AM-101 Clinical Trial — Participants Updates and Discussion

[AlexSongitus]

Nevertheless the AM-101 trials are running since 2009/2010 right and we have like three to cero official positive statements on the internet from people who have received AM-101 (confirmed) during a period of 6 years?

I don't know how to rate this.
In my opinion there are two options.

1. AM-101 is effective (especially in cases of acoustic trauma and otitis) but most of the ones who received drastic improvements or even got cured don't want to talk about it any longer in order to end with the topic T for their lifes.

>> Don't know but I think this option is a bit improbable, because why should someone who received AM-101 (confirmed) doesn't want to tell others about the improvement/cure if it happened.

2. AM-101 is not effective at all and official statements from people who received the treatment (confirmed) and talking about improvements or even cures are people who usually have become more habituated to their T. Mean we're talking about the acute phase which is three months and many improvements (drops in T sound, better habituation) are happening in that period.

What do you think?

I really don't know where you guys are getting your numbers of "3" people from. What I do see is that there are quite a few members that participated lat year that haven't been back to this forum since last year. That is a good sign to me.

As far as your 2nd point, I think it's ridiculous. The company wouldn't be in phase 3, with published results, spending millions of dollars continuing trials, if it was not effective "at all". But to humor the point, I habituated far before AM-101. I think by my 2nd week with T I was habituated. I got silence, complete silence, day 1 and day 3 after the injections that lasted the entire day, along with fluctuations of louder T than base T in between on day 2 and 4. Before this, my T had pretty much settled into a constant pattern of 3/10 in my left ear, 1/10 in my right. That's not habituation. That's the exact opposite, major fluctuations that can only be attributed to the procedure or AM-101. And yesterday and today I woke up with a 1/10. Yesterday it stayed that way all day. My T constantly reset after sleeping, and was loudest in the morning. So this is a good sign for me so far.

It's still too early to say anything definitive in my case, but having said that, I also really think these kind of posts that are not based on any personal experience or actual data, are not helpful, and you may end up dissuading members from something that could be helpful for them. I think before you make statements like that, you should at least actually take the time and scour through the thread and post the number of members and their actual results, and not come up with arbitrary numbers like "3" out of thin air.

 

[Alue]

I think some people that missed the boat on AM101 like to come in and shit on results.

I'm going through it now, I still haven't came to a conclusion with it regarding myself, think I may have gotten the placebo but it's too early to tell.

Maybe it works maybe it doesn't, but the conclusion I came to after reading all the data on various treatments is that this is our best shot at this time for treating acute onset tinnitus. There really isn't anything else with proven results besides steroids within 48 hours after onset.

 

[Dutchy]

I think some people that missed the boat on AM101 like to come in and shit on results.

I'm going through it now, I still haven't came to a conclusion with it regarding myself, think I may have gotten the placebo but it's too early to tell.

Maybe it works maybe it doesn't, but the conclusion I came to after reading all the data on various treatments is that this is our best shot at this time for treating acute onset tinnitus. There really isn't anything else with proven results besides steroids within 48 hours after onset.

It's not so much missing a boat lol,eventually they will sell this to people with chronic T as well.
They might as well conduct a similar trial with people with chronic T to see if it really doesn't work.

They know there's a lot of people out there with chronic T so them doing a trial and ending up with bad
results means they won't try it.You have to look at the big picture here.

 

[Alue]

It's not so much missing a boat lol,eventually they will sell this to people with chronic T as well.
They might as well conduct a similar trial with people with chronic T to see if it really doesn't work.

They know there's a lot of people out there with chronic T so them doing a trial and ending up with bad
results means they won't try it.You have to look at the big picture here.

I have serious doubts this will work on chronic T, but it may be determined by the underlying cause as everyone is different.

It would be nice if it would, but chronic T is seen as more of a neurological issue.

 

[bill 112]

I have serious doubts this will work on chronic T, but it may be determined by the underlying cause as everyone is different.

It would be nice if it would, but chronic T is seen as more of a neurological issue.

Your right Alue Chronic T is seen as a neurological issue but what you have to remember is that this is just a theory,it hasn't really beyond doubt been proven yet so who knows.

 

[Alue]

True, and it may come down to the cause. It wouldn't surprise me if some people had chronic inflammation or excitability in their cochlea. In which case AM101 may be able to help.

