AM-101 Clinical Trial — Participants Updates and Discussion

#1,411
Zug said:
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.
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Nucleo said:
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.
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I agree. Generally I feel that this has gone a bit off-topic. A support forum should not be the place for finger-poining

However, I have to admit that it does suprise me how many people (and this is not directed at anyone specifically, there have many people stating their intentions to "sneak" their way into the trial througout this thread) do not seem to realize that they endanger what could become the first and only effective treatment for actute T sufferes.

Consider the following:
Assuming that AM-101 does work if administered within 6 months after onset and that the quantifyable benefits is only measurable in that period, anyone participating with chronic T would claim the treatment to be ineffective. Phase III is a legalisation trial i.e. if the treatment does not prove to be effective in a given number of cases, authorities will not approve the final Go Live and AM-101 will never make it beyond the trial phase. It is not an unlikely scenario that a the market introduction of AM-101 might eventually fail because people who were not eligible forced their way into the trial.

In the worst case, this would mean that for another few year or maybe even decades, there will be not treatment for T sufferers.

I do understand that many people with chronic T grasp after every little straw. It is the classic situation with 100 people floating in open waters and a small rescue boat fitting 10 people only. Nobody will volunteer to drown, but if everyone tries to enter the boat....

The only way of limiting the damage after signing up would be to drop out of the trial in purpose after the injections (e.g. "forgetting" the diary, or use forbidden medicine such as vapour rub). This would affect the sponsor financially, but at least it would not affect the outcome of phase III.
 
#1,412
Zug said:
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.
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Sorry but in my opinion you are being quite rude with the guy. I agree with the fact that someone who makes his way to the trial even being in the exclusion criteria group would potentially harm the research results but in other way could be really interesting to see how a chronic sufferer reacts to AM101.
Beside that you have to, please, take in account how desperating and miserable this condition is. I can fully understand if a chronic member makes its way into the trial.

By the way; I have the impression of having read lots of cases from people either being far from the 6 months mark or whose T causes are not the acoustic trauma/barotrauma/otitis media which Auris Medical determined for the AM101 to be effective... So, let's figure how contaminated the results already are...
 
#1,413
Joe Bananas said:
Sorry but in my opinion you are being quite rude with the guy. I agree with the fact that someone who makes his way to the trial even being in the exclusion criteria group would potentially harm the research results but in other way could be really interesting to see how a chronic sufferer reacts to AM101.
Beside that you have to, please, take in account how desperating and miserable this condition is. I can fully understand if a chronic member makes its way into the trial.
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We all got T here. He's suffering, you are suffering, I'm suffering. It's not about the suffering. Let's imagine for a moment that those people with PHD's and real research experience had their motives for focusing on acute T. Say that you're desperate and think that your situations justifies some moral bending, so you distort your story a little to get access to the product. Ok, you did it.

Now, you have two options: Keep the charade with the full knowledge that you are distorting the results by simply being there, and in doing so you can mislead researchers into bad results. Or you can just tell what you did, say you were confused to save face, I don't care. You already got what you wanted, so let the researchers get the best result they can.

If you are really selfish, you can say "fuck the world" and keep the charade, you already had your turn right? Who cares if you hinder medicine development for more people in need? It wouldn't be "interesting" to know about chronic as you said, because nobody knows you're a chronic sufferer, and if you know how research is done there is a tiny chance that your small lie will bring some problems to the actual results.

My point is, just do the right thing now, and that's it.
 
#1,414
I understand why people might be angry about people lying their way into the trail but I must say the chances of that would be really low, especially in a country with great health care. I assume almost 100% of individuals who suffered from Tinnitus went to the doctor numerous times so with the gathering of pre screening information many people would be disqualified based on medical records if they decided to try and be dishonest. At least in Canada health care records are universal.
 
#1,415
Zug said:
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.
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Interestingly enough I found out my location only consisted of about 6 participants during Phase 3 and that it was very difficult for them to find people to complete the entire study. So at least at this study center it seems 1 person's results makes a huge difference.

