AM-101 TACTT1 Results Released

[Hudson]

When I was being screened they specifically told me not to get on what they call the "tinnitus network," (i.e. this site and others like it) and talk about the effects of the drug. They insisted that sites like this are counterproductive because they are breeding zones for horror stories.

Well that's probably their position for a couple of reasons:

1. They want you to remain as impartial as possible about the drug and procedure. They don't want you reading up about it, freaking out, and becoming psychosomatic.

2. Auris doesn't want people talking on the internet about their experiences in a trial. As with any company, they make sure their press releases are carefully groomed and only what they want released is released. They especially want to avoid a situation where AM-101 could garner a negative reputation before it even hits the market among tinnitus sufferers.

 

[Grace]

Grace, did you call? Maybe call, get more information. You can just ask. - nobody is going to force you If you are on anti-depressants they might not accept you anyway And then at least you have some sort of timeframe to think about it.

Yeah gonna call when i go home today just for the hell of it.. Let you all know what they say!

 

[Hudson]

Yeah gonna call when i go home today just for the hell of it.. Let you all know what they say!

They will accept people who have been taking anti-depressants. There are a couple exceptions though:

1. If you have started the anti-depressant therapy recently, or are planning on discontinuing that treatment throughout the course of the trial.

2. If you are using them to treat tinnitus or you are on a particularly high dose.

 

[tom68]

I suppose from a research point of view they would rather collate the data and publish their results based on their own interpretation rather than have things leak out via forums like this. There may even be commercial considerations to do with keeping information away from competitors as long as possible. Of course none of that is for the benefit of us the people that suffer from it but you can understand their perspective.

Then it may just be that they truly believe people aren't mature enough to filter what they read on an internet forum and that all information should come through "official channels".

 

[Carlos1]

I got an email back from the company. They will contact me when a clinic opens in Western Canada. Supposedly in April. Even if they let me in, there is still a 50% it is just a saline solution. Maybe I'll just do my worst ear.

Good luck John hope it helps you man keep us posted

 

[Grace]

They will accept people who have been taking anti-depressants. There are a couple exceptions though:

1. If you have started the anti-depressant therapy recently, or are planning on discontinuing that treatment throughout the course of the trial.

2. If you are using them to treat tinnitus or you are on a particularly high dose.

Oh guess thats a good thing cause i been on lexapro 10 mg low dose for like 2 years now and plan on stayin on it for a long long timeeee

 

[GMac14]

Hypothetically, let's say AM 101 doesn't help chronic T, but say you go through threshold shift a second time that increases the volume of T. Would AM 101 be useful in bringing the volume of T back down to its original volume?

 

[attheedgeofscience]

40%/50% improving is great dude. I think, it will be even better, because stem cells are still working. Once, if I earn some cash, I will try your experiment. And you wrote before, stem cells made to you some other benefits

hearing tests will be interesting, for sure. I am curious, of course

Had my morning appointment at the ENT surgery clinic, this morning (www.acquaklinik.de). As predicted, the hearing test they use is 0-8 kHz. I did the test using a pulsating frequency (which is easier to hear for people with tinnitus). As the test was only 0-8 kHz, I asked the clinic to set up an appointment for me at another clinic if they could find one where the frequency is > 8 kHz. They did find one and I went there at 14 o'clock, today. This hearing test was a non-standard, non-pulsating frequency hearing test. The tests were done 4 hours apart. I had no noise exposure between the two tests. The last test was repeated for the 12,5 kHz frequency, both left and right ear. Comparison tests are the ones done last summer at dr. Wilden's practice in Regensburg (which I believe is now relocated to Spain).

Conclusion

My overall conclusion is that there in the audiotory speech frequency range (0-8kHz) is an overall improvement of 0-20 db vs. my very first audiogram done 10/JUN/2013; the improvement is beyond "statistical uncertainty" for 6 and 8 kHz. For 12,5 kHz, the result is status quo. Today's result compared with my audiogram done after 2 months laser therapy, last summer, shows a decline. My hearing ability from today's test indicates that my hearing - in the audiotory speech frequency range - is approximately equal to that of a normal hearing 20 year old (and I am 36).

I believe my current tinnitus frequency is affecting my ability to hear the higher frequencies (> 8 kHz) when using a non-pulsating hearing test.

Analysis

The most component influencing today's result is probably the "like-for-like" factor. By "like-for-like", I mean that tests should be carried out using identical criteria. The two tests done today - and with only 4 hours apart - show just how much variation there can be. This variation is due to testing standard (eg. pulsating, non-pulsating), testing environment (eg. properly noise insulated hearing cabin - or not in some cases), testing equipment (slight lack of calibration, responsiveness of equipment), the audiologist (eg. rapid/slow increase in volume for testing frequencies), and of course the patient him-/or her-self.

