AM-101 Clinical Trial — Participants Updates and Discussion

[Alue]

My right cleared up right away within 30 minutes and I could feel it draining down my throat, numbing my tongue and cheek. My left, where I keep experiencing these symptoms, and my T is loudest, still hasn't cleared up, and I also did not feel it drain while swallowing. Something is going on with the left side of my face/throat/tonsil/sinuses. It was also the 2nd ear they did for me too.

So far I am not experiencing a loudness increase others have reported even though my left ear is completely muffled. It's lower than it was when I left my house this morning. Probably the lowest T day I had in 2 weeks, but again, that started before I got the injections and it's holding.

Still 2 more to go, but I'm definitely glad I went through with this. It's really a simple and painless procedure.

So you experienced numbing too? I've heard several people now say that. Damn, I didn't get any of that. Did you taste anything?

I plan on doing a more thorough update, but I'm waiting till things calm down a little bit before doing so.

 

[AlexSongitus]

So you experienced numbing too? I've heard several people now say that. Damn, I didn't get any of that. Did you taste anything?

I plan on doing a more thorough update, but I'm waiting till things calm down a little bit before doing so.

In one ear only. Right side only. My left side of my face, tonsil, ear, nostril has other blockage symptoms and I did not feel the numbing on the left side, or the draining. Also the numbing has actually been described as the Lidocaine seeping through, and it also quieted my T 3 days in a row immediately after application.

So it doesn't mean anything that you did not feel it. It's not an indication of AM-101, it's more an indication of the Lidocaine and whether your ear/throat canals are clogged up or not. In my case there is something blocking that in my left ear, so no numbing on the left side. It was also the ear that they had to vacuum out today, because it leaked out through the ear drum, not down my throat, as was the case with my right ear.

 

[Alue]

In one ear only. Right side only. My left side of my face, tonsil, ear, nostril has other blockage symptoms and I did not feel the numbing on the left side, or the draining. Also the numbing has actually been described as the Lidocaine seeping through, and it also quieted my T 3 days in a row immediately after application.

So it doesn't mean anything that you did not feel it. It's not an indication of AM-101, it's more an indication of the Lidocaine and whether your ear/throat canals are clogged up or not. In my case there is something blocking that in my left ear, so no numbing on the left side. It was also the ear that they had to vacuum out today, because it leaked out through the ear drum, not down my throat, as was the case with my right ear.

Strange, I got bleeding out of my eardrum but no leaking of the drug/placebo.

 

[AlexSongitus]

Strange, I got bleeding out of my eardrum but no leaking of the drug/placebo.

And it may have been a combination. I do know he had to vacuum my left ear only today. I edited my post above but a bit too late so I will add the edit here instead.

My doctor repeatedly said that those reports of people being able to tell from numbing etc are irrelevant. And if you think logically he's probably correct and telling the truth. If it was so simple as the AM-101 causing numbing, and the placebo not causing numbing, it would be very easy for both the doctors and patients to figure out which one is which, thus rendering a useless double blind study. If that was really the case, then they would make sure the placebo also would induce numbing, and would use a placebo that creates that same effect. I don't think they would spend millions on multi phase research to ensure a double blind study and overlook such a simple tell-tell sign that renders it null. I have faith they're not that dumb.

So really the only way to tell you really got the real drug is:

-if there is an emergency and break open your case file
-your T disappears or lowers so significantly it can't possibly be anything else
-participate in the follow-up study.

Don't think you didn't get it just because you didn't experience numbing, because the placebo effect is very real. And you will do yourself a disservice by thinking you got the placebo and that it's not as effective as the real drug. Remember, even the placebo itself can be effective. So even with a placebo, your T can improve. Either way, if the placebo effect works in your case, you will hopefully experience some amount of improvement, but AM-101 would just give you a more significant level of improvement.

 

[Neilpk]

Hi there,

I'm sorry for butting in here but I looked on the Auris website and it states AM-101 is being tested for "acute inner ear tinnitus" and "post acute tinnitus inner ear tinnitus"

Does anyone know what these definitions actually mean, in particular "post acute"?

Thanks

 

[TC426]

Hi there,

I'm sorry for butting in here but I looked on the Auris website and it states AM-101 is being tested for "acute inner ear tinnitus" and "post acute tinnitus inner ear tinnitus"

Does anyone know what these definitions actually mean, in particular "post acute"?

