AM-101 Clinical Trial — Participants Updates and Discussion

Just an update ~2 mo. post open label (1st round): staff says I've shown an improvement in my hearing sensitivity. I'd wager this is due to the fact that my T is quieter, so picking up on quieter sounds is done more easily. Previously, I couldn't hear the sounds past a certain threshold, as my T was probably at least 2x-3x as loud as the quietest sound.

Going to do round 2, because why not.
 
I am very angry with AURAL team.
I am 26 and i suffer from T due an acoustic truama since 17 february. So i am perfect for trial and they could SAVE my life. But this is the answer:

Dear,


Many thanks for your interest in our study.

Unfortunately, we do not have a trial open in Italy.

Participation in a country outside your home country is also not possible due to legal aspects as the trial only enrolls residents and native speakers.


We can only wish that your tinnitus will become more manageable and that you will find relief through other means.


Sincerely,

The Study Team


so i send other two mails:

First:
Thank you...
I'm so sad. I would do everything to try. But so all remains for me is to hope that you will find a cure for... chronic tinnitus.
Now i am in acute phase but probably there is nothing to be done before a few years. Tinnitus is a nightmare that ruined my life.
best wishes

two:
Dear aural team... it is impossible? Really impossible? I take my responsibility. You can save my life!. I have tinnitus by acoustic trauma since two months now. And I would die for this noise in my head...

No answer. No hope.
They are cruel. I can pay. I would take a chance but nothing...
 
I said I was going to wait for three/four weeks before giving you guys and gals an update about my open label round. Well thing is I am on my second day with a quieter-than-ever T. Before shots my T was unmaskable, reactive and an almost constant 7 in a scale of 10. Now I can listen to music having it masked. Most of street noises also do mask it. I forget about it for long periods and I give it a 2 in a scale of 10. Two days now. I really hope it settles in here or it even goes quieter. I know it is most likely to go louder again but I wanted to share this with you people participating, going to participate or who have already participated in the trial. Will keep informing you.
 
I said I was going to wait for three/four weeks before giving you guys and gals an update about my open label round. Well thing is I am on my second day with a quieter-than-ever T. Before shots my T was unmaskable, reactive and an almost constant 7 in a scale of 10. Now I can listen to music having it masked. Most of street noises also do mask it. I forget about it for long periods and I give it a 2 in a scale of 10. Two days now. I really hope it settles in here or it even goes quieter. I know it is most likely to go louder again but I wanted to share this with you people participating, going to participate or who have already participated in the trial. Will keep informing you.

Thanks for the update! You're giving me hope. I too think I got the placebo the first round. Your before T sounds about the same as mine too. Fingers crossed for the both of us.
 
I am very angry with AURAL team.
I am 26 and i suffer from T due an acoustic truama since 17 february. So i am perfect for trial and they could SAVE my life. But this is the answer:

Dear,


Many thanks for your interest in our study.

Unfortunately, we do not have a trial open in Italy.

Participation in a country outside your home country is also not possible due to legal aspects as the trial only enrolls residents and native speakers.


We can only wish that your tinnitus will become more manageable and that you will find relief through other means.


Sincerely,

The Study Team


so i send other two mails:

First:
Thank you...
I'm so sad. I would do everything to try. But so all remains for me is to hope that you will find a cure for... chronic tinnitus.
Now i am in acute phase but probably there is nothing to be done before a few years. Tinnitus is a nightmare that ruined my life.
best wishes

two:
Dear aural team... it is impossible? Really impossible? I take my responsibility. You can save my life!. I have tinnitus by acoustic trauma since two months now. And I would die for this noise in my head...

No answer. No hope.
They are cruel. I can pay. I would take a chance but nothing...

Unfortunately their hands are tied in a situation like this. There are strict regulations for clinical trials and they have a lot of money invested in this.
 
I am very angry with AURAL team.
I am 26 and i suffer from T due an acoustic truama since 17 february. So i am perfect for trial and they could SAVE my life. But this is the answer:

Dear,


Many thanks for your interest in our study.

Unfortunately, we do not have a trial open in Italy.

Participation in a country outside your home country is also not possible due to legal aspects as the trial only enrolls residents and native speakers.


We can only wish that your tinnitus will become more manageable and that you will find relief through other means.


