AM-101 TACTT1 Results Released

[earsnothappy]

Having a hard day today. My tinnitus has spiked like I just got it. Hopefully it's just a bad day. I'm at about 5 weeks since my first injections. All the way up until a couple days ago it's been getting better and better, but today, this has been bad.

 

[Hudson]

People here are gonna say yes so you can report back. But you gotta do what u think is right.

But this is a pretty rare opportunity, wouldnt want to look back and regret...

I'm not saying it because I want to hear back about what the drug is like. Sure, that's nice. But I'm sure Auris will be more than willing to toot their own horn soon enough. What I would like is as many people to get some benefit while they are in their "acute" stage, if it truly only works for that.

 

[Hudson]

Having a hard day today. My tinnitus has spiked like I just got it. Hopefully it's just a bad day. I'm at about 5 weeks since my first injections. All the way up until a couple days ago it's been getting better and better, but today, this has been bad.

Just keep giving it time, and hang in there. will you have the opportunity to partake in the follow up clinical trials?

 

[earsnothappy]

Just keep giving it time, and hang in there. will you have the opportunity to partake in the follow up clinical trials?

As far as I know I can participate in the follow up.

I've had a few spikes in the past, but nothing this bad.

All I can do is give it time and do my best to live with it. I know many people suffer much more than I do, and I can only hope to be as strong.

 

[attheedgeofscience]

My fear with starting the AM-101 trial is centered around undoing the progress that I have made over the past month.

I don't see the connection; if anything the procedure should enchance your progress even further.

Like everyone else, I do want the ringing to go away forever. But I don't want to be in a worse place post-injections than I am right now.

This is a phase III trial - meaning it has passed phase I and II. That means both safety and efficacy has been demonstrated. Admittedly, the efficacy part may not be as good as we could have hoped for, but I believe it is a safe procedure. I was scheduled to have both ears injected with AM101 back in May.

See this post too...

https://www.tinnitustalk.com/threads/am-101-tactt1-results-released.1994/page-40#post-54129

 

[SteveToHeal]

I'm not saying it because I want to hear back about what the drug is like. Sure, that's nice. But I'm sure Auris will be more than willing to toot their own horn soon enough. What I would like is as many people to get some benefit while they are in their "acute" stage, if it truly only works for that.

I am hoping to see people get some relief in the post-acute stage too. The 3 to 12 months.

 

[khu85]

I assume there are plenty of results from the 3-12 month stage or they wouldn't be offering the open case study to those who might not have gotten the real drug in the initial 3 month period.

I am getting my second injection tomorrow and honestly I am not looking forward to the shot at all haha.

In my experience so far I cannot notice any real significant changes in my tinnitus. I am assuming that I wont be seeing any results until 10 or so days after the 3rd injection once the ear drum is healed.

 

[locoyeti]

Update:
It has been well over a month since my ears of healed after the AM-101 injections, and I must say my T is continually getting better. I must have had the placebo during the TACCT2 round, because I can definitely feel a difference between how my T sounded the few weeks before my AMPACT shots and how they feel now almost a month and half later (I really couldn't tell much of a difference when I got the TACCT2 shots). The volume must be something like 60+% reduced, to the point where they are not too intrusive at all, and I don't get any loud spikes at all. There are times that I don't hear anything at all, even when I turn the pink noise off. I have had to turn my pink noise volume down, because I don't want to completely mask my T, but sometimes it is very difficult because it is so faint. I have had almost 2 straight weeks of good days without any bad days. The last three days have been utterly fantastic. My bad days since the shots have numbered maybe 4 or 5 days, and even then they were what I would call a solid medium-good, a day that would have been 'good' during the first few months of my T. It's still early though, so I'll keep you guys updated. How are you feeling @Bart Marien ?