Thanks

Acute: 0...3 months after onset (major target group of phase III)
Post-Acute: 3...6 months after onset

More participants are allowed in the first category. Don't recall the actual numbers, but it was something like a 3:1 ratio.

 

[TC426]

Same, I asked my trial coordinator directly this week and I was told that I would have the option of doing up to 3 followup rounds.

That's odd. I am sure that I did not misunderstand it, the message from the doctor was very clear.
Either it is only valid for the institution I went to, or the information flow with the test centres is not as smoothly as it should be.

As some people are due with their post-injections, I hope we will have clarity soon.

 

[AlexSongitus]

That's odd. I am sure that I did not misunderstand it, the message from the doctor was very clear.
Either it is only valid for the institution I went to, or the information flow with the test centres is not as smoothly as it should be.

As some people are due with their post-injections, I hope we will have clarity soon.

Or perhaps your study center is ahead of the pack. Are you in the US? Could be that the word hasn't tricked down everywhere. I'm sure we will find out soon enough. Either way at least we get 1 set of injections but I hope that isn't the case.


Btw, I really love your structured reports and once again I'm going to call and ask for a thread where we can do structured progress reports in concise formats like the Trobalt thread and keep this thread for general discussions and questions, etc. Perhaps you can help me structure the questions.

I have a few to start off with which is more or less what you have already been reporting and perhaps you can help me if I'm missing anything:

1. Round number. Identify if you are still in the acute AM101 trial phase or the Round number of the follow up study. Ex: AM-101 Phase 3 or AMPACT Round 1, 2 etc.
2. Date of T onset.
3. Time since onset to either 1st or third injection of the round, especially the first round.
4. Loudness, and description of T the day before the first injection.
5. Current T level/changes/improvements since the final injection.
6. Side effects and complications.
7. Reports at, 24 hours, 1 week, 2 weeks, 1 month, 2 months or 3 months.
8. Link to previous post reports. That is great what you are doing there!

Would anybody else care to participate or find it useful to do this and what other categories, if any, should we include?

It's going to be months before they publish the results and even if the trial is ending, I still think this is beneficial for anyone that gets T next year when the drug will hopefully be available. Members wouldn't even have to complete all of them as long as they identified the time frame and round.

 

[Alue]

That's odd. I am sure that I did not misunderstand it, the message from the doctor was very clear.
Either it is only valid for the institution I went to, or the information flow with the test centres is not as smoothly as it should be.

As some people are due with their post-injections, I hope we will have clarity soon.

I hope they don't, that would be kind of unfair to the people who just underwent the double blind under a different impression. Especially to those who received the placebo the first round.

Some members saw a big improvement on the 2nd open label round like @OddV.

 

[AlexSongitus]

So I wanted to post an update. As I said, the third injection once again lowered my T after the numbing agent and vacuuming.

Friday night after napping, it lowered down to silence until I went to sleep around midnight. Saturday morning at 4am I woke up with the lowest T I ever had, and within an hour it was completely gone. From 4am yesterday morning until 2am this morning when I finally crashed, I had absolutely NO T. Since I got T I have never had a FULL day of silence, and complete silence at that. I have had days where it gradually lowered towards silence by evening, I had a few hours of silence my first and third day on Prednisone, but never this. And as usual, it reset when I slept, and was back full force this morning.

I woke up with a 3-4/10 in my left 1-2/ in my right, more or less my baseline before the injections. I'm having a hard time believing it was the numbing agent alone, and certainly not AM-101. If it was the numbing agent, you would figure it would gradually wear off yesterday from Saturday at 4am to this morning at 2am and my T would have gradually returned throughout the day. But no that isn't what happened and there was no sign of T as I was crashing on my pillow as late as 2am this morning. It stayed completely gone, the entire day, for as long as I stayed awake. And it came back to its baseline if not a bit louder, this morning. It was just doing what it's done many times in the past. Lowered to near silence and stayed there until I slept.

There is something seriously going on with sleeping and resetting my T and no doctors seem to have any clue why that is. Grrr! And something they did in this procedure made it completely disappear...so long as I never sleep again. Extremely frustrating!

