AM-101 Clinical Trial — Participants Updates and Discussion

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 can see how someone could feel bad and desperate to go into this trial even not being under the 6 months mark Auris Medical has estimated to choose subjects. My only concern is about how this could have an impact in the final numbers needed for AM101 to hit the market. If the drug doesn't show certain eficacy during this trial it wont be aproved. That would be a really major drag for future T newbies...
I know I can sound rough and I feel really sorry about that but, since AM101 is suposed to hit the market by the end of 2016 beginning of 2017... it might be wiser to give it a try once it is made public. Hell! just for the sake of future T newbies...
 
I can see how someone could feel bad and desperate to go into this trial even not being under the 6 months mark Auris Medical has estimated to choose subjects. My only concern is about how this could have an impact in the final numbers needed for AM101 to hit the market. If the drug doesn't show certain eficacy during this trial it wont be aproved. That would be a really major drag for future T newbies...
I know I can sound rough and I feel really sorry about that but, since AM101 is suposed to hit the market by the end of 2016 beginning of 2017... it might be wiser to give it a try once it is made public. Hell! just for the sake of future T newbies...


My question would be how are they certain that it only effects early T onset?How could you be that sure?.
Judging the outcome and reporting from people it's been very inconsistent with that predetermined notion.
 
My question would be how are they certain that it only effects early T onset?How could you be that sure?.
Judging the outcome and reporting from people it's been very inconsistent with that predetermined notion.
Believe me I am not anywhere near of being sure about any T related thing. From what I understand they decided to bite that 6 months mark just in order to make things more measurable in terms of cuantification of improvements. It is very difficult to determinate when T gets chronic in each individual. Even having been under the first round of shots and being looking forward for the open label one, there are LOTS of things about AM101 I don't fully understand. I don't know if there have been someone in the pre 6 months mark who has experienced full or a considerable recovery. Neither a post 6 months mark subject who has seen improvement having been under the drug trial...
 
Hey guys. I'm supposed to be going in for screening next week. Does anyone have any advice? Anything I should be aware of beforehand? Is there anything that you can do or answer wrong that can exclude you at screening?
 
Hi everyone,

I am a 28 year old male living in Canada. I had tinnitus for a few months last year which went away then suffered a sudden onset after a gun shot. I am scheduled to get the AM 101 shots tomorrow. I am starting to feel a little freaked out especially since over the last 2 months my T has become so much better but still pretty annoying at night. I guess I would feel much better if I knew 100% for sure I was getting the real thing. It is just a lot to go through missing work etc only to have a 60% chance of the real drug.
 
300 bucks is grand. I get 30 euro's for each visit to the facility. Admittedly, it's under an hour's drive though. Win some, lose some i guess.
 
There's one here who got significant relief after 2nd open label round, around 8th month. Just don't remember the name.
Thanks again @liquefact for your fast response. Three weeks today from first shot and even considering my T has fluctuated from the quietest point ever to a really loud spike three days ago, I think it is more natural T development related than having received the AM101 which I think it wasn't administered to me but the placebo.
I installed a really accurate aplication in my phone to measure decibels. Yesterday I was in a bar I use to go and decibels there were 70 on average. I still was able to hear my T crystal clear there. I am shocked about the fact my T is not maskable even in a 70dbs environment... I hope open label round set things a tad quieter but I will receive it in my 7 months mark. Having a hard time here.
 
I believe it was @OddV
That was me and I'm still here


What bugs me is that a lot of people left this forum after taking the shots, never to be heard from again.
 
Hello everyone,

Tomorrow I will get my first injection. 2 days after that my second and a day later my last one.

At the moment I give loudness a number of 7/8 on a scale from 0-10. I got it from a concert, even with ear protection (not custom made, just bought some plastic ones from the pharmacy).

I will keep you guys updated on the loudness of my tinnitus. Hopefully nothing goes wrong :banghead:, taking the shot or I
otherwise will surely regret it later on.

Sorry for my bad English :wacky:.

See you next time!
 
Hi @OddV
You have documented your journey in great detail. Thank you for that.
There are plenty of other folk who have undergone the procedure never to be heard from again though. I was referring to them.
 
