AM-101 Clinical Trial — Participants Updates and Discussion

[Nucleo]

John, from my understanding you absolutely have to fill the HTC questionary on a daily basis from now until they give you the next appointment in order to demonstrate your involvement with the trial. English is not my first language so I don't know if I am explaining this the propper way. The goal for them having you to fill that questionary now is, beside collecting details about your T to compare them with the post-injection ones, to see how serious you are about filling it on a daily basis, so my adivice is that better you try to fix the problem asap.
Regards, bro.

This is my understanding as well. If you fail to complete the log book every day you will be disqualified from the trial.

 

[liquefact]

Update on my AM101 trial:
I've been to LA for screening after trying to set this up for ~1 month. I've signed ~20 pages of forms and went through hearing tests, questionnaires, doctors examinations etc. The doctor approved me for the study but the decision shall be made just before the injections next week Wednesday. I also got the electronic diary device to use every night before sleep. They told me that the diary is the most important criteria for decision about the candidates inclusion into the study. So i've entered my first entry yesterday night.

One interesting thing they've told me is, according to the records they've, the ratio of placebo/esketamine is not 40/60 but around 34/66, so the chances are even better. The doctor also told me that they know about the fact that the material they use to numb the ear drums hurts a lot but only for a minute or so. That's OK i guess.

Doctor told me that i should not expect a full recovery after injections, according to him he never saw someone had 0 T after the injections but a lot of people who had significant reliefs.

I'll be flying to LA again next week Wednesday and if i'm qualified i'll have the first injection immediately and second the next day. The date for the third might be postponed to after holidays, still not decided though.

I'll let you know what happens.

 

[Joe Bananas]

Update on my AM101 trial:
I've been to LA for screening after trying to set this up for ~1 month. I've signed ~20 pages of forms and went through hearing tests, questionnaires, doctors examinations etc. The doctor approved me for the study but the decision shall be made just before the injections next week Wednesday. I also got the electronic diary device to use every night before sleep. They told me that the diary is the most important criteria for decision about the candidates inclusion into the study. So i've entered my first entry yesterday night.

One interesting thing they've told me is, according to the records they've, the ratio of placebo/esketamine is not 40/60 but around 34/66, so the chances are even better. The doctor also told me that they know about the fact that the material they use to numb the ear drums hurts a lot but only for a minute or so. That's OK i guess.

Doctor told me that i should not expect a full recovery after injections, according to him he never saw someone had 0 T after the injections but a lot of people who had significant reliefs.

I'll be flying to LA again next week Wednesday and if i'm qualified i'll have the first injection immediately and second the next day. The date for the third might be postponed to after holidays, still not decided though.

I'll let you know what happens.

Do you know if that material to numb your ear is Lidocaine? My Doctor told me I am not going to feel the most minimum pain at any moment, just full ear sensation and he mentioned the material to be Lidocaine. He also told me there have been a couple of patients having their T fading to a complete zero after injections but nobody could ever know if that's due to injections or natural development of their particular T. By the way, he also comented about some people having permanent increases on their T after injections but again, is not possible to know if it is part of the natural development of those particular Ts.

 

[JohnK]

Good news, the device seems to have a global roaming SIM so I can submit entries from over here.

 

[Atlantis]

Have any of you ever wondered how we would be feeling if all the people reporting their outcome in the am101 trial had said they've been cured? When will that day come? With what treatment?

 

[Koen]

Started reading on the trobalt section today and I was wondering ... .
What's the benefit of AM-101 compared to trobalt?

So from what I've read so far, if we'd start taking trobalt to relax the cortex nerves just long enough for the so called 'glutamine storm' to settle, wouldn't we be avoiding the chronical state much more efficiently? Compare it to taking amitryptiline for nerve pain after recontructive surgery for instance.
And AM-101 participants typically have a 30% to 50% reduction, so what remains I guess is the chronical buildup of cortex overactivity anyway until the uptake of the AM-101 +-2 months later. My T after 5 weeks seems much much much louder than in the first 3 weeks so the brain is capable of fucking it up a lot all the time,with or without AM-101 I guess.
Guess the only thing still worth mentioning is that AM-101 also prevents the auditory nerves themselves from 'blowing up' from the glutamine storm. But how important is that after 2/3 months of getting your sound trauma, I wonder what the graphical curve of destruction of the glutamine storm would look like.

