AM-101 Clinical Trial — Participants Updates and Discussion

[ruben ruiz]

Im confused has am 101 helped anyone? It seems all I read is about whats done to the eardrum?

 

[liquefact]

I've been to the site for the 2nd follow up visit today. Actually it's technically 3rd if i count the conditional one that happened 12 days ago.

Audiology tests revealed that, my hearing is perfectly back to pre-injection level. No loss at all up to 8K. Bone conduction was already fine. No signs of fluid in middle ear. The eardrums are still a little bit stiff, but better than 3 weeks ago and on the way to complete recovery. The audiologist was very happy about the progress.

There are changes in my T as well. Exactly 10 days ago, last Saturday, i woke up to a different T. The difference was, the right tone which was arguably around 6-7 Khz before was much quieter and i could only hear it when i plugged my ears. This however, made the even higher pitched left tone the dominant one which was a whooshing sound and irregularly fluctuating, like a wind (This fluctuation though is nothing significant.). If i quantized it, it'd probably be a 3-4. It was >4 before injections.

The Saturday, Sunday and Monday were awesome. During these days i could rarely hear my T and only the left one. Starting from Tuesday, loudness increased only slightly, which was no problem at all. On Saturday, i spent 3-4 hours outside shopping and when i came back home T was significantly louder with also the the missing right ear tone. (5-6) I can't say i missed it honestly I slept and in the morning it was gone again. Than the flight to LA for the visit and back, it's still loud (5). It'll be probably like this for a while and than subside to ~3 (hopefully my new permanent baseline) again.

The doctor was surprised about this new development as my case was one of the hardest. After the injections i had severe pain and fullness, the elevated T did not go down for weeks, i experienced ~20db conductive hearing losses in both ears and had crackling/popping whenever i gulp (i still have this btw). After all of these he decided me to pay another visit as they were concerned. Right now i can say that my T is not higher than pre-injections and i only have popping left as a nuisance which i can see this as a fair trade-off with decrease in T. Doc said that according to my experience in the last 2 weeks, i can be considered as one of the best success stories. Provided that this new baseline becomes permanent of course.

I'm not sure whether this is because of the drug or is a result of the natural healing that may happen. I want to attribute this to the drug as this decrease in T happened almost overnight, but who knows.

I also told the site that i'd be in the open label round starting in the middle of March. Maybe it'll decrease the loudness 10-20% more. This was the whole point from the very beginning after all.

I thank to every fellow AM101 participants here to share their experiences that allowed me make up my mind and participated in the trial. I do not know whether this is permanent or not. Maybe it'll be worse tomorrow, next week or month, idk. Regardless, i'm so glad that i forced my way in to the trials (they rejected me first and i fought for an hour to be accepted) because of these two reasons;
1. This is a the only reasonable chance that one acute sufferer has
2. I'd have great regrets later on if i hadn't participated

As a conclusion, i strongly suggest to anyone who recently have T to apply to AM101. The trials shall not last forever. There'll surely be a gap bw the end of trials and the drug becomes public in 2017. During this period there'll probably be no way to reach esketamine. So do not miss that unique chance guys.

 

[lapidus]

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

There's this article. I posted this earlier in this thread but the article has been re-written. When I first found the article, it said that he got T and H 2 years before entering the trial. That was either a typo or this guy lied his way into the trial. Anyway, they have removed that info from the article now.
http://www.icenimagazine.co.uk/tinnitus-patient-gratefu/

if you have one, there's a good chance that you'll have another.

Yeah, that's Richard Salvi's theroy. He thinks everyone with T has H but most people with T have it in a such a mild form that they don't even know they have it.

 

[Sebastians]

Just got accepted for the screening today. I'll be just over 3 months in, but the facility accepts patients up to 6 months as part of the trial.
Can't say i'm not apprehensive about this... But it will be an opportunity to hopefully het my T to a lower level. And it's only an hours drive from my place and 15 mins from my parents, so i can take some days off and rest.

 

[Mirage]

Shoot... I've applied (web form), but heard nothing back... been about a week I think. How quickly do they typically try to get in touch for more info?

 

[Sebastians]

At first they called me after a week or two (this was holiday season mind you) to ask some generic questions about my T. Then they called back about two week later. Screening is due two weeks from now. I'll be having my T 4 months by then, but still fit in the post-acute 'window' for treatment.
I think it just depends on the facility and the trial coordinator i guess. Some reported a response after 3 workinh days already..

 

[bill 112]

Anyone know if they're recruiting for these trials near Ireland?Wouldnt mind giving it a go if they'll accept me

 

[Nick86]

So this is my first post on the forum. I'm sitting in the doctors office awaiting my second screening before the first injections(injections will start today)

I'm having some second thoughts. Unsure what to do and the clock is ticking. 2 months ago I got it from a loud concert. My tinnitus annoys me when it's quiet but seems to be fairly easy to mask. My hearing tests have come back fine as well. It does fluctuate from a 2 to maybe a 4. I'm just undecided if this is worth doing. I know the injections apparently heal quick but do the eardrums heal back to normal or become scarred from the piercings?? I'm scared of the hole not closing properly. The syringing makes me nervous as well because I have heard of people from here getting their tinnitus from syringing. I'm just wondering if I'm making the right decision here. I would blame myself if it got worse from this but then also regret it if I didn't try and it gets worse. It's mainly in my left ear but I hear minor tinnitus in my right ear which I believe was caused by the suction of yanking a silicon earplug out too quick. It's minor but I can hear it a little when plugging my right ear. Not sure if I should request they do the other ear aswelll

 

[liquefact]

I know the injections apparently heal quick but do the eardrums heal back to normal or become scarred from the piercings??

