AM-101 Clinical Trial — Participants Updates and Discussion

The real drug is guaranteed to be administered after the first round as an appreciation for participating to the study. First round is for science, the others for us sufferers. Every round is 3 injections for each ear.

I'm in the first round and had 2 injections for each ear so far. 3rd injections shall be tomorrow.
 
As far as i know (and i think i have read all posts) the only hearing loss reported has been temporary, the worst case reported was oddv with a drop to 70 db which he reported was only temporary. Myself i reported a 15 db loss and a little bit of hyperacusis after second round of injections which lasted maybe about 15 to 21 days.

Hi again, I've had the 3rd injection to my left just now.

Doctor said there was inflammation in the eardrums, more in the right, explaining the pain. Also the hearing test before the injections showed that there is a conductive hearing loss (~20 db) in the right ear. The guess is there is still some gel trapped bw middle ear and inner ear. Not mentioning the screaming T.

I'll write again after the injection to the right.
 
Update, the third injections:

First, the audiologist performed the regular battery of tests. In the audiogram (right one), i knew that it'd be worse than before since 1. the ringing was/is so loud interfering with my hearing 2. muffled ears and it turned out to be worse indeed. The audiologist was worried when she found out that the hearing went worse since last Tuesday and immediately asked whether i participated into a concert or likewise loud event. Told her that i protected myself as much as i could. Her initial guess then was the canal being blocked because of the gel not discharged from the inner ear so she performed a bone test to prove this idea. My hearing turned out to be unchanged/fine through bone (relief!) but the canal is blocked, which is conductive hearing loss and expected to resolve after the inner ear is cleared from gel. So we'll see in time whether this'll be true for me or not.

Next, injections. No Phenol again as the numbing affect could stay for 1 week as the doctor said.He also told me that there was inflammation in both ears, more in right (cause of pain) but still he'd use the same spot for perforation.

The left was painless and was over in an instant. But few seconds after left, i started feeling dizzy and world started to whirl around me as the gel was a lot colder than my body temperature. This feeling went away after a minute or so.

The right one was seriously painful but the pain went away after 30 secs. Doctor agreed to the audiologist about the theory about the hearing loss; as while injecting the gel, he felt some substance resisting in the beginning but some of them went away so i would be having some relief hopefully. Also he gave me a nasal spray to unblock the eustachian tubes so that the excess gel can leak to my mouth, which i have not experienced so far, neither during injections nor after it.

The ringing is about the same, nothing changed in terms of T, H and pain. So i've completed the first round of injections. Hope i'll be back to baseline soon without any permanent hearing loss. If i'm given placebo and this severe ringing and hearing loss do not resolve, i'll blame my fate:)

The first follow up visit shall be on Thursday.
 
Hi everyone. Just a forum lurker here, coming out of the shadows with a gift for you. (see attached documents)

I just came back from the Santa Monica, Los Angeles office that @bellringer and @liquefact went to. I did the 7 day screening process. After taking another audiogram and speaking to the physician, decided not to go through with the AM-101 study and injections.

For the following reasons:

1) My Tinnitus is not that bad - I can sleep without a masker. Everyone who reported improvement - improved only to where I think I already am. (only able to hear it in quiet rooms and when I focus on it).

- The worst my Tinnitus has been was last night (night before 1st injection). Worrying about it! For the first time in 80 days, I couldn't sleep because of the Tinnitus. I was "searching for the sound" to be "sure" I had it "bad enough". And I got what I wished for. I found it and it stayed all night with me. No longer the ocean & crickets, but the "peeeeeeee" that used to fluctuate in and out stuck.

2) Intratympanic injections, and ketamine to the inner ear are low risk. But the risk is not worth what I personally think I'd gain. Nobody has achieved complete silence from what I've read. And it could possibly be habituation + placebo affect to the one's who achieved something. (but I could be wrong! The results from TACCT1 show efficacy)

Again just a personal decision. Everyone is different.

I read through every AM-101 participants posts:
@Aaron @Fish @James White @Bart Marien @Robb @urtica @BuzzyDave @Matt h @bedouin @Chelovek @cullenbohannon @StayPositive @locoyeti @Mikey Cliff @earsnothappy @khu85 @Icho @NewGuy @Marius T @OddV @Laika @Kent Sabo @tomm @Brian meadows @Romain B @Sharpfire @EarsKid @Stu @papu @shantelle @Watermelonhead @jay-alex @Hoser @grandfunk1 @greenpointer @Jeffrey F @T-Bach @Anthony Magareli

Thank you so much for your contributions. You helped me make a very difficult decision.

I hope any other lurkers out there that have taken AM-101 will sign-up to tinnitus talk and post their experience too.

