AM-101 Clinical Trial — Participants Updates and Discussion

Keeping my fingers crossed your spike will subside soon mate!

 

@liquefact

Sorry to hear that. Hope it gets better.
Irrespective of your worsening I think this is good news.

1. The fact that your T loudness has increased up to 9 shows that your T is still in the inner ear and has not been centralized in the brain. So best circumstances that AM-101 can have an effect.

2. We know that AM-101 can cause a louder or more intensive T as a temporary side effect. So in fact you know now that you got AM-101 and your hair cells are reacting to it. I mean you haven't experienced this increasement in loudness after your first round where you maybe received the placebo, right?

3.

"After the injection my tinninuts worsened for about a month before completely disappearing. Currently I have a very, very faint ringing, but nothing compared to what I have experienced in the past. ... I just received a phone call that let me know I actually received the drug during the test."
(Source: https://www.reddit.com/r/tinnitus/comments/1m1kiy/follow_up_on_am101_study_i_participated_in/)

According to the experience of this guy who received the AM-101 treatment and posted on reddit, you should be fine.

 

Being full of the drug and flying probably did it. Flying right after your third injection isn't the most pleasant experience, I did it too.

 

Hang in there, mate. It will fade.
Sometimes I ask myself if in a distant future some researchers will have a look through this pages saying: "Look at this bunch of poor bast*rds offering their sanity out of desperation just to get rid of a tad of this ridiculous shit we can solve with a single pill nowadays..."
For you researchers out there in that fuck*ng future; Eat my shorts!! You have the brains. We had the boll*cks!!!

 

@matt89, thanks dude.

Yeah, i started to think like this as well. If a gel injection in the ear can spike my T like this, it should mean that the transition to brain is not complete yet. Good news.

I had that temporary spike in the closed-label round but the spike that time was nothing compared to this one. It was like 7-8. This time it was ~9, just nuts, screaming!

Well this is interesting, in two ways.
First i really do not expect an improvement due to AM101 one month after injections. As the gel drains out of the system very quickly. You cannot imagine how much it drained during the flight and sleep. So it should be that, even though the gel does not stay inside inner ear, it's affects are long lasting.
Secondly, i was explicitly told by the doctor and the assistant who was overseeing the trials that unless an emergency occurs, no participant is told whether he/she gets esketamine or placebo. This is interesting. I hope that i'm told later on though, like this guy.

 

I bet they will dude. They'll look at this shitload of comments and laugh, especially to your words here

 

AM101 Update:

The flight back home was terrible, the gel drained like crazy. My ears were like a teapot, constantly whistling and spitting gel during the ascent. During the descent the pain became so unbearable that i had to take two ibuprofen pills at once to take the edge off. It worked like magic and in minutes the pain became bearable.

The ringing was around 7-8 before i reached home and jumped to 9 at home. It was no different than my first night after the onset while i was having panic attack. Except this time i was completely sane and balanced, just thinking about how i would get to sleep. It happened quickly though, i did not struggle much, probably because i was too tired.

In the morning, woke up refreshed, the ringing was down to 6. Still at the same level, can hear it over anything, but do not make it a problem. I'm confident that it'll go down to around 3 in weeks. No pain as well.

Will fly to LA for the first follow up visit on Tuesday, shall update again after that. I'm expecting to get back some of my hearing that's lost after injections (>40db on the left) until then.

By the way, i cannot appreciate you guys and this forum enough. It helps so much to know that we're not alone. Thank you all.

 

Hey you researchers from a distant future... Is a ghost in tracksuit a sports spirit?? I'll be running after you!

 

It sucks. But let's imagine we would live with this condition in the 1960s (no internet, maybe one ENT in a radius of 50 miles and much less knowledge about treatments which can cause T improvements).
And think of all the T victims for example of WWII. I mean these people mostly suffered without getting anything.
At this time there is still no instant cure available but we know a lot more about the phenomenon. There is a lot of research going on and science in this area is making bigger steps than ever before independent of the fact that many ENTs seem to be unfamiliar with newer T research/treatments (that sucks but we have the internet so we can get the knowledge we need).
Let's be a bit grateful to live in the 21st century and the future you're talking about is coming closer:

- Invasive/Non-Invasive Vagus Nerve Stimulation (http://www.microtransponder.com - https://clinicaltrials.gov/ct2/show/NCT01962558, http://www.tinnitustreatmentcentre.com).
- AM-102 is probably starting next year with clinical trials (http://www.aurismedical.com/product-candidates/pipeline).
- Furthermore there is a therapy with stem cells available in Asian countries. @attheedgeofscience documented that he has received an improvement of 50% in his T loudness/intensity by doing this (https://www.tinnitustalk.com/threads/my-trip-to-bangkok-stem-cell-treatment-journal.1884/).