 

[Joe Bananas]

My T after 5 weeks seems much much much louder than in the first 3 weeks so the brain is capable of fucking it up a lot all the time,with or without AM-101 I guess.

I've also thought about that. Maybe AM101 helps you to get rid of a 30%-50% of your T intensity but, what about spikes and the so common increase over time? Does the AM101 also prevent that to happen?

I also wanted to ask you; Do you think the increasing of your T along those 5 weeks have been due to any fact or has it been increased just by itself? I mean, have you been exposed to noise or something like that?

 

[Koen]

Don't know Joe. I personally believe the product seems just a temporally soothing agent for the auditory nervers. And what happens after it worked out maybe depends on the cortex activity that was initiated. I believe spikes are still gonna happen if one doesn't accept or habituate later on.

About the increase in loudness. No I have not been exposed more lately, not at all. I think I have some H going on which is spiking it. An excepted idea on this forum is that when we constantly try to figure out our T loudness, it'll annoy us, scare us and re-enforce itself, thus get louder. That's one explanation. But can this be physically as well? I imaging neurons in the cortex recruiting nearby friends to join the overactivity party. I would also like to know if a conscious approach like TRT, mindfullness is making this neuron activity spread less or if these therapies just make you cope with any existing dynamic overactivity. If it's just coping, then what makes cortex neurons recruit and spread overactivity around? I'm full of questions too.

 

[Joe Bananas]

An excepted idea on this forum is that when we constantly try to figure out our T loudness, it'll annoy us, scare us and re-enforce itself, thus get louder.

That's another aspect of the AM101 which holds me back a little. After the dosage you have to fill the questionary in a daily basis during 90 days. That would make you more aware of the T. I think it is even like a "training" where you can develope a habit of being conscious of it. Besides you can get the placebo... The mix of both those possibilities is a bit scary.
I am going to give a try to Mindfullness therapy as soon as I finish my AM101 trial. This is a nightmare...

 

[Jahhsoul]

Hi guys, I was emailed to join to the phase III for AM-101. Sorry for my bad English.

My T: I dont know the cause of my T (2 months with it, bilateral with right ear dominancy), but I had ATM, cervicals and benzos treatment and no one changed the volumen or frecuency, so I guess it must be due to a middle ear infection or an "delayed" acoustic trauma (I mean I used headphones but T appeared some days leter, is this possible right?). The audiometry was perfect up to 8Khz, but I tested my deafness in 8Khz> and I have very slight hearing loss in 11,800 Hz. I have 3 or 4 pure tones and I cannot identify the exact frecuency of them. I would rate it mild like 2.5/10 (0 silence and 10 something like 120 db)

My Question: Do you think is worth take part in the study, since I only have 2.5/10, and Im not sure about having hearing loss up to 11 Khz (and very slight on this frecuency)? I mean, is AM-101 better when you have some kind of deafness? It still works when your haired cells are alive but maybe you have some disbalance on glutamate-related regions in the inner ear?

PD: In the first visit they test your urine/blood to check if u have some benzos in your body? My first visit would be the day 28 of Dec and Im still on a benzos treatment, should I stop it now or can I wait until 2 weeks before the injections (injections would be the day 14).

Thank you guys, your answers will be determinant to take part on the study.

 

[Koen]

Lately when I wake up for a pee, the sound is much lower. Soon after I eventually wake up, the T regains a lot of strength. Is this a sign that it's already chronical? And that AM-101 won't do much anymore?

 

[GrosBalou]

After the dosage you have to fill the questionary in a daily basis during 90 days

The ENT responsible for the trial at my end told me that you don't have to fill the questionary every day. She told me that I would have to do it like a week or two before follow-up meetings.

Lately when I wake up for a pee, the sound is much lower. Soon after I eventually wake up, the T regains a lot of strength. Is this a sign that it's already chronical? And that AM-101 won't do much anymore?