I wish we had a better understanding or a way to at least treat the neurological side, but one step at a time I guess.

 

[bill 112]

W

True, and it may come down to the cause. It wouldn't surprise me if some people had chronic inflammation or excitability in their cochlea. In which case AM101 may be able to help.

I wish we had a better understanding or a way to at least treat the neurological side, but one step at a time I guess.

Were getting there Alue but in my opinion we won't be able to tackle this problem effectively until we develop a device that can monitor or view inside a live human cochlea,until then it's really just a guessing game,the good news is Harvard or another university are developing such a device I believe.Dont buy too much into the whole neurological side of things,as I said before it still by no means has been proven.Best Wishes
Bill.

 

[matt89]

@Alue

Nobody's shitting on results. We are all in the same boat and someone who misses the AM-101 trial/treatment misses in fact a great opportunity to get better depending on the kind of T he or she has.

@AlexSongitus could be right with the thesis that many members who have participated in the AM-101 trials in the past have left this forum because of an improvement or cure of their situations.

The results published by Auris Medical concerning the first two phases of the AM-101 trial look very promising especially for someone who has received T from an acoustic trauma or otitis.
But it would be nice to get a feedback from someone here who received a confirmation after participating in the trial that he or she has received AM-101 or who has done the second round where he or she has received AM-101.

 

[OddV]

There are several in this thread that did round 2

 

[Joe Bananas]

I'll have my 2nd round done next April 18, 19 and 20. Will be on my 6.5 months mark after onset. Will keep you updated.

 

[matt89]

@Joe Bananas

thanks. May I ask did you receive a confirmation after the first round that you've received the placebo?

 

[OddV]

He will not receive confirmation until Phase 3 is closed and the data published

 

[AlexSongitus]

Ok guys I went for my 1 week follow up today and will post my 1 week report using a similar format to what TC426 has been doing:

Trial:
AM-101 initial trial

Date of initial T Onset:
1/21/2016

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.

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. Yes.

I had 4.5 days below my baseline, including 2 days of silence, and 2 days above my baseline as high as 4/10 in both ears. I also had periods of silence the days of my injections. My T also reversed from left to right ear the 2nd day of my injection, then reverted back the final day, then remained at the same level in both. Saturday it was completely gone, no matter how hard I listened for it. Sunday louder than my base. On Monday I had another day of silence, but it was intermittent in the sense that there were times it fluctuated in and out of total silence, extremely faintly, if I listened for it hard enough, which is why I marked it as 0.1 Tuesday it was above baseline. So major fluctuations the days during injections, and the days after. Seems to have settled closer to my baseline now.

These are my last 7 days tracking from my spreadsheet including today:
NT = not tracked.

Wake up/Morning/Afternoon/Evening/Night
03/05 Left ear: 2/0/0/0/0 Right ear: 2/0/0/0/0
03/06 Left ear: 4/3/3/3/2 Right ear: 2/1/1/1/1
03/07 Left ear: 1/1/0.5/0.1/0.1 Right ear: 1/1/0.5/0.1/0.1
03/08 Left ear: 2/2/3/4/3 Right ear: 2/2/3/4/3
03/09 Left ear: 1/1/1/1/NT Right ear: 1/1/1/1/NT
03/10 Left ear: 1/1/2/2/NT Right ear: 1/1/2/2/NT
03/11 Left ear: 1/2/3/NT/NT Right ear: 1/1/2/NT/NT

My biggest change other than the silence is waking up with low T. My T had previously had a pattern of either waking up with it loud, and lowering throughout the day, or remaining constant. Sleep reset it, and was loudest in the morning. Now I'm noticing I'm waking up with it lower, and of similar level in both ears, but I am also noticing rising in intensity throughout the past couple of days which is a bit worrisome since I think I only had a spike in the middle of the day once or twice prior to the injections since my T onset. I did notice that the days I ended up getting silence or very low T, I woke up with my T more narrow and centered in the back of my head as opposed to panned wide in my ears. If it's panned wide, wide left and right in my ears, and it feels as if it's my ears hissing, it either did not lower, remained constant, or got louder.

