AM-101 Clinical Trial — Participants Updates and Discussion

There is still the possibility that your T has susided on its own but it is not a big one. Also, at the begining you had some hearing loss, now you have perfect hearing!
It seems you got the real deal, and the fact that in 1 week you will DEFENITELY get the real drug in 3 new injections makes all of us waiting for your news in great agony!
I am glad you have had really good results and if the new injections do cure you, we are talking about a drug that really cures Tinnitus! Please let us know how it goes!

PS: Did you have hearing loss and tinnitus due to acoustic trauma?

 

So I am not really hearing anything super positive. I was thinking about AM 101 trials as I have a suoer high pitched tone 18htz area according to hearing loss test and static sounds. I started taking vinpocetine which was a life savor. It is sold in europe as cavinton. It is a naturally anti inflammatory and vasodialtor. However, I will report that I just got an abnormal EKG and was told to stop taking any supplements i am on. that is bad news because im afraid off the supplement I will regain the T volume. Is there anyone out there that experienced acoustic trauma from gun shot with ear protection and has had T for less than 3 months and has found something that works? I keep hearing that AM 101 is the best solution for this, but I am told this by the doctors and research staff, never have heard that from a normal Joe on this forum. Would be nice to hear anything at all.

 

I know that one person on the thread @NewGuy did the AM-101 trials after acoustic trauma from a gunshot. I am not sure if he is active on here anymore or what his results looked like but I believe he did the AM-101 double-blind placebo trial and may have participated in the Stratum B where you receive the actual trial drug. As far as success, there have been a number of people on the forum who have experienced decreases in tinnitus loudness and additionally reading the literature on the Phase II results for AM-101 suggests success there.

 

@NewGuy did do first injections of AMPACT1 (real drug), which is the companion to TACTT2 (placebo or drug). If I remember correctly, he did experience significant reduction in volume 30 days post AMPACT1

 

@OddV Do you have any more good news ? How is your T now, far better since the 2nd round of injection than before ?
Could you say that the real drug actually did have a real effect on T loudness ?

@Laika Any news from your 2nd round ? everything is ok ? could you make us a tiny report when you will be able to ?

Thx all

 

I am still here. I am getting my third set of injections today.

 

Anyone around the Des Moines, IA area, they are looking for participants! Just a heads up.

 

@NewGuy

I'm so glad to read from you !! So what pushes you to do the third set of injections ? Is it the fact that the 2nd set of injections went well and bring you some good/positive results ?

I'm about to do the 2nd set of injections with the real drug in a week and i'm really curious about people who went through it.. because i must admit that i'm still pretty scared even if i did it once. But it would be a shame to not doing it again cause of fear especially when you know you gonna get the real drug. My mood about this 2nd set of injections is : "If i have been a guinea pig once so it would be better to left the study knowing that i got the real drug at least once"

Please correct me if i'm wrong thinking this way.

Let me/us know NewGuy

 

@NewGuy

By the way good luck for the third set of injections !!

 

As an ex Trial participant of AM-101 I await with great interest if I had placebo or not the first round. When it was no Placebo the first round than I dare to say that AM-101 will have negligble benefits for chronic sufferers.

As can be seen the most positive ratings are from people having T lets say no longer than 6 Months.

 

@Robb

So when you do the 2nd set of injections you're still under 6 Months.. so maybe you still have a chance.. it's worth the try i think !

 

here is a post I just made in a private message to an individual I wont mention without their permission. I am describing my situation and fear of doing the trial. Can someone please help with advice. I have been given very mixed advice and i only have 20 days now to get into the tril or not:

Hello I have high pitched static also from a gun shot.. It seems to be getting better but has stayed the same for about 3 weeks now. I have had tinnitus for 60 days. It was horrible at the beginning. It was from a gun shot near my ear. I am thinking about the trial but I am not sure since my tinnitus is very low.. annoying. It can be masked by running water. I hear it pretty loud when in a room with no noise though. I am afraid if i don't do something then it can migrate to my brain forever but i also am scared that if i do do something I could get the placebo or just end up back where i started at the very beginning of all the trial kinda like you described. Can you give me some advice. Im open to neuromonics and serenade also. I just figured since AM 101 was in its 3rd trial that it was almost proven by now.