Sincerely,

The Study Team


so i send other two mails:

First:
Thank you...
I'm so sad. I would do everything to try. But so all remains for me is to hope that you will find a cure for... chronic tinnitus.
Now i am in acute phase but probably there is nothing to be done before a few years. Tinnitus is a nightmare that ruined my life.
best wishes

two:
Dear aural team... it is impossible? Really impossible? I take my responsibility. You can save my life!. I have tinnitus by acoustic trauma since two months now. And I would die for this noise in my head...

No answer. No hope.
They are cruel. I can pay. I would take a chance but nothing...

Bro try to keep your mind sane and positive. Do not get dragged down in depressive thinking! I know how u feel having T that devestates your life. Also it sucks very much that Italy has no study center for u to participate in the study :(. I felt exactly the same as u 7 months ago when I first got my Tinnitus. I was desperate to join the AM-101 trial and I would have done pretty much everything to get cured. But keep in mind the fact that many companies study tinnitus brings us sufferers all closer to a cure.

I have been lucky and blessed to be able to participate in the AM-101 study here in Belgium, and ofcourse I hope for a positive outcome. But regardless of the result this is my first month that I made my way out of my depression. Eventough due to the injections my T spikes really loud. I feel positive about the outcome and the future.

Maybe u can read the Tinnitus Retaining Therapy book in the meanwhile? Because I've noticed that u have to be able to not react emotional and stressed on the annoying T for your mind to get eased and destress. I know this might not be what u want to hear on the fact that u got denied on the am 101 trial but maybe it can help u in the meanwhile.
 
@Kyxwz
I also suffer from acute acoustic trauma.
Did two rounds of am 101 *at least the second round was the real drug* and it did not to anything for me. So dont feel sad. There are some story of people getting better but al least in this forum the majority from what i have gather and heard did not have any improvements appart from those expected from habituation like my case.
 
Bro try to keep your mind sane and positive. Do not get dragged down in depressive thinking! I know how u feel having T that devestates your life. Also it sucks very much that Italy has no study center for u to participate in the study :(. I felt exactly the same as u 7 months ago when I first got my Tinnitus. I was desperate to join the AM-101 trial and I would have done pretty much everything to get cured. But keep in mind the fact that many companies study tinnitus brings us sufferers all closer to a cure.

I have been lucky and blessed to be able to participate in the AM-101 study here in Belgium, and ofcourse I hope for a positive outcome. But regardless of the result this is my first month that I made my way out of my depression. Eventough due to the injections my T spikes really loud. I feel positive about the outcome and the future.

Maybe u can read the Tinnitus Retaining Therapy book in the meanwhile? Because I've noticed that u have to be able to not react emotional and stressed on the annoying T for your mind to get eased and destress. I know this might not be what u want to hear on the fact that u got denied on the am 101 trial but maybe it can help u in the meanwhile.
Since February 17 I suffer from tinnitus, after a concert (acoustic trauma). A hissing sound (now seems a sizzling sound).

For a month, I went into a depression. Think about suicide was the only thing that gave me relief but during this period I read plus 53 studies completely and some others partially (174 in total), I talked to many people and read more than 300 posts (on Facebook and on forums, for example tinnitus talk) and pathogenesis of many stories, but there is a lot confusion and lack of clarity. I wrote to Susan Shore, to dr. Rauschecker, to dr. Tzounopoulos, to Bettina Stubinski (aural team, of AM101) and the Mulders researcher. So I tried to get an idea about the genesis of tinnitus putting together the data. What I understood is that there could be different causes, but the effect is the same for everyone: an ''alarm signal'' that remains active. But why do many people have different signs and sounds at different intensities (I read pretty much everything from those who have a whistle, to those who train, who buzzing, rustling/hiss like me, or whatever)? May it be similar to when the clutch of a car is triggered and doesn't stop? Shouldn't we all hear the same sound? I know it is a difficult problem and I'm certainly not a scientist.
No doctor can tell me why this happens. If it is caused by a coclear damage with a certain signal depending on the lost frequency, for a nerve damage, brain damage or ... but I say: why?
I study philosophy. Philosophy can't help me in this difficult moment but, thanks to philosophy, I go on asking myself some questions (without answer), it seems legit, doesn't it? Why does this happen?
Personally, I have a hearing loss of 35db at 8000Hz due to an acoustic trauma and I struggle to hear even the 7000 until 12000Hz. Tinnitus really bothers me, it's a constant hiss followed by hisses and boos of about 20db or more. If I move my neck to the right or to the left, the sound becomes more high and it happens the same if I clench their teeth.
I tried corticosteroids (after acoustic trauma), hyperbaric room for 8 days (!!), Citicoline, tricortin, acetylcarnitine, Bromazepam, Clonazepam, duloxetine (ssri), nimodipine with ginko biloba supplements or vitamins, neyron 750, delecit 600, nootropil 1200, campral (acamprosate) 333mg but for nothing worked. So. I mask the tinnitus if necessary but it is not what I want. Know (after only two months) i am the admin of official T italian group on Fb so i know a lot of doc. and other figures. Now i am just a commercial that working in the field of wheelchairs and electromedical. I hope that in future i could work in this area.
 
