AM-101 Clinical Trial — Participants Updates and Discussion

[Dutchy]

Neil Hearne thought his life was ruined after receiving a devastating Tinnitus diagnosis. Two years later, a pioneering clinical trial conducted at the Norfolk and Norwich University Hospital has allowed him to live life to the full again.
(Source: http://www.thebrecklandview.com/201...ful-to-nn-research-team-ive-got-my-life-back/)

What is this. Are they accepting people with chronic T in the UK for the trials?
Furthermore if this guy with chronic T (2 years when getting into the AM-101 trial) has experienced an improvement from the trial then maybe people with chronic T can benefit from the treatment too.

The guy is a musician. There's no information within in the article what the cause of his T is.
I think the probability is high that it's noise-induced due to the fact that he's a musician.
Maybe his case can be seen as a prime example which demonstrates that noise-induced T can sometimes for whatever reason remain in the inner ear (even after 2 years) without getting centralized in the brain.

I was waiting for someone to notice it as well,hence why i don't understand they only accept early onset.
Perhaps they wanted a poster boy?i still haven't heard anything from the trial request and that was a month ago.

 

[Alue]

I was told that I would be offered the followup round at my next visit in early May. The paperwork they handed me to review prior to my second round mentions more than one round of followup shots. I mention this only because I saw several comments earlier mentioning that they were limiting followups to 1 round. I guess its possible they just gave me old paperwork but I will certainly be asking when I go in again.

I talked with @AlexSongitus about this, we're both pretty sure the three followup rounds still stands in the US. I believe it was the study that accepted patients up to 6 months in Europe that is limiting the number of followup rounds.

 

[liquefact]

What's considered high db's though? I have to work in some noisy areas, just this past week I had to work in one for about half an hour. I made sure to wear high db earplugs and large industrial earmuffs on top of them, even then it seemed a little too noisy to me. Where do you draw the line?

Good thing that you're protecting yourself well enough it seems.
Where do i draw the line, it depends. I cannot say that i'm OK until 70db but start protecting my ears after 80db. This is all relative and pretty much aligns with the Loudness Discomfort Level of the individual (LDL). Around 2 months after onset, the LDL was 85db for me, which is ~90db for people with health ears. Idk how is it right now but i assume it went up slightly as my sensitivity is lower than before.

My ground rule without playing with all db's and such is, if you're unsure that the noise level is safe for you, just stay away. This works for me. I was in a restaurant 2 weeks ago and a mild ambient music was playing so i thought i'd spend an hour or so there. 15 mins after i was seated, suddenly the music changed to rock and they dialed up the volume as well. The unfortunate thing is i was under the speaker. I just flew out of the restaurant in 5 secs, plugged my earplugs, went back in, talked with the host to lower the volume, and sat again.

What i wanted to advise was just to steer away from loudness and noise that's it. I just do not take any risks and highly encourage anyone do the same too.

 

[liquefact]

That's the main point I am looking after; How many are high db's for an already fu*ked up ear? I mean; Am I at any risk being in a place where some music played low and people talking sum 70dbs?

An audiologist shall give you a much better advise if you want numbers but; when loudness level is too high, i feel the my T goes up (still) racing with the external sounds. I recently had this when i went to a movie theater. I had earplugs + earmuffs, so probably the net db was 30db less than the actual. But still after 1 hour or so, i felt uncomfortable and went out.

You can get your LDL via a test and also buy an decibel meter to see which db levels make you uncomfortable. After a couple of samples, you'll probably have a clear picture of your noise sensitivity level.

 

[Bobby B]

The scary part is that the best earplugs 32db and the best earmuffs 31db when used together only give about 36 Db of reduction since it's a logarithmic scale
So if you feel 70db is noisy / spiky then you cannot be in 105db environments for very long and that's not even taking the bass sound into account which is far less reduced that's maybe the movie theater / noisy clubs problem for ear protection

 

[Alue]

Good thing that you're protecting yourself well enough it seems.
Where do i draw the line, it depends. I cannot say that i'm OK until 70db but start protecting my ears after 80db. This is all relative and pretty much aligns with the Loudness Discomfort Level of the individual (LDL). Around 2 months after onset, the LDL was 85db for me, which is ~90db for people with health ears. Idk how is it right now but i assume it went up slightly as my sensitivity is lower than before.

