AM-101 Clinical Trial — Participants Updates and Discussion

Hi guys, I'm brand new to this forum and this is my first official post. I recently began the am101 clinical trial and this question is directed to any and all former/current participants. I just finished my first round of injections yesterday and I fortunately had absolutely no side effects other than a slight increased perception of my tinnitus.

My question is: has anyone had positive results with the clinical trial, and like me, had no side effects during the initial round of injections?

 

not to high jack the thread, but what kind of airplane ride can cause a barotrauma capable of causing permanent inner ear injury ? was it Military ?

 

Sorry to hear that. How many injections did you have. It sounds like you just had 1 then left it for some time. I had 3 in 3 days. P's I had 18 day spike my T is still spiking think my have had placebo. Good luck.

 

Let me know what they say. I just don't see the glutamate storm going on for months and months. It just seems to me like this would be a process that takes days or weeks. I don't really know. The process by which the tinnitus is ingrained in the brain may take longer.

I can't really say if I had 'head' tinnitus at day one, I didn't really take note of such things, but there has been a centralized tone there since early on.

 

Hi everyone,

Just had my 1st day of open label injections today.

My T has remained fairly constant at 5 with no perceptible change in tone or pitch. So I either got placebo or AM-101 doesn't work for me.

Hopefully the open label will shed some light on this

 

That's great John. Hope you get some relief soon. You're around the 5 month mark right? Please keep us posted.

Are they using Lidocaine on you btw? Injected?

 

I hope it goes well! I'm in the same boat as you, only a month behind. I hope you get some relief.

 

I believe it's lidocaine but not injected. They just pour it into the ear, let it sit there for 30 mins, then pour it out and carry on with the injections.

 

Strange that out of so many people doing AM-101, I seem to be the only person, at least recently, that's had Lidocaine that reported an immediate decrease and even silence from it. Most people seem to be reporting spikes after their injections. But there are many people that have reported a decrease in their T due to Lidocaine, either from injections or IV. I really can't say now for 100% sure if they just stuck something in and placed it on the ear drum, or actually injected the Lidocaine, but I remember feeling a needle poke. And they only timed me for 15 minutes. I need to remember to ask this to be 100% sure now.

 

1 week update
2 weeks update

1 month update
(Technically, Sunday marks a full month and going in for my one month follow-up on Monday, but this is the 4th week mark, and I'm eager to stop tracking it 4 times a day and enjoy my weekend):

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!

I am doing great. Mainly hearing a low new centralized sizzling sound, as opposed to hissing in the ears before AM-101. Much better than my previous T. Week 3 was a bit of a setback after a great 2nd and 1st week where it got progressively better. It started with feeling my throat hurting before bed one night, and the next morning hissing returned. After that day, it started trending downwards again, and eventually went back to the centralized sizzling sound, and stayed that way.

Week 4 has been my best week yet. Had silence 3 days in a row, that began with low T in the morning which faded away to complete silence within a few hours. I even woke up in silence one out of those 3 days before falling back asleep again. That's the biggest encouragement because prior to AM-101 my loudest T was in the morning. That was followed up by a day where my T got up to about a 2, hissing in my left year but still did not reach up to my baseline. So even that day I wasn't really bothered by it. After that one day it resumed to the centralized sizzling sound and has stayed very low since or had silence.

Really I haven't actually been annoyed by it in over a week. I have not reached my baseline of 3/10 in my left ear since last week. Thanks to the 3 days of silence I have even been able to report my T as low as 1 on the AM-101 tracking device a couple of nights this week. The first time since the injections.

After today I'm no longer going to track it 4 times a day as I have been doing. I actually have been tracking this way from my first day on Prednisone, so since day 7 after getting T, and I am thinking of figuring out a way to post all the data, along with all the treatments I did, in a way that is ready to read and might provide some insight. If I succeed to find a way to format it correctly and doesn't take too long I will. It's interesting because the improvement is certainly not gradual. It's been with setbacks, it's fluctuated, but overtime it's been obvious. My T also reacted positive to a lot of other medication, even before AM-101, so it might all be worth noting alongside tracking numbers.