@Kyxwz
I also suffer from acute acoustic trauma.
Did two rounds of am 101 *at least the second round was the real drug* and it did not to anything for me. So dont feel sad. There are some story of people getting better but al least in this forum the majority from what i have gather and heard did not have any improvements appart from those expected from habituation like my case.
But am 101 it is for acute trauma. How long have you T and when did you do the trial?
 
But am 101 it is for acute trauma. How long have you T and when did you do the trial?
two months after acoustic trauma first round Placebo or Drug
five months into acoustic trauma second set of injections real drug
so you see i was as acute as they can be
 
Can someone tell me if this would do any good for patients that have had tinnitus for over a year? Because from that I read in their website It does not appear to be the case...
they are conducting post acute studies along side the acute trial, so we would have to wait for the results.
 
Well after being 99% sure I got the placebo back in February I start my 2nd round open label injections on Monday. I'll keep you guys updated.


Only thing I'm still curious about is everyone's ENT seems to have had the no swallowing after the injection rule. Mine didn't. I already didn't have much confidence my ENT gave much a of a damn about AM 101 participants, he seemed to just want to rush me in and rush me out. I'm gonna bring this up to him.
 
two months after acoustic trauma first round Placebo or Drug
five months into acoustic trauma second set of injections real drug
so you see i was as acute as they can be

I think it's really fuzzy what we consider acute, sub acute, and chronic. The acute phase could last 3 months or 6 months, or be just a couple weeks. Nobody really knows. And it could be different for everyone.
 
Hi folks,

Noticed that i was away from TT long time. So let me give an update on my AM101 experience do far.

It's been 1.5 months since the first open label round. In the last control visit 1 month ago, the audiologist noticed there's a sight drop (~5db) in my hearing in both ears. But this is well within the error margin of the test itself, so nothing to worry about. No other problems were detected.

The post-injections period for the open label round was much smoother compared to the first round. The pain, clogged feeling, increased T/H was over in ~10 days. Now after 1.5 months what i can say is there's probably a slight improvement in the loudness scale which i cannot easily attribute to esketamine with certainity. I stopped gauging my T long ago and mostly do not notice the T during the days unless i'm having a spike. It's the nights i'm annoyed still, but it's causing far less frustration i had in the beginning. As i'm not measuring my T, i neither do not know nor care whether the T is quieter or not. I believe this new behavior (or lack of concern) is a manifestation of habituation rather than a measurable drop in my T. Maybe a slight decrease helped me to develop this ignorance against T but again i do not precisely remember how loud it was 3 months ago.

Along with this change, the H retracted to a point where it's no longer impacting my life as well. I can listen to music during my commute mornings and evenings and not suffer a spike afterwards.

Coming back to AM101, in the worst case, this experiment did no permanent harm to me. At best it reduced the ringing a little bit and helped me habituate. Regardless, i'm glad to have participated. At this point i'm not sure i'll continue or not. I started thinking about getting the next injections (open label round 2) and bailing out after the first control visit to make some time for RTG maybe??. I still have some time to decide.

In general, 7 months after my onset, i still can very well hear the T whenever i listen to it. Nevertheless i'm 90% back to my previous life, the remaining 10% being the fights to sleep at night. I believe i'll be better in that regard as well. I've never used any medication aside from the supplements i used for a brief amount of time. No anti-depressants, no anti-anxiety drugs, no sleeping aids, no masking. The idea here is, i won't lean towards any solution that gives temporary relief, making you feel better temporarily but causing you go south afterwards. Instead i'm trying to rely on the plastic capacity of brain to learn to ignore it. I believe it's working, the more i deliberately do not give a damn, the more my brain calms down and ignore it. On top of that if i get somehow another 1-2 level drop on T loudness in some way, i'll not seek any more relief anymore until some potent drugs come out.

Good luck to us all in this endeavor.
 