Just wanting to give anyone that's on the fence a heads up. I just found at least one study center in the US will be ending the trial in 3 weeks(no more new patients), per sponsor request, aka Auris Medical. If you are still on the fence now's the time. Barely got in. Will be going for my screening this week.

I hope their results are positive.
 
@liquefact , and you is it better now ?
Yes i'm better, definitely. Even though because of the nature of the double blinded study there's no certain way to say that this is due to the injections or natural healing (The reasons or mechanisms of this healing is unknown but i have a theory.) that may happen after onset, i believe it's because of esketamine as there was a sharp decline in the loudness and sudden change in the characteristics of my T ~3 weeks after last injection.
 
3 weeks after last injection.

I am right at my third week after first shot mark. I noticed the fluctuation goes from a quieter than before shots point to a loud spike I experimented last Friday. I want to think things are improving here due to AM but maybe I am already too nuts to discern things...
What's that theory you have about natural healing?
 
What's that theory you have about natural healing?
This is just a theory but i believe it's mostly true even though it seems little bit mystique.

It's all about your brain loosing trust to you. After the incident (if the t is caused by a trauma), brain reacts to this damage in your cochlea and a series of things happen;
1. Lack of signal or alien(corrupt) signal starts coming from cochlea
2. Immediate lowering of hearing thresholds which causes T and H at the same time. The reason is brain gets less information that's needed to be able to understand the whole signal but it's either missing or corrupt. In either case brain tries to make up for this loss and tries to recover it by post-processing and this definitely includes lowering of the hearing threshold which's probably the same as amplification of the signal.
3. This post processing was not there before the trauma. Some neurons start working hard to be able to recover this lost info as part of post processing. If the signal in a wider range is amplified (the broader band of the threshold is lowered) this causes H/T. If not, just T.
4. BTW, lowering of threshold is another protection mechanism of brain that keeps you away from loudness and noises. While you have T/H you do not expose yourself to noises deliberately. In the beginning brain is in panic mode and gets the control from your consciousness and tries to protect you from anything and lowers the threshold all the way across a very wide frequency band. Over time this band becomes narrower which means the transition from T/H to T.
5. This lowering of the threshold is also another manifestation of hyperactivity of neurons and when you cool down these with some potassium channel blockers like RTG, the symptoms are diminished. But the control mechanism that decides to lower the threshold is still there.
6. This controller is the culprit actually and it's the trust issue that i mentioned. It'll start trusting you again if you can show that;
* You're in control of your body and protect yourself from any shit
* You'll protect your ears and avoid loudness

Once that happens, brain shall start restoring the original threshold as much as it can (there's some hearing loss in place so it'll never go back to original) and give back the control to you. As the threshold slowly rises, the T shall be quieter in time. It may be very slow or even may not happen at all depending on the amount of damage in cochlea. In my case i believe i (my conscious) convinced my brain to take good care of my body and the threshold is rising. My H is almost gone and T is quieter. I think this improvement is partly because of esketamine but anyway this is the natural healing i'm talking about.

This threshold is actually a linear function (map) of sensed db to perceived db but it's not a flat line. Brain uses it to amplify certain frequency ranges in 0KHz-maxKHz (max is 20Khz for young people) when needed. When a hearing loss occurs in some frequency, in the beginning a wide range of the threshold around the frequency that's lost is lowered (H and T). Over time this range becomes narrower, H mostly goes away.

As the last thing, i really do not care more than that about the inner workings of ear or how hearing loss/T/H occurs. Do not take the above explanation seriously, make your own study if you need. I won't fight against counter arguments about how this is wrong.
 
Hi everyone, just received my first shot. The numbing agent hurt but the needle was not too bad. Ear feels full definitely feels like a needle was in there and the ringing is quitena bit worse. I guess that is because my ear is blocked. Hope I am getting the real thing.
 
Today I received my first shot too, just like you, T is higher but the feeling of fullness has decreased , tomorrow I get the second shot ... also I slept tongue a few hours and could barely taste the food , I hope it is effect of esketamine!!!
 

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