 

[Alue]

I gotta admit I'm a little jealous Alex. 2 months with 0 moments of silence and I can't even mask mine.
Thinking I got the placebo too.

 

[AlexSongitus]

I gotta admit I'm a little jealous Alex. 2 months with 0 moments of silence and I can't even mask mine.
Thinking I got the placebo too.

Well if it's any consolation, today it's like getting T all over again. All the emotions you have when you first get it rush back. Makes it a bitch to habituate. I was used to it for its consistency the past 2 weeks. The break yesterday was tear inducing, but then so is it's return, for the opposite reason.

I really don't know what caused that, and I'm finding a harder time accepting Lidocaine as the reason, but I'm pretty sure it's got little to do with the AM-101 and probably not the numbing agent either. I can understand Lidocaine silencing it immediately after the injection and for a couple of hours afterwards, but 21 hours straight the next day, and then 5 hours of sleep being enough to completely wipe out the effect, makes little sense. If it was Lidocaine it should have gradually worn off, and T should have gradually returned. Or at least start off at a lower level this morning. But from no T for a full day to a 4/10 2 in 5 hours of sleep doesn't add up with that strictly being a result of Lidocaine. Really wish I could figure out why sleep does that and how to prevent it from triggering it. The only thing I know is my ears were still full yesterday, and this morning the fullness was gone.

 

[Alue]

Well if it's any consolation, today it's like getting T all over again. All the emotions you have when you first get it rush back. Makes it a bitch to habituate. I was used to it for its consistency the past 2 weeks. The break yesterday was tear inducing, but then so is it's return, for the opposite reason.

I really don't know what caused that, and I'm finding a harder time accepting Lidocaine as the reason, but I'm pretty sure it's got little to do with the AM-101 and probably not the numbing agent either. I can understand Lidocaine silencing it immediately after the injection and for a couple of hours afterwards, but 21 hours straight the next day, and then 5 hours of sleep being enough to completely wipe out the effect, makes little sense. If it was Lidocaine it should have gradually worn off, and T should have gradually returned. Or at least start off at a lower level this morning. But from no T for a full day to a 4/10 2 in 5 hours of sleep doesn't add up with that strictly being a result of Lidocaine. Really wish I could figure out why sleep does that and how to prevent it from triggering it. The only thing I know is my ears were still full yesterday, and this morning the fullness was gone.

My ears have been plugged off and on too. Sleep sometimes makes it worse, but it's a little better once I get up and about.

Out of curiosity what was your tinnitus volume matching level? Are you able to hear it in normal non-silent situations (e.g. a restaurant, driving around, etc.)?

 

[AlexSongitus]

My ears have been plugged off and on too. Sleep sometimes makes it worse, but it's a little better once I get up and about.

Out of curiosity what was your tinnitus volume matching level? Are you able to hear it in normal non-silent situations (e.g. a restaurant, driving around, etc.)?

They never told me their numbers. The first day it was lower than normal. By my rating I would have rated it a 2 in my left and barely audible in my right, to the point where she could barely measure it the day of my first injection. My baseline is more of a 3 and 1. Yes I can hear it over traffic in a moving car if it's a 3. I basically consider a 3 or higher if I can hear it over normal non-silent situation. Perhaps others would rate that a 5, I don't know.

 

[Alue]

They never told me their numbers. The first day it was lower than normal. By my rating I would have rated it a 2 in my left and barely audible in my right, to the point where she could barely measure it the day of my first injection. My baseline is more of a 3 and 1. Yes I can hear it over traffic in a moving car if it's a 3. I basically consider a 3 or higher if I can hear it over normal non-silent situation. Perhaps others would rate that a 5, I don't know.

I see, that's why it's so hard to put a number on things when it's completely subjective. I think they should give a little more guidance for ranking things, like 1-3 only audible in a quiet places, 4-6 hear in most situations, 7-10 unmaskable in almost any situation. I feel like mine is about a 6 or a 7 most days, but I know for sure it could get a whole lot worse.

I guess the most important thing is to be consistent with your rankings wherever you start.

 

[AlexSongitus]

I see, that's why it's so hard to put a number on things when it's completely subjective. I think they should give a little more guidance for ranking things, like 0-3 only audible in a silent room 4-6 hear in most situations 7-10 unmaskable in almost any situation. I feel like mine is about a 6 or a 7 most days, but I know for sure it could get a whole lot worse.

