AM-101 Clinical Trial — Participants Updates and Discussion

[liquefact]

@Koen, in which site did you have the injections? I was in Santa Monica, LA and the doctor had no such data regarding not closing eardrums. My right eardrum was not completely closed by the 8th day after 1st injection but it was closing.

Now it's 12th day and probably it's closed as it's not leaking from my ears anymore but there's still an annoying popping coming from both ears whenever i gulp.

 

[Koen]

Mine was at UZA Antwerps. Dr. Vincent Van Rompaey told me about the 5%. Can't really believe it ... . I don't find much statistics about it on the internet.

 

[attheedgeofscience]

Folks... I have - since - early childhood had ear tubes inserted due to chronic ear infections. With ear tubes, there isn't just a puncture, there is cutting of the eardrum: a small hole. Now... last year, I asked the ENT I went to see to have a live image of both my eardrums shown on a monitor (full colour). 30 years later, the scarring was still lightly visible but of course the holes had closed.

The point I am making (if it isn't clear): holes in the eardrum close by themselves. If they don't, I am pretty sure that there is corrective surgery that can be done (also for excessive scarring).

Could we please stop this non-sense about holes not closing. Holes close. Just like they do when you cut your finger.

If in doubt, raise a question in the doctor's corner...

 

[Koen]

Well du uh that's what I thought as well. And the doc said 5% does not close. That scared me off course. Pfff I don't get this world sometimes.

 

[Atlantis]

Well du uh that's what I thought as well. And the doc said 5% does not close. That scared me off course. Pfff I don't get this world sometimes.

Your doctor wasn't wrong.

https://www.bcm.edu/healthcare/care-centers/otolaryngology/conditions/tympanic-membrane-perforation

It says

"Data show that within one month 6 percent are healed, and within three months 94 percent are healed."

The correction surgery may not fix it either

"The rate of successful repair of a tympanic membrane perforation is about 90 to 95 percent. "

 

[Koen]

No Atlantis that's not the same. A random accidentally perforation vs controlled injection.

 

[JohnK]

The sites I talked to both reported 0 perforated drum issues.

Some other interesting tidbits:

I learned you can have an ear infection, get tinnitus, and have perfect hearing (afterwards (including high frequencies!)

There doesn't seem to be correlation between cause of tinnitus and result (aside from it not working well on SSHL, which is a known issue). Some people with acoustic trauma got improvements, others didn't.

One person went down to 0 tinnitus, his issue was some perforation/physical trauma from surfing.

 

[Koen]

I clearly asked him if he ment 5% in 2/3 weeks or forever and he said 5% forever stays open. That must have been either his own experience or a random puncture of the eardrum, right. I don't get it then why that ENT would tell me 5% when that percentage wasn't representable for this procedure that I was going to undergo.

 

[Nucleo]

Well du uh that's what I thought as well. And the doc said 5% does not close. That scared me off course. Pfff I don't get this world sometimes.

I can make up technically true statements as well. 100% of ear drums don't close within the 15 seconds following the procedure.

 

[JohnK]

@Koen so did you go through with it or no?

 

[Jeffrey F]

Hey guys!
Just had my first round of real injections. My tinnitus spiked so loud at first it was terrible. The first three hours after the injections my tinnitus was a fifteen out of ten. I actually drove around for three hours with the air blasting and music on because I couldnt bear the thought of getting out of the car and hearing the terrible, terrible spike that occured. For a quantitative value- I had to achieve a decibel level of 68 in order to mask the tinnitus I had post injections. I usually only need a decibel level of mid forties to drown out my tinnitus.

About five hours later now and my tinnitus has settled down, its still definitely louder than before the injections but nowhere near as loud as the immediate spike. I can't tell you how much sympathy that episode made me have for people who have very severe tinnitus, and have to live with that constantly. Fuck this disease.

Anyhow, Ill keep you posted on how the next few injections go. Not looking forward to the spikes I know will come over the next two days but hey, a little pain for a worthy gain, eh?

 

[liquefact]

Very interesting, i had no spike, no pain, no H, no fullness after the first injections. But 3 hours after the second one all these kicked in. Very contrary to most people experience.

I hope the real drug shall give you a permanent relief and all this suffering does not go in vain.

 

[Koen]

@Koen so did you go through with it or no?

No. But my decision seems to be based on false information.

 

[attheedgeofscience]

Okay, so I have taken the trouble of finding the information related to puncture of eardrums from the 2nd Q&A that was done with Auris Medical and physicians of the trial. (For a "historic note" I was the one who set up the first ever internet based Q&A session: link is www.tinnitustalk.com/threads/auris-medical-q-a.8201. It is also well worth a read).

Is it really medically safe to perforate the eardrum multiple times? What are the possible complications?

Dr Maxwell and Dr Mühlmeier: Puncture of the eardrum has been performed in adults and children for many years. It has been used for injecting other drugs into the middle ear, and some of them require multiple treatments. Another common use is for the insertion of ventilation tubes (grommets) into children's ears. Some children require repeated sets of ventilation tubes, resulting in their eardrums being punctured multiple times. In our experience, multiple punctures do not cause any long-term problems.