My ground rule without playing with all db's and such is, if you're unsure that the noise level is safe for you, just stay away. This works for me. I was in a restaurant 2 weeks ago and a mild ambient music was playing so i thought i'd spend an hour or so there. 15 mins after i was seated, suddenly the music changed to rock and they dialed up the volume as well. The unfortunate thing is i was under the speaker. I just flew out of the restaurant in 5 secs, plugged my earplugs, went back in, talked with the host to lower the volume, and sat again.

What i wanted to advise was just to steer away from loudness and noise that's it. I just do not take any risks and highly encourage anyone do the same too.

Yes, I do my best, but there are a few times at work (maybe a couple times a month) where I can't avoid it. The incident I talked about before was next to some industrial pumps/machinery. If I had to guess it's somewhere between 90db-100db, but that's some rather low tones that I'm not sure how much the plugs/muffs protect. Sure they block out some, but how much is enough? I'll take my decibel meter to measure some time. It's loud enough that people have to holler when standing 2-3 feet away.

Also, from my understanding of hearing protection, doubling your hearing protection (muffs over plugs) only adds about 3-5 db of attenuation. Hearing plugs at their best ideal fit in a lab can achieve about 30-33 db attenuation (which I would guess is less for most people) and my earmuffs are rated at 30db. So I would guess my total real attenuation would be somewhere between 33-35 db. But low tones aren't attenuated as well as high ones. My ear muffs say they would attenuate 20db at 125 hZ and 40db at 8kHz.

 

[Alue]

The scary part is that the best earplugs 32db and the best earmuffs 31db when used together only give about 36 Db of reduction since it's a logarithmic scale
So if you feel 70db is noisy / spiky then you cannot be in 105db environments for very long and that's not even taking the bass sound into account which is far less reduced that's maybe the movie theater / noisy clubs problem for ear protection

You pretty much said what I was typing.

 

[liquefact]

AM101 Update

Pre 1st Injection T Level: 3, barely noticeable during the day.

Monday:
I went to the site to continue with open label injections. All my vitals are checked, signed 20 pages of documents, had the regular battery of hearing tests. My hearing was normal, no hearing loss according to the tests.

Then the injections. Doc checked my ear canal, eardrum and told me that there was no signs of previous perforation, which was good. The Phenol (numbing agent they use) hurt like hell this time unlike the previous round. The good thing is the pain went away in 15 secs.

After that the injections were done. They were not completely painless, but nothing to bad as well. The pain did not persist too long after the injections. Pre checks, hearing tests, injections, blood draw, urine and etc, everything was done in like 3.5 hours.

As i just had come to LA after a 8 hours journey, i was already too tired and went directly to hotel. At that point the pain started. Not just my eardrums but i had a severe headache as well. In the last round, the night of the 1st injections was very peaceful, no pain, fullness, nothing. Even the T was quiet. The pain had started after 2nd set of injections. This time (open label round) however, the same pain visited me after the 1st injections. The T spike followed the pain and the loudness went up to 6. I had a paracetamol with me and kept myself so hard from using that med. I could only sleep around 2 am as the T and pain was hard to ignore.
Post 1st Injection T Level: 6, almost impossible not to hear at any setting.

Tuesday:
Pre 2nd Injection T Level: 4-5, not audible in shower.
Woke up better. T around 4-5, pain was ignorable. Found some leaks on the pillow, i had these the last time as well.

Had breakfast and went straight to the site. Had the hearing tests, the conductive and bone. As expected, my conductive hearing was down 5-10 db as the inner ear was filled with gel. The results of the bone test was fine, no loss, again as expected.

After that went to have the injections. Told the doc about the pain last night and he told me that i could use some painkillers (ibuprofen etc) for that. The injections were extremely painful this time, as i was one inch away from shouting. But you just can't do that when you have a needle in your ear. Terrible! Doc told that there was inflammation and i was sick, this might have been the reason of the redness and pain. He also told me that the existing gel from 1st injections was resisting while injecting the gel inside. Probably due to the nature of my inner ear and eustachian tubes, the gel is just trapped in the inner ear, i never had the gel in my mouth. But this also may mean that it never reaches to cochlea and stays behind the eardrum? No one knows.

After the injections are done i left and immediately took a ibuprofen. It acted fast and erased the pain, leaving me with a whooshing T. Headed to the beach (maybe the only good thing about having participating to AM101 in Santa Monica) and listened to waves, being laid on the sand.

