AM-101 Clinical Trial — Participants Updates and Discussion

[AlexSongitus]

Thanks for the info. Honestly i was expecting more or less the same thing. Esketamine in theory should only be effective shortly after onset. I'll be in the open label round next week (5.5 months after onset) and had already decided to not go for the other round. The more time passed after onset the less effective esketamine. Honestly my expectations from the open label round is gone down to almost 0. Any noticeable change shall be appreciated very much though.

They know this fact much better than us as they must've collected shitload of data so far and it's reasonable for them to put an end to the AMPACT trial. The reason they are trying to assess the efficacy of the drug in the border of acute/chronic phases (3-9 months) is to extend the reach of the medicine to a broader range of people as much as possible i guess. Of course this is partly driven by the smell of profit. 1K more people means roughly 2M USD additional revenue if the pricing is in the ballpark you've mentioned. This'll easily more than what they've probably spent for the extended trials.

We'll probably see miracle like results after the drug is made public and is administered very shortly after onset. It'll pretty much prevent the development of tinnitus in the case of acoustic trauma. We're all ready to spend tens of thousands of dollars for a cure and for 1-2 K USD, it'll sell like cakes.

I hope no one needs to suffer from this shit in the future anymore.

I think the way they collect data from us will make results look worse than reality.

My T the past 3 days:

0 T for 21 hours on Saturday.
4/10 to 3/10 on Sunday(one ear only).
1/10 for 2 hours yesterday, followed by no T, or intermittent T of 0-0.2 until midnight last night.

I woke up with a 1-2 this morning, as usual sleep resets it. But what I reported because of the way they ask the question as the loudest T in the past 24 hours, reported at 9pm:

2 Saturday (because of Friday night)
4 Sunday
3 Monday (because of Sunday night)

In reality I had 2 days of silence out of 3, which I have never experienced since I got T but my results reported show no improvement, in fact it would show it got slightly worse from baseline!

 

[Hotaru]

T is worse since getting injections. Tmj kicks in after years of being dormant. Hole in right ear keeps blowing open when I blow my nose, not too hard. Ears feel full, pressured, and I'm still hard of hearing, although maybe not as bad as yesterday. If I could rate my t higher than ten, I would.

 

[liquefact]

Me: - Are there any chances of AM101 having positive effects in a person who receives it 7 months after onset?
Dr: - Yes, yes, yes, yes, yes, yes, yes, yes, yes, yes...

I hope I'm wrong of course but there's no known reason that it should work in long term. Esketamine will prevent glutamate storm yes but will quickly be thrown out of the system. I have serious doubts of any improvements because of esketamine happening months after injections. It should be because of natural healing+habituation but there's no way to prove or disprove that in an individual basis as there can be no control group for a group of one.

Again I hope the whole reasoning turns out to be wrong for whatever reason I do not care and I go for the other round. I'll see by myself in a month.

 

[liquefact]

In reality I had 2 days of silence out of 3, which I have never experienced since I got T but my results reported show no improvement, in fact it would show it got slightly worse from baseline!

I also agree that the whole system of capturing the max loudness/annoyance is misleading. The average and deviation information is lost in the process. This in turn, as you stated, will cause the results to be worse than it actually is. Maybe this was the whole point, the reasoning was; if the results taken from nx100 people shows an undeniable improvement with that approach, the real life results shall be much better.

I'm also leaps and bounds better than 3 months ago. The loudness went down a bit but the important thing is I can ignore this shit almost always. Of course I'd give a lot of things to experience the silence like you, even temporarily, but still I'm so grateful that I could save my mind from this monster.

By the way, I'm so happy when someone experiences improvement because of anything that's been tried here. Glad that it went down for you dude. Hope that we'll all experience that one day.

 

[Charles Vitale]

Does anyone have actual RESULTS from the real AM 101 full treatment ? I understand the need to post treatment info and the need to question trial authenticity but a true report on results would be great . Good or bad.

 

[matt89]

@Charles Vitale

There are some positive results from people with AM-101 treatment on other sites:

https://www.crn.nihr.ac.uk/news/tinnitus-patient-grateful-to-nhs-researchers-ive-got-my-life-back/
(Obviously received AM-101, otherwise there wouldn't be the article with statements from the research leader of the trial)

https://www.reddit.com/r/tinnitus/comments/3hiy9f/am101/
(Obviously received AM-101, he states "AM-101 was allright" and did not mention that he maybe got the placebo)

https://www.reddit.com/r/tinnitus/comments/1m1kiy/follow_up_on_am101_study_i_participated_in/
(He got a confirmation that he received AM-101)

But would be nice to get some feedback from people here who received the AM-101 treatment (someone who got a confirmation after the trial that he or she has received AM-101 or who has done the second round where he or she received AM-101).

