AM-101 Clinical Trial — Participants Updates and Discussion

[Mirage]

Seeing as you got your tinnitus in ''mid 2015'' acording to your avatar, I guess that means June. I do not know if they accept patients beyond 6 months in the US.

Yeah, like I said... the timing is fuzzy. I've had periodic T for years... lasting only minutes (10 on the outside) at a time, maybe once per week at the peak.

Then just before the 2015 Christmas Holidays (Nov/Dec) it became constant. Loss of sleep and concentration, increase in my irritability, etc... so, I took a guess when I filled in my profile since I didn't have a real, single, "event" I could anchor it to :/

 

[Joe Bananas]

Same for me, I forgot it today. They accept you if you did 70% of diary entrys. So, no problem

Al final te meten los chutazos en Linares?

Are you getting it in Linares?

 

[Charlie396]

Well dudes, looks like I'm starting the screening process this Friday 2 hours away in some little town I've never heard of.

Add another (potential) human guinea pig to the list.

 

[Jeffrey F]

2-week update after Real drug (round 2)

Tinnitus from a 6 down to a 3.25

Small amounts of popping in my left ear have started up as of yesterday, but I took a long flight so that could be why.
Glad I stuck it out. Had no relief after round 1 as I believe I received placebo.

 

[liquefact]

This is awesome dude, giving me great hope.

It's been 3+ weeks since my last injection of the 1st round and my T is back to baseline, i'm even having days which T is lower than pre-injections. Still believe i got placebo as this reduction in my T is nothing compared to @Jeffrey F is experiencing after 2nd round. It may be just the natural slight improvement that's happening to some people.

 

[Bobby B]

4 1/2 days since injections. Ringing 5/10 from usual 3.5/10. My ears feel full and weird. Clicking and pressure sensation when yawning or burping. Occasionally feel ringing worsen with pulse. really frustrated by this. I've stopped going to class and sleeping has become difficult. Starting to become a little depressed unfortunately- im usually a pretty upbeat guy. I think it's Damn unfair that they give placebo to 40 percent of indivuals.

That's a bit confusing since he says 3.5/10 was his baseline before starting am101

 

[Jeffrey F]

That's a bit confusing since he says 3.5/10 was his baseline before starting am101

Well my tinnitus was a 2 when I started looking at AM 101. Then a 3 when I got accepted into the trial. around a 3.5 at my first injection, then continued all the way up to 6 before my first real injection of AM 101. I know people have this feeling that tinnitus always goes down, but that wasnt the case for me. I received a placebo I believe, and the natural progression of my tinnitus continued upwards during that time. I dont think the placebo shot caused the spike though, as it was like a month and a half after last placebo shot of AM 101 when my tinnitus raised to a 5 and then later a 6. It was a 5 for probably a week after the first placebo shot then settled down to a baseline of 3.5-4. I hope this makes sense.

TLDR
my tinnitus was a 3.5 before first placebo shot over three months ago
my tinnitus was a 6 before first real drug shot two weeks ago

 

[greenhopper]

Is there a chance to get in the study as a chronic tinnitus sufferer who experienced an acute worsening?

 

[Joe Bananas]

Is there a chance to get in the study as a chronic tinnitus sufferer who experienced an acute worsening?

Don't really know but, is your worsening due to acoustic trauma, barotrauma or otitis media? I have my first round of injections this next Monday morning. I can ask it to the doctor. Let me know it.

 

[Nucleo]

Is there a chance to get in the study as a chronic tinnitus sufferer who experienced an acute worsening?

I am pretty sure the presence of tinnitus since 2007 is an exclusion criteria, should you disclose it.

 

[liquefact]

Is there a chance to get in the study as a chronic tinnitus sufferer who experienced an acute worsening?

I believe this drug will work for people who had chronic T but it worsened lately because of some "additional" inner ear damage. In other words, any worsening in the acute stage could be undone (maybe partially) with esketamine. But i'm pretty sure this (having chronic T) will be an exclusion criteria for AM101.

 

[JohnK]

Seriously, can I drink on this? @OddV did you drink on this?

 

[kerryt]

Hi, first post on here. I completed the form for the AM101 trial, don't know if they are still taking on participants. I'm just wondering roughly how long after applying have the centres contacted participants?

Having a really tough time at the moment.

 

[JohnK]

Between 1 and 3 business days for the ones I contacted

 

[Philip]

Considering the fact that most people find that alcohol increases their tinnitus the next day I would personally lay off the sauce while you're on the trial.

You want to subtly notice any audio changes with your tinnitus.

I am a chronic sufferer but I was given an injection into my eardrum before to relieve eustachian tube pressure.

It never properly closed after and it eventually perforated into a 5mm hole last January(comfortable)..no this wasn't the cause of my T because it was on the other eardrum. I had a tremor and a lot of pressure on the right side.

I still have a tiny hole in that eardrum after a year now...point is I would never agree to an injection into my left eardrum with T after that experience.

I don't,currently, have terrible unbearable tinnitus so I'm gonna just live with it...though I am very aware that is quite impossible for many people.

 

[Alue]

Considering the fact that most people find that alcohol increases their tinnitus the next day I would personally lay off the sauce while you're on the trial.

You want to subtly notice any audio changes with your tinnitus.

I am a chronic sufferer but I was given an injection into my eardrum before to relieve eustachian tube pressure.

It never properly closed after and it eventually perforated into a 5mm hole last January(comfortable)..no this wasn't the cause of my T because it was on the other eardrum. I had a tremor and a lot of pressure on the right side.