These are my last 2 weeks tracking from my spreadsheet including today:
NT = not tracked.

Week 3:
Wake up/Morning/Afternoon/Evening/Night
03/19 Left ear: 2/2/2/2/3 Right ear: 1/1/2/2/3
03/20 Left ear: 1/1/1/1/1 Right ear: 1/1/1/1/1
03/21 Left ear: 1/1/0.1/0/0 Right ear: 0.5/0.5/0/0/0
03/22 Left ear: 2/2/2/3/NT Right ear: 1/1/2/3/NT
03/23 Left ear: 1.5/2/2/3/NT Right ear: 1/1/0.5/0.5/NT
03/24 Left ear: 2/2/2/2/3 Right ear: 1/1/1/2/3
03/25 Left ear: 2/2/2/1/1 Right ear: 1/1/1/1/1

Week 4:
Wake up/Morning/Afternoon/Evening/Night
03/26 Left ear: 1/1/2/2/2 Right ear: 1/1/2/1/2
03/27 Left ear: 1/1/0.5/0/0 Right ear: 1/1/0.5/0/0
03/28 Left ear: 1/1/0.5/0/0 Right ear: 1/1/0.5/0/0
03/29 Left ear: 1/1/0.5/0/0 Right ear:1/1/0.5/0/0
03/30 Left ear: 1/1/2/2/2 Right ear: 1/0.5/0.5/1/2
03/31 Left ear: 1/0.5/0.5/0.5/0 Right ear: 1/0.5/0.5/0/0
04/01 Left ear: 0.5/0.5/0.5/0.1/NT Right ear: 0.5/0.5/0/0.1/NT



Current T severity and average T severity over the past week:

Current: Today it started at under a 1, and kept dropping. Somewhere between between 0-0.5. It's really hard to rate differences at this low of level. I can just tell it's not complete silence at times but I also have to listen for it to actually hear it. Sometimes I can't hear it at all and drops to complete silence.

Average over the past week: 1 or less with the exception of 1 day that got a bit louder. Really the last time I was bothered by my T was over a week ago.

Do you believe that you got the real drug or the placebo?
Yes. Either that or the Lidocaine during injection days triggered one heck of a permanent, long lasting change. I still don't know what to make of the setback in week 3 though. Why a drug would work in treating T this way, with setbacks after continued progress over 2 weeks, and then getting better again, is a little strange and not how we are usually used to medication working over time.

Have you experienced any lasting (side) effects from the procedure?
No. Nothing.


Will you participate in the next round?
If it's still there, yes. If I get stuck with the way it is today and the past week permanently, I won't complain, but I still wouldn't call it cured as long as I'm aware of it, and sense it, middling around just under my hearing threshold, sometimes creeping above it, living under its shadow, thinking it can return at any moment. But there's no annoyance from an actual noise. So yeah, I'm greedier now a month later. I want perfect, continuous, uninterrupted silence and to completely become unaware of it for good. Then I can go back to actually making music the way I love to do, scrutinizing every little note and pitch to the slightest of change, which currently I am still afraid to touch. Full cure or bust!

Edit: In case anyone's wondering, this is not an April Fool's joke. T is not something to joke about.

 

Are they still runing this trials in america?

 

Still running, no longer recruiting.

 

Wow, well thats great
i hope the trials go fantastic

 

4 week update,
Well after having an 18 day spike (7) had 2 days at a about (4) it's been mostly on the high side since then. But have had a bad problem with over sensitivity every moderate to loud noise seems to give bad spikes. Hopefully this will get better soon.
I'm hoping that when I get the real thing at the end of May ill get some good news but my T will 8 mouths on.

 

Any one had any good news at 8 months from onset with am-101

 

Congratulations! Why in the world would you go through more perforations in your eardrum when your tinnitus is LESS THAN ONE????? You will habituate and it will be GONE. I did Am-101 at the three month point and am now on a year of about level 8, nearly every day. I guess I got the placebo, it didn't work for me.
Be happy with what you have and enjoy. I'm sorry to say, but I'm really, really jealous.