Current T severity and average T severity over the past week:
Currently Left ear: 3/10, Right ear: 2/10. Still fluctuates throughout the day. My past week has been a roller coaster so it's hard to put an average number on it when you have days of silence and days that are louder than baseline, followed by my T settling down. I would say for the past 3 days my T was slightly lower in my left, and slightly louder in my right than my baseline. There was definitely a larger discrepancy between my ears prior to the injections.

Do you believe that you got the real drug or the placebo?
Inconclusive. I had similar results of silence my 1st and 3rd day after starting Prednisone then it returned after that. The procedure itself, the numbing agent or AM-101 could have all played a role in my fluctuations.

Have you experienced any lasting (side) effects from the procedure?
Still experiencing some mild popping when I swallow from time to time. Fullness and ear pressure came and went multiple times. It also strangely coincided with my silent days or low T. When the fullness cleared up T either returned or was louder. I have not experienced any fullness yesterday or today. Today they confirmed my ear drums healed and holes closed up. They said I did really well with the procedure. The audiologist did make a statement my hearing had some discrepancies compared to my last test a week ago, but not enough to worry about. The day I had my ears checked prior to the injections, I had an unusually quiet day to the point where she could barely match the loudness in my right ear. Today it was slightly louder than that day, so it could have affected the test. I also used to experience swollen tonsils on random mornings, or clogged up nose overnight. In fact even the day of my last injection, it would hurt to swallow when I kept my head turned to the side. I have not experienced any of those symptoms since the injections.

Will you participate in the next round?
Too early to say. Depends on how it goes the next 3 months. I hope it lowers so much or goes away that I don't have to, but if it's still at this level, yes, I will.

 

[RaZaH]

Obvious downside to am101 is that you sort of have to monitor your t all the time

 

[OddV]

Obvious downside to am101 is that you sort of have to monitor your t all the time

Only for the first series of injections, when you do round 2,you do not.

 

[AlexSongitus]

Obvious downside to am101 is that you sort of have to monitor your t all the time

Quite the contrary. I do not believe it's enough. If you are referring to the daily tracking I showed above throughout the day, that is just what I did on my own since I got T.

They actually only ask 2 questions, once a day, at night, pertaining to the loudest it was in the past 24 hours and your annoyance of it. Not only do I feel it isn't enough, but this actually significantly skews results in my case. I reported it either the same or louder even during my days of silence, because of how my T was the night before, since they don't want you to average it out. There is no way to report progress over 24 hours until you go back in for the follow up and get some additional questions, and even then it's very general.

As it stands the daily reporting is only going to track if someone's loudest spikes lower over a long period of time, months. In the end everyone cares about the same thing: for it to show a permanent improvement over time, and I get that. I just think getting more insight into what is going on with people's T over the course of 24 hours as opposed to their loudest T in the past 24 hours, every day, particularly in the first week of injections, may have given them some additional valuable information from participants that they could use to tweak their drug or procedure and make it more effective in the future. Who knows what would have happened if I would have gotten a 4th injection on Saturday when my T was completely silent. If it would have still returned the next day. I'll never know. And they won't either. They won't know if more more people had similar experiences to mine because they don't ask. In my opinion, this is a missed opportunity to learn more about Tinnitus from real participants as opposed to lab rats.

 

[Alue]

Quite the contrary. I do not believe it's enough. If you are referring to the daily tracking I showed above throughout the day, that is just what I did on my own since I got T.

They actually only ask 2 questions, once a day, at night pertaining to the loudest it was in the past 24 hours and your annoyance of it. Not only do I feel it isn't enough, but this actually significantly skews results in my case. I reported it either the same or louder even during my days of silence, because of how my T was the night before, since they don't want you to average it out. There is no way to report progress over 24 hours until you go back in for the follow up and get some additional questions, and even then it's very general.

As it stands the daily reporting is only going to track if someone's loudest spikes lower over a long period of time, months. In the end everyone cares about the same thing: for it to show a permanent improvement over time, and I get that. I just think getting more insight into what is going on with people's T over the course of 24 hours as opposed to their loudest T in the past 24 hours, every day, particularly in the first week of injections, may have given them some additional valuable information from participants that they could use to tweak their drug or procedure and make it more effective in the future. Who knows what would have happened if I would have gotten a 4th injection on Saturday when my T was completely silent. If it would have still returned the next day. I'll never know. And they won't either. They won't know if more more people had similar experiences to mine because they don't ask. In my opinion, this is a missed opportunity to learn more about Tinnitus from real participants as opposed to lab rats.

