AM-101 Clinical Trial — Participants Updates and Discussion

[Hopeful1]

@linearb
Yes i know..just anxious as this is my only chance of having my life back

 

[linearb]

@linearb
Yes i know..just anxious as this is my only chance of having my life back

Nah, you're probably going to be fine, horror stories aside. In my real life I know a good number of people with NIHL and tinnitus who aren't bothered by it and still go to concerts and shooting ranges; I've also known a number of people who had increased tinnitus after a concert or loud event, took care of their ears, and had their tinnitus settle down or resolve over the following 6-12 months. Despite knowing a large number of people with tinnitus, none of them have ever bothered to post on this forum, and none of them have struggled with the issue to the same degree I have.

What I'm saying is that tinnitus itself is much more common than having one's life totally upended as a result, so if you're someone who can go with the odds, the odds are that you're not going to be stuck struggling with this forever, one way or another, no matter what happens as a result of the AM-101 trial. It's very easy to find worse-case scenarios to try to compare out to, especially if you're looking at internet posts (which inherently come from the self-selected group of people who struggle significantly with tinnitus, since people who do not struggle with something aren't very likely to write about it) -- I think it's a more productive use of time to find best-case scenarios to compare out to, or to simply not engage in such comparisons.

 

[Hopeful1]

@linearb
Thanks for the positive reply.....i am the type who is very carefully in everything....fit and healthy....irony is that i got H and then T eventhough i was wearing 25db earplugs when exposed to loud music....and i now blame myself ever going to salsa partys.....trying everything i can to get better and not regret

 

[Sebastians]

Well good luck with the am101. Did you get a slightly numbed feeling in your face or tongue after the shots? Some people, myself included have reported this and it might denote you got the real stuff..
Improvement will come after a few weeks to one month based on anecdotal evidence. You are lucky you got the shots so early after onset..

 

[dan26]

I emailed the company and they said they know about people who have long term chronic tinnitus such as myself but i guess they are working on things for the short term, then the long term? i dont understand. I've had T for over 30 years!! Need relief!

 

[Alue]

I emailed the company and they said they know about people who have long term chronic tinnitus such as myself but i guess they are working on things for the short term, then the long term? i dont understand. I've had T for over 30 years!! Need relief!

Unfortunately AM101 mostly seeks to treat excitotoxicity in the cochlea, which is probably only present for the few months(?) after tinnitus onset. After a certain undefined amount of time tinnitus is seen as more of a neurological problem which becomes harder to treat.

 

[lonestar651]

Well good luck with the am101. Did you get a slightly numbed feeling in your face or tongue after the shots? Some people, myself included have reported this and
might denote you got the real stuff..
Improvement will come after a few weeks to one month based on anecdotal evidence. You are lucky you got the shots so early after onset..

The Numbness does not indicate whether you got the real thing or not I know that was floating around here for a while but it does not mean that if anything it's the freezing going through the sinuses.

 

[Hopeful1]

@Sebastians
I dont have any numb feeling and by this morning the spike has gone as well and its like before the injections. So is wondering what i got. If this is a placebo that i got i will get the med 4 months after onset...so not sure if it works by then..also i read AM only worked for some rats not all when they injected after 2 days of onset....so you got right person to respond to AM 101

@dan26
The audiologist told me that it is difficult to get the drug approved..so AM is focussing on below 3 months as this the best chance to get approval. Once its approved chronic T suffers will try and see what happens.

 

[Hopeful1]

I had 3rd injection of am 101 or placebo......as expected i have a spike as ears blocked.....will update if have any changes in my H and T

 

[Hopeful1]

4 days after my last injection i still have the spike in my right, how long did the spike last for you guys?

 

[Sebastians]

4 days after my last injection i still have the spike in my right, how long did the spike last for you guys?

Three weeks for the major spike, then an extra week for it to settle down. Don't get scared, it will pass.

 

[AWilson32]

Have been invited to AM101. Agonising over whether to accept.

On one hand, I dread a post-injection spike and related side effects. I really need to know more about its efficacy. Also I'm quite reliant on my maskers which are apparently prohibited during the trial.

