AM-101 Clinical Trial — Participants Updates and Discussion

[Hopeful1]

I have AM 101 or placebo 10 days ago.

My T goes down in volume some days and it spikes for a couple of days when i listen to high frequeny noise like bread trimmer. It used to come down before am as well for a couple of days, 01 however it was not as low as it now after injections.

Does it mean that i need to avoid high frequeny sounds that make my T spike temporarily so that AM 101 takes it down. If i avoid noises that spike my T does it make my H worst in the long term?

 

[Sebastians]

I have AM 101 or placebo 10 days ago.

My T goes down in volume some days and it spikes for a couple of days when i listen to high frequeny noise like bread trimmer. It used to come down before am as well for a couple of days, 01 however it was not as low as it now after injections.

Does it mean that i need to avoid high frequeny sounds that make my T spike temporarily so that AM 101 takes it down. If i avoid noises that spike my T does it make my H worst in the long term?

Just my suggestions: avoid loud noises/ places for the duration of the trial. I started wearing filtered earplugs on the busy streets to work/tram/metro/supermarket etc and when using loudish applications like blender/nespresso machine etc.
In my case, my mild H and sound distortion got better using this protocol. I did listen to a lot of low volume music at home, so in a controlled environment.
Don't buy into the overprotection thing from the TRT folks, ears need rest too, not exposure to noise from fire trucks, construction sites and honking cars.

 

[Hopeful1]

@Sebastians
I have been avoiding loud noises what i observed is that it is not the loudness that triggers my spikes...but the high frequencies....the higher the frequency the more trouble it causes me..

Bye the way my PT has gone i think...but i get burps often now and i can the sense the pressure senation going from my mouth to the right ear...i had this sensation on both ears during the injections...but now i have it only in my right....did you also have it? I am thinking if there is some problem with my eustachan tube controlling pressure or propably just congestion in the right ear causing my pulling sensaton when i burp.

 

[Sebastians]

I had a lot of trouble with high frequencies in the first three months, that sort of fizzles out by now since i started protecting my ears as explained above too. May be some kind of reactiveness you experience. Remember you are still very short after onset of T, give it time. It will most likely dissipate just like the PT.

I never burp, can't help you

 

[Hopeful1]

I never used to burp it only started after the injections...

 

[Sara_Bond]

Can someone tell me if they still accept on post acute phase, which means at 6.5 months?

 

[Hopeful1]

It depends on the centre and country....i know they did for someone at 9 months at the centre i am going to in the UK.

I recommend you apply to all the centres in France and some centre might do it.

 

[Sara_Bond]

@Hopeful1 Thank you.

I was accepted in the early stages but I refused to do it. Now Im telling to myself that it maybe might help but I am really afraid of the side effects (that's why I was so afraid, and in the early stages I wasn't stable enough to make any decision).

 

[Sebastians]

@Hopeful1 Thank you.

I was accepted in the early stages but I refused to do it. Now Im telling to myself that it maybe might help but I am really afraid of the side effects (that's why I was so afraid, and in the early stages I wasn't stable enough to make any decision).

There are no real side-effects of am101 except for a spike, just a few possible complications with the injections as with any surgical procedure, even a dental appointment can go wrong..
I believe 6 months is the cut-off date in Europe, but you never now. The trial will run just till the end of this month. Act now Sara!

 

[Sara_Bond]

@Sebastians Thanks for the motivation post!

I already sent an email, I know she will only read it tomorrow as this is Sunday here. Fingers crossed

 

[Hopeful1]

@Sara_Bond

I have read tons about AM 101, but could not conclude if it works...apparently it worked for some rats and some rats did not respond and the they specified a percentage of responders so i assume it is 50% . So, it does not work for everyone...because you only have 60% chance of getting medicine against 40% chance of placebo....considering only half of people respond....there is 30% chance of improvement.

However there another problem with AM 101, during initial phases
when primary end point was tinnitus masking level , there was no improvement....so in the phase 2 and phase 3 testing the primary endpoint is changed patient reported tinnitus loudness. So why does AM101 does not seem to work as measured against making level.

Another problem is they say the improvement is permanent...i am not sure as they dont followup patients beyond 3 months...so we dont know.

So its just 30% chance of improvement if the medicine actually works.

My experience.
10 days after injections: T is lower than before injections.... my T is fluctuating...its reacts to high freq. sounds and spikes. So, I have wait and see if have a long term improvement.

Side Effects:
T Spike in my right ear for a week.
Pulsating Tinnitus in tight hear for few days.
Looks like pressure problems in the ears..still have this after 10 days.

