AM-101 Clinical Trial — Participants Updates and Discussion

My final AM-101 update.

I am now in the "got moderately worse" column after my second round of injections. I decided not to take part in a 3rd round as I didn't want to risk getting potentially even worse. This is to much disappointment as I feel I had good progress from the first round. I now feel like I'm back nearly where I started from.

And when I say "got moderately worse" it's from my the beginning for the second round to completion.

 

I have just had my third set of injections on round two also. I know from the last time it takes four weeks to know what you are left with. I will let you all know - this will be 23rd Feb 15

 

How long ago did you have your second set of injections please? Would you definitely know then that it hasnt worked? Did it work after the first set of injections? And now you have had your second set of injections it has made it worse? or is it because you have just had the injections and are going through the temporary post injection spike?
thanks for clarifying and sorry to pester you for answers...........

 

Sorry I saw that you had your first lot of injections back in July so apologies for the above post.

I have pm'd you...............

 

@earsnothappy and @Chelovek Firstly, I apologize profusely if I'm ploughing old ground, I'm currently mobile and can't look up your details. Would you mind providing the following as I'm scheduled for my 2nd round on February 2nd.

General Information

• Date of T Onset:
• Cause of T (if known):

1st set of injections

• Date of First Injections:
• Do you suspect placebo or AM-101:
• Loudness (on a scale of 1-10) prior to the first set of injections:
• Annoyance (on a scale of 1-10) prior to the first set of injections:
  
  
• Loudness (on a scale of 1-10) at the end of the first injection cycle:
• Annoyance (on a scale of 1-10) at the end of the first injection cycle:

2nd set of injections

• Date of Second Injections:
• Loudness (on a scale of 1-10) prior to the second set of injections:
• Annoyance (on a scale of 1-10) prior to the second set of injections:
  
  
• Loudness (on a scale of 1-10) at the end of the second injection cycle:
• Annoyance (on a scale of 1-10) at the end of the second injection cycle:

3rd set of injections (if applicable)

• Date of Third Injections:
• Loudness (on a scale of 1-10) prior to the third set of injections:
• Annoyance (on a scale of 1-10) prior to the third set of injections:
  
  
• Loudness (on a scale of 1-10) at the end of the third injection cycle:
• Annoyance (on a scale of 1-10) at the end of the third injection cycle:

 

@OddV
Until you get a full reply from earsnothappy and Chelovek I hope the below may help a little bit:

@Chelovek got his T in november 2013 and he had his first set of injections in October 2014 and is so far reporting a lot better.
@earsnothappy got his T in May 2014 and had his first set of injections in July 2014 (in which he reported big improvment) He had his second round of injections and at his three month mark now is reporting it to be worse than before but not sure if he means since his T started or since the first lot of injections but before the second lot of injections (as is not clear in what he wrote).

How are you?
I am lost...........getting worse.......

 

@amandine I'm doing better... My annoyance continues to be lower (a 2 or a 3) and I've stabilized at a 5 on loudness... If I'm busy, I don't pay attention to it... I'm also practicing @I who love music's back to silence technique.

I want to get the next round to kill another 20% but now @earsnothappy experience is freaking me out a bit.

 

Me too!! And the only person to have reported that their T is much better is @Kathi who has not once reported in the AM 101 thread.
If you are much better then I dont know why you would let someone elses report bother you........although I wonder how much of that is better through the injections or through habituation cos you have a busy and satisfying home life to help you concentrate on other things and not your T all the time.
Sadly I have not a happy life and think about the T 24/7 and sit on this forum every day like a drug addict.
I have tried the i who love silence stuff but it doesnt seem to make any difference to me.
I sometimes think that I am habituating and that it is going to be something I can get used to and then it goes up again.
I stopped with the panic stage and then it started again.
I wasnt able to sleep and then I was and now I am not again.
Jeez, I just dont know what to do.
But I can go for the trials here in france but I dont intend to stay in france. So if i do the trials here it will mean I have to keep coming back to france for the following year every three months....
Would prefer to do the trials in UK ......but going back there is very difficult cos nowhere to live except a studio flat in London which could be a killer for me.
Otherwise have to live in motorhome which if not for T would really not be a problem for me.
Non supportive drunken partner.......very unhappy and boring lonely life here with huge money problems plus I have to sort out all the problems here as I am the only intelligent one between me and my partner....and the only one who speaks french.....
You have reported that it has made your T much better and that gives me hope....but so many others have reported it to be the same or worse plus the ten per cent chance of worsening just from the injections....
Havent got a clue what to do and no one to talk to about it either........really need some help.......
anyhow going off the thread cos this is about am 101 which continues its trials......ongoing......here in europe....
but am happy for you that you are doing better!!!