 

Sorry but my T has never been 1. It's been between 4 & 8.

 

Sorry, I was commenting on AlexSongitus' comments ...

 

Actually I din't have a problem with the injections. It may sound crazy to some, but I really enjoyed the process of Lidocaine and suctioning.

I just had my 1 month follow up today and had a good conversation with my doc. Even with my improvement he doesn't rule out the possibility that my T could have improved coincidentally, and we talked about risks, the possibility of it getting worse, and the chances of a complete cure.

He said they have had a few people that have reported to be completely cured. Definitely an outlier, but I wouldn't be the first. Even if mine is as low as it is, and getting silence, there are no chances of it getting worse from the injections, and he believes it's a win/win to do it and be 100% sure you got the real thing in round 2. So I went ahead and said I want to go through with it and unless it permanently goes away by 2 weeks prior to that date, almost 2 months from now, I will probably go ahead with it.

I actually had silence by the time we got to loudness matching test. There was nothing to match. The audiologist had to go ask because the lowest tone she had was actually below my hearing threshold due to my hearing loss, and since I had no T at that time, but also didn't have a lower beep that I could hear, she didn't know how to handle that.

As far as habituating, I was more or less habituated by week 2 since I got T, when it was permanent, hissing pretty loud and relentless. But honestly, there really is no way to truly habituate, when you go from intermittent silence to T, even low T, and some days returning as a hissing 2/10 which is far more annoying after a day of silence, then when it's a constant 3/10. It's easier to habituate, at least for me it was, when it's permanent. It's there, you're stuck with it, so you begin the process of habituation. This is different. I go to bed in total silence, and then I wake up and it's back. Even if low and not a bother, it's not something you can ignore. I still feel there is something wrong with me and that I have a disease lurking in the background.

It's kind of like having cancer and saying you have a little bit left, it's probably never going to kill you at this point. Personally, I'd rather get rid of the last freaking little cell of it if there is a chance to do that. But the biggest reason is that I still have not touched music since I got T, and probably won't as long as this thing comes and goes. I haven't even listened to music. I want to get back to playing my guitar, making music and enjoying music because I really miss it. And right now it's like I have been psychologically scarred and I can't feel comfortable going back to that if I still have it.

 

Hi All,
I have until Monday to decide about geting the real am-101. Still no reports of people having good news at 8 months.

 

I believe Oddv did get good results at 8 months. At this point what do you have to lose if you tolerated your first round well?

 

You have this small window of opportunity. Take it!

 

I am going to have my open label round next 18, 19 and 20 and I will be on my 6.5 months mark by then. Nothing to lose.

 

Why did you try antibiotics? I thought it was ototoxic for the ears! Strange that your doc gave you antibiotic, I think that prednisolone helped you the most. When I was on prednisolone (alas 3 weeks after the onset of my T which was far too late to save some of my precious hair cells ) I woke up 3 times in silence end december, but it was alas temporary. If only I could have had the drug within the 24/48h, I'm sure it would have saved me a lot of damaged hair cell, and I'm conviced I wouldn't have developed permanent T, maybe I would have had a temporary one It's a shame that nobody warned me the day of my accident to check my ears immediately, anger is still there after 4 months....

 

Just thought I'd let people know that when having conversation with my Dr he informed me that there or only 41 places on the up to 3 month trial & 32 places on the up to 6 months trials in Europe after that it is finished.

I have decided to have the real thing in May. Thanks for the support

 

Its been 5-7 days since my noise induced H and T started...wondering if i can take perdinosane now and still be eligible to participate in AM 101 study.....

Appreciate any comments on this.

 

Hi.
Start looking into getting Am-101 but you are still in early days . Hopefully you won't need it.
You can always cancel,
Good luck

 

Thanks John.....my ENT said its not realistic to expect it to go away on its own.

I am not sure if perdinosane actually works for loud noise induced H and T...and if it works...whether it is permanent as in AM 101?

 

Prednisone helps with hearing loss not so much for tinnitus

 

Thought too what the hell is perdinosane

@Hopeful1 you mean Prednisone I guess.