AM-101 Clinical Trial — Participants Updates and Discussion

[Brian meadows]

Hi all. I've been ghosting this thread for a while. I got my am-101 injections last week and am afraid that I made a terrible mistake. I've been using the soundcure serenade for over 2 months and honestly, it reduced my tinnitus by 95%. In fact, for a good 10 days leading up to my first injection appt, I was no longer bothered by the tinnitus. It was effectively gone. So I was very hesitant to get the injections because what if the tinnitus comes back? But..I figured this would kill off the little remaining tinnitus I have, plus I could definitely use the participation money, plus there was the pressure of doing the injections now or never being able to qualify for the study again (I'd be past my 90 days). Well so far, my tinnitus is back (again, after being almost gone) and I'm having extra hearing loss, which is more concerning. Hopefully this is temporary hearing loss but it's been 4 days (not that long I know) but at this point, I feel like a complete dumbass who went thru hell, got better, and then allowed himself to get worse again because of the money. I hope my story changes, but I regret doing the injections. On the other hand, I can't recommend the serenade enough to you all. It's expensive as hell and takes weeks/months to work, but it truly has worked for me. And thank God, cuz if my tinnitus had never improved from where it was at onset, I don't think I could go on living. It was the worst thing I've ever gone thru. I'm sure u all can relate. Even now that I have the post injection spike, my tinnitus is nowhere near as bad as it was a couple months ago.

 

[James White]

It took me around 3 or 4 weeks before my ear was as before

 

[OddV]

I had hearing loss, fullness, spike, everything you described above for 1 to 2 weeks.

My hearing test on my 2nd follow up appt was as good as the pre-injection one. As a FYI, my 4th day post injection was my worst and I thought I had made a mistake as well.

 

[Brian meadows]

Is your tinnitus better over all?

 

[OddV]

@Brian meadows Here you go, I've gotten 14% to 28% better, in terms of loudness, and 40% to 50% better, in terms of annoyance, since injections; I don't know if I can attribute that to AM-101/placebo or habituation.

 

[Jon73]

Thanks for sharing your outcome here Oddv, I have been concerned with hearing loss as a result of the trial.
I have read that almost all participants had only temporary hearing loss which is reassuring. It was a big factor that would worry me about this trial.

 

[amandine]

But..I figured this would kill off the little remaining tinnitus I have, plus I could definitely use the participation money, plus there was the pressure of doing the injections now or never being able to qualify for the study again (I'd be past my 90 days).

Was whereabouts are you in the world that you get participation money in this trial? How much do they pay? Why would you only qualify if it was within 90 days? Please could you let me know..thanks
In Europe qualification is up to 12 months from onset.

 

[OddV]

In the US, TACTT2, which is the Phase 3 trial HERE.... Inclusion is ONLY up to 3 months.

I do not know about the European trial or how the include/exclude. I believe Phase 3 in Europe is TACTT3, which does state Stratum B is between 3 and 12 months. Perhaps one of our European members that have gone through this AND received injections could shed some light on this for us.

 

[amandine]

In the US, TACTT2, which is the Phase 3 trial HERE.... Inclusion is ONLY up to 3 months.

I do not know about the European trial or how the include/exclude. I believe Phase 3 in Europe is TACTT3, which does state Stratum B is between 3 and 12 months. Perhaps one of our European members that have gone through this AND received injections could shed some light on this for us.

Yes but @Brian meadows said you get participation money too so this must be in the States that this happens only?

 

[OddV]

You get up to, maximum, USD $350.

 

[amandine]

You get up to, maximum, USD $350.

wow!! here you have difficulty even getting the petrol costs which are considerable due to long distances to travel

anyway glad to hear that the injections appear to be working..
dont u think it is weird that @NewGuy disappeared back in November - he said he was on way for second appt check up and would post again after that and then nothing - zero - he disappeared which is so strange!!
@bedouin said the same...........he was just into his second set of injections and said he would post as well and zero - nothing - disappeared

 

[OddV]

I'll post after my 2nd set of injections, just hope I have the burning desire to stop posting here afterwards

 

[Jon73]

At least you'll know this time you have the am-101. I can understand that they don't tell you. But I guess it would help you decide on the second set. if there is any difference in feeling with these injections and you will be able to make an educated guess as to what you had first time. I hope you are lucky.

 

[Jean-Daniel Guay]

@Brian meadows

Is it T back to pre-injections level? I must say that I'm getting slowly habituated as well and that I'm still not sure that I should go forward with the injections. Reporting your T level on a daily basis is annoying to me as it seems that it slows my habituation process.

