AM-101 Clinical Trial — Participants Updates and Discussion

[Nick86]

Side affects of the perforation of the eardrum IMO. I had a similar issue, but my eardrums were more stiff than usual. I'll see whether it went away or not next month. Do not worry that much.

Ya a little worried. I just am sick of dealing with issues of my ears. I can control my tensor tympani muscle voluntarily and was fluttering it the other night to see if this had any effect on my tinnitus(was frustrated and looking for anything to help). I read that when this muscle tenses it tightens the ear drum. Now I'm thinking I may have stretched it myself!! Bleh. I couldn't see how else it could happen. I hope it goes back to normal

 

[AlexSongitus]

Melatonin helps For sleeping

I need more than that. I have anxiety and here it throughout the day.

Have you tried any of the masking or sound therapy I and others have been doing? I had to use it all day yesterday to mask it. Masking it can give you instant relief from your anxiety. Did they say you can't use anything like that?

 

[JohnK]

Feeling any lasting side effects John?

None whatsoever

 

[goose4485]

so long story short, 3 weeks ago I had ringing start in my ears and it hasn't stopped (it's not crazy loud where during the day I'll only hear it if I'm in a quiet room, it's mainly an issue at night). I also have the ear pressure many of you speak of. So I went to an ENT a week into it and he confirmed tinnitus after running some audio tests. Said I didn't really have any hearing loss, outside of 1 frequency where I dipped slightly below the average person. He also claimed it would most likely go away in a month (sure it will....)

Anyways, fast forward to this week and I stumbled upon this thread and applied and today the clinical team got back to me saying I can't be in the study as I have a history of tinnitus and that in the past I have been exposed to tinnitus triggers.

So my question to all of you is, is this the first time you have ever had any ringing in your ears? I have been to concerts previously where walking out I had a little bit of ringing, but by the next morning it was gone. It's never been like this.

And in regards to the tinnitus triggers in the past, I mean isn't everyone technically exposed to tinnitus triggers? Isn't any overly loud sound technically something that could trigger tinnitus? A loud movie? A concert? etc???

Just trying to wrap my head around this as it doesn't make a ton of sense to me.

I'm Chris btw, nice to meet you all

 

[TC426]

in regards to the tinnitus triggers in the past, I mean isn't everyone technically exposed to tinnitus triggers? Isn't any overly loud sound technically something that could trigger tinnitus? A loud movie? A concert? etc???

Just trying to wrap my head around this as it doesn't make a ton of sense to me.

I'm Chris btw, nice to meet you all

Hi Chris

I understand your disappointment. But look at it from a different angle. Auris Medical is currently in the final phase, trying to get the approval for the AM-101 treatment. In phase III of the legalisation, lots of restrictions apply to potential participants. Some make more sense, some less. These restrictions are set by both the sponsor (in this case the owner of the treatment, who, if the trial fails, loses the whole investment) and official instances (who are responsible for the approval of treatments) and aim to ensure a very clear framework for the legalization process.

To my understanding, for phase III it is required to be able to refer to the event which caused the T. I agree that, technically, everyone has been exposed to potential T triggers before the, however, for the sake of the study it is crucial to be able to quantify the history and the event causing it. In my case, it was a very distinct event on a specific date which brought me here.

This does not mean that the treatment is useless for you, and once it has passed all the required approval, you may want to re-assess the situation with your ENT. But for now, you are not considered a "representative standard case" for the trial.

 

[Charlie396]

T minus 8 hours till the first injection, here we go.

 

[Sebastians]

Screening tomorrow, almost 4 months in so part of the post-acute crowd here.
Crickets in left ear/head changed to hissing in the past few days, slightly louder, but not as annoying as the crickets. Might be a sign of some nerves healing? or might not mean anything at all, time will tell.

 

[goose4485]

To my understanding, for phase III it is required to be able to refer to the event which caused the T. I agree that, technically, everyone has been exposed to potential T triggers before the, however, for the sake of the study it is crucial to be able to quantify the history and the event causing it. In my case, it was a very distinct event on a specific date which brought me here.

Thanks for the reply TC426, but this is sort of exactly my point. I went to a concert a few Saturdays back, woke up with ringing that hasn't stopped since. To me that seems like a very specific event, and not sure why I would then be excluded.

 

[TC426]

Here, as promised, my summary of the last 7 days.

Sequence of updates:
24 hours after last injection
1 week after last injections
1 month after last injections
3 months after last injections

7 days after my final set of injections, I would sum up with: "So far, so good"

By now, the clogged feeling is not so present anymore, but it is still obvious to me that there is gel in the middle ear. The popping happens less often, only few times a day now, and typically, that is when the clogged feeling sets in (or during exercise). Changes can be noticed in particular after getting up in the morning. Pain/pressure feeling mentioned was gone after 2-3 days. Holes seem closed but not yet verified due to minor blood crust.