 

[ryant]

I hope it comes to market soon. I was denied the treatment. The office manager of the clinic I called told me they are only accepting people who have had tinnitus for 2 months or less at this time. When I called I was 2 months and 1 week. He asked me when the T started before he would tell me if I was eligible. I was really disappointed because I was looking forward to trying something that would actually work.

So now I'm looking for other options. my audiologist suggested sound therapy, but the system they have cost $5,000. I'm not sure if I'm willing to drop that kind of money (it's a lot for me) for something that may not work, and has very little research behind it.

Good luck to all of you who are in the trial. Hope you have success. And for anyone on the fence don't wait too long. I wish I had learned about it sooner. The ENT doc I saw a month after this started told me there was nothing that could be done. I wasted 2 weeks waiting for that stupid appt.

 

[AlexSongitus]

I hope it comes to market soon. I was denied the treatment. The office manager of the clinic I called told me they are only accepting people who have had tinnitus for 2 months or less at this time. When I called I was 2 months and 1 week. He asked me when the T started before he would tell me if I was eligible. I was really disappointed because I was looking forward to trying something that would actually work.

So now I'm looking for other options. my audiologist suggested sound therapy, but the system they have cost $5,000. I'm not sure if I'm willing to drop that kind of money (it's a lot for me) for something that may not work, and has very little research behind it.

Good luck to all of you who are in the trial. Hope you have success. And for anyone on the fence don't wait too long. I wish I had learned about it sooner. The ENT doc I saw a month after this started told me there was nothing that could be done. I wasted 2 weeks waiting for that stupid appt.

That can't be right. It should be 3 months or less, not 2 months. How long ago was this? Can you call back and confirm?

 

[ryant]

That can't be right. It should be 3 months or less, not 2 months. How long ago was this? Can you call back and confirm?

It was 2 weeks ago. I did call back to confirm. They said no exceptions. I was very disappointed.

 

[AlexSongitus]

It was 2 weeks ago. I did call back to confirm. They said no exceptions. I was very disappointed.

Where was this study center? This is directly from Auris Medical's official Tinnitus study website:

http://www.tinnitus-study.info/us-en-the-study

The following people may take part in the clinical trial,

• those who are older than 18 and younger than 75,
• those who have tinnitus following an acoustic trauma, barotrauma, an operation on the middle ear, a traumatic perforation of the eardrum or an infection of the middle ear,
• and who contracted the tinnitus within the past 3 months.

Even on the contact form, it asks if you have had it for less than 3 months. I have not heard of anyone else on this forum reporting being denied for being over 2 months. They are not following procedure if that's what they are doing.

Since you still technically are within that window I would try get to the bottom of this, because they should let you in.

 

[Alue]

Where was this study center? This is directly from Auris Medical's official Tinnitus study website:

http://www.tinnitus-study.info/us-en-the-study

The following people may take part in the clinical trial,

• those who are older than 18 and younger than 75,
• those who have tinnitus following an acoustic trauma, barotrauma, an operation on the middle ear, a traumatic perforation of the eardrum or an infection of the middle ear,
• and who contracted the tinnitus within the past 3 months.

Even on the contact form, it asks if you have had it for less than 3 months. I have not heard of anyone else on this forum reporting being denied for being over 2 months. They are not following procedure if that's what they are doing.

Since you still technically are within that window I would try get to the bottom of this, because they should let you in.

Might depend on when they can set up the treatment date. The treatment date has to be within 3 months, it took like 6 or 7 weeks from my initial contact to get the actual injections.

 

[AlexSongitus]

Might depend on when they can set up the treatment date. The treatment date has to be within 3 months, it took like 6 or 7 weeks from my initial contact to get the actual injections.

That is a good point. It could be that.

 

[Dutchy]

Where was this study center? This is directly from Auris Medical's official Tinnitus study website:

http://www.tinnitus-study.info/us-en-the-study

The following people may take part in the clinical trial,

• those who are older than 18 and younger than 75,
• those who have tinnitus following an acoustic trauma, barotrauma, an operation on the middle ear, a traumatic perforation of the eardrum or an infection of the middle ear,
• and who contracted the tinnitus within the past 3 months.

