AM-101 Clinical Trial — Participants Updates and Discussion

[OddV]

I did have catastrophic hearing loss up around 8 kHz after my first injection of the real stuff... Doctor asked me to skip a day... I was back to my baseline by the 3rd day.

I have to echo @NewGuy's sentiment... "I would rather live knowing I tried than live regretting that I didn't do anything when I had the chance."

 

[Romain B.]

@NewGuy
@OddV

I have to give you a BIG THX !! You made my day..
It's perfectly how i see it deep inside me :
"I would rather live knowing I tried than live regretting that I didn't do anything when I had the chance."
It's just what i needed.. some people to bring it back to the surface..
Read those words from someone else has shut my inquiries down and comfort me in the decision to do it.. there is no way to have regret plus T in your head to remind you that you had maybe a chance to keep it quieter.

Definitely thanks to have pointed out this kind of reflexion that in an unconscious way i was looking for.

No way to live with regret and the "if i had.."

big thanks both of you.

Hope the third set of injections will give you more relief.. and silence !!

 

[tomm]

@Romain B.

Spike for 2 weeks, then moderately quieter than before. I'll be doing all three further rounds.

 

[tomm]

Are talking about synaptic connections between hair cells and neurons? https://www.tinnitustalk.com/thread...ugh-increased-nt3-production.6563/#post-71886
Although this is connected to hearing loss... maybe I 'm wrong. If not, we should boost NT3 production within 6 months! I am at 6 months and 2 weeks!

Also, acording to your info, AM-101 should work on chronic sufferers.

I was eating very large quantities of vit-D3 for 3 months. Didn't do much, although I know nerves take time to grow.

 

[amandine]

My own reasoning is that Tinnitus may be a complicated thing and the 6 months 12 months 18 months intervals that are given are just alleged significant periods by the trials that suits their needs.
Why 6, 12, 18 months and not 2 and a half, 7, 11 etc? Nice round numbers, like it is calculated! I dont buy it.

No sorry I didnt explain myself well - sorry. I mean when you said that in that case it should work on chronic cases according to what Grandfunk1 said.
I didnt understand that bit....why it should work on chronic sufferers in that case...

 

[chase.j]

I am all for what that doc said but it is much different than what Auris medical says "who is the manufacturer of AM-101": Acoustic trauma and other insults to the inner ear may trigger increased levels of extra-cellular glutamate, which in turn cause excessive activation of cochlear NMDA receptors. This process results in damage or killing of sensory cells and is thought to be responsible for abnormal spontaneous "firing" of auditory nerves, which may be perceived as tinnitus. Under normal circumstances, the NMDA receptors are thought to play no role in fast excitatory neurotransmission, respectively normal hearing. AM-101 is blocking cochlear NMDA receptors to suppress the aberrant excitation of the auditory nerve that is perceived as tinnitus.

 

[Romain B.]

@tomm

Big Thx for the quick answer and your feelings regarding Am-101 !! it's giving me confidence .. I will stick to the am-101 ship to sail on that T sea during the next months !! Thx

 

[skoupidis]

@Romain B. I'm glad I did the 2nd set and I'm about 70% sure I'll do the 3rd set.

It's helped me... Cured, no... Habituated and a lot quieter, yes.

Whole reason I did it to begin with was to get the guaranteed drug after the 1st set.

So, after a shot with the real thing you feel better, the T is lower and you habituate? Waiting your report after the 3rd shot (when will that be?).

 

[skoupidis]

No sorry I didnt explain myself well - sorry. I mean when you said that in that case it should work on chronic cases according to what Grandfunk1 said.
I didnt understand that bit....why it should work on chronic sufferers in that case...

Well, here is your answer:

...Tinnitus is believed to be caused by nerve fibers that have been detached, from trauma/other ways and that they can reattach with time, and after roughly 6 months when tinnitus is considered chronic, they can no longer reattach. ... I understood what was said to me, for the nerve fibers that don't reattach, AM-101 is suppose to suppress the auditory firing they cause.