Yet on the other, I've had T for 3 and a half months now so don't think I can afford to wait any longer ?

It feels like this is my last straw to clutch. Appreciate any feedback.

 

[Sebastians]

You got T from gastroenteritis and yet they invited you for the trials? To my knowledge, only people with T from noise trauma or otitis media were allowed..

Then again, if i may quote you from your first post:
'I cannot live with myself if this is permanent, I'd take even a 50-60% reduction at this stage.'

So why wouldn't you? The spike is only temporary, mate

 

[Hopeful1]

Please check Auris Medical website and check the publications section to see phase 2 results....i think some people respond to it others dont....same with rats when they tested....lets say 60 percent chance that you get medicine and 50% Chance it works for you. It might be 30% chance of improvement if you take your chances.

 

[TC426]

Overview of past updates:
24 hours after last injections
1 week after last injections
1 month after last injections
2 months after last injections
3 months after last injections

So, my one-week update - which is in fact almost a two-week update by now.
I wanted to wait a bit as things have been very uncertain for me.

After the second injection set, I experienced a massive spike in the right ear only. So massive that I was scared that something went really wrong. Over the first 4 days, the increase was permanent and on a never-seen-before level (approx. 8/10). Then it came down (to 4...5/10) for two days, only to rise again to a 6...7/10 shortly after. Moreover, I have felt an additional hearing loss on the right ear only.
During the entire time, my left ear was very peaceful.

End of last week, I had the regular 1-week checkup. The hearing test did not indicate the perceived hearing loss. In fact, my right ear seemed better off than my left ear. However, the dynamic resistance measurement of the eardrums (in lack of a better name, that's how I call it) supported my feeling, that the injections did not quite go according to plan. My right eardrum is deflecting way beyond normal. The doctor says, this could be the cause of my spike, and that these issues should dissovle after some time. He seemed a little concerned though. Naturally, I am worried too. After all, my stereo hearing is affected and my right ear is much more prone to random T triggers (in my case: Computer, TV, office) than before.

Since last weekend, it's been an up and down. I have even had "spikes on top of the spike". Once during the night (woke me up, lasted till the morning), another one lasted for 24h before dissovling gradually. Very hard to get my head around, as it's constantly changing.

On the other hand - I had almost complete silence today. Not 0/10, but <1/10. With the long weekend, I had time to relax a bit at home, do some sports and avoid loud environments. This is the second time since the injections that I experience this kind of silence, and it feels like Christmas and birthday at once

I will see how things develop over the next 1-2 weeks. Given that the physical issues on my eardrum heal, I am guardedly optimistic that this may actually turn out well after all (expect from a few grey hair more)

Will keep you posted!

 

[AWilson32]

You got T from gastroenteritis and yet they invited you for the trials? To my knowledge, only people with T from noise trauma or otitis media were allowed..

Then again, if i may quote you from your first post:
'I cannot live with myself if this is permanent, I'd take even a 50-60% reduction at this stage.'

So why wouldn't you? The spike is only temporary, mate

Thanks for the reply. I'll clarify that - I came down with gastroenteritis in late Jan. I wanted to take my mind off things and plugged in my earphones for an hour.

Ever since then my ears haven't stopped ringing. I have used earphones heavily in the last few years, at stupidly loud levels occasionally, and I think looking back that's what came back to haunt me. I'm still angry with myself for being so careless.

I'll get in touch with them tomorrow. Thanks guys for the replies.

 

[AlexSongitus]

Overview of past updates:
24 hours after last injections
1 week after last injections
1 month after last injections
2 months after last injections
3 months after last injections

So, my one-week update - which is in fact almost a two-week update by now.
I wanted to wait a bit as things have been very uncertain for me.

After the second injection set, I experienced a massive spike in the right ear only. So massive that I was scared that something went really wrong. Over the first 4 days, the increase was permanent and on a never-seen-before level (approx. 8/10). Then it came down (to 4...5/10) for two days, only to rise again to a 6...7/10 shortly after. Moreover, I have felt an additional hearing loss on the right ear only.
During the entire time, my left ear was very peaceful.

