AM-101 Clinical Trial — Participants Updates and Discussion

[JohnK]

Doing round 2 John?

Absolutely. The only thing that would dissuade me is if they said I actually got the real drug in the 1st round and it just doesn't work on my T.

 

[lonestar651]

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!!!

Do you mean your tongue was numb? I did not feel anything. Did you taste anything strange in your mouth after? I did not.

 

[bellringer]

I believe it was @OddV

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

What are we suppose to do? Dwell on our condition? Most people stop coming here after a while because most move on. I try not to visit this forum too much as it only aggravates my condition. I still communicate with a few earlier trialees and we don't visit the site much anymore. You can review my previous posts pages back, but nothing has changed. I went through two rounds and the injections did not help. If anything my hearing got about 10db worse by the end of the treatment when I dropped out.

 

[Sebastians]

@bellringer
I'm sorry to hear your condition did not improve over time. In fact i read your posts (and the whole thread).
The fact that your hearing permanently decreased by 10 db (you mean in general or in some frequencies?) is something people should know before they decide to go through the procedure. What do some of the former trialees say? I was not referring to anyone in particular, but there are some who never reported back unfortunately.

 

[Joe Bananas]

Who of you who has received the open label shots has experienced numbness in tongue and no flavour when eating after the shots?
I've heard that several times and I haven't experienced that. In my opinion it is a clear indicative of having received the actual drug as esketamine is an anesthesic.

 

[Albertus]

I am waiting to shoot my left ear while the AM101 sits in my right ear , I have told the doctor about feeling numb tongue and hearing taste for more than three hours after injection yesterday , and he has clearly said that I was lucky that I have received the actual drug. It is a clear symptom of esketamine, says that local anesthesia has not been and is because the esketamina reached by the middle ear to contact the nerve to the tongue. I am very happy that at least almost 99 % chance I are dealing with the actual drug.

 

[lapidus]

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!!!

You've had T since 2014. How come you're in the trial?

 

[monacco]

You've had T since 2014. How come you're in the trial?

who knows may be it works also for cronic suffers

 

[Albertus]

You've had T since 2014. How come you're in the trial?

Ok, no more updates.

 

[lonestar651]

Can anyone else say that when the real drug was administered they tasted sourness or numbness in the mouth?
I don't really feel like anything escaped into my nasal passages.

 

[Atlantis]

You've had T since 2014. How come you're in the trial?

Ok, no more updates.

You lied your way into the trial?

 

[bellringer]

@bellringer
I'm sorry to hear your condition did not improve over time. In fact i read your posts (and the whole thread).
The fact that your hearing permanently decreased by 10 db (you mean in general or in some frequencies?) is something people should know before they decide to go through the procedure. What do some of the former trialees say? I was not referring to anyone in particular, but there are some who never reported back unfortunately.

The two I talk to don't notice an improvement or worsening either way. My loss was at the upper frequencies, the same as I had loss following a loud concert that brought me into the study. I had three tests done prior to the injections, and then several more through the course of the injections. Averaging them comes out to about 10db. My doctor wants me to get another test now, but I am not sure what it would do for me at this point. There is no bringing it back.

As for the report of numbness that someone else reported. I had numbness on half my face and my nose starting 30 minutes after injection and lasting about three hours. I was a little loopy too and attribute it to the real drug. That was the third injection during the first blind cycle.

 

[AlexSongitus]

Can anyone else say that when the real drug was administered they tasted sourness or numbness in the mouth?
I don't really feel like anything escaped into my nasal passages.

I don't know what to think of that. When speaking with my ENT who has been very much a part of the research from Phase 1, including administering injections, I was told to disregard any hearsay about such symptoms, because not even they can tell. The doctor specifically mentioned some people claim they know they got the real drug because of numbness, or this or that, but doesn't believe it's necessarily a sign one way or another. I just find it strange, dare I say unethical, that a doctor would volunteer information to a patient about getting the real drug, when they are attempting to do a double blind study. That's bad science. Or perhaps there is something to that, and my doctor was trying to do and say the right thing as far as research ethics is concerned. Make of it what you will.

Personally I'm beginning to wonder just how many people in this thread that are reporting really went in the acute stage. I don't want to judge anyone with T for trying anything at all to get rid of it it, since we all can sympathize with the desperation T can bring, but I do think chronic T sufferers that got themselves in should at least consider the idea that posting results could dissuade others in acute stages from doing the treatment that might get some benefit, so it would be nice to let people know from the get go, anonymously, if you were a chronic T case or otherwise, since the reason it may not be effective is due to the fact it was administered in the post-acute stage.

I think post-acute results and acute stage results should at least be reported separately. Likewise, it really would be helpful to know if there are more people experiencing hearing loss or other harmful side effects.

I also feel Auris Medical should also have foreseen this and still offered an incentive even to participants that may have gotten around the requirements in order to ensure an objective study. Something along the lines that even if you are removed from the study, you will be allowed to take open label injections and just disregard those particular results.