Any update?

 

[OddV]

@Jean-Daniel Guay I will say, at first, reporting T loudness and annoyance was not a big deal. Now that I'm almost into the 3rd month, it's annoying the crap out of me. I've made a conscious effort over the last 2-3 weeks to not check in on it regularly and when I do, follow @I who love music 's advice and measure my reaction to the T and not the loudness, so I only have a general sense now when I report on what it was for the day. My favorite mantra when I do "check in on T" is "I hear the T and I don't care" (I sometimes throw an expletive in there too if I'm particularly annoyed by the fact that I've checked in on it ).

I'm very specific that I don't call it "my T" now too, it's an invasive phenomena, so it's "the T"... not sure that this makes a difference, but I've been pretty particular about it.

I'm 99% sure I'm going to do the 2nd round, if I did get AM-101 in the first round (and not the placebo), then, as stated earlier, it only reduced it between 15% and 25%, my hope is I can kill another 15% to 25% consistently, and at that point, habituation or not, I think I can live with "it".

 

[Laika]

Hello everyone, this is my third entry regarding my AM 101 trial.

This is will be a quick update.
Currently as it stands right now my T has decreased over 70% in volume since prior to the injection.
I can only hear my T if I truly focus on it in a quiet place.
Its been about a month since the injection period and since then there have been good days and bad days.
Today has been the best day yet with a major reduction in my T.

I am happy to say that this AM 101 drug has been effective in total tinnitus reduction.

I have my 1 month follow up next week and I will try to give another post regarding the actual numbers and levels of T reduction.

One thing that has helped me get through this is learning to not care about having it. If you can just tell yourself that you don't give a fuck about the noise and not have it on your mind it will help. My T was high pitched and loud so I know it can be hard to drown it out but if you can I know the benefits outweigh the cons.

I recommend anyone to try this program as I am a direct result of success.

Here is hope to all that suffer!

 

[sergerold]

Hello everyone, this is my third entry regarding my AM 101 trial.

This is will be a quick update.
Currently as it stands right now my T has decreased over 70% in volume since prior to the injection.
I can only hear my T if I truly focus on it in a quiet place.
Its been about a month since the injection period and since then there have been good days and bad days.
Today has been the best day yet with a major reduction in my T.

I am happy to say that this AM 101 drug has been effective in total tinnitus reduction.

I have my 1 month follow up next week and I will try to give another post regarding the actual numbers and levels of T reduction.

One thing that has helped me get through this is learning to not care about having it. If you can just tell yourself that you don't give a fuck about the noise and not have it on your mind it will help. My T was high pitched and loud so I know it can be hard to drown it out but if you can I know the benefits outweigh the cons.

I recommend anyone to try this program as I am a direct result of success.

Here is hope to all that suffer!

Amazing news.

How long after onset was your first injection?

 

[amandine]

@sergerold

Amazing news.

How long after onset was your first injection?

If you look @Laika profile she says that she got T in 09/14 and she says she is due her one month update next week which means the 19/01/15......which means that she got her injections round about 19 Dec 14 so september to december is approx three months. depending on when in september she got T.....if you scroll back through this thread she posts the date of when she went for her first injection which was on dec 10 and third one was on dec 12th 2015......hope this helps...........

 

[sergerold]

@sergerold



If you look @Laika profile she says that she got T in 09/14 and she says she is due her one month update next week which means the 19/01/15......which means that she got her injections round about 19 Dec 14 so september to december is approx three months. depending on when in september she got T.....if you scroll back through this thread she posts the date of when she went for her first injection which was on dec 10 and third one was on dec 12th 2015......hope this helps...........

ok thanks, should have figured that out myself...

 

[OddV]

I wanted to wait a few days before reporting this, but starting Sunday, I've had some changes.

Early Sunday, the Tinnitus in my left ear completely disappeared (a 0 on a scale of 0-10) and I had a mild sense of Tinnitus move into my right ear (roughly a 2 out of 10). This lasted for about 2 to 3 hours (I plugged my left ear multiple times and could not hear it at all) and then reverted to normal.

The T did move back, but since then, has been significantly lower in both loudness and annoyance consistently. I'm waking up to a 5 (instead of a 6) in terms of loudness and then it goes down to 1 or 2 and stays there all day until the next morning. I typically get a spike in the afternoon back up to a 5 or 6, which hasn't happened. My annoyance is also down to 1 or 2 every day, which is roughly a 50% reduction from last week.

