AM-101 Clinical Trial — Participants Updates and Discussion

[attheedgeofscience]

I'm trying to make up my mind if this is worth the risk or not.

The saying goes: "...but in this world nothing can be said to be certain, except death and taxes."

If the statement by Benjamin Franklin is true, then everything else in life is assigned a probability between 0 and 1 (strictly speaking: 0 <= x < 1). Where on the "probability scale" the chance (= risk) of a "bad outcome" for the AM101-intervention falls, is something you need to decide for yourself. But the AM101 phase II trial results probably provide a fairly good indication (the trial paper has even interpreted the statistical results on behalf of the reader: "The study drug and I.T. injections were well tolerated").

The human mind has a tendency to "amplify" the probabilities of good and bad events (eg. winning the lottery, catching a disease). The current Ebola "crisis" in the US is a good example. I spoke with my Father a few days ago. He mentioned he had been to Spain with his wife and my younger brother. They - my Father's wife and brother - decided to cut the journey short because of the single Ebola-hospitalized nurse female assistant there (now released). If it wasn't so sad, I would have fallen over laughing - with cramps - because of that kind of decision making. A person going to any modern city in the world would have a greater chance of dying from Salmonella, a car crash, or slipping on a banana peel. But the human mind likes to draw attention to matters of fear: it is a survival instinct (from the past). But the survival instinct can also be(come) an enemy. The brilliant mathematician, Kurt Gödel, died from a fear of food poisoning. More specifically, he died from the fear that the food he was served in hospital would be infested with germs - he knew that all surfaces eg. tables, door knobs, and drinking glasses, and so on, would "automatically" be contaminated with germs. He starved to death because he wouldn't eat. He weighed only 30kg at the time of his death. Logically speaking, if you are going to die from starving, then why not take a chance and eat? After all, the worst thing that can happen is that... you die.

But the human mind is not logical and psychology is a part of any human being. The answer - if you want to call it that - to your original question is probably somewhat different than you had expected. I leave it - as an "intellectual exercise" - to figure out whether I think you should participate in the trial. Or not.

 

[OddV]

Thanks @attheedgeofscience not a tough riddle, you, of course would do so in my shoes, but I have YOUR history to go on to answer that question.

I had already decided to move forward with it, the window of opportunity is too small and I happen to fit in it... Never do I want to regret not trying it, and I would if I were not to do so.

 

[stelar]

The other way of looking at it is through the eyes of a guy who's been involved in tinnitus for some twenty years now and who has seen drug after drug with what truly looked on paper like real promise ... only to learn after all the studies are in that it's a bust. So viewing it that way - if 50% were my cutoff, I would take a pass.

hello dr.nalger, which drugs are you referring to, can you list them?
thank you.

 

[Dr. Nagler]

hello dr.nalger, which drugs are you referring to, can you list them?
thank you.

Furosemide, lidocaine, tocainide, carbamazepine, phenytoin, propranolol, nimodipine, pentoxifylline, clonazepam, gabapentin, acamprosate, the list goes on and on and on.

Each agent had its die-hard believers in its day. Each represented a new ray of hope to millions of tinnitus sufferers. Each made theoretical sense. And each came crashing down.

Let's hope the story will be different this time, OK?

Dr. Stephen Nagler

 

[kmohoruk]

It looks like more then ever that theres new hope in not only drug, but also physical therapies as well. Such as Vagus Nerve Stimulation, Re-teaching the brain etc...

I really feel that Tinnitus, Hyperacusis and many other auditory issues are going to be tossed to the fore front of medical research these days with my generation and our love for noise. iPods, Concerts, Clubs etc...

As it says on the American Tinnitus Associations website.... "It's a noisy world that we live in..."

 

[lapidus]

Furosemide, lidocaine, tocainide, carbamazepine, phenytoin, propranolol, nimodipine, pentoxifylline, clonazepam, gabapentin, acamprosate, the list goes on and on and on.

Each agent had its die-hard believers in its day. Each represented a new ray of hope to millions of tinnitus sufferers. Each made theoretical sense. And each came crashing down.

Let's hope the story will be different this time, OK?

Dr. Stephen Nagler

But none of those drugs were made to treat T. As far as I understand, AM-101 and AUT00063 are the first drugs ever aimed exclusively for T.

 

[Dr. Nagler]

But none of those drugs were made to treat T. As far as I understand, AM-101 and AUT00063 are the first drugs ever aimed exclusively for T.