End of last week, I had the regular 1-week checkup. The hearing test did not indicate the perceived hearing loss. In fact, my right ear seemed better off than my left ear. However, the dynamic resistance measurement of the eardrums (in lack of a better name, that's how I call it) supported my feeling, that the injections did not quite go according to plan. My right eardrum is deflecting way beyond normal. The doctor says, this could be the cause of my spike, and that these issues should dissovle after some time. He seemed a little concerned though. Naturally, I am worried too. After all, my stereo hearing is affected and my right ear is much more prone to random T triggers (in my case: Computer, TV, office) than before.

Since last weekend, it's been an up and down. I have even had "spikes on top of the spike". Once during the night (woke me up, lasted till the morning), another one lasted for 24h before dissovling gradually. Very hard to get my head around, as it's constantly changing.

On the other hand - I had almost complete silence today. Not 0/10, but <1/10. With the long weekend, I had time to relax a bit at home, do some sports and avoid loud environments. This is the second time since the injections that I experience this kind of silence, and it feels like Christmas and birthday at once

I will see how things develop over the next 1-2 weeks. Given that the physical issues on my eardrum heal, I am guardedly optimistic that this may actually turn out well after all (expect from a few grey hair more)

Will keep you posted!

Wow talk about a swing of extremes. From 8/10 down to near silence. Huge. I'm sorry you had problems with the procedure and hope it heals up in time back to normal but it's encouraging to hear you are experiencing some good days even if far between.

 

[Kent Sabo]

Long overdue update from page 12 on 2/20/2015.

AM-101 didn't help my tinnitus, but at least the volume has returned close to pre-treatment levels. The spike following the second set of injections lasted nearly 2.5 months for me, so I do have regrets about participating.

I'm tolerating my tinnitus fairly well these days, so that's a good thing.

I wish everyone else good luck!

 

[Hopeful1]

I just started hearing pulsative tinnitus in my right ear......may be some water went in the ear frum during shower ...i am freaking out ...please help

 

[Sebastians]

Relax man, i had some short-lived PT after the third set of injections and some other people had it too. It will go away. Your ear took quite a hit with all these shots and is now in healing mode. Buckle up and ride it out!

 

[Hopeful1]

@Sebastians

Thank you its actually is https://en.m.wikipedia.org/wiki/Patulous_Eustachian_tube as i hear my breathing.....anyone apart from you also experienced after the injections? as i dont remember reading this as a side effect

 

[Hopeful1]

And I had two 500ml bottles of diet coke today.....so caffeine did not help it

 

[Alue]

I just started hearing pulsative tinnitus in my right ear......may be some water went in the ear frum during shower ...i am freaking out ...please help

I had some PT in one ear after my first round. Its likely just things healing, lots of blood flowing in that area.

 

[philipb]

From what I read on the website, trials seem to be progressing nicely, but its still quite obscure and hard to find information about it. I have a few questions, as it seems promising.

Has anyone participated in the trial?
Will the drug only be for new tinnitus cases?
Is it close to being finished with trials?
Rough time on it being released to public?

Thank you in advance.

 

[Mario martz]

i have a question about am 101,
the results are permanent or just temporary?
also.... if you "expose" to loud noises....
you are back to baseline?

 

[Bobby B]

Long overdue update from page 12 on 2/20/2015.

AM-101 didn't help my tinnitus, but at least the volume has returned close to pre-treatment levels. The spike following the second set of injections lasted nearly 2.5 months for me, so I do have regrets about participating.

I'm tolerating my tinnitus fairly well these days, so that's a good thing.

I wish everyone else good luck!

You wrote that your t is most likely due to hypothyroid issues - makes sense that am101 isn't going to have a major benefit

 

[Hopeful1]

@Alue
Thank you.....how long did you have the PT for? Did it sort in a few days..

 

[Sebastians]

From what I read on the website, trials seem to be progressing nicely, but its still quite obscure and hard to find information about it. I have a few questions.

http://www.tinnitus-study.info
And this thread..

 

[Pleasure_Paulie]

Is there anyway to get on these trials if you're not from the country where they offer it?

 

[AlexSongitus]

Is there anyway to get on these trials if you're not from the country where they offer it?

From talking to just a couple of other members that called and asked that question, I don't think so.