Was your last injection just this past week or 2 weeks ago? How is it in comparison to your baseline today?

 

[Alue]

Past week, a little bit worse (new tone in one ear).

 

[wizman]

Habituhation 1 - 0 AM-101

 

[Hotaru]

I think my eardrum ruptured after blowing my nose. How? There was only a small hole in it, and then to tear it open simply from blowing my nose? My mom looked in my ear and saw nothing but darkness. The other ear had the eardrum with a hole in it, as it should be. My mom isn't a doctor.

 

[Alue]

I think my eardrum ruptured after blowing my nose. How? There was only a small hole in it, and then to tear it open simply from blowing my nose? My mom looked in my ear and saw nothing but darkness. The other ear had the eardrum with a hole in it, as it should be. My mom isn't a doctor.

Call the site and ask? When is your followup appointment?

I had a similar experience where there was a small pressure change and I heard a little pop then 'beeeep'. I think it just popped off the scab that was forming and re-opened the hole.

 

[Sebastians]

Yeah, had something like that too last week. Blew my nose lightly and then this beep for a few seconds. You probably just forced the hole open again when it was almost healed. I would not yet worry about it, it happened to me two days in a row actually.
Just don't get any water in there

 

[Louise77]

OK, I have applied to the UK Middlesborough site TWICE with no reply to my emails (got a email to say form was successfully received but no reply since). Three weeks since my last application.
I have now applied to the Sheffield site in the UK.
Has ANYONE done the trial with a UK site? What was your experience?
Are they definitely still accepting participants?
Thanks.
Louise

 

[Hotaru]

Call the site and ask? When is your followup appointment?

I had a similar experience where there was a small pressure change and I heard a little pop then 'beeeep'. I think it just popped off the scab that was forming and re-opened the hole.

Yeah, I could have just been freaking out about that. However, I still feel fullness in my right ear and the ringing is worse than ever.

 

[Joe Bananas]

@AlexSongitus I am also one of those guys who experience clear changes in his T after sleeping. Everytime I have a nap my T has moved from one ear to another or is just "at the back of my head". Funny thing is when this shit is "sounding" back there I can notice 0% tinnitus in my ears... I think that makes clear is not my ears what's fucked up but my dearly beloved brain...

In other order of things, just came back from my second after-shots screening and my Dr told me the open label round is reduced to one. Not 3 open label rounds anymore. He also told me he is travelling to Nottingham next week in order to attend a summit organized by Auris Medical where every Dr worldwide who has conducted the trial will meet. They are going to receive the definitive results of the trial. He also confirmed to me that AM101 has already been aproved to hit the market with a price of 1500€/2000€ the 3 shots round. The reason he gave me for Auris Medical not giving three open label rounds anymore is because they realized there's no more improvement the more rounds a subject receives. I guess the truth is way simpler... Auris Medical has already received the permission for marketing the drug and doesn't need to "waste" more shots...

 

[Alue]

In other order of things, just came back from my second after-shots screening and my Dr told me the open label round is reduced to one. Not 3 open label rounds anymore. He also told me he is travelling to Nottingham next week in order to attend a summit organized by Auris Medical where every Dr worldwide who has conducted the trial will meet. They are going to receive the definitive results of the trial. He also confirmed to me that AM101 has already been aproved to hit the market with a price of 1500€/2000€ the 3 shots round. The reason he gave me for Auris Medical not giving three open label rounds anymore is because they realized there's no more improvement the more rounds a subject receives. I guess the truth is way simpler... Auris Medical has already received the permission for marketing the drug and doesn't need to "waste" more shots...

That's unfortunate.
Is this everywhere? I have still yet to hear this. I don't think its really fair to the participants to promise one thing then go back on that once they went through the double blind.

 

[Alue]

I am curious if everyone that has been told the trials are limited to one followup are a part of the up to 6 months group, not the less than 3 months group in the US.

 

[AlexSongitus]

@AlexSongitus I am also one of those guys who experience clear changes in his T after sleeping. Everytime I have a nap my T has moved from one ear to another or is just "at the back of my head". Funny thing is when this shit is "sounding" back there I can notice 0% tinnitus in my ears... I think that makes clear is not my ears what's fucked up but my dearly beloved brain...