 

@OddV

To finish what I was saying...the only people to say got moderately better are @Ilija and @Chelovek...
@Ilija is currently still experencing problems according to her posts and their is no record of her am 101 participation..... plus she also said that she had very low T to begin with.
@Chelovek you know about
@James White who had one injection and didnt carry on says no difference
the other reports are all negative.
@Laika has reported that her T has gone down 70% since her first lot of injections!! She also said she was having her month checkup on around the 19th January but cannot see a promised post from her either.....(her report is on page 10 of this thread if it is of any help to you)
Just all seems to be a waste of time this thread cos no continuity apart from a few like you....and so grateful for this OddV
Anyone else seems to have disappeared but we dont know why so cannot assume it is cos they are better.
Sigh......no help and no support and no future like this.......hardest time in my life now...........

So I guess what I am saying @OddV is this: Are you absolutely sure that the injections did you good and caused your improvement? I just need some definite answers from someone to tell me yes or no.......

 

How on earth can he say that when it's a placebo controlled trial?

 

@amandine I wish I could give you the definitive answer that you are looking for, alas, I cannot... I've posted everything that I can, my thoughts that I suspect that I received the placebo and have naturally habituated... I know it's a scary proposition, but I'll say this... Most everyone has gone back to baseline after the 1st set of injections, so the worst you can probably expect is a 2 week spike... Is that worth it to you for a shot at a reduction?

 

@OddV @amandine

To clarify. After my second round of injections, my tinnitus has returned to near the level it was before I started the trial as a whole. This is a more recent development after the trial concluded, as when I finished the trial for the 2nd round I felt as if it was still better than it was before I started. I no longer feel that way as my tinnitus volume has increased since.

I don't want to discourage anyone from participating as I know some people have had a great response to AM-101. I'm just stating how things went for me.

 

Hang in there A. I have suffered so bad yesterday over the computer listening to crickets on youtube. No sympathy anymore from noone in my family. Just feels so alone and helpless. I am in there with you. Don't let it get worse. Get an mp3 player and get some cricket or other nature sounds on their to mask the tinnitus. This will help you get through the tough days. I have been using this method faithfully since this damn noise damage that started this to me on July 4, 2011.

It gets better, but we need to fight it with out imagination.

 

enrolled on am101 today

happy to answer any qs

 

Congrats Sergerold.

What is the status of your Tinnitus rating going into the AM101 Trial? That is on a scale of 1-10, 10 being worse where do you average and how does it change day over day? Also, does it affect you emotionally enough to cause stress and axiety?

All this is important to know for us going into the trial. If you have a moment, we would love to hear about this before you go in for your first injection. Also, can you provide some detail on your trial schedule and if you will be able to keep us posted regularly? I would like to follow you on this thread as i am sure so many others will. Also, please be sure to make a selection from the selections at the top of this thread when the time comes for all of our benefits.

Thank you.

 

Sorry if I did not answer the long questionaire someone posted but it was just a bit too time consuming. Don't stand at the side of the pool shivering and scared, dive in. It has been five days since my second round of injections. The spiking has reduced quiet a bit. I do not know yet if I will get further tinnitus level volume drop like on the first round in October but I have always been a positive person and always have a go at something once I have assessed the possible outcome. I am hoping it drops another 25% or so because it was quite a tiring week with a lot of driving and very early starts. I am lucky to get full sick pay though. If I do get another volume drop I will defo keep going for round 3 in April 15. I noticed my tinnitus got to the lowest of the drop just a few days before my second round. Approx 80 days after the first round so that was interesting. Also to remind you the time when I noticed the biggest drop in volume was after 4 weeks from injections, which was interesting because another guy had mentioned 4 weeks as his main level drop too. I will keep you posted. I am also very interested in the Autofony results when they materialise. My ideal would be to get done and dusted with AM 101 but if it does not fully do the job then maybe a few Autofony tablets swallowed with a bacardi and coke and bag of crisps will finish it off? We will see - Chelovek (человек).

 

LOL thats how I'd take my first dose of autifony tabs.....but I'd go with a jack and coke!

 

Off for round 2 tomorrow, wish me luck.

I won't be posting a blow by blow like I did in round 1...if anyone has questions, I'll answer them in this thread.

 

I'm sitting in clinic having just officially finished TACTT2.

The problem is, I view tinnitus as two parts... The loudness and the annoyance.

From a loudness perspective, I had slight improvement... From an annoyance perspective, I've had significant improvement... So, I guess if I average the two, I had moderate improvement.

Problem is, I was really hoping for a larger drop in the loudness.

I'm going to ponder this the rest of the day.

T-3 hours until round 2.