After the period they consider to be 6 months, the tinnitus becomes chronic, that is the nerve fibers cannot reattach. And the AM-101 is to suppress their firing...
I cannot explain it much further, according to these, AM-101 is for chronic sufferers!
Unless there is more to it that meets the eye, or grandfunk1 misunderstood them.

 

[grandfunk1]

I hope i understood him right and gave you guys the right information. He did say there was a window of time for AM-101 so i dont know if that meant it gets burnt in the brain or something else happens, i dont know.

 

[Sharpfire]

How did you guys sign up for the trial? I registered on the website weeks ago but haven't heard back since. Should I just give them a call?

 

[skoupidis]

I hope i understood him right and gave you guys the right information. He did say there was a window of time for AM-101 so i dont know if that meant it gets burnt in the brain or something else happens, i dont know.

You didn't mention this before, from what you said before, no window was mentioned. How much time is it?
How do they know about the window? Did they tested the drug for long time patients?

I guess we can only wait, these are really important questions and I don't know even if they are able to answer right now.

 

[OddV]

So, after a shot with the real thing you feel better, the T is lower and you habituate? Waiting your report after the 3rd shot (when will that be?).

3rd set would be end of May. Yes, I feel better after the real thing... I've experienced a few moments of complete silence, alas, they haven't "stuck".

I would be remiss if I didn't mention this to those of you getting ready to sit in the chair for the first time.

1) 1st set...take someone with you... After the first set you'll be able to do it on your own
2) take a stress ball (use it during injections)
3) take a travel pillow (lay your head on it during injections... You've got to lay there a while)
4) take entertainment (tablet, phone, book, computer, something to help you pass the time, you're going to be in "your" clinic for a while)
5) breath in through your mouth and out through your nose... Control your breathing... It's over quickly... The "thought" of it is worse than the reality

Not trying to scare anyone, but just some tips I wish someone had given me before I went the first time.

 

[Romain B.]

@Sharpfire

You must give them a call at the location nearby you !! ask for a rendezvous ! email them etc.. just don't wait an answer ! Call buddy call !

 

[Romain B.]

@OddV

Thx for the tips !! i was also thinking to take a pillow to keep the head down, to not loose one sip of this drug !! Much more confortable i guess !!

 

[Sharpfire]

@Sharpfire

You must give them a call at the location nearby you !! ask for a rendezvous ! email them etc.. just don't wait an answer ! Call buddy call !

Seems like I've been accepted on to the trial after calling them. Will keep this thread updated with progress.

 

[OddV]

My last follow up for the 2nd set of injections is on April 28th. I've let the clinic know that I'm 70% likely to do the 3rd set. My coordinator is setting up those injections for April 28th, 29th, and 30th.

My T is not gone, but I'm able to handle it much much better. It is lower, I think I'd rate it at this point a 3 or a 4. I've had a few days of high annoyance, but I know that those days I was very stressed, which is a definite trigger for me.

 

[Joel86]

I've had T for one week now. It came on in my right ear as a mechanical buzzing but then shifted into a high pitch squeal the next day. The very next day, I woke up with the same mechanical buzzing in my left ear and now it has shifted to a squeal as well. It's constant. I'm now tapering off Prednisone and still taking antibiotics. Someone told me to check out AM-101 and there is a trial place only a few miles from me. They're ready to screen me and do injections, but I'm pretty nervous about it. I'm already a hypochondriac, and I know that it won't be a comfortable procedure, and no gaurantee I'll even get the drug for the first 90 days, or that I'll ever know that I did. With the emotional state I'm in already about my T, I would hate to make it worse with a few more days of worsening T or hearing loss. I haven't even seen an ENT yet. Should I wait to do the trial for another month or so and see how my T progresses?