I also wanted to add to anyone else that might still be able to get in, that as far as the fluctuation criteria, I was ok to participate if my T got lower in volume over time since onset, just not higher. I listed my tracking exactly as I have described it on this forum, including the fact that it gradually lowers throughout the day, and resets with sleep, and apparently, that was ok.
 
#1,416
I thought I would weigh in on my results and experience so far. I received my first round of shots last week. It has been 6 days since the last shot. I have Tinnitus in both ears that I acquired in late November '15 so I was pushing up against the 3 month mark.

First I will say that I was apprehensive about undergoing the procedure after reading through a great percentage of the posts on this forum and hearing about the negative experiences that many seem to be having. I am only the 2nd patient to go through at the testing site I was at so they really could not answer many of my questions in regards to their personal experiences / results.

The day before I was scheduled to go in for my first shot, I call another site. This one in Philadelphia. The lady I spoke with was able to give me some generalized information in regards to the results they were seeing. According to the individual I spoke with they have had 8 test cases so far. One did not complete the trial. 2 had their Tinnitus drop so low that they had to really focus to hear it. 2 said that they were better able to manage their Tinnitus after the trial and 3 claimed no difference before of after treatment. To me this kind of looked like the odds you would expect if 1/3 received the real thing at full dose, 1/3 received a weaker dosage and 1/3 received the placebo. I know some of these individuals went back for the open label study but I do not know if they all did. Obviously it is a different picture if they all went back and received the real drug at full strength. I also know the sample size is terribly small and this could all be chance but it was enough for me to decide to give it a try.

As far as the actual procedure went, the anticipation was far worse than the procedure itself. I'm not sure if all the doctors involved in the study use the exact same procedure but my doctor told me he injects the drug with the smallest needle he can find. There was a small bit of discomfort as he numbed the eardrum but I would not call it pain. It was just the discomfort of having your eardrum pushed on. I did not feel the actual shot itself. I could feel the drug entering my ear and, on a couple of the shots, I think there may have been a little air in the injection as I felt something similar to the pain that anyone who has flown with a cold at high altitude might feel when the pressure finally breaks loose. It was not intense and at no time did I ever feel pain that I would rate over a 1. In fact I'm not sure I should even rate it at a 1. Really not a big deal.

After each shot there was a wave of dizziness that last something less than a minute and then was gone.

Not swallowing or coughing for 1/2 hour per ear was more of an issue to me than the shot tbh. They gave me a truckload of paper towels to deal with the mess and I was so busy grabbing for the next towel that the 1/2 hour was over before I knew it. I have a beard so drooling in a cup just did not seem like a good solution to me.

After the shots on the first day, my left ear remained clogged until some time after I went to bed that evening. It was clear the next morning when I woke up. The next day I noticed absolutely no pain and frankly it was as if I had not received a shot at all. No difference. I received no shots on day two and was scheduled for the second round on day 3. I experienced no drainage on my pillow during the night as I have read about in other posts.

Day 3:

Day 3 was slightly more problematic but only marginally so. I was a bit too anticipatory for my first shot. In addition I think the doctor pushed a little too hard on the drum while numbing it. The combination of him pushing and me jumping led to some pain in my right ear. It was temporary and only lasted about 2 or 3 minutes.

I made up my mind to just accept the pushing pressure which is brief and not anticipate it. All the shots from that point on went much better. Really I think relaxing during the procedure is the best thing you can do.

I again experience the brief dizziness and the drug clogging my left ear until after I went to sleep. Again the next morning I was fine but with perhaps just a touch more soreness. (Which means I knew I had a shot the day before and that was about it.)

I should mention on day 2 I was able to work remotely from my hotel. I had to attend a meeting and I put my earpiece (not buds) on my right ear to listen in on a meeting. After about 15 minute on the call I started to feel a small amount of pain in my right ear where the earpiece was. I immediately removed the earpiece and the level 1 or perhaps even .5 pain was gone in about 5 minutes. It was nothing serious but I thought I would mention it to remind folks if you have this done to stay focused on what you are doing with your ears even if you have no pain.