There may be a realtion between your T and your blood pressure in your case. I don't think that's a sign of your T becoming chronical, but who knows ?

@Jahhsoul , I don't think we've got enough data to say on which types of Tinnitus AM-101 is working best. However I know they do not accept anymore some kind of T in the trial, so they already ruled out some. And if they let you in, it means you fit the profile.
Personnally, I do not have hearing loss (or so few in the range < 8khz). I did not see any difference in my hearing before and after the accident. I have a T which varies from 1 to 4 (somehow stable around 2) and I applied to the trial.
Concerning benzos, the best is to ask them and eventually delay your first visit accordingly.

 

[Bryan101]

Any news on neuromodulation? I don't want pills or injections!

F**K!
Just ready to remove my audio cortex with a 12 gauge at this point!!

 

[Edu]

Hi,

just filled in the form to participate in AM-101 trial in Madrid. My T started 17 days ago and ERTs already confirmed inner ear damage cannot be recovered.
I will continue reading about this AM-101. I would not like to become a guinea pig for nothing (or for worse)

Cheers,
Edu

 

[Jahhsoul]

Fast Question:

In phase III trial do they use the 0.27 mg/ml dose or 0.81mg/ml? Extrapolating data from phase II I guess they use the high dose? Does anyone know?

 

[Ecip]

Any news on neuromodulation? I don't want pills or injections!

F**K!
Just ready to remove my audio cortex with a 12 gauge at this point!!

With MRI guided high intensity focused ultrasound that's pretty much what they do!

 

[Asvalian]

I'm also thinking about going though the trial, but I'm also afraid in case it gets worse.. Mine is a 7-8/10, and I'm already feeling suicidal at times, I'm sure I wouldn't be able to endure a 9/10 T

 

[liquefact]

Do you know if that material to numb your ear is Lidocaine? My Doctor told me I am not going to feel the most minimum pain at any moment, just full ear sensation and he mentioned the material to be Lidocaine.

The anesthetic agent is Phenol. Yes it hurts in the beginning like 10-15 secs but then it's gone. It's just a neglibigle cost to pay to have the chance of a permanent decrease. I do not give a damn to temporary reliefs, IMO they're setbacks.

He also told me there have been a couple of patients having their T fading to a complete zero after injections but nobody could ever know if that's due to injections or natural development of their particular T. By the way, he also commented about some people having permanent increases on their T after injections but again, is not possible to know if it is part of the natural development of those particular Ts.

The doctor told me to expect some relief if the real drug is given, but not expect something like 0 T. So we'll see. BTW they've got no data related to permanent increase related to Esketamine (AM101).

 

[liquefact]

My update with the injections.

Dec24, Wednesday:
I've been to the site on noon. They've given me the questionnaire which contains the questions related to T and perception of it. Then detailed audiology tests followed it and i was declared i'm accepted to the study.

Next step was the injections. Taken to a room, the doctor explained me the all procedure. It started with the numbing of the eardrum. They've used Phenol for this, yes it hurts, but only hurts for 15 sec. After that the doctor performs a dry run an waits for your GO signal. When the injector goes through the eardrum, you feel it obviously, the feeling was like you dive deep in water. Then the gel is released, you feel coldness and fullness inside, nothing annoying though. That's it, it takes a total of 2 minutes, 20 sec for Phenol, 30 sec for Esketamine.

After the injection you lay on the inclined patient chair for 30 min with your head oriented precisely by the doctor. This is for the gel to permeate into Cochlea. I was expecting some of the gel in my mouth as some early participants reported that but it did not happen. After 30 mins, it's time for the next ear, same procedure.

After all is done i left the site with no PAIN, no increase in T/H. Went to hotel, had a peaceful night, got to sleep easily to wake up early in the morning for the second injections.

Dec25, Thursday:
Was on the site at 7:30. Same procedure except the application of Phenol. After inspection of the eardrum, the doctor told me that i do not need Phenol again and he'd use the same spot on the eardrum for the injections. He did the injections starting from right ear. For some reasons, he injected the injector 3 times and in the last one i felt some pain. Left one was OK, no pain.