My thoughts:
I was skeptical that this treatment would work because I believe that T is mostly in the brain (still do), and that intratympanic injections were just a gimmick. I am guessing that what I am experiencing now is something like an anterograde cascade which is patching up the hyper-excited neurons in the auditory system, since the esketamine is long gone from my system. Or there may be some other feedback going on, because I am continually getting improvement. Again, it is still early I guess, but positive signs definitely. Anyone else have thoughts on this?

As good as this has been, I would still love to have complete cessation (ala Potassium modulators), but I consider myself very lucky at this point. If this drug can bring the volume and spikes down for most T suffers I consider that a major victory in the war. I am definitely planning on getting the second round of AM-101 shots (3rd round of shots overall).

 

[SteveToHeal]

Update:
It has been well over a month since my ears of healed after the AM-101 injections, and I must say my T is continually getting better. I must have had the placebo during the TACCT2 round, because I can definitely feel a difference between how my T sounded the few weeks before my AMPACT shots and how they feel now almost a month and half later (I really couldn't tell much of a difference when I got the TACCT2 shots). The volume must be something like 60+% reduced, to the point where they are not too intrusive at all, and I don't get any loud spikes at all. There are times that I don't hear anything at all, even when I turn the pink noise off. I have had to turn my pink noise volume down, because I don't want to completely mask my T, but sometimes it is very difficult because it is so faint. I have had almost 2 straight weeks of good days without any bad days. The last three days have been utterly fantastic. My bad days since the shots have numbered maybe 4 or 5 days, and even then they were what I would call a solid medium-good, a day that would have been 'good' during the first few months of my T. It's still early though, so I'll keep you guys updated. How are you feeling @Bart Marien ?

My thoughts:
I was skeptical that this treatment would work because I believe that T is mostly in the brain (still do), and that intratympanic injections were just a gimmick. I am guessing that what I am experiencing now is something like an anterograde cascade which is patching up the hyper-excited neurons in the auditory system, since the esketamine is long gone from my system. Or there may be some other feedback going on, because I am continually getting improvement. Again, it is still early I guess, but positive signs definitely. Anyone else have thoughts on this?

As good as this has been, I would still love to have complete cessation (ala Potassium modulators), but I consider myself very lucky at this point. If this drug can bring the volume and spikes down for most T suffers I consider that a major victory in the war. I am definitely planning on getting the second round of AM-101 shots (3rd round of shots overall).

That is fantastic news. SO happy for you! And you are in the 3 - 12 months category correct? You also said ears, so I take it you have bilateral T. Injections in both ears.

I know the TACCT2 is Treatment of Acute Peripheral Tinnitus 2. i.e. the one where you could receive the placebo?

And is AMPACT = Auris Medical Acute Peripheral Tinnitus? Is this the follow up where you definitely receive the drug?

If so, then it looks like the real drug is working, which is good news for T sufferers. Then your intention, is to do another round of AMPACT after this? So round 3. Then hopefully your T will be almost non-existent and stay that way!!!!

 

[khu85]

Has it been proven that taking more injections will further reduce tinnitus?

Just took my second injection. I really wish we were told if we got the real injection or not after the 100 days so we can make a good decision. My worry is that if I did in fact get the real drug, and it didn't work, I would then be subjecting myself to another 100 days and three shots.

I will say that todays round of shots went a lot smoother than the first round. The ear drum did not fully heal in my left ear so it was pretty much painless while the right ear did heal so it was fairly uncomfortable.

How long after the shots did you all notice changes in your tinnitus?

 

[Mpt]

what is their hypothesis as to why it would work after the acute state--- as glumate has already done damage by that point that this drug can't reverse-- does anyone know? --- Next year around this time I'm going to start loading up on EARS puts in anticipation of their results being released

 

[Bart Marien]

i'm at day 6 no after my injections. Tinnitus is back at the level that it was before the injections.
Hopefully it will go down more.

 

[jazz]

I don't know if this has been listed previously in the thread, but I just checked Auris Medical's pipeline and they are working on another drug for tinnitus that's in the preclinical stage. Not exciting, but still--the more drugs developed to treat tinnitus, the better!