In the Santa Monica site, the doctor told me that out of the ~10 subjects, only one of them had not closing eardrum issue. Later it turned out that this was not related to injections and even though they offered the subject a surgery to close it, he refused as it was a non-issue for him.

The syringing makes me nervous as well because I have heard of people from here getting their tinnitus from syringing.

I don't believe getting T from piercing the eardrum is possible. Getting an infection is easier while the eardrum is open though and ear infection can cause T. So protect your ears at all costs after injections.

I would blame myself if it got worse from this but then also regret it if I didn't try and it gets worse

There is a chance that it may get worse later, so i'd suggest having the injections while you can benefit from them.

 

[Nick86]

In the Santa Monica site, the doctor told me that out of the ~10 subjects, only one of them had not closing eardrum issue. Later it turned out that this was not related to injections and even though they offered the subject a surgery to close it, he refused as it was a non-issue for him.


I don't believe getting T from piercing the eardrum is possible. Getting an infection is easier while the eardrum is open though and ear infection can cause T. So protect your ears at all costs after injections.


There is a chance that it may get worse later, so i'd suggest having the injections while you can benefit from them.

Thanks this has given me some more motivation to go through with it. In regards to the syringing. I was referring to the auction they use to get rid of the numbing agent. Does this pose any potential risk? I took some NAC this morning. Could this have any effect on the injections? I wonder. My anxiety is a mess right now.

 

[Alue]

It's mainly in my left ear but I hear minor tinnitus in my right ear which I believe was caused by the suction of yanking a silicon earplug out too quick. It's minor but I can hear it a little when plugging my right ear.

I'm curious about this suction from yanking silicon earplugs out. I've had this too, although my tinnitus was caused by an acoustic trauma. Did you suddenly notice the ringing after pulling the earplugs out or was it just coincidental?

Thanks this has given me some more motivation to go through with it. In regards to the syringing. I was referring to the auction they use to get rid of the numbing agent. Does this pose any potential risk? I took some NAC this morning. Could this have any effect on the injections? I wonder. My anxiety is a mess right now.

I would go through with it at this stage. I doubt the NAC would have any effect positive or negative, you don't want to take anything that would make you bleed more or prolong healing, or anything that would be counter-indicated in the study. Did they give you a list of medications not to take or tell you not to take any medications during the study? I'd expect this because they don't want anything influencing the data.

 

[RaZaH]

Quick question, anyone had any actual T reduction with Am-101?

 

[liquefact]

Quick question, anyone had any actual T reduction with Am-101?

See;

There are changes in my T as well. Exactly 10 days ago, last Saturday, i woke up to a different T. The difference was, the right tone which was arguably around 6-7 Khz before was much quieter and i could only hear it when i plugged my ears. This however, made the even higher pitched left tone the dominant one which was a whooshing sound and irregularly fluctuating, like a wind (This fluctuation though is nothing significant.). If i quantized it, it'd probably be a 3-4. It was >4 before injections.

 

[RaZaH]

Yeah, read that , hard to decipher if you feel that is positive change
Although , reading it again it seems so.

 

[liquefact]

Yeah, read that , hard to decipher if you feel that is positive change
Although , reading it again it seems so.

Yeah it's definitely positive. One tone (my right ear) is reduced so much that the higher pitched left tone masks it now. I believe that's because of AM101.

 

[RaZaH]

Ok, awesome , anyone else ?
Also , has anyone with chronic or almost chronic T sneaked their way into the trial and had any result ?

 

[Alue]

Ok, awesome , anyone else ?
Also , has anyone with chronic or almost chronic T sneaked their way into the trial and had any result ?

I don't think this is a good idea for a few reasons.

If AM101 is effective only for acute onset tinnitus, people with chronic T sneaking their way into the trial could effect data. Enough to make a difference if the drug is accepted or rejected at the end of the trial.
If does turn out to be helpful in chronic tinnitus, then waiting isn't going to make much of a difference.

 

[Nick86]

I'm curious about this suction from yanking silicon earplugs out. I've had this too, although my tinnitus was caused by an acoustic trauma. Did you suddenly notice the ringing after pulling the earplugs out or was it just coincidental?



I would go through with it at this stage. I doubt the NAC would have any effect positive or negative, you don't want to take anything that would make you bleed more or prolong healing, or anything that would be counter-indicated in the study. Did they give you a list of medications not to take or tell you not to take any medications during the study? I'd expect this because they don't want anything influencing the data.