I'm only on my third day of this new reality and am feeling great; I'll report back in a few days.

 

[marqualler]

@OddV That is awesome; great to hear! And thanks for the clarification--I did not realize that the "double-blind" part was not taken off until after the results were published, not at the end of the 3 month process. I forget, did you get the injection in both ears?

For comparison's sake (I think you and I had onset around the same time and under similar circumstances), my T has reduced quite a bit in annoyance for me, but it's impossible for me to tell if it is lower in loudness. I think my annoyance has greatly reduced because of habituation, which has happened very drastically the last few weeks after starting to resume the types of activities I had been afraid to do post-T onset (ex. go to restaurants, practice with my band (with extra hearing protection now!), hang out with friends, etc.) What you are talking about is different because I can plug my ears and "hear" my T in my left ear even when I haven't noticed it throughout the day. Yesterday was my first full work day where I can honestly say that my T did not distract me at all, and today it has been a little stronger and noticeable but not all bothersome. (And only louder because I stayed up a little later than usual going to a happy hour last night--a tradeoff I'll take any day as long as the T doesn't bother me as much.)

Regardless, that is great to hear and I hope it continues for you!

 

[OddV]

@marqualler Onset for me was September 22 due to ear infection, I only had it in the left ear. There have been a few times that it has moved to my right ear since then, but this was the most dramatic and longest lasting

 

[Brian meadows]

Update: Its been 11 days since my last injection and my tinnitus returned to its pre-spike level a couple days ago. Its such a luxury to not be preoccupied with it.

 

[Hugh Hart]

I just missed out on the January / February 2015 AM-101 clinical trial in Los Angeles. I'm hoping there will be another round of tests later this year. Curious to hear how Los Angeles-area participants are doing?

 

[earsnothappy]

I just missed out on the January / February 2015 AM-101 clinical trial in Los Angeles. I'm hoping there will be another round of tests later this year. Curious to hear how Los Angeles-area participants are doing?

Who / Where in Los Angeles was the trial? I wouldn't think it would stop as this is an ongoing trial until it's completed. Do you have a link to the information? Thank you!

 

[Champ]

Update: Its been 11 days since my last injection and my tinnitus returned to its pre-spike level a couple days ago. Its such a luxury to not be preoccupied with it.

That's awesome to hear.

 

[OddV]

Just a quick update, not as good as I was sun-wed this week... On Thurs it went back to previous daily cycle, but it's better than it was last week.

The T seems a bit different too... Almost seems a little softer around the edges and a bit higher tone... Tough to tell and I know I'm not describing it well.

2 weeks from Monday will be the start of my 2nd set of injections.

 

[amandine]

@OddV

sorry to hear it is not as great as last week.
I get that too.......goes real low for four days which was last week too and the week before but in the past it only went down for 2 days at a time so this is better......then goes back to where it was.............thank you for being loyal and updating constantly......much appreciated....4 days not of bliss but of hope...........maybe softer sound due to acceptance, habit, time? Do you now think that it was placebo? Well you get the real shot in 2 weeks so well done to you for getting there....and for being prepared to go through all those injections again!

 

[OddV]

@amandine I'd say "slightly better"... My loudness has decreased about 25% since day before first injection. Annoyance a bit better.

If I get another 25% from next round, I'll be happy... Still think I got placebo and I've experienced habituation... My experience just doesn't fit the model from phase 2...perhaps I'm just Odd (pun intended) and don't fit any mold... ☺

 

[Chelovek]

I'm sorry if I did not reply to anyone's queries. I cannot figure out how this forum works? There are no instructions so I can only post and cannot answer. Just had first one of second batch of three sets of injections (both ears and defo no chance of placebo this time). Long wait in hospital, very long journey over 100 miles each way. Very early set off time of 4 am. Just got up day after first day of injections, ears sore, tinnitus loud because of gel, headache, was a bit dizzy straight after injections for 5 mins. Went through all of this last time and tinnitus level dropped around 25-30% after 4 - 5 weeks. Back Wed and Fri for full process again. I am allowed to go through it all again in April and July. I intend to carry on if this second process is positive. Prior to this my tinnitus was very loud, so loud that could heard it above driving, above TV and dare not go in even reasonably loud places in case it got worse. The guy who does the hearing assessments said to me "your tinnitus seems to be loud", I assured him it was. If it had been mild I may have waited a few more years to see if someone invents a course of tablets instead. So yes we all know that in 15 years there will probably be an instant cure but I am 60 now so I need some comfort now and I was chosen from a select few for the trials and feel very grateful.