OK.

But I'm still not holding my breath.

Like I have said on many occasions, I would love to be wrong about this.

And like I have also said on many occasions, what I personally believe the future will or will not bring does not have any bearing whatsoever on what indeed the future will or will not bring. It's just an opinion.

Dr. Stephen Nagler

 

[lapidus]

OK.

But I'm still not holding my breath.

Like I have said on many occasions, I would love to be wrong about this.

And like I have also said on many occasions, what I personally believe the future will or will not bring does not have any bearing whatsoever on what indeed the future will or will not bring. It's just an opinion.

Dr. Stephen Nagler

No, I'm not holding my breath either for AM-101. Even if it do work, it will only work in the really acute cases anyway and that boat sailed a long time ago for me.

 

[Mikey Cliff]

Update for me: I've had really 2 good days since my post. I relate it more to my psychological state. I don't think the T is any lower, I think I FINALLY got tired of listening for it and being upset about it 24/7. I would rate my day at work yesterday as a good day at work before I had T. This has been great, as I'm starting to get back to how I was mentally before I got the real drug.

 

[tshapiro]

OK.

But I'm still not holding my breath.

Like I have said on many occasions, I would love to be wrong about this.

And like I have also said on many occasions, what I personally believe the future will or will not bring does not have any bearing whatsoever on what indeed the future will or will not bring. It's just an opinion.

Dr. Stephen Nagler

Thanks for your perspective Doc. For me, personally, seems like a round of steroids and focusing on getting my head right (positive attitude) would be better than a potential 90 day placebo run followed by a potential real drug run. A factor in my thinking is that it seems acute cases (like mine) may have positive results from the body healing itself or adapting in a 1-3 month time frame. I'm going to hold up hope that I fall into that category. I'm, also getting better at my use of electronics (phone apps and ear buds) that let me blend sound on top of my conference calls (Android - Player Pro and White Noise app)... both let you blend sound over a phone call or other streaming music/talk shows.

 

[Dr. Nagler]

Thanks for your perspective Doc.

You are welcome.

A factor in my thinking is that it seems acute cases (like mine) may have positive results from the body healing itself or adapting in a 1-3 month time frame.

I think that a lot of newbies miss that important point. They seek information on the Internet and often wind up on support sites whose populations are largely comprised of the minority of folks for whom their tinnitus has not satisfactorily resolved over the first few months (or they wouldn't be seeking support in the first place!)

Dr. Stephen Nagler

 

[Marius T]

Hi guys i'm getting my 3rd injection done in a hour . Yesterday I've noticed that since the first injection I could hear the blood pulsation in my ears (heard it like 4-5 times only for 5-10 minutes), I've told it to the chirurgian who assure me that this is normal (due to the inflammation in the ear). I gotta say it's a bit painful (especially for the anesthesia) but pain is transitory

 

[Marius T]

this evening my t is way louder than before, but I know that this is normal because of the injections, so i'm alright .

 

[Matt h]

Hi everyone,
Just had a quick flick through some of these posts regarding Am 101 in i think i am further along than most i have had 6 injections to date no side effects at all no pain or issues with injections, can relate to other trialists and there spikes up to 2/3 weeks after injections but i have really felt the benefit in week 4 after both treatment phases i have had some great days in weeks 4 and 5 and am now looking forward to my next 3 injections in dec and then again in March, yes i have had bad days but would have to put a lot of that to stress from work for 3 rd set of injections i have booked 8 weeks off and intend to give the drug every chance of working which i have not done on previous trials but still had great results hope this helps !!

 

[Marius T]

Hi @Matt h , how did you get T, and why are you going for another set of injections ?

 

[Matt h]

Hi ,
I am having my third set of injections because you can have up to 4 including the first placebo or drug

 

[Davo]

Hello. I am new to this thread. My tinnitus has been improving with treatment. I am asking if anyone knows a factual/evidence based review of medications that increase tinnitus and a review of dietary issues/foods that increase tinnitus? Any links would be most appreciated.

 

[tomm]

Hello. I am new to this thread. My tinnitus has been improving with treatment. I am asking if anyone knows a factual/evidence based review of medications that increase tinnitus and a review of dietary issues/foods that increase tinnitus? Any links would be most appreciated.

Hi Davo,
AM-101 has been helping you? If you wish to discuss ototoxic medications, let's start another thread. Here is a large and (relatively) recent list of ototoxic chemicals.