Even on the contact form, it asks if you have had it for less than 3 months. I have not heard of anyone else on this forum reporting being denied for being over 2 months. They are not following procedure if that's what they are doing.

Since you still technically are within that window I would try get to the bottom of this, because they should let you in.

I think they're refusing many applicants now,there's not much improvement within the people that have participated.
Maybe they're close to ending this phase?

 

[Joe Bananas]

I think they're refusing many applicants now,there's not much improvement within the people that have participated.
Maybe they're close to ending this phase?

Do you have any data to support that?

 

[Dutchy]

Do you have any data to support that?

I see 3 people that are reporting improvement,other than that not much to be found.

 

[AlexSongitus]

I see 3 people that are reporting improvement,other than that not much to be found.

On here perhaps. And you have to consider the fact 40% of them would have gotten the placebo. They have already released results for prior studies which look promising, and if the questionnaire I have to fill out every night is anything to go by, then every indication points to those numbers being a worst case scenario, since it only tracks the loudest spikes in a 24 hour period. In my case the results have been better so far than the numbers I have to report. Also if what Joe is saying is correct and the drug has already been approved, then it certainly sounds like their results have been convincing.

In either case I don't think it's good to rush and make blanket statements about something like that. We will know their results in a few months.

 

[Dutchy]

On here perhaps. And you have to consider the fact 40% of them would have gotten the placebo. They have already released results for prior studies which look promising, and if the questionnaire I have to fill out every night is anything to go by, then every indication points to those numbers being a worst case scenario, since it only tracks the loudest spikes in a 24 hour period. In my case the results have been better so far than the numbers I have to report. Also if what Joe is saying is correct and the drug has already been approved, then it certainly sounds like their results have been convincing.

In either case I don't think it's good to rush and make blanket statements about something like that. We will know their results in a few months.

What are those results from prior studies?

 

[AlexSongitus]

What are those results from prior studies?

Well here's one article with numbers:

At Day 90, the mean improvement in tinnitus loudness was 48% in the high-dose group, compared to 28% in the low-dose group and 9% in the placebo group. Overall, 64% of patients in the high-dose group rated their tinnitus severity at Day 90 compared with baseline as ''much improved'' or ''very much improved'' compared with 44% and 35% of patients in the low-dose and placebo groups, respectively.
https://globenewswire.com/news-rele...in-Treatment-of-Acute-Inner-Ear-Tinnitus.html

These were their results of their first trial.

 

[Dutchy]

Well here's one article with numbers:



These were their results of their first trial.

Hmm,they mention locations in the Netherlands but i could only find locations that are located in Belgium for this trial/phase 2.

 

[AlexSongitus]

Hmm,they mention locations in the Netherlands but i could only find locations that are located in Belgium for this trial/phase 2.

Yeah they may have stopped offering it in Netherlands. Although I did get contacted by another member interested in participating saying they are doing it in Turkey too, and that's also something they are not listing on the official site. You can read the conversation on my profile page.

 

[liquefact]

Yeah they may have stopped offering it in Netherlands. Although I did get contacted by another member interested in participating saying they are doing it in Turkey too, and that's also something they are not listing on the official site. You can read the conversation on my profile page.

Turkey was on the list previously and i know a guy who enlisted. It's been taken out of the list later though, probably they've reached the necessary numbers. There are more and more signs that the trial is coming to an end.

 

[Aaron123]

These were their results of their first trial.

The published paper is available: http://journals.lww.com/otology-neu...d_Safety_of_AM_101_in_the_Treatment_of.4.aspx so everyone can read it if they would like.

To be clear, these results

At Day 90, the mean improvement in tinnitus loudness was 48% in the high-dose group, compared to 28% in the low-dose group and 9% in the placebo group. Overall, 64% of patients in the high-dose group rated their tinnitus severity at Day 90 compared with baseline as ''much improved'' or ''very much improved'' compared with 44% and 35% of patients in the low-dose and placebo groups, respectively.
https://globenewswire.com/news-rele...in-Treatment-of-Acute-Inner-Ear-Tinnitus.html

are for the sub-sample of individuals with unilateral tinnitus due to either acoustic trauma (AAT) or ear infection (OM). (These results also likely guided inclusion and exclusion criteria for subsequent studies.) These results do not apply to the entire sample in the study.