Well after being 99% sure I got the placebo back in February I start my 2nd round open label injections on Monday. I'll keep you guys updated.


Only thing I'm still curious about is everyone's ENT seems to have had the no swallowing after the injection rule. Mine didn't. I already didn't have much confidence my ENT gave much a of a damn about AM 101 participants, he seemed to just want to rush me in and rush me out. I'm gonna bring this up to him.

Did you go to the trial in Havertown PA? I heard this from someone else that the office was rude.
 
Did you go to the trial in Havertown PA? I heard this from someone else that the office was rude.

No I'm over in Southern California, what bothered me was how aloof their attitude was toward us participants. At no point did he say 'in case you feel something bad is happening contact us or whoever'. Just, came in, got injected and see ya later.

Now after hearing everyone else was told not to swallow after injection I'm worried he just flat out didn't care to remind me of that little detail.
 
I would contact the company doing the testing and let them know that detail about the testing site. My friend did that with the site in PA and they got back to her. They were more responsive to her after that...
 
After a few weeks of absence, I am back with the final update for round I.

Overview of past updates:
24 hours after last injection
1 week after last injection
1 month after last injection
6 weeks after the update (unplanned)
3 months after last injection

I can keep my summary quite short: There has not been much of a change since my last update.

After the initial improvements, things went back baseline, before improving again, getting worse again, and so on. Bottom line, there seems to be a pattern with approx. 1...2 good weeks followed by 1...2 bad weeks.

I do not believe that this has anything to do with the AM-101 trial. Of course, it is difficult to say with certainty, as I cannot really compare. My feeling is that there is a 50% chance that I received the placebo and the relief that I felt initially was not due to the injections. The other option is that I did in fact receive the real stuff, but that the effect did not last very long.

Furthermore, I still insist that external factors (which I cannot specify) play a key role in my case. I spent the last week at a hotel due to business travel, and when in the room, T was 3x or 4x as strong as at home. Thus it is even more challenging to monitor the development over time.

Tomorrow, I will start with round II. I will keep track on the procedure similarly to my previous posts.
 
Coming back to AM101, in the worst case, this experiment did no permanent harm to me. At best it reduced the ringing a little bit and helped me habituate. Regardless, i'm glad to have participated. At this point i'm not sure i'll continue or not. I started thinking about getting the next injections (open label round 2) and bailing out after the first control visit to make some time for RTG maybe??. I still have some time to decide.

In general, 7 months after my onset, i still can very well hear the T whenever i listen to it. Nevertheless i'm 90% back to my previous life, the remaining 10% being the fights to sleep at night. I believe i'll be better in that regard as well. I've never used any medication aside from the supplements i used for a brief amount of time. No anti-depressants, no anti-anxiety drugs, no sleeping aids, no masking. The idea here is, i won't lean towards any solution that gives temporary relief, making you feel better temporarily but causing you go south afterwards. Instead i'm trying to rely on the plastic capacity of brain to learn to ignore it. I believe it's working, the more i deliberately do not give a damn, the more my brain calms down and ignore it. On top of that if i get somehow another 1-2 level drop on T loudness in some way, i'll not seek any more relief anymore until some potent drugs come out.

Good luck to us all in this endeavor.

Do you remember your tinnitus loudness matching level at the beginning and at the end? Was there any change in that?

What about your loudness / annoyance levels?
 
I said I was going to wait for three/four weeks before giving you guys and gals an update about my open label round. Well thing is I am on my second day with a quieter-than-ever T. Before shots my T was unmaskable, reactive and an almost constant 7 in a scale of 10. Now I can listen to music having it masked. Most of street noises also do mask it. I forget about it for long periods and I give it a 2 in a scale of 10. Two days now. I really hope it settles in here or it even goes quieter. I know it is most likely to go louder again but I wanted to share this with you people participating, going to participate or who have already participated in the trial. Will keep informing you.

That's really great news Joe. From a 7 to a 2 is huge man. That's awesome, if not the biggest improvement anyone's ever reported. Crossing my fingers it settles somewhere around this range for you.
 
1 week update
2 weeks update
1 month update

2 months update

Trial:
AM-101 initial trial

Date of initial T Onset:
1/21/2016

Cause:
Noise induced. Ear buds. Prolonged session of producing music in FL studio.

Base T the day/week before injections:
Left ear:
3/10
Right ear: 1/10

Tinnitus description before injections:
Hissing in both ears, slightly different frequencies. Loudest in the mornings.