Yup I had noise induced T in my left ear but my right was perfect. Yanked my right silicon earplug out too quick and heard a loud pop from the seal breaking. As soon as it happened I got a loud 5 second ring in that ear. The ring went away but then I had a slight hiss in the ear with faint morse code like beeps. I was so pissed. I'm assuming the suction pulled on the innards of my ear and creating very mild T. Google "kiss of deaf". It's not nearly as bad as my left but I felt so stupid. Be careful removing earplugs if they create a tight seal!

 

[liquefact]

After my injections i was having shower with silicon earplugs and the first time i was taking them off from my ears, i noticed a slight pressure on my eardrums and immediately stopped. Later i took them away slowly while gulping thus opening my eustachian tubes. Nothing happened after that.

 

[Nick86]

So I guys I went ahead with it. Just got home a little while ago from my first set of injections. Decided screw it and did both ears. Wasn't that bad at all. It wasn't comfortable by any means but the pain was minimal. The pain from the suction they use to remove the numbing agent might even have been more painful then the needle itself! Didn't some people here get tinnitus from getting earwax suctioned out??? This scares me if I have to get this before every injection! I would hate the suction to somehow have an effect on it worsening!

Anyways overall the pain wasn't bad and my ears feel slightly muffled but nothing horrible. T is a bit louder and a sharper tone but I expected it to spike so I'm not bothered by it. Overall I'm glad I decided to pull the trigger. If I doesn't work atleast I gave it a shot. Much better feeling then not doing it and wondering "what if".

 

[liquefact]

Anyways overall the pain wasn't bad and my ears feel slightly muffled but nothing horrible. T is a bit louder and a sharper tone but I expected it to spike so I'm not bothered by it.

In my experience, the pain, clogged ears sensation, severe increase in T started after my second injections, very weird. I had a really peaceful night after the first ones. So, do not relax that early. I hope your experience won't be terrible as mine though.

Overall I'm glad I decided to pull the trigger. If I doesn't work atleast I gave it a shot. Much better feeling then not doing it and wondering "what if".

Definitely. Glad that you went for it.

 

[Alue]

Yup I had noise induced T in my left ear but my right was perfect. Yanked my right silicon earplug out too quick and heard a loud pop from the seal breaking. As soon as it happened I got a loud 5 second ring in that ear. The ring went away but then I had a slight hiss in the ear with faint morse code like beeps. I was so pissed. I'm assuming the suction pulled on the innards of my ear and creating very mild T. Google "kiss of deaf". It's not nearly as bad as my left but I felt so stupid. Be careful removing earplugs if they create a tight seal!

I don't doubt you, I too have been wondering about the earplug thing, but I'm not sure what to think about the "kiss of deaf". It seems like it would have to be a pretty traumatic to cause tinnitus. Wouldn't there be obvious signs of damage to the eardrum? I don't see how it would damage the hair cells in the coclea. Or maybe it could be 'the straw that breaks the camel's back' or so to speak.

 

[Alue]

After my injections i was having shower with silicon earplugs and the first time i was taking them off from my ears, i noticed a slight pressure on my eardrums and immediately stopped. Later i took them away slowly while gulping thus opening my eustachian tubes. Nothing happened after that.

So that's what they suggest to keep water from getting into your ears after the injection? Good to know.
After the injection (and before the hole seals up) I would think your ears would equalize more quickly.

 

[Nick86]

In my experience, the pain, clogged ears sensation, severe increase in T started after my second injections, very weird. I had a really peaceful night after the first ones. So, do not relax that early. I hope your experience won't be terrible as mine though.


Definitely. Glad that you went for it.

Ya I've been following your story. Great...now I'm going to be full of anxiety until the next ones on Thursday
Glad to hear you've gotten relief though! Fingers crossed that I got the real thing. Didn't somebody say they noticed the medication less thick during the second round of injections?...I haven't really hard any leakage or major dripping down my throat from this first one

 

[liquefact]

now I'm going to be full of anxiety until the next ones on Thursday

There's really nothing to be anxious of. Whatever goes worse after the injections are temporary. Just hold on for some time.

 

[Nick86]

There's really nothing to be anxious of. Whatever goes worse after the injections are temporary. Just hold on for some time.

Nah I'm just kidding. I'm feeling pretty good actually. I'm just relieved from the stress of whether to go through with it or not. The clock was ticking and I kept flip flopping on if I should or not. Whatever happens now happens.

 

[JohnK]

In my experience, the pain, clogged ears sensation, severe increase in T started after my second injections

For me it wasn't until the 3rd night. I think the goop doesn't completely drain between the injections so there is more and more going in there and by the time of the 3rd day it's definitely a full house in there.

 

[lapidus]

Ok, awesome , anyone else ?
Also , has anyone with chronic or almost chronic T sneaked their way into the trial and had any result ?

Read my previous post:
https://www.tinnitustalk.com/thread...dates-and-discussion.6558/page-40#post-160877

 

[Hotaru]

Can you get these injections with severe ETD?

 

[Aaron123]

It looks like a middle ear infection is an exclusion criterion: https://www.clinicaltrials.gov/ct2/show/NCT01934010?term=am+101&rank=4