I take risks when am back to the wall....so i just took my chance..so that i dont regret later on...even though it is unclear if AM 101 works and no one in this forum has definitively confirmed that it made significant improvement that lasted 6 to 12 months...Guys please correct me if i am wrong in saying this.

 

[Sara_Bond]

@Hopeful1

Thanks a lot for sharing your experience. I really appreciate like a lot of fellows here.
I hope you'll get permanent improvement and a lowering of your T. Let's hope!

 

[Alue]

Well I got my 3 open label injections this week. The injections themselves went very smooth, but I had a cold on top of things which just adds to the fun.
Odd thing is my T seemed a bit lower on injection days 2 and 3. After injection #3 I made the mistake of taking a nap on my side and woke up with my ear completely muffled. I think being sick and having the extra drainage added to this. The flight back home was not pleasant, I knew it wouldn't be with my ear totally blocked. I kept hearing these bleep bloop and whistle sounds in that ear as it tried to equalize pressure. It sounded similar to when you get the injections. No pain, though, so that's a good thing.
My T has fluctuated since then.

I do think I got the placebo first round, I did not notice a net improvement and it took a long time to get back to baseline. No way to tell for sure. I could not tell any difference between the drugs. No numbness, no taste, nothing. This time around it did seem to drain a little bit faster, but that's about it, and that's something you really can't tell unless you have had it more than once.

Some times my T seems a bit lower, like when outside in busy environments it has been low enough to be in the background. It's still loud if I plug my ears, and today it seems a bit louder than baseline.

The doctors and trial coordinator at my site have all been great. I know people have talked about varying experiences depending on their location, which makes me feel lucky to have a such a good team.
Auris should have participants rate the trial location at the end of their trial. That way they know which ones to repeat business with for future trials and which ones to avoid.

 

[John D]

Hi All.
Day 1 open label today.
Bad news I'm at 7 and half months stage.
Not looking forward to long T spike again. My last spike lasted 18 days after treatment.

 

[AlexSongitus]

Hi All.
Day 1 open label today.
Bad news I'm at 7 and half months stage.
Not looking forward to long T spike again. My last spike lasted 18 days after treatment.

Good luck John. Let us know how it goes.

I'm going in on Wednesday for my first injection of the open label round.

 

[John D]

Not so good so far. The Dr nicked the back of the ear behind the eardrum . But only short term pain. Last night not so good. Lots of ear pain and some pulsing tinnitus 4 hours. Much better after 400mg ibuprofen in the morning.
Good luck Alex.

 

[Alue]

Not so good so far. The Dr nicked the back of the ear behind the eardrum . But only short term pain. Last night not so good. Lots of ear pain and some pulsing tinnitus 4 hours. Much better after 400mg ibuprofen in the morning.
Good luck Alex.

When you say nicked the back behind the eardrum, do you know where he nicked?
I have had the pulsing tinnitus after both injections, it was worse the first time but not really worrisome; it went away as things healed. I actually prefer the pulsing sound of my own heartbeat to my baseline tinnitus tone; wish I could trade the two!
Hope things get better for you. Good luck.

 

[AlexSongitus]

When you say nicked the back behind the eardrum, do you know where he nicked?
I have had the pulsing tinnitus after both injections, it was worse the first time but not really worrisome; it went away as things healed. I actually prefer the pulsing sound of my own heartbeat to my baseline tinnitus tone; wish I could trade the two!
Hope things get better for you. Good luck.

You didn't experience that type of change the first time round, right? Maybe that is a good sign.

Getting ready to go in for my open label round. Will keep you guys posted.

 

[John D]

Hi.
No pain today but monster spike.

 

[Alue]

You didn't experience that type of change the first time round, right? Maybe that is a good sign.

Getting ready to go in for my open label round. Will keep you guys posted.

Good luck!

Experience what? I had pulsate tinnitus as well as a new tone (both went away) my first round. The baseline tone never went away, it was just new tones on top of it. This time the recovery seems to be faster, still waiting to make a judgement, it's too early to tell. At this point I'm not expecting a complete cure even in my dreams. I'd just be happy with a reduction in volume.

 

[AlexSongitus]

I see Alue. I though the pulsating tone was something new this time around.

I had my first injection of the Open label round today. My T has been at a either 1-2 for the about the past 4 days or so, having not experienced a day of silence in at least 4 days. So of course since today it was my injection day, I wake up with extremely low T which disappeared completely before the injections. I'm in the office filling out paperwork and the freaking thing keeps dropping. By the time I get to the matching test, there's pretty much nothing to match. And before they even applied the Lidocaine to numb me, I was in complete silence. Go figure!