 

concerning this response from Dr. Nagler... If you are hearing the ringing still in your ear after 60 days does that mean it is not established in the brain by theory?



And now the unasked question:
"If you had a crystal ball, where do you think AM-101 will fit into the grand scheme of things in tinnitus treatment?"

So I do not have a crystal ball, but as I see it, the drug may ultimately be found to have a limited role in the treatment ofrecent onset tinnitus that is not overly bothersome. However, as far as clinically-relevant bothersome chronic tinnitus goes (i.e., the tinnitus that brings most folks to support sites), it is my feeling that once the self-reinforcing vicious circles and feedback loops that make intrusive tinnitus intrusive are established centrally in the brain, then treatment with agents administered at the ear level will have little, if any, effect. Please note that my answer is based largely on theory - and I would be thrilled to be wrong.

Best to all -

Dr. Stephen Nagler

 

Maybe I missed it but could you let us know how you are doing?

 

So, not even hair regeneration would work for tinnitus?
That is hard to accept without proof, sounds illogical that the brain wouldnt adapt to the new situation as it adapted the tinnitus in the first place.

 

We are veering a little off topic but...

Hair cell regeneration will treat the hearing loss component but tinnitus will likely remain if it has settled in the brain (depending on how long the person has had it and what their aetiology is). It is also probable that regeneration won't give you the same quality of hearing back, but this is speculation until it has been achieved.

I would bank on an audio treatment, possibly something very simple, to stimulate the neurons and rewire the brain. It may come back on its own in time with natural sound stimulation from hearing the full range however; it seems feasible that this could happen.

All speculation though at the moment and a matter of opinion.

 

About Tinnitus being in the brain, it is all speculation. Nobody can prove it. Let hair cel regeneration happen first (if ever) and we talk. I thing that acute phase being several months is just a makeup fraise to be used by the companies just to justify the limiting of patients. They say so themselves, it is quite arbitrary. Acute tinnitus condition could medically be described as the time in which tinnitus can be healed by itself, meaning the hair cells remaining inflamed and then either recover or die. Which doesn't last more than a couple of days...

Now about sound quality an alleged hair restoration can provide: Well, compared to no sound at all from those dead hair cells, It shouldn't be that bad, or else they wouldn't talk about it. We don't know of course if it will be done for people with mid hearing loss. It will have to be a precise procedure... All in the distant future I guess. And keep in mind there those who claim to try to enhance the procedure with more genes than just atoh1. I guess we won't know until it happens.

Audio treatment? Like TRT or Neuromodulation? Or just listening to music at full range and (I guess) low volume?

Lets get back to topic: I keep wondering why don't we have a list of people who did take the real drug (after their placebo/real drug trials) and how their progress goes!

 

Just had my first visit for the AM-101 trial. Everyone was very nice, and I learned some news about current research. Tinnitus is believed to be caused by nerve fibers that have been detached, from trauma/other ways and that they can reattach with time, and after roughly 6 months when tinnitus is considered chronic, they can no longer reattach. Hair cells are separate from this, which is why people with no hearing loss have tinnitus. Some nerve fibers were detached, and the hair cells might be intact. I believe if I understood what was said to me, for the nerve fibers that don't reattach, AM-101 is suppose to suppress the auditory firing they cause.

This was told to me by a very knowledgable doctor who is in research where my trial is.

Also, this audiogram turned out better than my one after my acoustic trauma. He told me it was probably a threshold shift. My first one showed slight hearing loss, now i have none.

This visit has removed my doubts of the trial.

 

Are talking about synaptic connections between hair cells and neurons? https://www.tinnitustalk.com/thread...ugh-increased-nt3-production.6563/#post-71886
Although this is connected to hearing loss... maybe I 'm wrong. If not, we should boost NT3 production within 6 months! I am at 6 months and 2 weeks!

Also, acording to your info, AM-101 should work on chronic sufferers.