 

[locoyeti]

what is their hypothesis as to why it would work after the acute state--- as glumate has already done damage by that point that this drug can't reverse-- does anyone know? --- Next year around this time I'm going to start loading up on EARS puts in anticipation of their results being released

I haven't had a chance to go over all of the papers that @benryu sent me, but apparently new research suggests that glutamate does not damage neurons (which kind of makes sense to me- why would an acute excess of one of the most ubiquitous neurotransmitters in the brain lead to immediate cell death? It seems as implausible as aliens having corrosive acid for blood). From my understanding the excess glutamate results in hyperexcitability/polarization of the neurons, and this state could be reversible. Perhaps having excess glutamate for a long time might lead to some serious problems, but I don't think the time frame has been worked out yet. If glutamate is blocking the Kv channels, resulting in an inability to repolarize the cell, then Kv modulators can bypass that blockage (theoretically). Since esketamine is blocking the NMDA receptors, perhaps this results in some further mechanisms which result in reuptake of the glutamate, which would also resolve the problem. Thats my understanding (so far).

 

[jazz]

apparently new research suggests that glutamate does not damage neurons

@locoyeti This is significant news. Keep us posted as you delve into the research. Very interesting.

 

[benryu]

I haven't had a chance to go over all of the papers that @benryu sent me, but apparently new research suggests that glutamate does not damage neurons (which kind of makes sense to me- why would an acute excess of one of the most ubiquitous neurotransmitters in the brain lead to immediate cell death? It seems as implausible as aliens having corrosive acid for blood). From my understanding the excess glutamate results in hyperexcitability/polarization of the neurons, and this state could be reversible. Perhaps having excess glutamate for a long time might lead to some serious problems, but I don't think the time frame has been worked out yet. If glutamate is blocking the Kv channels, resulting in an inability to repolarize the cell, then Kv modulators can bypass that blockage (theoretically). Since esketamine is blocking the NMDA receptors, perhaps this results in some further mechanisms which result in reuptake of the glutamate, which would also resolve the problem. Thats my understanding (so far).

Yeah I agree with ya, you're a smart one, you figured out on your own what decades of T. research just found.

Your statement fits perfectly with the latest work of Dr Hall (Autifony)

The article:
http://informahealthcare.com/doi/pdf/10.3109/14992027.2013.846482

For the lazy one:
Auditory network connectivity does not appear to be reliably altered by the experience of chronic subjective tinnitus.
--> T. auditory connections (neurons) are damn fine and healthy.
--> T. is very localized and attached to a specific channel blockage caused by Glutamate.
(http://www2.le.ac.uk/departments/cpp/staff/dr-martine-hamann/hamann-neuroscience-group) (Dr Hamann, also part of the Aut00063 project)
--> The Blockage very likely reversible (at least on rats lol)


If you want to read more of probably one of the most knowledgeable Dr in the world about T.
http://www.nottingham.ac.uk/medicine/People/deborah.hall

It's like Elvis, you can't go wrong with that

 

[benryu]

I don't know if this has been listed previously in the thread, but I just checked Auris Medical's pipeline and they are working on another drug for tinnitus that's in the preclinical stage. Not exciting, but still--the more drugs developed to treat tinnitus, the better!

View attachment 2581

Ok guys my 2 cents AM-102 = AUT00063 and will target Kv3.1 potassium channels.

 

[MarkD]

I respect the heck out of Hudson, but I have to disagree.

Lesson No.1: Don't ever disagree or correct someone that you "respect the heck out of".

Whenever you disagree with someone you have immense respect for, you should use subtlety such as asking a question.

 

[lapidus]

Ok guys my 2 cents AM-102 = AUT00063 and will target Kv3.1 potassium channels.

Yup, That was my thought too. Whish they could speed things up a bit though. Does preclinical stage mean that they are doing their "rat study" now or what?