So yeah, there is nothing to judge there other than the procedure which went smooth. Had the very soft hands doctor today, so it was painless. I don't have the problem others have with suctioning, so that didn't bother me. Had one air bubble, but again, doesn't really bother me. He checked out my ears before the injections and said you can't tell I ever had my previous injection performed. I even took a short 10 minute nap, after my 1st injection. Came out of there with the typical fullness, left was more or less deaf, my right cleared up quickly. I once again experienced slight numbness in my right cheek only, though not as strong as round 1.

The only interesting things worth noting is that after napping late this evening my T came back. So sleep is still my #1 enemy . When I do get silence it still triggers my T and it seems AM-101 cannot combat that, at least not immediately. Also I am once again experiencing muffleness reversing ears. Before sleeping right was clear, left was full, I woke up with my right ear muffled, left is clear. I'm guessing it has to do with sleeping on my right ear. No popping when I swallow. I felt popping only when I had my ear on the pillow.

In my case it should be pretty easy to judge improvement. I was down to about 1 or 2 days of silence days a week in the past month prior to injections. And low T of 1-2 everywhere between. If the frequency of the silence days improves, then that's the only thing I would consider an improvement. And this is something that I will notice long-term. Will see if I end up having as many days of silence in a row as the first round during the first month and if this time it sticks long term.

 

[AlexSongitus]

Oh yeah, I want to give others a quick heads up that have yet to do theirs that may help with numbing. In talking to one of the assistants the conversation came up about the effectiveness of the numbing gel when there was presence of ear wax, basically saying the more ear wax the harder it is to penetrate.

During my first round, right before my 1 week screening period I do remember doing a thorough wash of my ears, using a pump and drops. I didn't do that this time and I did notice the numbing didn't reach my tongue today and this evening I definitely felt more soreness compared to last time. So it seems like the numbing agent did not penetrate as thoroughly on Day 1 this time around, as last time, and I suspect washing out the wax thoroughly in my ears last time may have played a role.

Now its too late since I have holes in my ears, but for those of you that are still going in for future rounds, give it a shot. If you do a good de-waxing a couple of days before the injections it will help the numbing agent penetrate better and hopefully end up with a more painless experience.

 

[TC426]

Good luck Alex & Co. and thanks for the updates!

As I am 3 weeks ahead of Alex, and my one month checkup is in fact just after 5 weeks, I thought I quickly give some insights on my progress after the injections, before I forget all the details.

Overview of past updates:
24 hours after last injections
1 week after last injections
3 week after last injections (unplanned)
1 month after last injections
2 months after last injections
3 months after last injections

My pre-injection baseline was between [2/10] and [4/10] during 4 weeks before the 2nd round:

First week
Day 1: [8/10]
Day 2: [8/10]
Day 3: [9/10]*
Day 4: [8/10]*
Day 5: [4/10]
Day 6: [5/10]
Day 7: [7/10]

Second week
Day 8: [5/10]
Day 9: [5/10]
Day 10: [4/10]*
Day 11: [1/10]*
Day 12: [0/10]*
Day 13: [1/10]
Day 14: [1/10]

Third week
Day 15: [4/10]
Day 16: [1/10]
Day 17: [3/10]*
Day 18: [3/10]*
Day 19: [3/10]
Day 20: [4/10]
Day 21: [2/10]

*the star marks weekends/days off (generally better)

Summarized I can say that the first week was hell because of the massive spike. During the second week I had significant improvements and a couple of days that were clearly below the baseline. The third week, unfortunately, has not really confirmed this positive trend.

I would say that my left ear is pretty much back to pre-injection level, while the right ear is still moderately worse and much more prone to external T triggers than before. Furthermore, I feel that some characteristics of the T have change, most noticeably the tone has diversified and now consists of a higher frequency hiss combined with a lower frequency static-ish sound. I would not call it "worse", just a bit different. What's definitely worse, however, is that T has become more resistant to masking. I do not think that it hasn't become louder as such, but more intrusive. I can currently often hear when I am outdoors or e.g. in a train, which previously only happened from time to time. So for right now I would say things are slightly-moderately worse overall.

This is an interim update, and I am still confident that there will be some more progress over the next weeks.

Best luck to fellow participant

 

[AlexSongitus]

Just got back from my 2nd injections. I experienced some pain and soreness overnight, which I didn't during the first trial round. Because of that, I expected it to hurt today, but it ended up being similar to my first round. Slightly worse than the first day, but still overall ok. Felt the needle a bit when it penetrated deep, but really more of a discomfort than pain. I had the head doc today. He took note of the soreness and gave me a few extra minutes to numb me up really good, and he worked really fast. He finished in seconds really.