Currently the pain is non-existent, T is manageable around a max 5. Planning to watch a movie and sleep if i can.
Post 2nd Injection T Level: 5

Something i realize after the injections is, my T has probably almost moved to the brain as aside from the change in volume because of the injections, it's perfectly stable. No fluctuations, no frequency change. I cannot tell it's coming from left or right anymore. This realization makes me sad as after this point it's unlikely that AM101 shall have an affect on me. Probably i'm out of acute stage.

Shall continue tomorrow with the results of 3rd injections.

 

[Alue]

Something i realize after the injections is, my T has probably almost moved to the brain as aside from the change in volume because of the injections, it's perfectly stable. No fluctuations, no frequency change. I cannot tell it's coming from left or right anymore. This realization makes me sad as after this point it's unlikely that AM101 shall have an affect on me. Probably i'm out of acute stage.

That's how mine is even though it was a bit more recent than yours. Does this mean anything? Have you ever asked one of the specialists about this?
I asked before if people's tinnitus seemed to be coming from their ears or their head. For me it's been both, but mostly my head shortly after onset.

I hope your 3rd injection and flight home go well.

 

[AlexSongitus]

AM101 Update

Post 2nd Injection T Level: 5

Something i realize after the injections is, my T has probably almost moved to the brain as aside from the change in volume because of the injections, it's perfectly stable. No fluctuations, no frequency change. I cannot tell it's coming from left or right anymore. This realization makes me sad as after this point it's unlikely that AM101 shall have an affect on me. Probably i'm out of acute stage.

Shall continue tomorrow with the results of 3rd injections.

Wait a second. Don't get disheartened. That's actually exactly what happened to me too. And I can tell you with certainty, I even posted about this a couple of days ago: every time my T moved from the noticeable hiss in my ears to a quieter but more centralized sound in the back of my head is actually the days that it stayed either extremely low or died down to complete silence.

Happened again today. Woke up with it centralized in my head, by 2pm I was in silence. It's 2am now, I'm in a perfectly quiet room, and I haven't heard my T since. I'm dreading going to sleep because sleep always freaking resets it and so far the pattern has been a pretty loud day after silence. But I'm noticing some significant improvement from AM-101 guys. Had periods of silence this past Saturday as well and my T has generally remained below my baseline this past week.

But yeah, that isn't necessarily a bad thing. I now look for that centralized sound, because it's the cue for me having a low day or silence. It is most likely the AM-101 attacking the source of the problems in your ears and hopefully your brain will also follow along.

That's kind of the idea behind the treatment from my understanding. AM-101 is supposed to block the source of the problem if they are correct in their guess, which is excessive glutamate that hyper excite the NMDA receptors.

So I'm totally guessing here, but here's my theory. There are probably 2 things at play. The NMDA receptors constantly creating a T sound due to the excessive glutamate, the initial source, and eventually your brain getting locked in on it in the form of a phantom sound. So most likely our T is a combination of both components. An active antagonist and a phantom component. When the receptors are being blocked by the drug, what you are left with may simply be whatever phantom sound your brain has developed since onset. With time, the idea is the brain will also follow along and let go of the phantom noise if the receptors are blocked and don't continue sending that signal.

 

[liquefact]

With time, the idea is the brain will also follow along and let go of the phantom noise if the receptors are blocked and don't continue sending that signal.

What a nice idea this is. I wish that turns true. Regardless, I'm good by the way. Not stressed, not having anxiety, just balanced. Believing that someday something will come up and relieve us from this annoyance.

 

[TJohns]

@liquefact Glad to know your toughing out round two pulling for you

 

[Joe Bananas]

Update:
Sorry I am not as good as other members here presenting their updates. As I received my last first round injection more than one month ago I don't know if this is AM101 related or is more into a natural change on T behaviour or something about habituation but today is the third day in a row where my T seems to have get estabilized and is more a pure tone sounding from the back of my head instead of those crickets, white noise, air leaking wheel, bacon being fried, etc... I was experimenting for the last 5 months. Also is not reactive and even if it sounds really loud when I am at bed it has become more maskable when I start moving, listening to music or watching a film, activities I haven't enjoyed for those last 5 months but which has started to be more pleasant. Hope things get settled in here or go even better.