I agree that the questions seem a little limited. I also think some more involved testing at the start would be beneficial, instead of loudness matching with a single low tone, they could do tone matching then loudness matching with a similar frequency as your tinnitus.

With the fluctuation, that's part of the reason they try to screen out people with fluctuating T from the start. Did yours fluctuate before? Mine was steady and constant 24/7 with almost no fluctuation, since the injection it's been fluctuating a bit more.

Another thing is they probably wanted to keep it simple so a lot of different facilities can handle the same test and people are more likely to be consistent with a questionnaire that takes less than a minute each day than one that takes 5 minutes.

 

[AlexSongitus]

I agree that the questions seem a little limited. I also think some more involved testing at the start would be beneficial, instead of loudness matching with a single low tone, they could do tone matching then loudness matching with a similar frequency as your tinnitus.

With the fluctuation, that's part of the reason they try to screen out people with fluctuating T from the start. Did yours fluctuate before? Mine was steady and constant 24/7 with almost no fluctuation, since the injection it's been fluctuating a bit more.

Another thing is they probably wanted to keep it simple so a lot of different facilities can handle the same test and people are more likely to be consistent with a questionnaire that takes less than a minute each day than 5 minutes.

I had patterned fluctuations after I started Prednisone. It never fluctuated like this week. My first month once I started Prednisone and 2 weeks after I was off of it up to my screening it pretty much followed a similar pattern every single day of waking up with it loud, and gradually lowering by evening, then resetting the next morning, and the pattern repeated.

The two weeks during my screening, it stayed much more constant, either a 2 or a 3 in my left, and a 1 in my right the entire day. I had one single anomaly, a spike on the night of my first day of screening, where I reported it a 7, a real bad spike that woke me up in the middle of the night. The only time that ever happened. They also said if your T lowered over time since onset, it was ok, just not louder. Mine did. My first 6 days at onset, before Prednisone, I would have rated a constant 5/10 in both ears. By the time screening came around it lowered to a consistent 3 in my left and 1 in my right. If it gets louder, then that would disqualify you.

Simplicity is definitely a reason, but I still feel 2 questions is not enough. It literally takes 30 seconds to 1 minute to complete and send the info each night. I don't think 5-10 questions would have been pushing it. Seems like an awful waste of a lot of money, time and opportunity just to track our loudest spikes. At least ask what was the average T over the past 24.

 

[OddV]

I was sick of just the two questions at the end of the first round. I wanted to stop thinking about it everyday and just move on. Had they asked me to continue that activity in the 2nd round not sure I would have done the third round.

 

[Joe Bananas]

I thought they were going to ask me to keep completing that daily crap after second round... Wow! feels like some really fresh breeze to know they don't.
By the way... when do they pay the 350€ for participating and the acomodation, travel and meals expenses?
Can I expect to have some relief in my second round even being in my 6.5 month after onset?
I really want this AM101 episode in my life to finish!

 

[AlexSongitus]

I thought they were going to ask me to keep completing that daily crap after second round... Wow! feels like some really fresh breeze to know they don't.
By the way... when do they pay the 350€ for participating and the acomodation, travel and meals expenses?
Can I expect to have some relief in my second round even being in my 6.5 month after onset?
I really want this AM101 episode in my life to finish!

I don't know what the deal is with the reimbursement. I forgot to even ask about that. When are you supposed to get it? I know they mentioned something about getting paid per visit, but I didn't ask and they didn't mention it either the last time I went in.

As far as you last question Joe, @OddV said he got some improvement after his 2nd round, but other than that I also wonder who else on here is currently undergoing 2nd round trials. I think you're going to be one of the few people to answer that question for the rest of us!

 

[Joe Bananas]

I think you're going to be one of the few people to answer that question for the rest of us!

 

[AlexSongitus]

Btw guys, I forgot to mention that yesterday when I went for my follow up I was once again told that they are closing enrollment this coming week at my center, so I imagine, all over the US. I was told it would end on the 15th. So basically you have Monday, maybe Tuesday, to still try to get in! Spread the word if you know anyone that wants to get in!

Please keep in mind that once they close enrollment the drug will not be on the market for some time, likely not until 2017, and it's supposedly most effective if you are in the acute stages. Meaning if you just got T, by the time the drug comes out, it most likely will not be effective or even prescribed for you.