Left the site after that with absolutely no pain, no T/H spike. It was very windy outside though i plugged the earplugs for the rest of the day. In the evening, some pain started along with a minor T spike. I also have fullness in the ears. The pain is probably because of the piercing of the eardrum.

The next injections are on Monday unfortunately because of the holidays. Worked so much to be admitted in the study and barely made it because of the timelines, i do not make this a problem though. Overall i'm very satisfied, i believe the drug either works or does not (if the real one) but having a permanent increase in T does not seem reasonable to me. I just hope be back to baseline ASAP.

Next update shall be on Monday evening.

 

[liquefact]

The T is more or less the same but the pain turned into an extreme one, very interesting. It was not there last night. I know that i could use ibuprofen pills as doctor let me do it, let's see what happens. Is there any one who had a similar experience with the injections?

 

[JohnK]

@liquefact how bad was your T to start?

 

[liquefact]

Well, it's long story but before the injections it was ranging bw mild and moderate. 1 month ago it was slightly louder maybe. Maybe because I believe I do hell of a job managing T and the anxiety coming free with it.
It's unmaskable though, very high frequency.

 

[liquefact]

Update:
After the sleep the pain subsidized to a minor one on the right, no pain on the left. The fullness on the right is on a new level though.

T still the same probably but hard to tell as either left is lower or right is higher. When the fullness go away, I'll probably know better.

 

[liquefact]

Whoaa, the pain I experience on the right is seriously something I was not anticipating. I feel like my ear is like a balloon right now, with severe fullness and pain. There is nothing in the looks though. T on the right increased a notch again. I hope I can survive this night.

I still cannot feel the T on the left though, the pain and T spike on the right might be masking it.

I've read this whole forum maybe 3 times but do not remember anyone experiencing extreme pain like this. It might be because of the multiple piercing of the right ear drum on the 2nd injections. Hope it's not anything serious.

 

[Ecip]

Do you have another ent meeting?

 

[liquefact]

The third injections are on Monday because of the holidays and i'll have the doctor to take a close look on the eardrums before the drug.

This is the worst, pain and ringing. When and if the pain goes away, I'll probably start appreciating my T

 

[liquefact]

I spent 5 hours in Santa Monica downtown with my kids, of course with earplugs during the whole time. But when i reached home in the evening, i realized that T is screaming with its all time max, probably 8-9 and stayed like this for a couple of hours. This level was a completely new experience for me and it was very hard to stay sane. Tried to calm down and T cooled down a bit to 6-7 which is my new baseline after 2 injections, which is hopefully temporary. My normal is ~4 i guess.

My ears are still completely muffled, plugging my ears almost makes very little difference in terms of T perception. The pain is mostly gone with some rare 1-2 sec attacks now and then, it seems that the ear drum is on the way to recovery.

It seems that i underestimated the courage required for participating to this study. The injections are a non-issue but the post injection period with the pain, muffled ears and dramatically increased T is terrible. Don't know if i could be in the study if i had known all these beforehand. I hope all this suffering pays off in the end.

 

[Jeffrey F]

I spent 5 hours in Santa Monica downtown with my kids, of course with earplugs during the whole time. But when i reached home in the evening, i realized that T is screaming with its all time max, probably 8-9 and stayed like this for a couple of hours. This level was a completely new experience for me and it was very hard to stay sane. Tried to calm down and T cooled down a bit to 6-7 which is my new baseline after 2 injections, which is hopefully temporary. My normal is ~4 i guess.

My ears are still completely muffled, plugging my ears almost makes very little difference in terms of T perception. The pain is mostly gone with some rare 1-2 sec attacks now and then, it seems that the ear drum is on the way to recovery.

It seems that i underestimated the courage required for participating to this study. The injections are a non-issue but the post injection period with the pain, muffled ears and dramatically increased T is terrible. Don't know if i could be in the study if i had known all these beforehand. I hope all this suffering pays off in the end.

Hang tight man it gets better!!

 

[Ecip]

Could it be you've received the placebo?

 

[liquefact]

Do not know and I may never know unfortunately.