The hearing loss which I felt initially has resolved by 90% over the last couple of days, however, I am having difficulties understanding people in loud environment and in group discussions. I have experienced this once before, namely after the main noise exposure last year. A detailed test upon the first checkup, however, only indicated minor hearing loss due to blocked ears. So I would say that, while my quantifiable hearing shows no major change, my hearing perception is still not quite back to normal.

Furthermore, the check-up identified a fairly sharp increase in T perception (doubled, according to the numbers, but in fact it should be a bit less). I have felt a slight decrease overall, but peaks are still off the chart (regarding to the normal pattern) and average is still around baseline+50% (rough estimate). Most relevant, I have gone through some changes which I do not yet know how to interpret. I cannot shake the feeling that the T has shifted toward one side, with a volume which is higher than the baseline. That makes it difficult to quantify the other side, but oddly enough, if I have to, I feel an opposite effect there (note: both ears should have got the same treatment, either placebo or AM-101). Apart from that, I had lower, different tones playing in at time, some quite intense for short periods of time, others repeatedly. This has not happened again within the last few days.

As I know that others have also had a recovery time of several weeks after the injections, I am not too worried and confident that things will develop well over the next weeks. But I will admit that it's tough at times.

Will keep you posted!

 

[Charlie396]

Literally laying here minutes after first injection. Awaiting the next. Hurts a lot more than anticipated

 

[Sebastians]

Had my screening today, had all the tests done, got the htc phone, you guys know the drill.
First round of injections due in two weeks. Will only have my left ear done, as that's the problematic one. Right ear T only audible in very quiet surroundings (possible spill-over from left ear damage actually).
The audiologist guiding me through the screening was completely new to the trial and was replacing a colleague, but super nice and calm. Really helped me in keeping my anxiety at bay. Assured me the risks are low and the doctors doing the shots are well experienced.
It's no real silver bullet, but i match the profile of a good candidate, and many have gone before me. I give it a 15- 20% chance it will still do 'something' good at this stage.

 

[Hotaru]

No one said anything about having to gather up all my medical info and send it to the place that's doing it. Now I'm scrambling all that together and it's going to take longer.

 

[Hotaru]

Again, no one said anything about having depression and anxiety as being exclusion material. What am I going to do now? Tinnitus CAUSES my depression!

 

[Nucleo]

No one said anything about having to gather up all my medical info and send it to the place that's doing it. Now I'm scrambling all that together and it's going to take longer.

I suggest you direct your questions to the people in charge of the trial at your location.

 

[Sebastians]

@Hotaru
Maybe depends on the country, but i was not asked any questions on depression and such. We went through my medical history a bit, but i could pretty much say whatever. I just needed a signed document from my GP that i am able to participate.

 

[Charlie396]

Again, no one said anything about having depression and anxiety as being exclusion material. What am I going to do now? Tinnitus CAUSES my depression!

I'll be posting my experience after injection 3 on Wednesday. As well as some tips for people who are having trouble getting accepted. There are ways around things.

 

[Hotaru]

I'll be posting my experience after injection 3 on Wednesday. As well as some tips for people who are having trouble getting accepted. There are ways around things.

Great. I need in this. It's my only chance.

 

[AlexSongitus]

Again, no one said anything about having depression and anxiety as being exclusion material. What am I going to do now? Tinnitus CAUSES my depression!

You can be sad about your Tinnitus, without calling it depression. You can be normally concerned without calling it anxiety. Know what I mean?

They can't ask someone suffering from depression not to be on AD medication for 90 days, since AD are an exclusion criteria.

 

[Hotaru]

You can be sad about your Tinnitus, without calling it depression. You can be normally concerned without calling it anxiety. Know what I mean?

They can't ask someone suffering from depression not to be on AD medication for 90 days, since AD are an exclusion criteria.

I'm not just sad. I'm borderline psychotic. T is the absolute worst thing to happen to me.

 

[Joe Bananas]

Hi
For the last four or five days I've experienced some unusual fluctuations in my tinnitus perception. Today marks the second week after the last shot and I don't know if these fluctuations are common to the AM101 development or if it's just that; my perception, since I don't know if I received that or placebo.
I woke up two intermitent mornings with a really quiet tinnitus which has also changed slightly in tone. That quiet perception remained at the same point for the whole day. The days in between those quiet experiences T went back to normal presence. Today is something in the middle; not so intrusive T and kind of maskeable (it has never been maskeable and I could hear it everywhere). Anyway I am going straight for the open label round as I am having a hard time conceiving the idea of having to live with this for the rest of my life, so any chance of getting rid of it will be targeted.

 

[JohnK]

Doing my 1 month followup today. No change in tinnitus from before I started. Probably got placebo. That or it just won't work with my T

 

[Charlie396]

Doing round 2 John?

 

[Joe Bananas]

Want to ask a cuple of questions:

- Does a person who has "abused" earphones use during his life but experiments tinnitus after a single loud sound exposition could be benefited from AM101?

- Why placebo? What is the role for it? What's the sense of giving it to some percentage of subjects?

Hey, I forgot... When it is reasonable time to consider AM101 healing effects to appear after last shot (if AM101 given)?

Thanks. This is HELL these days...