 

I think about that all the time. We're lucky really just to have TT and blow off some steam and share information and experiences. In other countries or 60 years ago people would be in torture and not even a person to share this with that really understood.

 

I periodically meet in a support group with a guy who has T since 1970's. His resolve, patience and strength is amazing me every time i see him.

We're just lucky, compared to all these guys, as i believe there'll be a cure in 10 years.

 

Let's not forget SF0034. It has my biggest expectation from current research so far.

 

Sorry to barge in on this. I'm not on the trial as I am not eligible, but I am interested in why people talk so much about centralising of the tinnitus on this thread.
What is the significance of this?
Is it a perception that it sounds more central, or something else?
Thanks for indulging me.

 

It is believed that tinnitus in acute phase originates in the ear, but over time moves onto the brain (centralizes). Once it's in the brain, fixing ears (or treatments like AM-101) might not be effective solution to stop / lessen tinnitus.

 

@Atlantis

Thanks for the response. Based on what you have said, even though I have had it for nearly 2 years, it doesn't sound as though mine has centralised.

I have commented before on the forum that my tinnitus can be totally removed by simply placing my smallest finger into my right ear and gently pulling - creating a tiny vacuum on the eardrum, pulling it outward (and it really does only need to be a very slight movement). Even when I remove my finger, it remains gone. I can then stand in a silent room and cannot hear it. If I yawn or make movements that specifically move the muscles within the ear (and only if it is these muscles), it returns - and loudly.

Even though I am past 6 months, should I apply for the European trial? Might they consider me, or is the 6 months absolute?

 

If you can silence your t so easily you may not even Need am-101

 

It's slightly more complicated than I made out, but yes, 4/5 I have the ability to get rid of it, or at least get it quiet enough so as to not hear it.

I keep thinking it is treatable, but try telling an ENT that it isn't in my brain!!!

I've got an MRI scheduled for April - maybe that will yield something.

Thanks for responding.

 

...and apologies for gate-crashing the thread.

I hope all of you the best of luck. I never thought something so simple could be so debilitating. Irrespective of the outcome of the trials, it is at least a landmark that the big pharmaceuticals are investing in finding a cure and it bodes well for the future.

Hopefully, soon enough that many of us on here can benefit.

 

1 week update
2 weeks update:

Trial:
AM-101 initial trial

Date of initial T Onset:
1/21/2016

Cause: Noise induced. Ear buds. Prolonged session of producing music in FL studio.

Base T the day/week before injections:
Left ear: 3/10
Right ear: 1/10

Tinnitus description before injections:
Hissing in both ears, slightly different frequencies. Loudest in the mornings.

Date of injections:
3/2/2016-3/4/2016, 1.5 months since onset

Have you felt any change/improvement/worsening since the injections?
Yes. Yes. Not anymore!

After a 2nd week, I can definitely say I'm noticing a significant improvement. I was actualy getting disheartened towards the end of last week after I had those amazing days of silence on day 1 and day 3 after injections and then it settling lower, but not silence, towards the end of last week. Thought it would just end up settling at a lower volume, but that the silent phase was over for me. Well I'm happy to report that has not been the case and I have noticed continued improvement. I have had silence for at least 4 hours or longer for the last 4 of 7 days, including today. I have constantly woken up with very low T. Last Saturday was the last day I reported my T as a 2 when I wake up. Every day since has been a 1. Prior to the injections, morning were always loud and my loudest T was in the morning. Most importantly, I was getting used to having a loud day, after experiencing silence. On one occasion this week I actually went to bed in silence, and woke up in the middle of the night still in silence. Never happened before since sleep always reset mine. This was a great sign to me. Yesterday afternoon until about 4am this morning I had silence, and even though I woke up with it at a 1 today, I'm in silence right now and has been fluctuating between 0-0.1 for about the past 4 hours. Never had silence 2 days in a row. My T has never gone above my baseline even once this week, I have reported baseline on 3 occasions on 3 different days(~12 hours total in the past week). Other than that it's been a 2, and more often a 1. Centralized sound as opposed to hissing.

These are my last 7 days tracking from my spreadsheet including today:
NT = not tracked.