An eardrum perforation closes very quickly. If the ear is healthy and pressure can be cleared easily, the eardrum closes usually within 2 to 5 days. Before the eardrum is fully closed, the patient has to be careful not to get water into the ear as this may lead to middle ear infection. This risk of infection is very small. When the eardrum is not fully closed, a patient may experience distorted hearing, altered perception of tinnitus or pressure in the ear.

Source: www.tinnitustalk.com/threads/am-101-clinical-trial-%E2%80%94-q-a.10629

Addendum: perhaps @Markku it could be considered to post those links as a banner of this thread?

 

[Markku]

Addendum: perhaps @Markku it could be considered to post those links as a banner of this thread?

Good idea. Done.

 

[Alue]

Are they still accepting new patients for this clinical trail? I read somewhere that the clinical trials are set to end February 2016. Will they even bother contacting someone that does not leave near a trial center?

 

[JohnK]

The trial runs until they get the number of subjects they need, which they haven't yet. As for distance, I reached out to a bunch of sites hundreds of miles away. From my perch in San Francisco, all 3 SoCal sites replied to me, but Vegas did not.

 

[JohnK]

Tonight I fly to San Diego. Tomorrow I get my first round of injections.

PRE-TRIAL SCREENING T LEVEL
On my little HTC thingy (which I was able to use and submit all through my trip to SE Asia--miraculously, it had a global roaming SIM and was neither lost nor destroyed by yours truly), I've been faithfully reporting my T daily. I only missed one day, and ironically it was just an ordinary day after I had returned to the USA! For the record, loudness and annoyance have been steady, alternating between 4 and 5 (maybe someone with better perspective would call it a 3). The 1-10 scale is inherently subjective, but in terms of making a baseline of comparison others can relate to, I would say it's not loud enough to drown out conversations at any volume (and I pray it never becomes that). And yet (infuriatingly) it's also too high-pitched to be masked (save by running water or cicada noises (similar to @Martin69...and like him, I was also under huge health anxiety around the time T started). I can still sleep without a masker (well, I wake up often throughout the night, but I was battling insomnia for months before T hit). I can sometimes forget about the T and not notice it for hours at a time now.

PRE-TRIAL HEARING TESTS
My hearing tests all came back normal...tymp, including one that went into the super high frequencies. For a 31 year old, my hearing tests are as good as could be expected. I have dropoff starting at 12.5 (becomes a ski slope at that point, with 30db @ 12.5khz, 40db @14khz, 50 db @16khz. Given that my T is super-high-pitched, it's at least possible that there is damage there causing the T, but it's equally likely this is a normal reading for a 31 year old

So many thoughts...

• What if I get placebo and spend 3 months of the window of opportunity doing nothing? (at least I'd get the 1st real guaranteed round before 6 months is up)
• What if I happen to be the unlucky minority who has issues with eardrum closure or worsened T?
• What if I just have the wrong sort of T that can't be touched by this and I'm barking up the wrong tree? If stress was the trigger, I think most models of how that works are purely in the brain, although there are some people on TT hypothesizing about a "glutamate storm"...

I would like to thank the @attheedgeofscience for his tireless advocacy in favor of...well, science Without all the information he has worked to bring to this site, I don't think I ever would have gone through with this. And thanks to @OddV for having a good experience. I must have read his experience a hundred times for hope.

If anyone is really bored, I may try to livestream it on Periscope (my twitter handle is @SirKneeland)

 

[liquefact]

What if I get placebo and spend 3 months of the window of opportunity doing nothing? (at least I'd get the 1st real guaranteed round before 6 months is up)

If you get placebo, you'll still be able to get the real drug before the opportunity window closes, which is 6 months, not 3. See the AM101 Clinical Trial Q&A session in which it's mentioned that the effectivity of the drug may go beyond 3 months;
https://www.tinnitustalk.com/threads/am-101-clinical-trial-—-q-a.10629/


**
In order to explore how far the therapeutic time window for AM-101 extends, we are enrolling in our European trial (TACTT3) also cases of post-acute tinnitus in addition to cases of acute tinnitus – i.e. up to 6 months from onset. The outcomes from this particular patient group will be analyzed separately. An interim analysis that was conducted after enrolment of the first half of post-acute tinnitus patients suggested that AM-101 could indeed be active also in the post-acute stage, and in particular up to 6 months.
**

What if I happen to be the unlucky minority who has issues with eardrum closure or worsened T?

It closes, even if it does not i do not believe it'll be because of the injections. There should have been another reason for it. In my case i still have fullness in my ears 2 weeks after injections and my ears still pop. But my ears and eardrums were always much more sensitive to anything before the trial. So i cannot blame AM101 for that. I could always blow air through my ears and i still can do that. I was thinking it was perfectly normal thing and the eardrum was allowing air through to some extent but the doc who made the injections could not believe that.