It has many times been indicated that Dr. Wilden's treatment is a scam - and that his hearing tests are somehow manipulated. I am not here to defend Dr. Wilden (he can do that himself), but I will say that based on today's experience, I can offer some explanation as to why there might be differences between his tests and other hearing tests. First of all, where would someone buy hearing test equipment designed with the sole purpose of cheating patients? Secondly, the fact that his tests show a better result than that of other hearing test providers is actually an indication that he has taken more care to create a reliable test environment (if you were to ask me). What do I mean by that? Well, today's hearing test at the acquaklinik was actually not that impressive. The room was not properly noise insulated (only slight padding on a normal door), there were wooden floors just outside where patients would walk right by, and the audiologist was located inside the room together with the patient - fiddling about with the equipment throughout the test. And that shows on a hearing test - as you can see...

But then in most cases, hearing tests are just for indicative - and not "scientific" - purposes. But, in my case I will probably need to find a clinic that offers:
1) 0-16 kHz test
2) a properly insulated testing cabin
3) pulsating frequencies
4) separation of patient/audiologist
5) slow increase in volume for all frequencies.

I would like to mention - in the acquaklinik's defence - that their main competence is not hearing assessment/diagnostic, but surgery. The staff there is highly competent, otherwise. My doctor today was a young female non-surgeon doctor - honest, direct, and competent. And able to answer all my questions. Just how I like it... Tomorrow, I will meet the ENT professor in charge of surgery.

I did not have scanner handy today, so I took photographs of the hearing tests indstead. Sorry about that...

 

[Johno]

Yes, i know I am overpositive about AM101, but

Had my morning appointment at the ENT surgery clinic, this morning (www.acquaklinik.de). As predicted, the hearing test they use is 0-8 kHz. I did the test using a pulsating frequency (which is easier to hear for people with tinnitus). As the test was only 0-8 kHz, I asked the clinic to set up an appointment for me at another clinic if they could find one where the frequency is > 8 kHz. They did find one and I went there at 14 o'clock, today. This hearing test was a non-standard, non-pulsating frequency hearing test. The tests were done 4 hours apart. I had no noise exposure between the two tests. The last test was repeated for the 12,5 kHz frequency, both left and right ear. Comparison tests are the ones done last summer at dr. Wilden's practice in Regensburg (which I believe is now relocated to Spain).

Conclusion

My overall conclusion is that there in the audiotory speech frequency range (0-8kHz) is an overall improvement of 0-20 db vs. my very first audiogram done 10/JUN/2013; the improvement is beyond "statistical uncertainty" for 6 and 8 kHz. For 12,5 kHz, the result is status quo. Today's result compared with my audiogram done after 2 months laser therapy, last summer, shows a decline. My hearing ability from today's test indicates that my hearing - in the audiotory speech frequency range - is approximately equal to that of a normal hearing 20 year old (and I am 36).

I believe my current tinnitus frequency is affecting my ability to hear the higher frequencies (> 8 kHz) when using a non-pulsating hearing test.

Analysis

The most component influencing today's result is probably the "like-for-like" factor. By "like-for-like", I mean that tests should be carried out using identical criteria. The two tests done today - and with only 4 hours apart - show just how much variation there can be. This variation is due to testing standard (eg. pulsating, non-pulsating), testing environment (eg. properly noise insulated hearing cabin - or not in some cases), testing equipment (slight lack of calibration, responsiveness of equipment), the audiologist (eg. rapid/slow increase in volume for testing frequencies), and of course the patient him-/or her-self.

It has many times been indicated that Dr. Wilden's treatment is a scam - and that his hearing tests are somehow manipulated. I am not here to defend Dr. Wilden (he can do that himself), but I will say that based on today's experience, I can offer some explanation as to why there might be differences between his tests and other hearing tests. First of all, where would someone buy hearing test equipment designed with the sole purpose of cheating patients? Secondly, the fact that his tests show a better result than that of other hearing test providers is actually an indication that he has taken more care to create a reliable test environment (if you were to ask me). What do I mean by that? Well, today's hearing test at the acquaklinik was actually not that impressive. The room was not properly noise insulated (only slight padding on a normal door), there were wooden floors just outside where patients would walk right by, and the audiologist was located inside the room together with the patient - fiddling about with the equipment throughout the test. And that shows on a hearing test - as you can see...

But then in most cases, hearing tests are just for indicative - and not "scientific" - purposes. But, in my case I will probably need to find a clinic that offers:
1) 0-16 kHz test
2) a properly insulated testing cabin
3) pulsating frequencies
4) separation of patient/audiologist
5) slow increase in volume for all frequencies.