Unlike that sub-group, the overall results aren't as positive. They didn't find a significant effect for the primary endpoint (minimum masking level), and it isn't entirely clear what was found for the secondary endpoints. I do like that they explored the data to see if there was a significant effect for some groups. Tinnitus is so varied that I wonder if some interesting results have been missed in other work when this is not done.

Importantly given some discussions around here, they found no effect for sudden hearing loss.

 

[AlexSongitus]

The published paper is available: http://journals.lww.com/otology-neu...d_Safety_of_AM_101_in_the_Treatment_of.4.aspx so everyone can read it if they would like.

To be clear, these resultsare for the sub-sample of individuals with unilateral tinnitus due to either acoustic trauma (AAT) or ear infection (OM). (These results also likely guided inclusion and exclusion criteria for subsequent studies.) These results do not apply to the entire sample in the study.

Unlike that sub-group, the overall results aren't as positive. They didn't find a significant effect for the primary endpoint (minimum masking level), and it isn't entirely clear what was found for the secondary endpoints. I do like that they explored the data to see if there was a significant effect for some groups. Tinnitus is so varied that I wonder if some interesting results have been missed in other work when this is not done.

Importantly given some discussions around here, they found no effect for sudden hearing loss.

From my understanding the sub-group they are referring to are the patients who had known causes of either otitis or acoustic trauma, which is of obvious importance here, and received the high-dose, 3 injections, vs 1 dose. Currently they are performing only high dose treatments. I highly doubt there is ever going to be a 1 shot fits all cure, just like with most diseases.

 

[matt89]

Nevertheless the AM-101 trials are running since 2009/2010 right and we have like three to cero official positive statements on the internet from people who have received AM-101 (confirmed) during a period of 6 years?

I don't know how to rate this.
In my opinion there are two options.

1. AM-101 is effective (especially in cases of acoustic trauma and otitis) but most of the ones who received drastic improvements or even got cured don't want to talk about it any longer in order to end with the topic T for their lifes.

>> Don't know but I think this option is a bit improbable, because why should someone who received AM-101 (confirmed) doesn't want to tell others about the improvement/cure if it happened.

2. AM-101 is not effective at all and official statements from people who received the treatment (confirmed) and talking about improvements or even cures are people who usually have become more habituated to their T. Mean we're talking about the acute phase which is three months and many improvements (drops in T sound, better habituation) are happening in that period.

What do you think?

 

[Bobby B]

I did speak to Sara Richards, the site coordinator for Santa Monica USA over the phone about a month ago .. I was planning to go for it but since my case involves flying from far away to even get there I wanted a bit more color from her . I asked her if to her knowledge there were people cured from T following am-101.

She told me something like that " we still don't know what the drug esketamine does exactly , but the people who did the best on it after the trial are the ones who had the injections for quite some time prior like several months or a year and got used to they tinnitus over time ..."

So it did not sound to me like a a clear " yeah it works " but more like a combination effect where time and habituation plays a role too..
Maybe it makes t go soft over a long period of time then eventually the new baseline level is easier to habituate ..

 

[Bobby B]

On a side note - for the folks with eardrum perforation healing issues , here is something to consider :


https://www.researchgate.net/public...ic_membrane_perforation_repair_in_guinea_pigs

 

[OddV]

Read through this thread, people have had positive results, I am one. Stop making broad remarks when the data for this phase hasn't been published.

 

[Dutchy]

Read through this thread, people have had positive results, I am one. Stop making broad remarks when the data for this phase hasn't been published.

How are you one?

Edit: NVM i see now this goes all the way back to 2014.

 

[matt89]

@OddV

Yes but we have two previous phases of the trial and actually there should be some more positive feedback especially due to the fact that there's a second round where someone can participate 6 months after on-set if he has received the placebo. Have read through the whole thread and noticed that you have had a positive experience. That's great!

Do know if you have received AM-101 or the placebo?
Have you done the second round where you receive AM-101 in case you have received the placebo before?

 

[TJohns]

I have read a couple threads, on TT involving people taking the am101 trial, then disappearing all together no real feed back. I would like to think if I did the trial i would want to share any positive results, though to each there own.
Little surprised that there is not more feed back being there is a huge number of people, involved in the trial over the last few yrs, I'm sure not everyone of them is on TT but seems there would be more feedback.
Thank you for those who have shared there experience and continue to share