I attached an excel sheet, that lists all the users, and the details of their procedure (lots of blanks, but helpful - you can read their posts). Also attached the official TACTT1 report my pharmacy school friend sent me. She has access to pharmacy documents I can't find online.

Happy New Year everyone.

P.S., a New Years Resolution:

If my quality of life before Tinnitus was a 7, and now Tinnitus has made it a 4... I'm just going to have to improve other areas of my life that I hadn't before (hot yoga, alkaline vitamin rich diet, further my career, deepen relationships with friends and family) to get me up to 9 or 10.

Good luck.
 

Attachments

  • AM-101 Results from TinnitusTalk Community.xlsx
    45.5 KB · Views: 229
  • mao-35-589 (1).pdf
    1.2 MB · Views: 114
  • 322641 (1).pdf
    267.2 KB · Views: 101
@PandorasHope great job and great resource you've provided in that spreadsheet for people considering doing this... Here's to you finding silence in 2016.
 
Hi everyone. Just a forum lurker here, coming out of the shadows with a gift for you. (see attached documents)

I just came back from the Santa Monica, Los Angeles office that @bellringer and @liquefact went to. I did the 7 day screening process. After taking another audiogram and speaking to the physician, decided not to go through with the AM-101 study and injections.

For the following reasons:

1) My Tinnitus is not that bad - I can sleep without a masker. Everyone who reported improvement - improved only to where I think I already am. (only able to hear it in quiet rooms and when I focus on it).

- The worst my Tinnitus has been was last night (night before 1st injection). Worrying about it! For the first time in 80 days, I couldn't sleep because of the Tinnitus. I was "searching for the sound" to be "sure" I had it "bad enough". And I got what I wished for. I found it and it stayed all night with me. No longer the ocean & crickets, but the "peeeeeeee" that used to fluctuate in and out stuck.

2) Intratympanic injections, and ketamine to the inner ear are low risk. But the risk is not worth what I personally think I'd gain. Nobody has achieved complete silence from what I've read. And it could possibly be habituation + placebo affect to the one's who achieved something. (but I could be wrong! The results from TACCT1 show efficacy)

Again just a personal decision. Everyone is different.

I read through every AM-101 participants posts:
@Aaron @Fish @James White @Bart Marien @Robb @urtica @BuzzyDave @Matt h @bedouin @Chelovek @cullenbohannon @StayPositive @locoyeti @Mikey Cliff @earsnothappy @khu85 @Icho @NewGuy @Marius T @OddV @Laika @Kent Sabo @tomm @Brian meadows @Romain B @Sharpfire @EarsKid @Stu @papu @shantelle @Watermelonhead @jay-alex @Hoser @grandfunk1 @greenpointer @Jeffrey F @T-Bach @Anthony Magareli

Thank you so much for your contributions. You helped me make a very difficult decision.

I hope any other lurkers out there that have taken AM-101 will sign-up to tinnitus talk and post their experience too.

I attached an excel sheet, that lists all the users, and the details of their procedure (lots of blanks, but helpful - you can read their posts). Also attached the official TACTT1 report my pharmacy school friend sent me. She has access to pharmacy documents I can't find online.

Happy New Year everyone.

P.S., a New Years Resolution:

If my quality of life before Tinnitus was a 7, and now Tinnitus has made it a 4... I'm just going to have to improve other areas of my life that I hadn't before (hot yoga, alkaline vitamin rich diet, further my career, deepen relationships with friends and family) to get me up to 9 or 10.

Good luck.

This is awesome stuff but- Just wanted to say- mine says worse however was only worse for two weeks its at baseline now. Sorry, probably should have given an update earlier :D

Also- When you look at people who were given more than one round of injections (as the first 3 injections tend to be real thing OR placebo) data looks pretty good. it looks like people who did more than 3 injections tended to have a good result, only a couple didnt change maybe one got worse
 
I had all three of the second set of injections and pulled out between my first and second followup visit.

In conclusion I found that the treatment reduced my intensity and loudness for exactly two months. I had my first injection the middle of July, my sound slowly went down before bumping up to as loud if not a tad louder two months post injection. On the second round I had the same result. I was softer post injection, then at the two month mark my tinnitus bounced to baseline or louder and has stayed there.

In the end my result was no change, or slightly worse.
 
Update:
Since the 3rd injections i had one more T spike which was severe, around 8. It happened after spending the whole day outside under the nice sunshine. When i got home, i found out that T was screaming. Could sleep without struggling much though. In the morning it was back to 6 (my new baseline after injections). Ears were still muffled, gel leaking out of left and right as i find stains on the pillow every morning.

