 3 months of onset at this point in time, and I'm not sure about Edmonton, but I think they should have something out there for you. It doesn't hurt to send them an email to see what they might have. Here's the link:


http://www.aurismedical.com/p/contact/contact.php?lg=en
 
#334
Kimbo Slice said:
Hey GMac, to be able to get into the trial you would have to email Auris Medical. I can send you the link to their contact information. Here's the thing though. They only accept people within a 100 mile radius of the location of the trial, and I don't know whether or not they're accepting applicants with Tinnitus with over 3 months of onset at this point in time, and I'm not sure about Edmonton, but I think they should have something out there for you. It doesn't hurt to send them an email to see what they might have. Here's the link:


http://www.aurismedical.com/p/contact/contact.php?lg=en
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Thanks a lot. I'll send them a message this evening and let you know what they say. I just want to be ready if they start trials for onset longer than 3 months.
 
#335
GMac14 said:
Thanks a lot. I'll send them a message this evening and let you know what they say. I just want to be ready if they start trials for onset longer than 3 months.
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Alright man. I know it sounds ridiculous that they don't accept people in more than a 100 mile radius. Where do they expect to find people for these trials if the research center is located in the middle of nowhere... Not to act like a child about this but it's so damn unfair that they do this, and all in all locate the trials in farmland where there are most likely no one with these issues. They need to place these trials into big cities, or remove that 100 mile limit they have going on.
 
#336
Yes Nilli's point on getting the drug later if one gets the placebo first is accurate. Companies generally not leave people feeling used and they will take care of their participants for sure.

I am also assuming that the mice died. Generally mice are used for 2 main ethical reasons. The first is for obvious anatomy reasons. The second ethical reason mice are used rather than monkeys, dogs, etc is because mice tend to not have a long life expectancy after their system is given an illness (in this case a chronic illness = T). Mice generally die in these studies. No one seems to intrinsically attach a huge value to mice, people tend to not care if a mouse did die. If a monkey or dog, or w.e. died because it was given an illness, the public might be a little upset.

Again I do not have a study that that shows that the mice died from AM 101 complications. I am just assuming they did die, because they ussually tend to die in most cases. In this case the mice if they did die did not die from AM 101 complications given that the study is in phase 3. So if they tested the mice 7 years ago or w.e. , the mice are probably dead, but the long term mouse saftey stats are not there to show anyone anything. The people in phase 1 can tell everyone the most about the long term I suppose. I guess I just have a general fear of the future regarding people getting their ear poked experimentally and I wish the mice were around because they would have the most post drug intake time to tell us about the long term safety. ALSO it could be the case that the mice are alive, I just doubt that given that most studies, the mice do die.
 
#337
Yea Kimbo the 100 mile radius is dumb. I think they are just concerned about attrition stats. I guess they think if someone comes from 5 states away or countries away, they might be less likely to be in the study for the long haul given the travel/ relocation inconvenience . (Though many would swim across the ocean to get physical relief, and I think a 100 mile radius is nothing inconvenient for the T sufferer).
 
#338
Mark Washington said:
Yea Kimbo the 100 mile radius is dumb. I think they are just concerned about attrition stats. I guess they think if someone comes from 5 states away or countries away, they might be less likely to be in the study for the long haul given the travel/ relocation inconvenience . (Though many would swim across the ocean to get physical relief, and I think a 100 mile radius is nothing inconvenient for the T sufferer).
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Country to country, state to state isn't the issue here. They said they have research centers located all across the country, and in different areas of the world. What the problem is, is capping the travel limit to 100 miles so only those who are like an hour or two away at most are able to join. On top of that, they locate these research centers in the middle of $%#@ nowhere farmland, where no one could possibly join. It's like how many people do they expect to join this trial if only 10% of Canada's population has Tinnitus, and one person's farm takes up 2 or more miles hahaha
 
#339
Kimbo Slice said:
Country to country, state to state isn't the issue here. They said they have research centers located all across the country, and in different areas of the world. What the problem is, is capping the travel limit to 100 miles so only those who are like an hour or two away at most are able to join. On top of that, they locate these research centers in the middle of $%#@ nowhere farmland, where no one could possibly join. It's like how many people do they expect to join this trial if only 10% of Canada's population has Tinnitus, and one person's farm takes up 2 or more miles hahaha
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Not to mention if there is only a 3 month window to apply!
 