 

[medal]

Update:
Sorry I am not as good as other members here presenting their updates. As I received my last first round injection more than one month ago I don't know if this is AM101 related or is more into a natural change on T behaviour or something about habituation but today is the third day in a row where my T seems to have get estabilized and is more a pure tone sounding from the back of my head instead of those crickets, white noise, air leaking wheel, bacon being fried, etc... I was experimenting for the last 5 months. Also is not reactive and even if it sounds really loud when I am at bed it has become more maskable when I start moving, listening to music or watching a film, activities I haven't enjoyed for those last 5 months but which has started to be more pleasant. Hope things get settled in here or go even better.

Good to hear your reactive tinnitus is fading and such My reactive T is still going strong unfortunately.. Got my am 101 screening next week, hope i get through.

 

[Joe Bananas]

Good to hear your reactive tinnitus is fading and such My reactive T is still going strong unfortunately.. Got my am 101 screening next week, hope i get through.

Let's see how this shit developes in the next... hours? days? It has been too sudden to be... real? Anyway I am enjoying it like a pig in a mud puddle!

 

[AlexSongitus]

Let's see how this shit developes in the next... hours? days? It has been too sudden to be... real? Anyway I am enjoying it like a pig in a mud puddle!

Good to hear Joe. When are you having your 2nd round done? Would be really awesome if your trend continues, to find out the first round having an effect as far out as 1 month or later after the injections.

I was actually a bit afraid that the biggest benefit I was going to get was day 1 and day 3 right after the injections, but yesterday was an amazing day, silence all day from 2pm until 4am last night, almost 2 weeks later, I even woke up after a couple of hours of sleep, and it was still gone. This was the first time that I ever woke up since I got T in silence that lasted, which was pretty amazing.

I went back to sleep and it did come back when I woke up for good, but it's low again today, and once again centralized in my head. Typically I normally had a fire extinguisher in the left ear in the mornings, and now it's more of a faint bacon sizzle centralized in my head! I was looking for a way to describe that sound, and that works perfect! It's actually pleasant when its like this. Like almost a tickling feeling, more than annoying. It's pleasant because it doesn't feel like it's obstructing my hearing at all since it doesn't come from my ears but the back/upper portion of my head. Feels more like I can hear the blood running through my veins in the back of my head. I hope that's nothing to worry about and it's really my T improving as it has been doing, and this doesn't turn out to be some sign my blood vessels are busted or I'm about to have a stroke or something.

 

[Sebastians]

Gonna keep it short as i have a shitload of stuff to do this evening, but at least i owe you guys some feedback on my experience with am-101 at just less than three weeks in (thurs). Only had my left ear done. Right ear is 1/10 and mostly only audible at night, so i did not want to risk any complications.
After the first injection, my T perception shifted from my left head/brain to my left ear. It's still there and i can't say it's not an improvement.
The first two weeks my T definately was louder and changed in tone to a 'frying bacon' with some 'metallic' quality to it. It was also more reactive to the environment and my very mild H also seemed a bit aggravated. I took this as a mental 'proof' that i got the real deal, as the placebo would in my opinion not interfere with the tone, only the loudness.

Ever since sunday, my T is as good as back to my pre-injections baseline: 2/10 during the day which ramps up to a 5/10 in the evening. Yet, it remains in my left ear still (hope that continues) and fluctuates between a hiss and a more tonal sound at times. Reactivity is much lower again too. Hope the shift from head to ear is a good sign and my T will eventually stabilise at a 2/10, and not increase in the evenings, but that's wishful thinking atm.
What i do notice is that the last three nights, i slept like a baby, even in a quiet room, which definately improved my mood so i'm coping better with my T during the day. F. Ex. I'm back to my gym routine and eating much healthier. This might be due to am-101 or natural healing/stress reduction or both.

Will keep you posted at regular intervals.

 

[Markku]

Update from Auris Medical

Auris Medical have reached an important milestone for the TACTT2 study.

They reached their recruitment goal yesterday and as of today are no longer recruiting new patients into the study.

The TACTT3 study (EU) is continuing to recruit until its target is met.

 

[liquefact]

Auris Medical have reached an important milestone for the TACTT2 study.

They reached their recruitment goal yesterday and as of today are no longer recruiting new patients into the study.

I've been told the same here in LA site. They will not accept any more patients for TACTT2. But AMPACT is still going on and anyone can go for all the three rounds.

That's how mine is even though it was a bit more recent than yours. Does this mean anything? Have you ever asked one of the specialists about this?
I asked before if people's tinnitus seemed to be coming from their ears or their head. For me it's been both, but mostly my head shortly after onset.