 

[liquefact]

- Does a person who has "abused" earphones use during his life but experiments tinnitus after a single loud sound exposition could be benefited from AM101?

Yes, the damage can come not only from an exposure to a short but very loud sound, but also to exposure to moderate loudness in long time. They both benefit from the drug as far as i understand.

- Why placebo? What is the role for it? What's the sense of giving it to some percentage of subjects?

There's the natural recovery + habituation going back shortly after onset of T and if there were no placebo, it'd be impossible to say whether the drug was effective or not. With the control group that's given placebo, the AM101 efficacy is measured as the difference AM101 group and Placebo group.

Hey, I forgot... When it is reasonable time to consider AM101 healing effects to appear after last shot (if AM101 given)?

In at most 2-3 weeks IMO you should see some improvement. Any improvement beyond that period has nothing to do with esketamine as the drug is not kept in the ears for long and this drug is actually not designed to be administered long after onset, ideally in days.

Your T is loud these days?

 

[Joe Bananas]

In at most 2-3 weeks IMO you should see some improvement. Any improvement beyond that period has nothing to do with esketamine as the drug is not kept in the ears for long and this drug is actually not designed to be administered long after onset, ideally in days

I thought improvement could be noticed anywhere between the last shot and around the 90 day mark (if AM101 given).

Your T is loud these days?

Yesterday was INSANELY loud in left ear. Loud and high pitched. Extremely bothering. Two weeks and three days today since my last shot. I've noticed a really perceptible fluctuation following an almost mathematically perfect pattern; One day is loud and focused in my left ear mainly and next day is really quiet and more in the back of my head. I already experimented a similar pattern the two or three weeks which followed onset, then it settled in a constant sound/volume. In case this time it settles in the quiet option I would consider I received AM101 since it represents a real improvement and I could get adapted to it in a much more easier way than if it settles in the louder side. Anyway I am going straight for the open label round even if it will be received in my 7th month after onset.

@liquefact , THANKS for your answers, support and communication in here. How are things rolling in your side? Have you experimented any improvement?

Oh! I forgot to mention that a friend who went through his first round is experimenting the common after-shots full ears plus deafness but he also complained about numb palate and weird flavours when eating.
I never felt any weird flavour draining through my throat or any foreign liquid... I have the impression I received placebo. That or AM101 doesnt work for me...

 

[Charlie396]

Oh! I forgot to mention that a friend who went through his first round is experimenting the common after-shots full ears plus deafness

Deafness or decreased hearing? There is a BIG difference.

 

[Sebastians]

Dammit, shots are due in 10 days. T fluctuates between 2/10 during the day and ramps up to 4-5 in the evening. Mostly maskable, a hiss in the left ear/brain and a soft whine in the right ear. Super loud spikes at night though, including tones i never hear during the day, unless i plug my ears and tune in to them, like a mosquito-esque whine and a low buzz. I'd take the shots mostly to counteract these spikes really.
But i'm not blown away by what i read here, some improvement in a few cases.. There's no backing out of this one though. Thanks for the constant updates, guys!

 

[Joe Bananas]

Deafness or decreased hearing? There is a BIG difference.

Decreased hearing, mate. Sorry, English is not my first language... Even my first language is not my first language... Hahahaha!

 

[liquefact]

I thought improvement could be noticed anywhere between the last shot and around the 90 day mark (if AM101 given).

In my understanding, this drug is incredibly effective very shortly after onset. I mean, if administered days after onset, it just kills the T. This is what they've found in rodents (by chance though). And as the inner workings of mice ear (cochlea, hair cells, nerve fibers, the chemical properties of medium that's transmitting the signals and etc ) are very similar to ours, it's extremely likely that it'll have the same affect on humans. What they're trying to assess is to understand the extent where the drug is affective.

Yesterday was INSANELY loud in left ear. Loud and high pitched. Extremely bothering.

Do not worry, there is no reason that the drug can make it worse permanently so it's probably a spike. Having he drug does not mean that you'll not have spikes. You'll still have bad days, but;
1. They'll be less and less frequent
2. You'll be less annoyed over time because of the habituation

THANKS for your answers, support and communication in here. How are things rolling in your side? Have you experimented any improvement?

Sure. When i'm stressed for any reason and/or tired, T becomes louder, almost non-existent H strikes back and i'm much more annoyed, like yesterday. Today T and H started to diminish, i'm working on annoyance
In general though, i'm mostly good. And definitely better than pre-injections. I cannot say this is a terrific improvement but as i was not expecting anything from the blinded round, this is more than welcome.

Oh! I forgot to mention that a friend who went through his first round is experimenting the common after-shots full ears plus deafness but he also complained about numb palate and weird flavours when eating.

Numbness might really be a sign of esketamine as it is used as a general anaesthetic.

 

[Dutchy]

I can clearly hear now where my T is coming from,it's definitely my right ear.
I'm also seeing that they're having an am-101 trial in Belgium,but i guess i'm already too far in.

I just filed a request to participate, i kind of lied but this vicious cycle of not sleeping and anxiety is not working for me.I need to try it.