This whole thing is becoming very confusing and complicated to me.

 

[Aaron123]

I don't want to judge anyone with T for trying anything at all to get rid of it it, since we all can sympathize with the desperation T can bring, but I do think chronic T sufferers that got themselves in should at least consider the idea that posting results could dissuade others in acute stages from doing the treatment that might get some benefit, so it would be nice to let people know from the get go, anonymously, if you were a chronic T case or otherwise, since the reason it may not be effective is due to the fact it was administered in the post-acute stage.

It's potentially much worse than people just reporting here. If people with "chronic" T as measured by Auris misrepresented their situation to participate in the trial and if AM-101 does not have an effect for people with "chronic" T, then it is possible that drug will be found to be ineffective even if it has an effect on "acute" T.

 

[AlexSongitus]

It's potentially much worse than people just reporting here. If people with "chronic" T as measured by Auris misrepresented their situation to participate in the trial and if AM-101 does not have an effect for people with "chronic" T, then it is possible that drug will be found to be ineffective even if it has an effect on "acute" T.

Right. That's why I think Auris Medical should have foreseen this, and offered some sort of incentive for chronic T participants to be able to come clean and still be eligible for open label injections. But then some people would still not have the courage to say so. So the best way would be to be able to voluntarily remove yourself and still be eligible for open label injections. I don't know....it's a precarious situation.

 

[Albertus]

You lied your way into the trial?

No, I have not lied about anything , that would be dangerous for me. In September 2015 I suffered severe acoustic trauma.
I decided not to share my experience with you because it bothers me that instead of thanking the information is questioned me from when I had T.
It is to be a loudmouth.

 

[bellringer]

I don't think it makes much of a difference if a handful of people lied about their length of suffering. In the end it is all about statistics and a few won't throw it off much. There were also people who took unpermitted drugs during the trial and that would sway the results too. My study location was so sloppy in the trial management that I don't know how they could get accurate results anyway.

The one thing striking to me in Phase II was the results were not exactly overwhelming. It looks like about 25% who got the drug showed improvement over those that received the placebo. Improvement varies from profound to subtle, but benefit could be found in the placebo group too. I found that my improvement wore off after about 2 months both rounds. Others may have found the benefit disappeared after the study period so we might be looking at a negligible, if any improvement. Most people do get better with tinnitus over time without treatment. At least that is what the doctors and other sufferers who have had it long term tell me.

My tinnitis has changed a lot since I got it. I can't say the ringing is quieter or less intrusive, though my attitude is better. I consider change good, and my hope is maybe it will quiet down to something more tolerable as time passes.

 

[Nucleo]

Right. That's why I think Auris Medical should have foreseen this, and offered some sort of incentive for chronic T participants to be able to come clean and still be eligible for open label injections. But then some people would still not have the courage to say so. So the best way would be to be able to voluntarily remove yourself and still be eligible for open label injections. I don't know....it's a precarious situation.

I'm sure they have. Some sites probably require referral from a doctor. Altough I assume you can get your doctor to lie for you, then it becomes an ethical problem.

 

[lonestar651]

Second round today, Doctor just used the previous hole, no anaesthetic required I have the same feeling of fullness yet it was amazing how fast that disappeared from yesterday. I think at the end of the day if you have e a good doctor this procedure is very low risk there is really nothing to worry about. It's frustrating that I was doing so much better beforehand,
almost to the point that I thought I was not going to go ahead with this but I think the loudness setback will be temporary and everything will be back to normal in short order. At worse I took a chance and nothing will change so be it

Henry

 

[liquefact]

The one thing striking to me in Phase II was the results were not exactly overwhelming. It looks like about 25% who got the drug showed improvement over those that received the placebo.

I believe this drug is not that much effective unless it's administered very soon after onset. Yes you'll probably get some improvements (like i did) or it'll push the tone of the ringing to a higher pitch if you get it months after onset but that's about it. However if you get it very soon after onset, there's a good chance that it'll restore some lost hearing and take the ringing below the hearing threshold.

I'm still glad that i participated as a chance of a 10% decrease means worlds to me and probably to all of us.

 

[AlexSongitus]

I believe this drug is not that much effective unless it's administered very soon after onset. Yes you'll probably get some improvements (like i did) or it'll push the tone of the ringing to a higher pitch if you get it months after onset but that's about it. However if you get it very soon after onset, there's a good chance that it'll restore some lost hearing and take the ringing below the hearing threshold.

I'm still glad that i participated as a chance of a 10% decrease means worlds to me and probably to all of us.

How long after onset did you have your shots?

 

[liquefact]

How long after onset did you have your shots?

3 months after i was subjected to acoustic trauma.

 

[Venkman]

No, I have not lied about anything , that would be dangerous for me. In September 2015 I suffered severe acoustic trauma.
I decided not to share my experience with you because it bothers me that instead of thanking the information is questioned me from when I had T.
It is to be a loudmouth.