Wake up/Morning/Afternoon/Evening/Night
03/12 Left ear: 2/1/1/0.5/0 Right ear: 2/1/1/0.5/0
03/13 Left ear: 1/1/2/2/3 Right ear: 1/1/2/2/3
03/14 Left ear: 1/1/0/0/0 Right ear: 1/1/0/0/0
03/15 Left ear: 1/1/2/2/3 Right ear: 1/1/2/2/3
03/16 Left ear: 1/2/2/3/2 Right ear: 1/2/2/3/2
03/17 Left ear: 1/1/0/0/0 Right ear: 1/1/0/0/0
03/18 Left ear: 1/1/0/NT/NT Right ear: 1/1/0/NT/NT



Current T severity and average T severity over the past week:
Current: Fluctuates between 0-0.1. I say that because if I listen hard for it every minute or so I can faintly hear something. I can't even rate it a 0.5
Average over the past week: 1.5 Honestly at this point it's easier to tell you when it bothered me. Just on the 3 days during the hours I rated it as a 3. I'd say 90% of this past week my T has been a non-issue.

Do you believe that you got the real drug or the placebo?
Yes, at this point I'm pretty sure I did.

Have you experienced any lasting (side) effects from the procedure?
No. If I was to be completely anal, and list absolutely every little thing I noticed this entire week, then I got some water in my ear today and I felt pain for 10 seconds which I thought was strange. Maybe it was more in my head than reality, because I was paranoid about it. That's it!


Will you participate in the next round?
If it's still there, yes. I hope this trend continues and I won't have to.


Edit: One more thing I should mention. Since the sound has become centralized in my head, more of a low sizzle than a hiss in my ears, even a T of 1 is a major improvement over my T of 1 when it was a hiss in my ears. When it was still coming from my ears, it felt more annoying, because it was affecting my hearing and made me feel more unbalanced, or like I wasn't myself. The days it was a 3, and annoyed me, it was hissing in my ears.When it's centralized in my head, it feels like I am normal again, because my ears feel normal, and you get the sensation that your hearing is not impaired in any way, and your ears are actually silent and that there is nothing wrong with them anymore. It's extremely easy to ignore it like this. So even at the same level loudness, it's a significant improvement on the annoyance factor due to it shifting to this new centralized sizzle. Hope that makes sense.

 

Dear AlexSongitus,
Could you please tell me what was the reason of your T ?
Do you have any hearing loss ?? (moderate or profound ?)
Thank you

 

Noise induced, it's on there now. I was on a very prolonged music session for 3 days with ear buds in my ears producing songs with FL Studio. They found me with about 40db loss in the 8k range I honestly can't really tell a difference from before T and after. I have a feeling not all that hearing loss came at that time when I got T, and probably most of it was over the course of my life. I highly doubt I had perfect hearing before T, since I have been playing loud rock music since I have been in my teens.

 

Does anybody know if they do a urine drug test for round 2 of injections? They do in round 1.

 

Why do you need that info? What are you planning to fake for?

 

Yes they do, after the 1st injections.

 

Hi all,
Sorry if this has been asked before.
10 days ago I completed the 3rd injection of am-101 and have had a very loud spike constantly since then,
Is the normal thing. Getting a little panicked that might stay this high!

 

Seems pretty much normal. In my first round, the T spike lasted ~3 weeks, gradually resolving after 2 weeks. If this spike does not fade away in 2-3 weeks, it's the time you should be concerned.

But, do not worry, it'll go away, there's no reason not to.

 

Thanks,
Fingers crossed it sorts it self out soon.

 

@John D
Mine took a bit over two weeks to gradually subside. Got a bit panicky too after ten days, it's normal.
Just over three weeks now and it's still a tad louder than baseline and still some popping/crackling sensation in my left ear when swallowing. Give it time

 

Been absent for the last week, quite busy these days, so I am not sure if the following has been discussed in depth.

Getting back to the topic for the follow-up trials, I have been thinking about it, and gotta admit that I am feeling (and this is purely emotional) cheated by the new regulations. Not because I planned to participate in all rounds, but because of having the option if I want to. I signed a particiation agreement and adhered to all the agreements made, so I expect the same from Auris.

Does anyone know if there was a clear statement about these follow ups in the trial documents? I cannot remember where I stored those documents, so I cannot check it right now. In my case, there was a verbal commitment from the doctor for up to four follow up rounds (legally binding but hard to prove), but I am not sure to what extent it is reflected in the agreement.

Any advice from fellow participants?

 

Have been thinking about this and my only concern is, if they can wipe their ass with the initial agreement, maybe they can also give placebo in the open label round just to save some pennies...