 

[Rube]

I've had T for one week now. It came on in my right ear as a mechanical buzzing but then shifted into a high pitch squeal the next day. The very next day, I woke up with the same mechanical buzzing in my left ear and now it has shifted to a squeal as well. It's constant. I'm now tapering off Prednisone and still taking antibiotics. Someone told me to check out AM-101 and there is a trial place only a few miles from me. They're ready to screen me and do injections, but I'm pretty nervous about it. I'm already a hypochondriac, and I know that it won't be a comfortable procedure, and no gaurantee I'll even get the drug for the first 90 days, or that I'll ever know that I did. With the emotional state I'm in already about my T, I would hate to make it worse with a few more days of worsening T or hearing loss. I haven't even seen an ENT yet. Should I wait to do the trial for another month or so and see how my T progresses?

They accept applicants up to 90 days after T onset, maybe you might want to wait a few weeks to see if it resolves on its own. Additionally if you don't get the drug during the actual trial they will give you the actual drug afterwards. I can't give any advice to help you decide but maybe some of the participants can or you can read through the thread and the participant experience thread.

 

[OddV]

@Joel86 do you know what caused your T? They'll want to know.

If I had know then what I know now, I would have tried to get on the trial earlier.

Once you go for screening, you have to wait two weeks prior to injections... So, go to the screening and then you have 2 weeks to make up your mind to see if it gets better.

My $0.02.

 

[Joel86]

I don't know for sure what caused my T but my gp treated me for an ear infection and saw fluid behind the ear drum.

 

[NiNyu]

and no gaurantee I'll even get the drug for the first 90 days, or that I'll ever know that I did.

Then I wouldn't do it. Getting injected through the tympanic membrane with a placebo.. is a no-go for me.

 

[OddV]

Then I wouldn't do it. Getting injected through the tympanic membrane with a placebo.. is a no-go for me.

But you're guaranteed the drug after the initial injection.... 10 seconds of pain vs. a chance that it works for you.

I've sat in the chair... Yes, the unknown can be scary, but an injection through the tympanic membrane is not something new... They've been doing it for a long time.

Don't discourage him from going to the screening just because a shot sounds scary. I've had 6 now and will probably end up with 12 within a year by the time I'm done.

 

[skoupidis]

But you're guaranteed the drug after the initial injection.... 10 seconds of pain vs. a chance that it works for you.

I've sat in the chair... Yes, the unknown can be scary, but an injection through the tympanic membrane is not something new... They've been doing it for a long time.

Don't discourage him from going to the screening just because a shot sounds scary. I've had 6 now and will probably end up with 12 within a year by the time I'm done.

That's a lot of shots. How many of them was the real drug for certain?

 

[OddV]

Everything after the first 3 is guaranteed real drug.

 

[skoupidis]

Everything after the first 3 is guaranteed real drug.

I hope you do see real improvement and go upto 12 to eleminate your T if possible. Isn't that a lot for the eardrum to take? Will it heal properly?

 

[OddV]

Ear drum was fully healed at the 7 day check up

 

[NiNyu]

But you're guaranteed the drug after the initial injection.... 10 seconds of pain vs. a chance that it works for you.

Don't discourage him from going..

Time is of the essence here!

That being said, injecting through the eardrum is an invasive treatment considering you might end up with nothing. A placebo. Personally, I think they should have conducted this study without placebo. They would have attracted way more participants. Of course, with pills it's a different story.

 

[OddV]

1st, they are attracting participants despite the fact that it is an injection. Their biggest challenge is the inclusion criteria. There is a very small subset of tinnitus sufferers that can even get on the trial. I suspect that @Joel86 might meet that criteria, which is why I encouraged him, at a minimum, to go to the screening session. There is no commitment to getting the injections by going.

2nd, this is how a drug trial works... Having a placebo... It helps prove that the drug does or does not work.

Lastly, there is MORE than enough information in this thread, if anyone bothers reading it from the beginning, to make an informed decision for themselves to participate.

 

[Danny Boy]

Time is of the essence here!

That being said, injecting through the eardrum is an invasive treatment considering you might end up with nothing. A placebo. Personally, I think they should have conducted this study without placebo. They would have attracted way more participants. Of course, with pills it's a different story.

Well, AM-102 is basically pills, so go figure lol