The doctor does not really say much about the T. Don't blame them, they do not know much. After the 2nd injections, I feel like it's shifted to ear a little bit as when I plug my ear the loudness increases.

now it's more of a faint bacon sizzle centralized in my head

I had that long before I got my T, look like for 10 years. Once or twice a month I hear that bacon sizzle coming from the back of my head, almost my neck. Like electrical crackling. Never paid too much attention to it though.

 

[AlexSongitus]

I had that long before I got my T, look like for 10 years. Once or twice a month I hear that bacon sizzle coming from the back of my head, almost my neck. Like electrical crackling. Never paid too much attention to it though.

Yeah same here, except it was a bit different than what this sounds like. I always described it like feeling a worm moving up through the back of my head, when I would get up really fast. I always though it was blood that rushed up, perhaps a clot that released it when I got up fast. The strange thing is I have no longer felt that since I got T. So at times I was wondering, did that burst, and is it what created this other sizzle?

 

[Joe Bananas]

Good to hear Joe. When are you having your 2nd round done?

April 18, 19 and 20.

 

[AlexSongitus]

April 18, 19 and 20.

Look forward to seeing how it goes Joe. I guess we are going to be the last batch in the US. I wonder if there is any way they can fast track it to market for new T cases because it really sucks for anyone that gets T after today and would have wanted to give it a shot. I did all I could to try and let people know to get in before they ended but I'm going to dread having to answer the next person that asks how they can get in and telling them they can't. Feels shitty.

 

[liquefact]

AM101 Update:

Wednesday:
Pre 3rd Injection T Level: 5-6.

Woke up with no pain, thanks to ibuprofen i guess, and T around 5-6. It's audible no matter what you do. Went to site, had the hearing test as usual and surprise, have a hearing loss about 40db on my left ear. The bone conductivity test shows no drop, so nothing to be concerned, i guess

Then the injections. They happened quicker and easier than 2nd injections yesterday. Doc says that the gel inside is clearing up as he saw no resistance from the gel during injection. As my eustachian tubes work under-optimally it's no surprise that the gel is draining out of my eardrum.

Post 3rd Injection T Level: 6, annoying.

I need to endure the flight back home now. Hope the popping does not go out of control like it did the previous time. And it was 4 days after the last injection then.

 

[Bobby B]

40db

is the 40 better or worse than pre injections ?

 

[TJohns]

Auris Medical have reached an important milestone for the TACTT2 study.

They reached their recruitment goal yesterday and as of today are no longer recruiting new patients into the study.

I went to Birmingham AL and am now in the two week screening. I was told I would be the last person aloud in at the hospital there. Hell for all I know I was the last person in the nation to be let into the screening.
Big thanks to @AlexSongitus and @liquefact for getting me that far. Still no guarantee but hey I tried.

 

[liquefact]

is the 40 better or worse than pre injections ?

I have no known sensorineuronal hearing loss below 8k. This drop should be because of the gel inside the middle ear and is supposed to fade away in weeks as the gel drains out.
Almost the same thing happened in the TACTT2 trial, except the loss was less back than.

 

[liquefact]

Big thanks to @AlexSongitus and @liquefact for getting me that far. Still no guarantee but hey I tried.

I believe that AM101 shall be a huge success and getting that substance into your ears while you can is the best thing one T sufferer can do. Good luck dude.

 

[AlexSongitus]

I went to Birmingham AL and am now in the two week screening. I was told I would be the last person aloud in at the hospital there. Hell for all I know I was the last person in the nation to be let into the screening.
Big thanks to @AlexSongitus and @liquefact for getting me that far. Still no guarantee but hey I tried.

What's that going to put you at in 2 weeks? About 6 weeks since onset? I had mine done at 1.5 months.

 

[liquefact]

Shit, this is a completely new territory for me, the loudness should be around 9!!! right now. I can't describe this otherwise, it's almost the same as the night of my onset. Plugging the ears does not change anything.

Hope it'll be better in the morning.

 

[AlexSongitus]

Shit, this is a completely new territory for me, the loudness should be around 9!!! right now. I can't describe this otherwise, it's almost the same as the night of my onset. Plugging the ears does not change anything.

Hope it'll be better in the morning.

You made it back home? It will. Your ears are probably still filled up with gel, so all you can hear is your T. Hope you can just fall asleep and the gel clears up some by morning. Mine seemed to clear up when I slept, but not before.