#343
Dude on reddit.com who had AM101 treatment said:
Hey there, I must have missed your other pm. What questions did you have?
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Hi, thanks!

Well, my own, and probably some from tinnitustalk.com..

First off, I've had tinnitus for 10 months now. My hope is that AM101 will work for me when it reaches the market in a couple of years.

My questions are:

For how long did you have tinnitus before you got the am101?

How loud, was your T, and what did it sound like before the treatment?

How is it now, a year later? Do your ears feel "weird" after the treatment?

Thanks you for this, really! So glad I have found someone who's had the treatment.


Reddit guy said:
I had it for maybe 3 months before the treatment. My trial was phase 2 and compared to phase 1 they lowered the threshold between time you got tinnitus and the time they thought the drug was effective. It was pretty loud before and I always had headaches. Since the treatment it is significantly lower and most of the time I can't even hear it unless I make an effort to. I don't have any weird feeling in my ear.
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You think they have less confidence that it will work in chronic cases? From what I've read they are not sure, but are sticking to 3 months only for strategic reasons to get approval as soon as possible.

In fact they will soon be rolling out trials for people who had T for 8 to 12 months.

The fact that it helped you gives me hope. My T is pretty low (high pitched, low volume, "soft" is probably the right word), I hope AM101 can lower mine.

Just to get a clear image - how loud did your surroundings have to be for you NOT to hear it before am101? Now you say you have to concentrate to hear it?

I'm sorry for this, but I've been tring to get in touch with someone who's had am101 for months :D

I really appreciate it. These are pretty much all my questions, I might ask couple more when the guys at tinnitustalk.com sees my post... ( https://www.tinnitustalk.com/threads/am-101-tactt1-results-released.1994/page-12#post-33199 )

Again, thank you!

Reddit guy said:
I'm not sure what their rationale is. To tell you the truth, once I got "cured" I sort of stopped keeping up with all the developments. Its a bit selfish but beyond a relief to stop worrying about that damn ringing all the time.

Before the treatment I remember the shower used to drown out the ringing. Since that time I have to stop and "look" for the ringing. Who can say it was the drug or I have just become "accustomed" to that sound being there.
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I can hear it in a silent room, and when it's silent outside, and it's louder when I drink, but that's not a problem if "default" gets lowered significantly..

Do you think I might benefit from am101 treatment? Altough you keep the possibility of you being "cured" being only by habituation, you seem very confident that the drug helped you, and the statistics form Auris Medical support that.. An avarage of 50% reduction is what they say.

Did you just wake up one day and suddenly it was super low, or did it happen over say, two weeks?

It's 2:41 AM here in Norway so I'm not gonna bother you any more now!

Again, thanks dude..

Reddit dude said:
It was actually louder for a few weeks after the treatment, but I believe that had to do with the hole in my eardrum from the injection. I could probably buy the 50% reduction claim. From what I understand there are really no side effects so if you could find a way to get the treatment, it isn't like it will get any worse.
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#345
Erlend said:
Hi, thanks!

Well, my own, and probably some from tinnitustalk.com..

First off, I've had tinnitus for 10 months now. My hope is that AM101 will work for me when it reaches the market in a couple of years.

My questions are:

For how long did you have tinnitus before you got the am101?

How loud, was your T, and what did it sound like before the treatment?

How is it now, a year later? Do your ears feel "weird" after the treatment?

Thanks you for this, really! So glad I have found someone who's had the treatment.




You think they have less confidence that it will work in chronic cases? From what I've read they are not sure, but are sticking to 3 months only for strategic reasons to get approval as soon as possible.

In fact they will soon be rolling out trials for people who had T for 8 to 12 months.

The fact that it helped you gives me hope. My T is pretty low (high pitched, low volume, "soft" is probably the right word), I hope AM101 can lower mine.

Just to get a clear image - how loud did your surroundings have to be for you NOT to hear it before am101? Now you say you have to concentrate to hear it?

I'm sorry for this, but I've been tring to get in touch with someone who's had am101 for months :D

I really appreciate it. These are pretty much all my questions, I might ask couple more when the guys at tinnitustalk.com sees my post... ( https://www.tinnitustalk.com/threads/am-101-tactt1-results-released.1994/page-12#post-33199 )

Again, thank you!



I can hear it in a silent room, and when it's silent outside, and it's louder when I drink, but that's not a problem if "default" gets lowered significantly..