In other order of things, just came back from my second after-shots screening and my Dr told me the open label round is reduced to one. Not 3 open label rounds anymore. He also told me he is travelling to Nottingham next week in order to attend a summit organized by Auris Medical where every Dr worldwide who has conducted the trial will meet. They are going to receive the definitive results of the trial. He also confirmed to me that AM101 has already been aproved to hit the market with a price of 1500€/2000€ the 3 shots round. The reason he gave me for Auris Medical not giving three open label rounds anymore is because they realized there's no more improvement the more rounds a subject receives. I guess the truth is way simpler... Auris Medical has already received the permission for marketing the drug and doesn't need to "waste" more shots...

I don't know if it's strictly brain related since things like sinuses, nasal congestion and ear pressure can change while sleeping. Today I woke up with about a 1/10 and then it kept dropping. I have been pretty much T free once again today for the past 8 hours or so, but it also came back with fullness in my ears this morning, which by now is almost gone. The fact that saturday my T was gone and also I had fullness, while yesterday it was back when my ears were cleared up tells me there might still be more to this than just brain. The fact that the Lidocaine and procedure gave me immediate silence afterwards also tells me it's more ear related than brain related. My T responded significantly to Prednisone, changed significantly overnight with Penicillin, and now once again with Lidocaine, AM-101 and the procedure. These medications target the ear, sinuses, infections, not so much the brain. Which makes sense in a way because in the beginning it is more ear-related, and only over time does it get centered in the brain.

Thanks for sharing that info about the open label round. Are you in Europe? I wonder if they only changed it there. I didn't think I was going to do more than 1 open label round myself, but that does suck since some members did report improvement after the 2nd round. And yes I definitely think it's a money issue, because this can't be cheap for them. But if it's already been approved that means the results look good, so great news indeed. I wonder if that's the price of the drug, and the procedure would cost separate. That's cheaper than one of my doctors was leading me to believe actually and yeah, if it's effective, a lot of people will pay that in a heartbeat.

 

[Sebastians]

I'm almost two weeks after the first round (thursday) and will post at length about my experience once the spike settles down completely.
What happened to me was that my T shifted IMMEDIATELY upon the first injection from my left 'brain' to my left ear..

 

[liquefact]

The reason he gave me for Auris Medical not giving three open label rounds anymore is because they realized there's no more improvement the more rounds a subject receives.

Thanks for the info. Honestly i was expecting more or less the same thing. Esketamine in theory should only be effective shortly after onset. I'll be in the open label round next week (5.5 months after onset) and had already decided to not go for the other round. The more time passed after onset the less effective esketamine. Honestly my expectations from the open label round is gone down to almost 0. Any noticeable change shall be appreciated very much though.

They know this fact much better than us as they must've collected shitload of data so far and it's reasonable for them to put an end to the AMPACT trial. The reason they are trying to assess the efficacy of the drug in the border of acute/chronic phases (3-9 months) is to extend the reach of the medicine to a broader range of people as much as possible i guess. Of course this is partly driven by the smell of profit. 1K more people means roughly 2M USD additional revenue if the pricing is in the ballpark you've mentioned. This'll easily more than what they've probably spent for the extended trials.

We'll probably see miracle like results after the drug is made public and is administered very shortly after onset. It'll pretty much prevent the development of tinnitus in the case of acoustic trauma. We're all ready to spend tens of thousands of dollars for a cure and for 1-2 K USD, it'll sell like cakes.

I hope no one needs to suffer from this shit in the future anymore.

 

[Joe Bananas]

Esketamine in theory should only be effective shortly after onset.

I reproduce a slice of my conversation with the ear Dr who is conducting the trial in Linares (Spain). I have to say that he is one of the most respectable ear Drs in my country regarding tinnitus research.

Me: - Are there any chances of AM101 having positive effects in a person who receives it 7 months after onset?
Dr: - Yes, yes, yes, yes, yes, yes, yes, yes, yes, yes...

Another bit of my conversation with him:

Me: - May a subject who received the actual drug keep experiencing improvements after one month since the first shot?
Dr: - Yes. Absolutely. Even not having experienced any sort of improvement, the subject could experience a sudden positive change even after 2 and 3 months since the first shot.

I want to believe!!