If it helps anyone, I will say today I once again had a very low T day. Woke up with it somewhere in the 1-2 range and it stayed at a 1 or lower all day long. I can barely hear my T right now. I can certainly rule out numbing agent at this point, so either I got the real thing and it's working, the procedure itself caused some permanent change for the better or my T is doing this on its own. I will continue posting updates for the next couple of days.

 

[TC426]

Unplanned update from my side.
Will add it to the list of my previous updates:

24 hours after last injection
1 week after last injections
1 month after last injections
6 weeks after the update (unplanned)
2 months after last injections (newly added)
3 months after last injections

In my case, things have taken an unexpected turn. Long story short, after 1 week at the office, I am back to baseline (which is an increase!). To be precise, I spend 3 days after my vacation (which ended on a Tuesday) at the office without any issues. Returning to the office on Monday after, however, loudness increased - I would say from 1 to 4 - within an hour or two.

It may be important to point out that I have always had the subtle feeling that in my case, T is actively triggered by outside circumstances (a high frequency, an electronic field, or something similar) which intensifies my perception of T significantly. I experienced this at the office and at a friend's place, but e.g. not at home, and also not in other places.

With regard to the study, I see two possible options:

1. I was in the reference group. In this case, the entire relief reported since the injections was not due to medical reasons, but because of the different environment during my holidays.
2. I was in the actual test group. That would mean that AM-101 worked at the time when the drug was administered, however, the effect only lasted while T was not actively triggered by outside circumstances.

Naturally, I am very disappointed by this change and am not quite sure how to feel about it. Either way, I see my theory proven that in my case there are some external factors influencing T. Also, I will definitely participate in round II, taking the chance that this time, the effects will last.

 

[Alue]

It may be important to point out that I have always had the subtle feeling that in my case, T is actively triggered by outside circumstances (a high frequency, an electronic field, or something similar) which intensifies my perception of T significantly. I experienced this at the office and at a friend's place, but e.g. not at home, and also not in other places.

I have wondered this too. I have a decibel meter, but 'A' filtering cuts off at around 10kHz. I have been wondering if high frequencies I encounter have been exacerbating things.

 

[OddV]

@Alue I've wondered this as well as there are a few environments that seem to cause me to spike.

 

[TJohns]

@OddV can you expand on this? What types of environments, I have noticed sounds that make my T spike but I wonder if its not more the frequency, or pitch within those types of sounds or noises.
Just for instance I like to take showers to mask out my T, tonight while I was in the shower I sat down in the tub and just let the water from the shower fill the tub. I noticed as the water filled the tub and the shower drops started striking the water my T went threw the roof when the water level in the tub reached a certain level. This does not happen if Im standing in the shower with no water in the tub. I know its an odd example but the pitch of the sound changed up. Could be I'm still suffering from some H as well and the over all noise just bothers that and spiked my T, but I could have sworn there was a certain moment where the pitch changed up and my T spiked at that exact moment.

 

[Joe Bananas]

I really want to chime in seeing this thread has take this direction at this point. No aim to go off thread!
I am really concerned about volume exposition. Recently I've been taking back some slices of my pre-T life and have started to go to some restaurants, bars and outdoor events in which volume is 70/75 dbs in average. I am not wearing earplugs in those situations but as soon as things get into the 85dbs ballpark I protect my ears with a pair of -25 dbs ones, and try not to be there for more of 20 minutes. I need to know if I am risking a permanent spike or more damage by being around places at 70/75dbs with no protection, sometimes for a 4 hours time spam. I would love toi gather as much info about this as possible but, please, just from you members who are really informed propperly about this. Thanks!
PD Springtime is coming in here and if I can't have some social life I will become nuts BIG TIME.

 

[matt89]

@Joe Bananas

I'm not experiencing spikes after visiting noisier places like loud bars for some hours. Not wearing earplugs in those places too (max 75 db) in contrast to clubs and cinemas (don't visit such places often since I have T). When I know that I will visit louder areas I am taking 600 mg NAC in the morning and evening. It's confirmed that it will protect hair cells from (further) damage if you are going to noisier places. Don't know if it protects from T spikes too, but I'm feeling safer after taking it.

 

[OddV]

When I'm around an excessive amount of electronic equipment is when I notice a spike and/or H.