Date of injections:
3/2/2016-3/4/2016, 1.5 months since onset

Have you felt any change/improvement/worsening since the injections?
Yes. Yes. No.

Since my last report on April 1st, I stopped tracking it 4 times a day, thinking it would help even more not to think about it so much. Ironically, beginning the very next day, April 2nd, I had a setback that lasted probably over a week where the freaking thing was on all the time after a week where I considered myself pretty much cured. After that crappy week I started getting silent days again, and has basically been a similar, random pattern, of low T days and silence days mixed in with the occasional day where it will rise up to a 2 or a 3. Basically the same as the first 3 weeks after the injections. Sleep still plays the biggest role, whether that means turning it on, or off. Week 4 was definitely my best week. Heck I was practically cured. But I have had a nice stretch of silence the past 3 days up until today.

So fluctuating T anywhere between complete silence and a 2 is basically where I am these days, and every once in awhile it will hit my baseline for hours or a day here and there and usually just in my left ear. Still a significant improvement compared to before the injection.

Current T severity and average T severity over the past week:

Current:
This morning I woke up in silence, stayed that way until I took a short 1 hour nap. That's all it took for it to come back on to probably a 2-3 in my left ear.

I actually got a bit overconfident yesterday and this morning, and started listening to music again, and didn't pay too much attention to the volume since it was on my phone and didn't think it could do any damage. It was amazing to be able to have total silence and listen to music again, and not hear that annoying hiss overlapping every song. Now T is back and I'm not sure if it's only from me taking that nap, because it did feel like it was reacting and getting louder while I was listening to music so I stopped. Maybe I'm just being paranoid and it's just a coincidence. Last night I didn't have any problems listening to music and went to bed in silence and woke up in silence.

I've also had some mysterious back pain that I am trying to figure out where it's from and my doctor prescribed me Ibuprofen 800 mg, which is making me really paranoid since I know that is ototoxic. I try to limit taking it as much as possible.


Average over the past week: 1.5

Do you believe that you got the real drug or the placebo?
Yes. Though it is weird that it took a turn for the worse weeks 3 and 5. I'm still thinking maybe there is a chance it was the Lidocaine during the injections days triggered a permanent, long lasting change. Just because it's weird how it is working with setbacks and fluctuations.

Have you experienced any lasting (side) effects from the procedure?
No. Nothing.


Will you participate in the next round?
Yes.
 
@Charlie396 looks like we are in exact the same place. 24h post 1st injections, 2h post 2nd injections. Needles were mosty painless, but now I feel pain and a sore feeling in both of my ears, combined with a terrible headache.
Last set in 22h (and really not looking forward to it...)
 
The pain from the suction they use to remove the numbing agent might even have been more painful then the needle itself! Didn't some people here get tinnitus from getting earwax suctioned out??? This scares me if I have to get this before every injection! I would hate the suction to somehow have an effect on it worsening!
I have been wondering about the same. Managed to convinced the doctor to not use the device for my set of injections yesterday, but simply dry it with a tissue instead. Thought I got away with it for this round, but during the 2nd set today, they somehow hurt my eardrum, which then filled with blood. For cleaning it up, they used the suction device with a felt volume of approx. 130...140dB, so extremely loud. Because of that, I have had a signifant spike in my right ear for the past 3h and am praying that it will go back to normal soon.

:bag:
 
I have been wondering about the same. Managed to convinced the doctor to not use the device for my set of injections yesterday, but simply dry it with a tissue instead. Thought I got away with it for this round, but during the 2nd set today, they somehow hurt my eardrum, which then filled with blood. For cleaning it up, they used the suction device with a felt volume of approx. 130...140dB, so extremely loud. Because of that, I have had a signifant spike in my right ear for the past 3h and am praying that it will go back to normal soon.

:bag:

Really amazing how we all respond so differently to the procedure. I actually liked the suctioning. It was like someone scratching an itch I had for a long time and by the time he finished suctioning it out, I had complete silence.

If they used Lidocaine, I really don't get why no one else is responding positively to Lidocaine. Lidocaine is known to quiet T or even silence it and had that effect within the 15-30 minutes on me. And it wasn't a fluke either, because it happened 3 days in a row before each injection

That's concerning about the blood. I had that the night after my 2nd injection in my left ear and they had to clean it out before my 3rd injection, but not during the procedure. Yours happened right after the injection?
 

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