 

I've decided to vote as slight improvement..... I weight the loudness component slightly more than the annoyance component.... As stated above, I'll answer specific questions but otherwise will not post again on my thoughts until the end of the 90 days for round 2. I did receive first injection of the real AM-101 today.

Starting off point for round 2:
Loudness = 5
Annoyance = 2

 

@OddV Good luck! Must feel good to know you are getting the real deal.

 

I know, I know... I said I wasn't going to provide commentary, but I did want to get some differences published.

1) I had my first injection on Monday
2) Tuesday, I woke up with a very full feeling AND muffled sounds
3) I flunked my hearing test on Tuesday...had a -70 dB loss at 8 kHz ... It was -30 the day before... Also, redness and swelling was greater than last time... The doc urged me to not take the 2nd injection and I agreed
4) Tuesday evening, I literally had AM-101 pouring out of my ear... The full feeling and muffled sounds decreased by 75%
5) I woke up this morning with tinnitus at a low 4 or a high 3... I have never had T this low in the morning
6) I passed my hearing test today and got 2nd set of injections, perhaps I'm being overly optimistic, but my tinnitus seems lower after this round as well.... I go back for 3rd injection tomorrow.

I think they missed a spot on my eardrum when they numbed it today, it was quite painful with the control hole... Injection site was fine.

 

@OddV Great information, thanks for the update. I think your updates would be helpful because as far as I know, you are the only one here currently getting the "real deal" drug. I'm especially interested to see if it is efficacious for you in their "post acute" window. Given this method plus the news about OTO-311 that @attheedgeofscience posted earlier today, I'm interested to see how the intratympanic injection works for effectiveness. It seems like from the surface that targeting the cochlea would not be as effective given where the science is going with "how" tinnitus happens but it is interesting that this is still a target of medication. Here's to hoping OTO-311 starts some US-based trials in 2015 like they said they would in that letter.

 

I would suggest staying away from this drug. It is definitely not safe, as no drug is safe that hasn't been on the market for at least 2 years. It can make your T worse and for me, I believe it has screwed my vision as well. Horrible because I am in extreme suffering every day. When you go through the trial they check your eye's for astigmatism which they never explain why because they don't have to. There was one session after I got the real drug when they were checking my eyes when the doc said it was difficult to tell whether I had them or not. My vision had always been perfect before the trial and now it is extremely wavy and getting worse. I had my eye checked by an advanced ophthalmologist who said I had 20/20 vision and that my eyes are completely healthy. He could give me no answer nor was interested in telling me about my wavy vision. I am seeing a neurologist in 2 months so I hope I make it that long. My vision does seem fine if I cup one of my eyes but when both are open, straight lines look wavy, looking at stacks of books is a nightmare and if someone is wearing a striped shirt it is horrendous. Hope this helps, as I fully believe this is no cure and far from it. I know we want help, but if I had to do it over I would have never participated in this trial. I'll be gone for a week so sorry if I don't answer any of your questions and before asking, please read my previous post in this thread.

Before doing anything drastic when you get T, I would focus on lifestyle changes that are going to provide a healthier life. Being healthy can dramatically reduce the effects T has on your life. Just when my T doesn't bother me much anymore, my vision is suffering and I am left with no help... helpless and suffering...

Thanks,

 

@Mikey Cliff what test did they run to check for astigmatism? Yours is the first report to mention this.

 

It's a light test, they put goggles over your face and look into your eyes

 

@Mikey Cliff

They're not testing for astigmatisms. They're testing for involuntary eye movement (Nystagmus).

The condition I think you may be having is a CSR (Central Serous Retinopathy) which is basically the swelling of the retina. This is usually brought on by stress.

http://en.wikipedia.org/wiki/Central_serous_retinopathy

The wavy lines is what makes me believe this is what is going on with your vision. A quick test is to look at a grid. Look at it with one eye closed and then switch eyes. If the lines are wavy in one eye, then that's the eye that's having the CSR.

If you have a CSR, I'd recommend seeing a different eye doctor. Tell them you believe this is what you have so they'll know what to look for when they look in your eyes.

Also, and I know this is easier said than done. Do everything you can to manage your stress. Just try to be zen about everything. Keep yourself relaxed.

 

I am still alive, I had my second round of injections about a month ago and it was completely different than the first time. So much better. I now only hear my T if I am in a quiet place or I think about it. I definitely think the drug has something to do with this as well as habituation.

 

Good to hear from you! So glad to know you are doing fine.
Very happy to get your report on this trial. Please New Guy will you stay with us now = dont be a stranger.

 

I was watching from a distance; ) . I thought it was best for me to not think to much about this and it worked well. Most days I feel 100%. I will do better to keep up, going back tomorrow for a 30 day check up.