 

[Viktor Salvatore]

This is very good news. Wow....we may actually get to experience silence of the ears. But we need it now.....our lives are unfolding and we are getting older....we need it now.

 

[StayPositive]

After some delays I finally got in for the first round of injections in the follow-up study today. This time they did it in both ears. T might have spiked a little, but nothing serious, and nothing I haven't heard in a quiet room before. Nothing else to report for now, as usual, but I'll keep posting as things develop.

 

[benryu]

Yup, That was my thought too. Whish they could speed things up a bit though. Does preclinical stage mean that they are doing their "rat study" now or what?

Yeah, they are fine tuning the drug on rats at the moment Then it will go to clinical trials (phase 1 & so on).

 

[Viktor Salvatore]

And Rats are unlucky? They get it before us? MMMmmmm...not fair.

 

[mavrik]

Hi all i think this am101 thread is more frequently so i try it again,

i have tinnitus since march 2014. It started after I had some earaches and fulliness unfortunately my ENT doesn´t found any reason why i get this funny sound. He told me that it may be stress inducted tinnitus because i have been very busy at this time (study, full time work...).

Now i have the chance to join the study with medication AM-101. But I am not sure if I should do that because they found no reason for my Tinnitus. What do you think, should I join it or is it senseless to join it? Do you know why only people with specific reasons for tinnitus could join the study?

Thank you for your help

Greetings, Mavrik

 

[Hudson]

Hi all i think this am101 thread is more frequently so i try it again,

i have tinnitus since march 2014. It started after I had some earaches and fulliness unfortunately my ENT doesn´t found any reason why i get this funny sound. He told me that it may be stress inducted tinnitus because i have been very busy at this time (study, full time work...).

Now i have the chance to join the study with medication AM-101. But I am not sure if I should do that because they found no reason for my Tinnitus. What do you think, should I join it or is it senseless to join it? Do you know why only people with specific reasons for tinnitus could join the study?

Thank you for your help

Greetings, Mavrik

I would see if you can participate. That's my opinion though. Where are you? If you're in the US, you're already outside the time limit. However, if you're in the EU, you probably can still participate.

 

[benryu]

Surprising story guys, I mentionned a while ago that I luckily met the person in charge of the AM-101 in Mtl thanks to my audiologist, and I just had her assistant on the phone and they are considering taking chronic T. people who had a recent (last 18months) increase to try the AM-101. The doctor will be back from holiday in 2 weeks and let me know if I can be part of the trial. Even if I don't think it would be very useful on chronic T, we could at least see what it does. let's wait & see :3

(And yeah for the one who noticed, she said 18 months, not 12months, surprising...)

 

[dan]

@benryu , ya think AM-102 is going to be a pill form or another intratympanic treatment?
Is there any indication to this anywhere etc ?

 

[dan]

This is very good news. Wow....we may actually get to experience silence of the ears. But we need it now.....our lives are unfolding and we are getting older....we need it now.

OSCAR post!

 

[mavrik]

I would see if you can participate. That's my opinion though. Where are you? If you're in the US, you're already outside the time limit. However, if you're in the EU, you probably can still participate.

Hi, yes i am from EU and here you can participate up to 12 months after first notice the T. My question is, make it sense to participate, even if there was no reason found why i got T.?

I read this Forum since 2 months, and find it really informative and helpfully.

I tried to life my live like before i getting this stupid Thing, and after the first time which was very hard to handle i think i learn to manage it. There are still many things which i avoid since i get it, but i think the list will be shorter and shorter... ;o)

Kind regards, Mavrik

 

[benryu]

@benryu , ya think AM-102 is going to be a pill form or another intratympanic treatment?
Is there any indication to this anywhere etc ?

The AM-101 is intratympanic because it's a localized glutamate blocker, but if the the AM-102 is targetting potassium channels, there is no reason it should be an injection, so most likely pills.

But again we are supposing a lot of stuff here
Let's wait for more info!