I still have a tiny hole in that eardrum after a year now...point is I would never agree to an injection into my left eardrum with T after that experience.

I don't,currently, have terrible unbearable tinnitus so I'm gonna just live with it...though I am very aware that is quite impossible for many people.

Any idea why the injection hole didn't heal? What size of needle did they use, and do you have any underlying conditions that could make it not heal properly?

 

[OddV]

Seriously, can I drink on this? @OddV did you drink on this?

I drank beer, stayed away from the hard stuff.

 

[Jeffrey F]

Shit my tinnitus has jumped back up to a 5 so damn frustrating! Was going down over two weeks then boom. @OddV how long did your tinnitus take to go down after receiving AM-101?

Just FYI I had a long plane ride a few days ago and I believe that might be the reason why my tinnitus has increased. I am getting the popping in my ears like I did the few days after my injection.

 

[Philip]

I have no idea why it didn't heal properly. Maybe the ear pressure exerted pressure on it.

It perforated because of fluid in the eardrum.

After a year the hole is tiny...it sometimes completely closes and then open slightly if I exert myself too much.

I have no medical conditions other than tinnitus.

The doctors say it will completely close in time.

If i put an earplug in my ear and swallow I can feel the earplug and air sucking in.

It doesn't bother me much now...it actually ensures my eustachian tube doesn't seize up as much.

But their is a kind of low wind,seashell sound now which wasn't there before.

It isn't annoying and high pitched like the tinnitus is in my left ear.

I don't know if my tinnitus has really gotten lower or I've just let it fade into backround noise. It's doesn't send me nuts like it did the first year or two.

The pain and discomfort from the perforation last year in the other ear kinda put it all in perspective.

 

[Alue]

@Philip

I see. I though having a hole in your ear would make it less likely to rupture because it's easier to equalize. Did you have an infection in that ear too?

 

[Philip]

Well I got the injections during the summer of 2015.


I got them about 6 weeks apart because the eustachian tube pressure was messing with my balance and the tremor maddening.

The hole isn't big enough to totally equalize pressure like grommets would. During that winter break last January I drank quite a lot over three days I then came down with a throat/ear infection that produced the fluid build up.

The tiny syringe hole burst into a 5mm hole as I said above.

Even now with the tiny hole(doctor would need a special machine to see it) I have eustachian issues. The hole doesn't stay open or seal up completely hassle.

Anyway to stay on topic don't mutilate your ears unless you really feel you have to.

 

[Jahhsoul]

How long for be marketed? Any thoughs? 4H 2016 maybe?

 

[Markku]

How long for be marketed? Any thoughs? 4H 2016 maybe?

When do you suppose this drug will be available on the market? In 1, 2 or 3 years?

Auris Medical: If all goes well, and the safety and efficacy of AM-101 is confirmed, Auris Medical plans to submit in 2016 an application for marketing authorization to the regulatory agencies of key countries. If approved, the drug may get marketed starting in 2017.

From: https://www.tinnitustalk.com/threads/am-101-clinical-trial-—-q-a.10629/

 

[Charlie396]

Hmm in terms of safety, there haven't been reports of permanent side effects have there? I wonder if theres any risk of stuff happening 5 or 10 years from now.

 

[JohnK]

Hmm in terms of safety, there haven't been reports of permanent side effects have there? I wonder if theres any risk of stuff happening 5 or 10 years from now.

No and no. If you can do the trial, I would (and I did!)

 

[Alue]

Well I got the injections during the summer of 2015.


I got them about 6 weeks apart because the eustachian tube pressure was messing with my balance and the tremor maddening.

The hole isn't big enough to totally equalize pressure like grommets would. During that winter break last January I drank quite a lot over three days I then came down with a throat/ear infection that produced the fluid build up.

The tiny syringe hole burst into a 5mm hole as I said above.

Even now with the tiny hole(doctor would need a special machine to see it) I have eustachian issues. The hole doesn't stay open or seal up completely hassle.

Anyway to stay on topic don't mutilate your ears unless you really feel you have to.

It's unfortunate what happened to you, but it sounds like you had other events (albeit unknown) that contributed to your problem with healing. It's not the norm. I wouldn't say everyone undergoing the AM-101 trial is 'mutilating' their ears.

 

[Alue]

In light of this thread: https://www.tinnitustalk.com/threads/poll-tinnitus-in-the-ear-s-brain-head-or-both.13136/

For those undergoing or have undergone AM-101, would you characterize your tinnitus as "brain" or "head" tinnitus or "ear(s)" tinnitus or both?

 

[bill 112]

Sorry if this has been answered somewhere back in the thread but anyone participating in this trial also have H?Interesting to know if it has any affect

 

[JohnK]

In light of this thread: https://www.tinnitustalk.com/threads/poll-tinnitus-in-the-ear-s-brain-head-or-both.13136/

For those undergoing or have undergone AM-101, would you characterize your tinnitus as "brain" or "head" tinnitus or "ear(s)" tinnitus or both?

I think ear

 

[liquefact]

Sorry if this has been answered somewhere back in the thread but anyone participating in this trial also have H?Interesting to know if it has any affect

I have minor H along with T and the it started like 2 months after T. Today, 1 month after the 1st injection i can say that when i have quiet T, i do not have H at all. If i have a T spike however, i develop H at the same time. T and H are not that much different if we think about their origins. They're are both manifestations of inner ear damage (later brain mechanisms) and if you have one, there's a good chance that you'll have another.