I would like to mention - in the acquaklinik's defence - that their main competence is not hearing assessment/diagnostic, but surgery. The staff there is highly competent, otherwise. My doctor today was a young female non-surgeon doctor - honest, direct, and competent. And able to answer all my questions. Just how I like it... Tomorrow, I will meet the ENT professor in charge of surgery.

I did not have scanner handy today, so I took photographs of the hearing tests indstead. Sorry about that...

Looks like your hearing is significantly better than before. Problem is, you may have notches between some frequencies. For example, my audiogram looks good (de jure i have healthy hearing), but i can feel, than my hearing is harmed. I have relatively huge notch at 4200 Hz, some betweet 5-7Khz and huge notch between 12-13 Khz on right ear. Left ear is better, but there are too some notches. Try http://www.onlinetonegenerator.com/hearingtest.html - you need Firefox browser to open it. Set volume to lowest as possible, because default volume of this site is high and hear. It goes from 0-20Khz. Of course, it can't show Db loses, but can show, if you have some weak places in your treshold range.

 

[Stina]

Looks like your hearing is significantly better than before. Problem is, you may have notches between some frequencies. For example, my audiogram looks good (de jure i have healthy hearing), but i can feel, than my hearing is harmed. I have relatively huge notch at 4200 Hz, some betweet 5-7Khz and huge notch between 12-13 Khz on right ear. Left ear is better, but there are too some notches. Try http://www.onlinetonegenerator.com/hearingtest.html - you need Firefox browser to open it. Set volume to lowest as possible, because default volume of this site is high and hear. It goes from 0-20Khz. Of course, it can't show Db loses, but can show, if you have some weak places in your treshold range.

How can your hearing be healthy is you have loss at 4200 hz?

 

[Grace]

Well called them bout am 101 and no answer :-/ left a quick message sayin callin in regards of the am 101 T trial
And have s few questions if you can call me back! Sooo will seeeee if they call me !

 

[Johno]

How can your hearing be healthy is you have loss at 4200 hz?

Is not, of course. On 4000 Hz audiogram shows -10Db, but i am sure, in 4200Hz (but on audiogram is not 4200) it is maybe -20Db, bcause this frequency i hear most worse than near lying 4000.

 

[urtica]

I just want to say: I stay with you guys since nobody told me not to leak something on the tinnitus-network ;-). After a bad weekend, with a depressing mood. My T is allright again. It seems to go up and down, but it has not changed much since last week (week 2 post injection). So no news..

 

[cullenbohannon]

Thanks for keeping us updated. Hopefully you'll get some good results soon.

I just want to say: I stay with you guys since nobody told me not to leak something on the tinnitus-network ;-). After a bad weekend, with a depressing mood. My T is allright again. It seems to go up and down, but it has not changed much since last week (week 2 post injection). So no news..

 

[JohnG]

Do you know what is in the placebo? Just curious if that would be a corticosteriod or just saline.

 

[Hudson]

Do you know what is in the placebo? Just curious if that would be a corticosteriod or just saline.

It is the "vector" - the complete gel solution that they administer to the ear minus the esketamine.

 

[attheedgeofscience]

As most people who have followed my stem cell treatment will know, I have a fairly extensive network of contacts in the medical business. Through my contacts, I have managed to track down a doctor who will administer the drug ketamine to my middle/inner ear. The procedure I will be getting is not part of the ongoing AM101 clinical trial, but it is equivalent to it. For that reason I can report back at some point in the future on the effectiveness of the treatment - and I will be able to do so with confidence as I will of course be 100% certain of not getting the placebo (but unlike the participants in the clinical trial, I will also have to pay for the treatment of course).

I will need to sign papers that I am taking the risk for treatment. The procedure is almost certain to go ahead, and will take place probably in May. There are still a few details to work out - possibly mixing the injections with cortisone, but we will get there eventually, I am sure. As with my stem cell treatments, I obviously cannot disclose where I am getting this done. But, I can at least provide feedback on the effectiveness of the drug - which I will do.

 

[JohnDoe]

As most people who have followed my stem cell treatment will know, I have a fairly extensive network of contacts in the medical business. Through my contacts, I have managed to track down a doctor who will administer the drug ketamine to my middle/inner ear. The procedure I will be getting is not part of the ongoing AM101 clinical trial, but it is equivalent to it. For that reason I can report back at some point in the future on the effectiveness of the treatment - and I will be able to do so with confidence as I will of course be 100% certain of not getting the placebo (but unlike the participants in the clinical trial, I will also have to pay for the treatment of course).

I will need to sign papers that I am taking the risk for treatment. The procedure is almost certain to go ahead, and will take place probably in May. There are still a few details to work out - possibly mixing the injections with cortisone, but we will get there eventually, I am sure. As with my stem cell treatments, I obviously cannot disclose where I am getting this done. But, I can at least provide feedback on the effectiveness of the drug - which I will do.