The final round of shots was early on Day 4. By now I knew what to expect and this round was the smoothest of the 3. The only difference is that both ears stayed clogged this time. One cleared before nightfall and the other, once again, required some sleep before it finally cleared.

Results so far? After Day 1 I experienced absolutely no change. There was a brief moment when I though My T dropped but it was back just as quick. I experienced no increase in T after day 1. After the shots on Day3 (second round for me) I did experience an increase in the loudness. I have been rating my T at a 5 just to give myself room to move up and down the scale while going through this. It has been constant since onset until these shots. I would rate the new level at 6 and it does not always stay there but its enough that I have been reporting my new level as 6 for the last few days as they ask for the highest level over the last 24 hours. It is my understanding that 90% of the individuals who undergo this treatment experience an uptick in their T during the first week. I'm hopeful that I return to at least normal levels in the next few days.

I am scheduled for the first follow-up appointment this Friday.

So far the best advice I have received, and it was somewhere on these forums, is to change your internal message about the tinnitus. I did not know how I could possible deal with this the rest of my life and it was driving me absolutely crazy the first couple months. Changing what I tell myself about it and focusing on things I enjoy has helped immensely. Does it still suck? Yes! However, I have already received a great deal of my life back.

I'll try and keep everyone posted in the coming weeks on my progress.
 
#1,417
@TorDog,

That was a great, detailed post. Thanks for that and I will keep my fingers crossed for you and look forward to your next progress report. Are you currently planning on doing the open label study as well? Also very surprising you were only the 2nd person. I thought the number was low at my location, that's a really low number!
 
#1,418
That makes me think, wouldn't it be better if we also had an additional thread for results only from the open label round? Since that eliminates placebo results. And from what I understood that is actually a completely different study, that is more geared towards tracking safety/side effects from repeated, multiple treatments.

But it could prove to be more helpful even to people with chronic T since the earliest you can really get those is at about the 4th month mark. At that point most acute T cases would have settled at a more constant level, and easier to determine any changes.
 
#1,419
Update about my Tinnitus. I did not want to dissuade anyone from participating in science. I decided to NOT go ahead with the trial after talking to the doctors both at the trial and my personal physician. I haven't visited this site in a while because well, my tinnitus is better. The number scale is subjective but I would rate mine at a 2 at worst. Blame it on habituation or it just getting better. Regardless, best of luck to you all participating.

Edit Additions: My Tinnitus is noise induced from firing range. Only my left ear has tinnitus and based on hearing tests, hearing loss at higher frequencies. Only my left ear because Doctors noticed my ear canal area is shaped slightly different/more narrow from my right ear so the ear protection left a slight gap? (Wear over the ear protection from now on) Right ear is fine.
 
#1,421
AlexSongitus said:
@TorDog,

That was a great, detailed post. Thanks for that and I will keep my fingers crossed for you and look forward to your next progress report. Are you currently planning on doing the open label study as well? Also very surprising you were only the 2nd person. I thought the number was low at my location, that's a really low number!
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Thanks AlexSongitus. Yes at this point I do plan on going through with the open label study. Given the general lack of problems I have had so far with the first round the only scenario I can see where I do not follow through and ensure that I received the real drug would be if I suddenly stopped having tinnitus.

I was very surprised as well about the low number of participants at this study site. They told me that they went a very long time with no applicants and that suddenly 3 of us applied at the same time. I found out when I went in for my first round that the other two ultimately decided not to participate. I also found out they had two fresh applicants who were coming in for their initial consultation.

It's my understanding that the study will soon be coming to a close. I was actually told somewhere along the way that only 30 more applicants are being accepted world wide. I'm not sure if that is true or how they would know. I'm just passing along what I heard. By now I'm sure that information is 3rd, 4th or fifth hand. I think I would take that information with a grain of salt.
 