Do you think I might benefit from am101 treatment? Altough you keep the possibility of you being "cured" being only by habituation, you seem very confident that the drug helped you, and the statistics form Auris Medical support that.. An avarage of 50% reduction is what they say.

Did you just wake up one day and suddenly it was super low, or did it happen over say, two weeks?

It's 2:41 AM here in Norway so I'm not gonna bother you any more now!

Again, thanks dude..
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Yesss!!! Some answers!!!! :) just positiveness like this makes all the difference and should give everyone hopee!!! Thanks for finding this out!!!! :)
 
#346
I feel like this guys a celebrity and were all the news reporters wanting answers!! Lol can you imagine more people that were treated with am 101 coming forward? Theyd be swamped by all of us!!!!!! :)
 
#347
Johno said:
Mice died, because was too much happy from T dissappearing and got a heart attack. It was good day to die for it. :cat:

This guy, who pulled back after first injection (from 3) was member Fish and he regrets it, because his T after temporary worsening significantly improves.
Click to expand...

My tiny little dream conclusion to pull from this is that if you do a high enough dosage of am101 you will be completely cured? They're only testing really small amounts, and they've also concluded that higher dosage means more relief.

Maybe we will see another trial where they triple the dosage or something, and every member of the trial comes out cured... Who knows
 
#348
Erlend said:
My tiny little dream conclusion to pull from this is that if you do a high enough dosage of am101 you will be completely cured? They're only testing really small amounts, and they've also concluded that higher dosage means more relief.

Maybe we will see another trial where they triple the dosage or something, and every member of the trial comes out cured... Who knows
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Thats exactly what i was thinking!!! There just giving out proper doses right now to see if it improves at all.. But when this stuff comes out on the market.. Or they may do a phase 3b trial or something with chronic t from 1 year to 5 and up the dose... Kinda like an anti depressant.. You have to up the dose until you feel any changes.. Hoping this is the case. And they may even know this right now and wont say anything cause it could potentially be the cure and dont want to get swamped with questions and harrassed cause they have to take from trial to trial and make sure its safe.. Which its looking good so far :)
 
#349
Grace said:
Thats exactly what i was thinking!!! There just giving out proper doses right now to see if it improves at all.. But when this stuff comes out on the market.. Or they may do a phase 3b trial or something with chronic t from 1 year to 5 and up the dose... Kinda like an anti depressant.. You have to up the dose until you feel any changes.. Hoping this is the case. And they may even know this right now and wont say anything cause it could potentially be the cure and dont want to get swamped with questions and harrassed cause they have to take from trial to trial and make sure its safe.. Which its looking good so far :)
Click to expand...

Would AM-101 work only in acute tinnitus? (http://www.aurismedical.com/p/therapies/am_101.php)

The animal studies with AM-101 were performed in a model of acute acoustic trauma with treatment shortly after tinnitus onset. It seems likely that after some time centralization of tinnitus sets in (i.e. the brain "memorizes" the phantom sound), and a pharmacological treatment of tinnitus in the inner ear may no longer be possible. This question is the subject of much scientific discussion. In general, brain plasticity tends to be more rapid in the type of animals tested than in humans. In the phase IIb trial, AM-101 was still effective after 3 months.

The memorization basically means that tinnitus later happens in different parts of the brain. Read the paper from here: http://www.audiologyonline.com/articles/integrated-approach-to-tinnitus-management-11598
 
#352
katriina said:
Does that mean that this could work even for chronic tinnitus?
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I think its going to work a large group of people.. Even chronic too. They are gonna have to study it more on chronic tinnitus and find out the right dose which is probably gonna be way more then accute. And if it doesnt completelt cure atleast it should have some sort of impact
 