 

Probably, im not sure. I didn't get to talk to the doctor long so i didn't get/understand everything. He said theres a window of time for AM-101 so maybe that meant about it shifting to staying in the brain is true. Ill ask more questions next time, especially about how the brain comes into play.

 

Please can you explain to those of us who dont know, why this is the case?
And also in the UK and Europe they are currently offering am 101 to those with T up to 12 months.

Some have taken it on their 12th month and found it worked for them and others have done it four months in and it had no effect and others have had it two months in and had moderate improvement and then of course there are those who had it four months in and had no effect and then went on to have it three months later and it worked (maybe placebo first time round) so maybe they were into their 7th month when they had the real deal; Also in one of the clinics testing here in france, one of the operators there who was intimately involved in the study said it was not going to be the miracle drug that is supposed to be........

then of course we have autifony in the UK offering it up to 18 months since onset..............but this is a pill and not an injection

 

You cant stop Xanex on a day- depends how long youve been on the Benzo.

 

@Matt h
@OddV
@NewGuy
@Laika
@tomm
@EarsKid
@Brian meadows
@Chelovek
@sergerold
@earsnothappy
@Marius T
@locoyeti
@Ilija
@Jokko

Hi everybody !

So what's up ?

If you could make us an update on how you feel since the 2nd set of injections could be pretty useful...
Did Am-101 bring you some benefits ? some relief in a way ? I mean the real drug for sure so 2nd set of injections for those who have tried it.

I'm about to do the 2nd set of injections and as you probably know i'm still shitting my pants to worsen the situation, even if i did it once.. but wherever i go in my thoughts, i always find myself to that conclusion : "You did half the way, you can't stop now that you will get the real drug for sure, you must give it a try and not have been a human guinea pig for nothing.."

So a little update from people who did it could eventually help me make this step forward as i'm wondering a lot to worsen the situation.. But on the other side i feel i can't quit now and move backward.. as my T is still here. It's really strange feeling !

PLEASE HELP !!!

 

@Romain B. I'm glad I did the 2nd set and I'm about 70% sure I'll do the 3rd set.

It's helped me... Cured, no... Habituated and a lot quieter, yes.

Whole reason I did it to begin with was to get the guaranteed drug after the 1st set.

 

@OddV

Just a big THX !!

 

Some of the people who did take the drug (injections) first time around said it made them worse and then they went on to have the second set of injections and we didnt hear from them again. Those people I refer to are no longer active on this forum.
According to the AM 101 data, it holds apparently a 10% chance of causing loss of hearing.....
It has never cured anyone although some report that it is better as above and some worse as above

 

@amandine

I did.. is the reason why i asked cause i'm wondering what to do.. I know already what says the AM 101 data. My inquiries is much more about : after i've done the exp once and so have taken all the risks that you mention .. what you would do about the 2nd set of injections ? Quit in the middle of the path and never have a clue that you did have really the real drug once and for all ? Is that all about i was asking... When you come close to the 2nd set of injections, what to do... Do it to know that you will have for sure at least once the real drug or fad away and never know what you got and maybe loose a chance to get a bit better.... When you have already done half the way.....

 

I did benefit, just finished my 3rd set of injections today. Most of the time after my second set i could not hear my T unless I am in a quiet place. My question is why would you not get the real drug for sure if you took the chance of getting the placebo in the first place? The only reason I did the study is because you are guaranteed to the real drug after.

 

It is not my reasoning, it is what grandfunk1 has been told by the doctors at Am-101 trial: https://www.tinnitustalk.com/threads/am-101-participants-updates-and-q-a.6558/page-13#post-102022

My own reasoning is that Tinnitus may be a complicated thing and the 6 months 12 months 18 months intervals that are given are just alleged significant periods by the trials that suits their needs.
Why 6, 12, 18 months and not 2 and a half, 7, 11 etc? Nice round numbers, like it is calculated! I dont buy it.

 

I have not heard any bad long term side effects of this that I am not willing to face. The way I look at it is I would rather live knowing I tried than live regretting that I didn't do anything when I had the chance. I hope this helps you in your decision. Good luck either way you go