#1,422
TorDog said:
It's my understanding that the study will soon be coming to a close. I was actually told somewhere along the way that only 30 more applicants are being accepted world wide. I'm not sure if that is true or how they would know. I'm just passing along what I heard. By now I'm sure that information is 3rd, 4th or fifth hand. I think I would take that information with a grain of salt.
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Yeah I was told the same thing. They didn't give me a number, but they said 3 weeks. So less than 3 weeks now. I also found out that Auris Medical has been at work on bringing this to market for 13 years, since before the company was even founded. And unfortunately I was given indications that AM-102 is further away than some hoped and that it also will likely target acute stages.

Ironically, right after my screening after deciding to stop all vitamins for the research, last night I experienced the worst spike I had since I got T. So bad that it woke me up in the middle of the night, which has never happened to me before, only able to sleep 1 or 2 hours or at a time. This is after being down to a consistent 3/10 in the morning to a 1/10 in the evenings for the past 2 weeks. It was down to a 1/10 yesterday before taking an afternoon nap, then woke up with it at about a 4/10, went to bed with a 3/10 and woke up an hour later with my T blasting the loudest I ever heard it, that I don't even know how to rate it, a bad headache that lasted through this morning and heartburn which would not go away on top of the spike. I think I woke up every 1 hour or so 3 more times. Seems to have settled again this morning at a 3/10 but I hope it's just a coincidence and it's not really from me stopping all vitamins cold turkey like that. It kind of gave me a system shock because I was doing so good with it for the past 2 weeks, even getting to the point where I could barely hear it in the evenings, then this happened. I'm going to weather the storm, I hope it passes and I hope this is worth it.
 
#1,423
@TorDog

If I were to explain my experience in detail like you I would say my overall experience was very similar. I did not however experience any dizziness and as soon as the study drug went into my ear my Tinnitus shot up dramatically. I would say it's because similar to putting ear plugs in, a gel blocking sound in your ear will increase perception of tinnitus. My follow up is next friday. Today is the first day after the first round. Still much louder than before but much better compared to yesterday. I would say that's because there is probably a fair amount of gel still in my ear. Experienced some pain last night but nothing unbearable.
 
#1,424
AlexSongitus said:
last night I experienced the worst spike I had since I got T. So bad that it woke me up in the middle of the night, which has never happened to me before, only able to sleep 1 or 2 hours or at a time. This is after being down to a consistent 3/10 in the morning to a 1/10 in the evenings for the past 2 weeks. It was down to a 1/10 yesterday before taking an afternoon nap, then woke up with it at about a 4/10, went to bed with a 3/10 and woke up an hour later with my T blasting the loudest I ever heard it, that I don't even know how to rate it, a bad headache that lasted through this morning and heartburn which would not go away on top of the spike. I think I woke up every 1 hour or so 3 more times. Seems to have settled again this morning at a 3/10 but I hope it's just a coincidence and it's not really from me stopping all vitamins cold turkey like that. It kind of gave me a system shock because I was doing so good with it for the past 2 weeks, even getting to the point where I could barely hear it in the evenings, then this happened. I'm going to weather the storm, I hope it passes and I hope this is worth it.
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Same thing happened to me about a month after onset. T was mild all day, went to bed totally relaxed and Boom, these insane spikes started plagueing me around 90 mins after falling asleep. That went on for a while unfortunately. Perhaps that's the moment when the brain realises this T thing is not going away. I,doubt it has anything to do with supplements.
Why do you need to give up on vitamins though? This was never asked of me during my screening..
 
#1,425
Sebastians said:
Same thing happened to me about a month after onset. T was mild all day, went to bed totally relaxed and Boom, these insane spikes started plagueing me around 90 mins after falling asleep. That went on for a while unfortunately. Perhaps that's the moment when the brain realises this T thing is not going away. I,doubt it has anything to do with supplements.
Why do you need to give up on vitamins though? This was never asked of me during my screening..
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Well because I started them when I got T. I took them to see if it would help and you are not allowed to try anything at all for T. Not even white noise. If you are taking them for your health in general it's ok from what I understand, as long as you continue taking them for the entire 90 days. I didn't, and I was also a bit worried about staying on vitamins for 4 months when it's not something I ever did in my life. I had planned on stopping in about a month, so it was either stop completely now or stop in 3 and a half months. I chose to go ahead and stop now and see where I really stand.
 