#353
I dont think Am101 takes tinnitus away ("cures"), it reduces it by some per cent. In your case, Grace, I think your volume is relatively low anyway so thats what they are probably aiming at. However, as you said they are gonna have to study more about chronic tinnitus. Only not about that, but also the difference and time frame between acute and chronic tinnitus is not sure and so on.
I read some boards from 2009 and saw that people were saying there that "oh there will be a treatment for it soon with the speed of science nowadays". 5 years later and there are no treatments available. Also, since Am101 is still in test phases we are not sure whether it works or not. Im not saying that to bring you down, Im simply saying that instead of counting years and hoping for a treatment (I know im doing that) try to focus on what you have now. Yes, science is moving fast but fast in science means maybe 10 years which for a person is around 1/9th of their life. Also, from what a read on Auris's website they said that in 10 years they had to build up a lot of devices and theories from scratch so I suppose in tinnitus research the spade is not so fast after all.
Your T is relatively mild so it probably doesn't have a major effect on your life. Since yours is noise-induced, make sure to stay out away from it. If you look around this board, there are many people who have NI tinnitus and managed to live maybe decades with it. Chances are better if you dont harm your ears too much. Of course we may be offered some kind of treatment soon but we must be ready that it wont come in no time soon :)
 
#356
Amelia said:
Me too @Erlend!
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Stina said:
I dont think Am101 takes tinnitus away ("cures"), it reduces it by some per cent. In your case, Grace, I think your volume is relatively low anyway so thats what they are probably aiming at. However, as you said they are gonna have to study more about chronic tinnitus. Only not about that, but also the difference and time frame between acute and chronic tinnitus is not sure and so on.
I read some boards from 2009 and saw that people were saying there that "oh there will be a treatment for it soon with the speed of science nowadays". 5 years later and there are no treatments available. Also, since Am101 is still in test phases we are not sure whether it works or not. Im not saying that to bring you down, Im simply saying that instead of counting years and hoping for a treatment (I know im doing that) try to focus on what you have now. Yes, science is moving fast but fast in science means maybe 10 years which for a person is around 1/9th of their life. Also, from what a read on Auris's website they said that in 10 years they had to build up a lot of devices and theories from scratch so I suppose in tinnitus research the spade is not so fast after all.
Your T is relatively mild so it probably doesn't have a major effect on your life. Since yours is noise-induced, make sure to stay out away from it. If you look around this board, there are many people who have NI tinnitus and managed to live maybe decades with it. Chances are better if you dont harm your ears too much. Of course we may be offered some kind of treatment soon but we must be ready that it wont come in no time soon :)
Click to expand...
I just read that paper that you posted and the guy with the stroke that recovered completely from t.. Well that explains the whole memorization thing is bullshit! If his went away then they will find another way of getting rid of it completely for everyone with chronic t. I know this may be ten or 15 years from now but im pretty positive that they will.. And yea deff stayin positive that this will reach the market summer of 2016 or lil after that. Its at least something we can all try and hope to work and will probably eliminate people thats t is really loud to a more quieter.. Until they find the actual cure!!!! :)
 
#357
Grace said:
I just read that paper that you posted and the guy with the stroke that recovered completely from t.. Well that explains the whole memorization thing is bullshit! If his went away then they will find another way of getting rid of it completely for everyone with chronic t. I know this may be ten or 15 years from now but im pretty positive that they will.. And yea deff stayin positive that this will reach the market summer of 2016 or lil after that. Its at least something we can all try and hope to work and will probably eliminate people thats t is really loud to a more quieter.. Until they find the actual cure!!!! :)
Click to expand...

I think the memorization theory means that in later stages (no one knows when) drugs that focus on the inner ear are not gonna work. Basically your brains limbic system and the attention center are involved in chronic tinnitus. Thats why drugs like AM101 wouldn't work - because they only focus on area of the brain that is connected to the ear. Therefore different drugs should be used. Nowhere is it stated that memorization means that it is gonna stay there forever and cant be treated. You brought the depression example yourself- theres a reason why depression is not treated with injections. These are just theoreis of course, and need more data anad analysis. Could very well be that it turns out to be wrong (as they are still fighting about it).
However, Autifony Therapeutics is working on a centrally acting drug (AUT0063, look at the research forum). I think they might start testing it on chronic T already this year so could be that by 2015 we know whether this works or not.
Also, little effort has been put into researching what are spikes and why they happen. Because if they do happen in the ear then maybe AM101 could help with that:) Naturally I am also hoping that it might help chronic sufferers and that it will pass the trials. Im simply saying that there is a 50-50 chance that it wont help people with chronic T and that the treatment working on us might reach the market in 10 years maybe. I have to say though that Im putting my bets on Autifony, as it is specifically designed for chronic tinnitus.
If you are interested in the subject I suggest you read this whole thread. There was a man here - ResonanceCEO - who is working a treatment for the inner ear. He had some wonderful insights about the matter:)
 

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