 

[Davo]

Thanks, sorry for intrusion to your thread. Will follow up on link.

 

[amandine]

@NewGuy
You had your follow up last thursday 30th October. Was just wondering how you are getting along. Has the stuff come out of your ears yet, has the hole healed up yet, has your T subsided yet fm the intital spike following your injections and has all your fullness of ear and earache gone now?
How did the follow up appt go?
Hope you dont mind me asking and appreciate, as do all of us, your feedback.
thanks a lot and hope you are feeling ok

 

[RCP1]

Is there a confirmed case of AM101 that has worked yet?

 

[OddV]

Is there a confirmed case of AM101 that has worked yet?

I'm on mobile or I'd go look... several on the other AM-101 thread stated they thought it helped (@Fish comes to mind) plus some guy on REDDIT. Plus AM's own published paper from previous trials.

 

[amandine]

@NewGuy

Please can you post a report of how you are and how is yout T now?
Desperately wanting to hear from you but you seem to have disappeared
Really wanting to know if things are ok or what = going to ring Toulouse today to go on trials myself but needing to hear fm other people who have taken part as I have not yet heard that it is really improving peoples T that much.
Hopefully all the ear probs due to the injections have now sorted themselves out and also your ear durm has healed up
and hopefully your t is better
but just want to hear please
thanking you

 

[bedouin]

Hi everyone,
Just had a quick flick through some of these posts regarding Am 101 in i think i am further along than most i have had 6 injections to date no side effects at all no pain or issues with injections, can relate to other trialists and there spikes up to 2/3 weeks after injections but i have really felt the benefit in week 4 after both treatment phases i have had some great days in weeks 4 and 5 and am now looking forward to my next 3 injections in dec and then again in March, yes i have had bad days but would have to put a lot of that to stress from work for 3 rd set of injections i have booked 8 weeks off and intend to give the drug every chance of working which i have not done on previous trials but still had great results hope this helps !!

That is really great @Matt h. I go for my 2nd set of injections tomorrow so you have really given me hope. I have had almost no improvement in my t from my first set of injections. There was a point at maybe 4 / 5 weeks that i had a "quiet" week but it is back up now, averaging 7's, 8's and 9's depending on just what it feels like making me deal with day to day. That is one of the most frustrating things with t, is that i feel i have no control over it. I try exercise, change diet, sleep early all the things a "good boy" should do and still rings like a bast**d the next day!

Do you only have t in one ear and was your t from noise exposure? I see you and i, roughly got t at the same time. You a month more than me. So you are beyond the year mark now. You will have got the real drug at 11 months (t since onset), if your 3rd set are in Dec. It will be amazing if you get relief from am101 in your next 2 sets as you will be getting them at t=14 months and t = 17 months. That indicates efficacy post 3 months.

I hope it was placebo that i had in the first round and that tomm (real drug) i now do see an improvement after a few weeks or so.

What i have really missed not being able to do on this trial, is try anything else such as sleeping tablets or ad's (to help cope). My plan was to monitor 4 - 6 weeks after injections. If no improvement then I would throw in the towel on am101 and not opt for the 3rd, 4th or 5th set of injections.

 

[tomm]

I hope it was placebo that i had in the first round and that tomm (real drug) i now do see an improvement after a few weeks or so.

Quick update, the hospital has put my first set of injections back a week - Tuesday 11th Nov through Thursday 13th Nov (starting exactly 1 month after onset).

 

[amandine]

And @NewGuy seems to have disappeared! Please come back NewGuy and let us know how you are and how well (hopefully) you are doing....please!

 

[Marius T]

Got my injections done, and the spike seems decreasing. Didn't had any earache/pain or any specific issue after the injections, and the mysterious pulsatile tinnitus is gone. I hope it's not the placebo!

 

[OddV]

I go tomorrow after work to the trial site (3.5 hour drive) and will have my first injections on Wednesday at 2 PM ET (7 PM UTC). I've been told I will have a ~4 hour hearing test prior to the injections. Will update this thread as I can.

@NewGuy can you give us an update?

 

[bedouin]

My injections (2nd set - real drug) are at 16h30 UK time today. Both ears. Day 1. Day 2 and 3, Weds and Thurs. Will keep you all posted.

 

[DavidX]

To any of the current participants: Would you have still entered the study if your T could be managed by a benzodiazepine? I'm asking because I'm weighing the option of participating in the study and a benzo would take my T way down in volume.