#1,429
#1,430
#1,432
If someone lied to get into the trial, that's complete bullshit... If this is what has been done, you owe it to EVERY OTHER T SUFFERER to go confess so they can throw out your results.
 
#1,433
Hi everyone,

I am waiting to hear from my doctor but I am experiencing some leakage out of my ear, I do not know how normal this is? I hope I am not getting an infection it is just a little sore but nothing serious. I had my last injection on Wednesday it is now Saturday. Also I was hoping to ask everyone on here how long the sense of fullness lasts? Does the gel stay in the ear for a long time? I think because of the fullness my tinnitus sounds way louder I am hoping this is a temporary symptom. Thank you hope to hear from you all soon.
 
#1,434
TorDog said:
Wow, I'm sorry to hear that. I'm not sure I understand why depression, especially caused by the T itself, would disqualify you.
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Most likely because anti depressants are an exclusion criteria. So if someone is saying they are depressed, they can't ask you not to take AD medication, while at the same time, you are more likely to need them and use them. They can also exclude you for depression simply if the investigator deems it clinically relevant. Psychiatric disorders are also an exclusion criteria.

That's why I believe it's important for anyone else trying to get in not to self diagnose yourself with depression or make such claims when you go sign up. If you are just experiencing the typical downs anyone new to T would experience, I would stay a steady course and maintain composure before jumping the gun and self diagnosing oneself with depression. Leave that up to the psychiatrists. For me depression is clinical...months, ongoing,....etc. Not I am going through a temporary rough patch due to a specific event that just happened. That's life. It's when months or years go by and you are still not out of it, that I would call that depression. I really dislike that word, because it's used too often, too careless, and it can become a self fulfilling prophecy. In my opinion, if you keep telling yourself that you are depressed over and over, you have a much higher chance of ending up there.
 
#1,435
lonestar651 said:
Also I was hoping to ask everyone on here how long the sense of fullness lasts? Does the gel stay in the ear for a long time? I think because of the fullness my tinnitus sounds way louder I am hoping this is a temporary symptom. Thank you hope to hear from you all soon.
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For me, the fullness lasted for about a week. After 7-8 days it had recovered partially (i.e. temporarily during the day) and after about 2 weeks it was back to normal. Same for sore feeling and T loudness. But all this is temporary, I would not worry much.

Good luck!
 
#1,436
TC426 said:
For me, the fullness lasted for about a week. After 7-8 days it had recovered partially (i.e. temporarily during the day) and after about 2 weeks it was back to normal. Same for sore feeling and T loudness. But all this is temporary, I would not worry much.

Good luck!
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Thank you for the kind words, very difficult right now because of the huge spike reminds me of the beginning.
 
#1,437
lonestar651 said:
Thank you for the kind words, very difficult right now because of the huge spike reminds me of the beginning.
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I understand your concerns, been there myself. A few times after the injections I even got scared that I would go deaf any minute now because the gel had such a massive impact on my hearing perception. But if you look at it objectively, it makes absolute sense that T has increased, as you are partially isolating your ear with gel. Your brain will automatically turn up its sensitivity. Even though it felt like it at the time, I do not believe that I experienced an actual spike after the injections, but rather that the gel caused the T to appear louder.

Wait 1-2 more weeks and you will see that you worried for nothing :)
Let us know about your progress.
 
#1,440
Hotaru said:
The doctor said I won't get the real drug until years from now. I thought during the month- later visit you get the real thing.
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You are supposed to be offered to participate in the open label follow-up study after 90 days where you do get to take the real AM-101. And you can have multiple rounds, I believe, it's up to 3. Your last follow-up visit of AM-101 is supposed to be the first day of injections of the open label round.

Not sure if its different where you are or what. Strange.
 

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