Follow Up Visit (Dec 31, Thursday):
I was in the site again on Thursday for the 1st follow up visit. First i had the hearing test and it was better than the last one in which audiologist had found a conductive hearing loss about 20db on the right one. This time the hearing loss was pretty much gone if not completely. But it seems i'd developed same type of loss on my left this time. Audiologist performed a pressure test and was pretty much convinced that i still had some gel left in my left ear, causing hearing difficulty.

Then i saw the doctor and talked about my status. He told that i'm not one of the guys he'd seen who'd recovered very easily from the injections but still, my conditions like pain, severely increased T and muffled ears, hearing loss are not unseen before and he was confident that these were temporary. I believe his judgement too, thus i'm not much worried. The left eardrum was 99% healed and i could easily confirm that as there was no leak from my left on that day. The right though is still open, but was closing and it was sure on the way to recovery. He took out some wax + somethings from my right and doc told me that i should have some relief from that.

I also asked him about the flight i'd make to get back to home and whether this was something i should be concerned about. He told me that i was more susceptible to pressure problems than other people as my eustachian tube is a little bit problematic, it does not open that easily and this is crucial for pressure equalizing. But still he saw no risk and told me that beside the discomfort of popping there would be no issues.

After talking with the doc i saw the trial representative. She was a little bit more concerned than the doctor as she was not expecting this much issues after the injections. Asked millions of questions, took a summary of everything after injections and told me that i could be invited to a conditional follow up visit as my case was seen something noteworthy (Trial protocol).

Flight back home:
Before flight: T : ~6, pain : nonexistent, clogged feeling : better than before and equal on each ears.
During flight: I was prepared to the flight with a lot of foods and chewing gums to keep my mouth busy so that the eustachian tube could be opened frequently to equalize the pressure inside the ear. Still during ascent and descent my ears popped like crazy, multiple times/second. I've never experienced something like this so far. Majority of these were painful. After the plane reached to max altitude, the poppings became reasonable, at least the pain associated with them was gone. The descent was roughly the same, i sighed and did nothing about it.
After flight: T: ~7, pain: exists because of million times popping of my ears. Right ear much more clogged than left. The pain is more prominent on the right as well.

Today:
After having a good sleep, my T is about 5-6 and not bothering me that much. The pain i had because of the poppings on the flight is gone but every time i gulp, both ears still pop very loudly. Also the ears are still clogged, do not know when this feeling shall disappear.

To be honest, i'm not expecting much improvement from this trial but i think i gave myself a chance to have a permanent decrease of my T. If not from round 1, i may come from round 2. This is of course by assuming that there'll be no permanent worsening. So first things first, my only expectation right now is to get back to my previous baseline ASAP. And as i vaguely sense a improvement, i'm hopeful.

Sorry for the lengthy post, i'm trying to be as informative as i can as the new participants to this trial are usually craving for info.

Happy new year to all. May SF0034 cure all of us.
 
@liquefact I recently got tinnitus from going to an outdoor gun range. I got accepted into the AM-101 study and am going in for a screening at the end of the week. Thank you for documenting your experiences. I have a couple more days to think about if I want to commit to this study. I am afraid of the side effects. The time frame is making it difficult because I was informed that space is limited and if I do not accept there is no guarantee I can get another spot. My personal doctors tell me that this is still early and to not go injecting anything into my ears - to give it time. The AM-101 doctor tells me he has not noticed any lasting negative side effects from the people they studied on but I am not sure he is being fully truthful based on what I have read on the internet.
 
Hi @spime,

This is precisely why i'm documenting my experience here, to help you and other people decide.

My ENT doctor told me the same before i applied for the trial. His guess was, 70% my T would resolve on its own. In the worst case that it does not, i'd habituate and live in peace with it. He had the point, i still agree with him. But i needed to do something about my condition while i still could. If i hadn't participated in this trial i feel like i'd blame myself.

I still have pretty bad days, today i have bad devils driving me crazy. Partly from T and partly from the never ending popping sound whenever i gulp. Grrrr! I do not remember in the forum who've experienced this much discomfort in the ears. I hope it resolves.

Participating into the trial is completely personal decision, there is no guarantee on anything but only probabilities. In the first round the chances of having the real drug is 67% (in Santa Monica site). The chances of the real drug working is about 60% (AFAI remember) based on the published results of Phase2 trials. So, in the best case, by combining these two, the chances of improvement is ~40%. After this if you continue on round 2, the chances are 60%. The doc there and trial coordinator have told me numerous times that there was no subject whose T got worsened permanently after trials.

These are not the improvement over control group, which means, even if you have the placebo, you may improve because of the natural healing of your T. It happens, most of the people get some relief by their own without doing anything.