What if I just have the wrong sort of T that can't be touched by this and I'm barking up the wrong tree? If stress was the trigger, I think most models of how that works are purely in the brain, although there are some people on TT hypothesizing about a "glutamate storm"...

If you're barking up the wrong tree and still participating in the trial, it's fine. There is no data AFAIK showing that
there'd been permanent increase in T, H, problems in eardrums related to AM101.

 

[JohnK]

it's mentioned that the effectivity of the drug may go beyond 3 months;

I know, I take solace in that (and in @OddV having his best results at 8 months out)...but still, I don't think it's like an all or nothing thing. It's got to be a sliding scale, and I hate thinking that I could get a better outcome with the drug RIGHT NOW than potentially having to wait another 3 months.

 

[JohnK]

That's not too long although I'm sure every week probably felt like a month for you.

Ugh so true. My 2 months have felt like 2 years

 

[liquefact]

I know, I take solace in that (and in @OddV having his best results at 8 months out)...but still, I don't think it's like an all or nothing thing. It's got to be a sliding scale, and I hate thinking that I could get a better outcome with the drug RIGHT NOW than potentially having to wait another 3 months.

You're right and i'm in the same position as you. Barely made into the trials, my 2nd and 3rd injections were even beyond 3 months after onset. Still as this is the best i could do, i'm not worried about the rest that much. Comparing what you have with something you cannot have does not help.

The effectivity of the drug shall not be flat until 6 months and become 0 immediately after. It'll probably decrease gradually but still we'll get some relief. %10 improvement means worlds to me, so i'll appreciate that.

Also the ratio of real drug / placebo was not 60/40 in Santa Monica, it was ~ 66/34. Fingers crossed.

 

[JohnK]

@liquefact what was your T pre-injections?

 

[liquefact]

Stabilized to 3-4 2 weeks before the injections. Mine is a high pitch, cannot say that it's too loud though. But nothing can mask it really except the shower, probably like yours.

2 weeks after injections, the ringing is slightly different, more annoying i must say. And louder too, like 5-6. But still can sleep without any maskers or anything. I'm habituating for sure as the decline in annoyance is without doubt. The decline in loudness though is questionable, maybe a little.

 

[Jeffrey F]

If you get placebo, you'll still be able to get the real drug before the opportunity window closes, which is 6 months, not 3. See the AM101 Clinical Trial Q&A session in which it's mentioned that the effectivity of the drug may go beyond 3 months;
https://www.tinnitustalk.com/threads/am-101-clinical-trial-—-q-a.10629/


**
In order to explore how far the therapeutic time window for AM-101 extends, we are enrolling in our European trial (TACTT3) also cases of post-acute tinnitus in addition to cases of acute tinnitus – i.e. up to 6 months from onset. The outcomes from this particular patient group will be analyzed separately. An interim analysis that was conducted after enrolment of the first half of post-acute tinnitus patients suggested that AM-101 could indeed be active also in the post-acute stage, and in particular up to 6 months.
**



It closes, even if it does not i do not believe it'll be because of the injections. There should have been another reason for it. In my case i still have fullness in my ears 2 weeks after injections and my ears still pop. But my ears and eardrums were always much more sensitive to anything before the trial. So i cannot blame AM101 for that. I could always blow air through my ears and i still can do that. I was thinking it was perfectly normal thing and the eardrum was allowing air through to some extent but the doc who made the injections could not believe that.



If you're barking up the wrong tree and still participating in the trial, it's fine. There is no data AFAIK showing that
there'd been permanent increase in T, H, problems in eardrums related to AM101.

Hey man- I had my doubts initially about the injections- but the fact is, this is our best shot of beating tinnitus. Its quite rare that someone knows the true cause of their tinnitus, and AM-101 is our best shot of beating it. Go into this study knowing you are doing the right thing.

 

[JohnK]

That's what I'm thinking. I'd anything I feel fortunate to have the opportunity to try.

My big fear is the time limit.

From the study literature I can't actually tell if the limit is due to a limited window to stop physical damage (more cells dying) in the ear, or if it's an issue of it getting imprinted in your brain.

 

[Alue]

Are they still accepting people for the trial? Do they care if you live near a testing location when you input your area code?

 

[liquefact]

Do not know whether they're accepting still or not, you need to ask to the sites i guess. I was rejected by Portland site even though it was the closest location me (Seattle) and later accepted by LA.

 

[locoyeti]

anyone have any info on why EARS has jumped so high in the stock market?

 

[Atlantis]

anyone have any info on why EARS has jumped so high in the stock market?

Searched and came to this
"it is very difficult to pinpoint the exact cause of this surge in the stock."

http://www.briefing.com/investor/analysis/story-stocks/auris-medical-(ears)--stock-has-been-soaring-for-over-a-week-on-sharp-pickup-in-volume.htm

AM-101 could generate $350 million annually

http://www.streetinsider.com/Analyst+Comments/Auris+Medical+(EARS)+Tinnitus+Therapy+Could+Bring+$350MMyear+-+Leerink/11195817.html