Would lying be more dangerous or less dangerous than using a time machine to start taking Trobalt in December 2014, nine months before your onset? It would be one thing if you had mild tinnitus for a while and then had a recent acoustic trauma, but I saw your first post in this thread before you got busted and changed the cause (from Ototoxic Drugs to Acoustic Trauma) and the date of onset so it's pretty clear you're straight up lying and ineligible on multiple fronts.

I honestly suspect you may be lying about being in the trial at all, given that your reported symptoms and interactions are highly irregular. But if you are truly in the trial I hope you do the right thing and withdraw from the trial now (you're convinced you had the real drug, so it should be no loss to you at this point) so your data can be properly excluded from the analysis.

 

[Charlie396]

What a tangled web we weave

 

[Albertus]

Would lying be more dangerous or less dangerous than using a time machine to start taking Trobalt in December 2014, nine months before your onset? It would be one thing if you had mild tinnitus for a while and then had a recent acoustic trauma, but I saw your first post in this thread before you got busted and changed the cause (from Ototoxic Drugs to Acoustic Trauma) and the date of onset so it's pretty clear you're straight up lying and ineligible on multiple fronts.

I honestly suspect you may be lying about being in the trial at all, given that your reported symptoms and interactions are highly irregular. But if you are truly in the trial I hope you do the right thing and withdraw from the trial now (you're convinced you had the real drug, so it should be no loss to you at this point) so your data can be properly excluded from the analysis.

Venkman you are retarded, to begin do not be a coward and gives the face, do not hide in a profile that you just created. And to continue I will say that I participated in this study entirely legally, without lying at all. Long suffered tinnitus yes, but before suffered a severe acoustic trauma this was very close to zero, so my source of tinnitus and timed perfectly meets the protocol. Here are many people who suffer severe tinnitus either chronic or not, and these people are very interested in whether AM101 works with people like me, and is awaiting my updates, and thanks to a jerk like you will not know if it works until that is not in pharmacies and implement it themselves.

 

[Venkman]

Long suffered tinnitus yes, but before suffered a severe acoustic trauma this was very close to zero, so my source of tinnitus and timed perfectly meets the protocol.

I'm having trouble with this sentence. Are you saying that you previously had tinnitus that was very mild, and then you had a qualifying event recently and that's why you're eligible?

 

[attheedgeofscience]

Venkman you are retarded, to begin do not be a coward and gives the face, do not hide in a profile that you just created.

Speaking of lying: incidentally, I noticed that you yourself changed your profile just very recently (eliminating cause and onset of tinnitus) - here is a snapshot from the Google cache (click to enlarge):

I am not sure why anyone would go about changing their profile info if they have nothing to hide.

 

[Zug]

Venkman you are retarded, to begin do not be a coward and gives the face, do not hide in a profile that you just created. And to continue I will say that I participated in this study entirely legally, without lying at all. Long suffered tinnitus yes, but before suffered a severe acoustic trauma this was very close to zero, so my source of tinnitus and timed perfectly meets the protocol. Here are many people who suffer severe tinnitus either chronic or not, and these people are very interested in whether AM101 works with people like me, and is awaiting my updates, and thanks to a jerk like you will not know if it works until that is not in pharmacies and implement it themselves.

Dude, please, please tell the whole story to the researchers. Never mind this forum, and hopefully one person's results won't skew the results that much. But it could. And you would be doing the whole Tinnitus community a huge disfavor by your actions. You got what you wanted, now tell them the whole story and move on with your life.

 

[Nucleo]

Venkman you are retarded, to begin do not be a coward and gives the face, do not hide in a profile that you just created. And to continue I will say that I participated in this study entirely legally, without lying at all. Long suffered tinnitus yes, but before suffered a severe acoustic trauma this was very close to zero, so my source of tinnitus and timed perfectly meets the protocol. Here are many people who suffer severe tinnitus either chronic or not, and these people are very interested in whether AM101 works with people like me, and is awaiting my updates, and thanks to a jerk like you will not know if it works until that is not in pharmacies and implement it themselves.

I find that hard to believe that you got in the trial legitimately. The exclusion criteria from Auris Medical is as follows:

1. Fluctuating tinnitus;
2. Intermittent tinnitus;
3. Tinnitus resulting from traumatic head or neck injury;
4. Presence of chronic tinnitus;
5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
7. Ongoing acute or chronic otitis media or otitis externa;
8. Other treatment of tinnitus for the study duration;
9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Either you got in by lying or it was some oversight from the trial site. Either way you got the injections. You do not have to justify your actions to random disgruntled internet people.

 

[lonestar651]

Done with the full round now I am starting to think I got the placebo I mean I just felt that I would notice something even if it was not regarding loudness just some kind of a change. Kind of disappointed I am going through many emotions thinking at least I tried and I wish I never went through with this. I was to a point where I did not need my pink noise machine but last night it did not help me much at all.