@attheedgeofscience Would you be interested in opening a new topic about this? I'm afraid this information will get lost between the AM-101 messages in this thread.

 

[Robb]

@attheedgeofscience Would you be interested in opening a new topic about this? I'm afraid this information will get lost between the AM-101 messages in this thread.

I am highly interested in knowing as well how such treatment will work out

 

[yonkapin]

Damn, so AM-101 really is basically just ketamine (well esketamine, http://en.wikipedia.org/wiki/Esketamine) injected into the ear?

I've had a bunch of ketamine sitting in my draws for well over a year now, was a bit timid to try it though because it's such an intense trip. Now I sort of wonder what effect it would have on my tinnitus.

 

[Hudson]

Damn, so AM-101 really is basically just ketamine (well esketamine, http://en.wikipedia.org/wiki/Esketamine) injected into the ear?

I've had a bunch of ketamine sitting in my draws for well over a year now, was a bit timid to try it though because it's such an intense trip. Now I sort of wonder what effect it would have on my tinnitus.

Well, the difference is they are administering the drug locally to the inner ear. Unless you can do that at home, I doubt you would be getting the same effect. You would probably have to take very high systemic doses to reach the kind of levels in the inner ear that they achieve with the local administration.

Taking a very high dose of ketamine systemically will produce profound effects. Be careful.

 

[yonkapin]

Well, the difference is they are administering the drug locally to the inner ear. Unless you can do that at home, I doubt you would be getting the same effect. You would probably have to take very high systemic doses to reach the kind of levels in the inner ear that they achieve with the local administration.

Taking a very high dose of ketamine systemically will produce profound effects. Be careful.

Yeah, I doubt it too. But it would still be interesting to see if there would be any effect at all, would definitely not mess with the dose though.

 

[Valentin]

As most people who have followed my stem cell treatment will know, I have a fairly extensive network of contacts in the medical business. Through my contacts, I have managed to track down a doctor who will administer the drug ketamine to my middle/inner ear. The procedure I will be getting is not part of the ongoing AM101 clinical trial, but it is equivalent to it. For that reason I can report back at some point in the future on the effectiveness of the treatment - and I will be able to do so with confidence as I will of course be 100% certain of not getting the placebo (but unlike the participants in the clinical trial, I will also have to pay for the treatment of course).

I will need to sign papers that I am taking the risk for treatment. The procedure is almost certain to go ahead, and will take place probably in May. There are still a few details to work out - possibly mixing the injections with cortisone, but we will get there eventually, I am sure. As with my stem cell treatments, I obviously cannot disclose where I am getting this done. But, I can at least provide feedback on the effectiveness of the drug - which I will do.

i think ketamine and esketamine are like omeprazole and esomeprazole, slighty different thus different names :

https://en.wikipedia.org/wiki/Esomeprazole

https://en.wikipedia.org/wiki/Omeprazole

 

[JohnG]

It is the "vector" - the complete gel solution that they administer to the ear minus the esketamine.

Yeah, I was just curious what the "vector" was. Probably saline gel or something. It would probably be easy to know if you had the placebo. If they added a corticosteriod to the vector, you might feel a change and think it was the actual drug. I will definitely ask what the "vector" is before I submit to this experiment. I'm not taking a risk for zero treatment. If it is just saline, them maybe it is worth the risk Although intratympanic injections carry risk such as permanent vertigo, infection...and even deafness.

 

[cullenbohannon]

First ent I found that was actually knowledgeable about t . I asked him if he knew about the trials and he had a patient with pretty bad t go and he has had pretty good results

 

[nills]

Ketamine produces changes in brain connections, but is very hard on the kidneys ... I wanted to do the experiment to see of it influences the T but haven`t found enough reason to do it yet.

 

[attheedgeofscience]

Could you elaborate and explain why you think so?

I prefer to let results speak for themselves. If I believed that words were more important than actions, I would be a tinnitus researcher working on a continuously prolonged 10-year timeline...

 

[Robb]

ok guys! let us have at least this year some more clarity about in what extense certain substances like ketamine can help us..

 

[Erlend]

I prefer to let results speak for themselves. If I believed that words were more important than actions, I would be a tinnitus researcher working on a continuously prolonged 10-year timeline...

Indeed the numbers for AM101 look really good.

And maybe you know something about this;

Could it be that they use really small doses? I saw a report that said "Dose 1.5x" gave no results, but "Dose 4x" gave good results.

Could it be that "Dose 15x" is safe, and will completely cure people? That would be cool.

 

[Robb]

Indeed the numbers for AM101 look really good.

And maybe you know something about this;

Could it be that they use really small doses? I saw a report that said "Dose 1.5x" gave no results, but "Dose 4x" gave good results.

Could it be that "Dose 15x" is safe, and will completely cure people? That would be cool.

Where are those numbers?