The thing about limited availability is probably true as the trials shall end in Q1/2016. Auris Medical shall start on making the drug public if Phase3 trials proves it's effectiveness. So you have to act fast if you wanna be in this as they do not need tons of people in this trial and they're are incredibly picky on the subjects (which is understandable).

Good luck deciding what to do. It's not an easy decision.
 
The AM-101 doctor tells me he has not noticed any lasting negative side effects from the people they studied on but I am not sure he is being fully truthful based on what I have read on the internet.
You can read just about anything on the Internet - if you search long enough. And... in some cases you don't really need to search that hard: youtube is a good example. TinnitusTalk is to some degree the same, except people come here to vent their fear of needles, fear of hearing loss, suspicion that Auris Medical is "hiding something" in their statistics - because that's what all pharma companies do, right? I get a good laugh coming to this section of the forum, I tell you.

In addition, I find it interesting that you - and others - would choose to believe the people who will feed you just about any kind of invented information over the information provided by a physician of the trial.

His guess was, 70% my T would resolve on its own. In the worst case that it does not, i'd habituate and live in peace with it.
In my opinion (for what it is worth): I consider tinnitus which lasts beyond two days to be a concern, tinnitus which lasts longer than a week to be a real worry, and tinnitus which persists beyond a month to be probably permanent.

That's why I always make an effort to inform folks of the AM-101 trial where it is available: a pretty unique chance to avoid a lifetime of misery.

The thing about limited availability is probably true as the trials shall end in Q1/2016. Auris Medical shall start on making the drug public if Phase3 trials proves it's effectiveness. So you have to act fast if you wanna be in this as they do not need tons of people in this trial and they're are incredibly picky on the subjects (which is understandable).
This is something that I - or someone from the staff need to follow up on - as I do believe a drug is made available via the trial programme until it comes to market (if proven effective). But I am unsure if this only applies for drugs associated with life threatening diseases, or, if it is also done for pathologies with no available treatment (e.g. tinnitus). Or if it is done at the discretion of the pharma company. Not sure.
 
I had Doctor Simon at the Santa Monica site and he was a wonderful doctor. I wish he was my regular physician outside the study. I was only going to enter into the second phase if they used a lidocaine cream instead of the phenol and he had no issue meeting this request. I found using the lidocaine healed quite quickly. One day later I was closed up. Immediate relief unlike the phenol that took a week before I closed up.
 
Does someones knows how do they measure T loudness for TACTT3 ?

Only through participants reports ? Or do they still do the loudness matching test / minimum noise masking level ? (as I read in some other post for TACTT2).
 
This is something that I - or someone from the staff need to follow up on - as I do believe a drug is made available via the trial programme until it comes to market (if proven effective). But I am unsure if this only applies for drugs associated with life threatening diseases, or, if it is also done for pathologies with no available treatment (e.g. tinnitus). Or if it is done at the discretion of the pharma company. Not sure.
Auris Medical came back to me regarding the above.

The main point is that while certain "pre-approval" or "pre-access" programs are available in some countries, they are rather exceptional and, if ever, primarily used with life threatening conditions within relatively small patient populations. Also, various restrictions apply and implementation of the programs can be challenging. Realistically, Auris Medical do not see any possibilities here for AM-101 / tinnitus. Of course they will seek to minimize the duration of the approval process to the extent possible or allowed.
 
Does someones knows how do they measure T loudness for TACTT3 ?

Only through participants reports ? Or do they still do the loudness matching test / minimum noise masking level ? (as I read in some other post for TACTT2).

Yes, they perform loudness matching test. In my case I had it two times, one before 3rd injection and one during the first follow up visit. Idk if I'll have it in the later visits though.
 
Annoying. I'm at the hospital ready for the injections. Doc told me 5% of eardrums didn't close. I have to decide now but I find 5% a lot.
 
I find 5% a lot.
Are the 5% is related to the intratympanic injections done along AM-101 ? Is he doing follow-up visits as well ? Or is it more a general thing over perforated eardrums ?

Quoting AM-101 phase 2 results (for the 227 patient which completed the study) :
"In 93% of cases, the eardrum was already fully cicatrized at Day 7. For 1 patient in the placebo group, the paracentesis was still open at Day 90; however, the patient was asymptomatic and declined a restorative intervention."

Here it's less than 0.5%, and this guy even refused surgery to close the hole.
 
I don't know! It was the ENT doc just before the injections. I saw him for only a few minutes. I didn't have a chance to ask for details with him. Based on that that I didn't do it though. I only had 25 min to make up my mind.

Let's just presume he was talking generally. Where does he get that number? So is it less less than 5% then? Are the injections from AM any different?
 

Log in or register to get the full forum benefits!

Register

Register on Tinnitus Talk for free!

Register Now