I did notice leakage this time around from my ears after the injections, when I was laying on one side, something that didn't happen the first time around. Once again I did not feel it draining down my throat at all, so for whatever reason it seems my cochlea cavity cannot hold as much this time around as the first time, or the fact its not draining down my throat, that a little bit is pushing back out of the holes. Or perhaps this time they used the same holes, I forgot to ask. I know last time after my first injection, it was already healed overnight and had to do new holes.

The other part worth mentioning is that today my T was on unlike yesterday where it was silent, about a 2/10 before we started. However, unlike the first round 3 months ago, where the Lidocaine silenced my T on all 3 consecutive days during the procedure, that did not happen today. It's a bit lower now than before the injections, but no silence this time. So perhaps time does play a major factor. At least when it comes to that Lidocaine effect. And maybe also the fact it's not penetrating as well as last time.

Other than that everything went smooth. Eye test was fine. No popping at all this time 2 days in, so that's a plus. I would have to go back and read my posts to be sure but I think by my 2nd injection, and definitely by the third, I had popping when opening my mouth really wide or chewing hard. This time I don't seem to be experiencing that, at least not yet. And my ears actually feels a bit less muffled so far today than yesterday.

One more to go tomorrow!

 

[Michi1986]

hello people, I have received these injections 30 days ago . My tinnitus has since fluctuated greatly . On making days he is almost gone , and sometimes totally strong. My Doctor said that this is normal and a very good sign. Do you also have such strong fluctuations ? I have great fear that no longer my tinnitus ceases . My tinnitus is now 4 months old , who was the trigger my dog barked in my ear . I hope you can me a little break .

Greetings Michi

 

[AlexSongitus]

Back from my third injections. Totally painless today which was surprising, because around 10pm last night my ears were hurting and so were my teeth. It was inflated down from my ear, jaw, to my teeth, and I thought I was getting an infection. I took some Ibuprofen and I woke up fine in the morning, and didn't feel the needle at all today.

It's curious this time around I felt this pain over night, where in the first round I did not. I guess for whatever reason last time the Lidocaine lasted much longer and now it's wearing off in the evening, though my doc said he didn't even expect it to last to evening.

Once again, I had a T of about a 2 before I started, and it's still the same, so unlike the trial round, this time I did not get silence from the procedure. Make of that what you will, but the first time around I did get immediate and instant silence during all 3 injections within 30 minutes. This time it's had no effect on my T.

It's possible they are related. Perhaps last time Lidocaine penetrated enough to both silence my T immediately and keep me numbed over night. And this time, for whatever reason, that did not happen. I am also noticing immediate leaking after the injections, something else I did not notice the first time around. Leaking only happened over night in the last round.

Will see how things pan out over the next week. Will keep you guys updated.

 

[AlexSongitus]

hello people, I have received these injections 30 days ago . My tinnitus has since fluctuated greatly . On making days he is almost gone , and sometimes totally strong. My Doctor said that this is normal and a very good sign. Do you also have such strong fluctuations ? I have great fear that no longer my tinnitus ceases . My tinnitus is now 4 months old , who was the trigger my dog barked in my ear . I hope you can me a little break .

Greetings Michi

Yeah, I experienced this. However, before the trial round, mine was already fluctuating, where it would be loudest in the morning, and lower by evening. But after the injections I began getting fluctuating and fleeting T. Some days of silence, some days with low T. That has continued for the past 3 months, though the frequency of silent days has dropped compared to the first month when I got as may as 4 days of silence a week. Now it's more like 1-2 days a week. Will see if this round I just finished improves on that.

 

[Michi1986]

but in total it goes better for you ? My doctor said just must be . I do not know either. I have especially great fear that it remains forever . how are you you now?

 

[AlexSongitus]

but in total it goes better for you ? My doctor said just must be . I do not know either. I have especially great fear that it remains forever . how are you you now?

Overall it's better yes. I didn't have days of silence before the injections and even when I got T overall its lower than before. But it was best my first month after the injections. But even now, yes it's better than before the injections. I'd still rather have 1-2 days of silence a week and low T rather than permanent T. I just hope this round can give back the frequency I had during my first month after the first set of injections. I will see over time and I will keep you guys posted.

 

[Michi1986]

my doctor told me I have a very good chance that I this noise forever rid .. he says it is a very good drug .. I'm in ulm / germany in dr . Mühlmeier .