AM-101 Clinical Trial — Participants Updates and Discussion

I think it can take up to 3 months to work so 3 weeks is still fairly early. Also even if you did get the placebo you still ofcourse have the guaranteed option of the real drug in a few months. Keep your hopes high!

 

I know each clinic is different but does anyone know how strict they are on the daily diary thing? I'm still a week away from my injections and missed entering the data on my diary by 2 minutes past midnight.

 

Don't worry, doing it the 70% of the time is enough to be in.

 

Hi, I am currently in the trial and got the last injection today. Does anyone know what the follow up exams involve? Do they involve blood tests or just more hearing test/talking?

Thanks for any information.

 

Sorry to hear that.

I was rejected too at first, before the injections as to one of the questions in the questionnaire about the stability of T, i answered it was fluctuating. And they rejected me because of that. I got seriously mad because of that and objected. Fought for like half an hour and finally made them ask me the questions again, i changed my answer to stable and got in.

But it was not fluctuating that much really, i just wanted to give as precise information i could, i mean the fluctuations were 10-20% range at most and they thought it was going up to 7 from 3 in one day by my answer.

I don't think it'll effective for T more than 1 year after the onset. The drug is a well known substance though, esketamine, and i wonder whether are there ways to get it injected or not, without involving in AM101 trial.

 

Good for you. I've so far been to site for 3 follow up visits (1st, conditional and 2nd). Follow up visits involve; hearing tests, blood draw, doctor's examination, urine test (only in conditional follow up visit). Nothing serious if there are no complications.

 

The more you enter your data, the more chance you got for being accepted, mine was 100% and still rejected at first. So take it seriously.

The 70% is for the post-injections phase. If you miss a lot after the injections, it may be a reason for them to not accept you in the open label round.

 

It may differ from agent to agent though. In my site they're using phenol, it hurts a lot for seconds but there's no suction afterwards at all.

Hope you got the real drug.

 

My doctor told me that it's reasonable to expect some improvements after 2 weeks, if you're given esketamine.

Yes, the T is supposed to be loud as the middle ear is filled with gel and it's blocking the sounds to be transmitted to cochlea. Which means, you hear external sounds less, your T is less blocked by them, thus you hear your T more.

 

Yeah I was just told by the dude the 9 days before the first injection are the most important.

I'm a bit confused, you were rejected at a previous clinic even after completing it 100% prior to injections?

 

This is weird, i cannot explain that easily. It may be your perception, the disturbance to your hearing system because of the injections or somehow drug is changing something.

I have a similar thing actually. My right tone which is around 6-7 khz is much fainter after the injections and in the beginning i was thinking that the very high pitched tone (>10 khz) was new and happened because of injections. Later on i realized that previously right one was masking it

It's still too early for you, just hang on, it'll stabilize and you'll be able to understand better.

 

Yes, 100%. No same site, they rejected me at first because of wrong answers in the questionnaire, i objected and fought, changed my answer and made my way in.

 

So weird, I know the Santa Monica one was SUPER strict about things. Was that the first clinic you tried?

 

No, at first i applied to Portland but got a reply saying that they just stopped accepting subjects so applied to Santa Monica afterwards. As i am in Seattle they did not want to accept me first but i'm a persistent guy, you know.

 

I'm learning persistence/being borderline annoying is the only way to get things done during this process.

 

Yes, as AM101 is the only viable option that we have to get a permanent relief during acute phase. If it means being annoying, so be it.

 

I suppose this has been already beaten to death but... Do you guys think AM101, if given in the first round, being this 3 months and 3 weeks from onset, could help things get better?
Also, for the first open label round, which I am going to attend independently of the development of my first round, being received that open label round at almost 7 months from onset could still representing a realistic chance for relief?

 

They already know that esketamine works, they don't know as much for long after the onset it works to a reasonable degree. I remember the report about the time the drug is found to be effective on rats and it completely (100%) eliminated the T on them if administered very soon after noise exposure.

These trials (especially the Europe one) are for the assessment of the effectiveness of the drug in various stages after onset.

It'll probably be effective for 3 quarters after onset with decreasing efficacy. They have a lot of data points right now to be able to say that. My personal opinion about the efficacy is;

Months Effectiveness over control group
0-0.5 100%
0.5-1 80%
1-3 60%
3-6 40%
6-9 20%
9-12 %0

So, after esketamine is made public, the doctors shall be injecting it immediately when the patient shows him/herself, which'll pretty much prevent T if he/she is not too late.

 

Hey guys, I had my daily shower this morning and forgott about wearing the earplugs...
I received last shot last Wednesday... I am worried about this, I mean, really scared about having an infection there. Does it really represents a risk of infection? What should I do?

 

Ask your doctor about what you should do. My doctor told me that even water goes in through the hole and u get an infection, curing it would be very easy. So contact them asap.

 

Had my 3rd and final injections yesterday morning. Right ear had already closed again after 1 day. Left ear had a bit of blood crust on it. Nothing major. Once again I didn't bother with any numbing agent. The pain was a little more then the last 2 times as my ears were a little sore. Regardless the pain was still pretty minimal. Ya it's uncomfortable for the needles to be in your ears for 5-10 seconds but overall there is very little to worry about.

A day later and my T has ramped up but nothing major. Ears feel a little full but my hearing seems fine. Overall the experience has been very seamless. I will definitely be going back for the second round of injections as there were no issues at all with the first round. I expected it to be worse.

 

Hi all!
I don't understand very well english so it's very difficult to read all the topic.
Someone could tell me if AM 101 give some positive results ?
Has AM 101 been tested on chronic tinnitus ?
Do you know when this clinical trial will terminate ?
Today I suffer a lot, I need to listen good news to keep hope...

 

Yes some people on here and on reddit have had positive results. Not totally gone but much much lower tinnitus then before. AM-101 is currently being tested on people with tinnitus of 3 months or less. Some of the trials have included people with up to 6 months or longer. Hard to say for sure at the moment if it will give people with chronic tinnitus any relief but so far it seems that the earlier the drug is used the more successful it is. The trial I think will terminate this year. Go here if you want to see if any trials are being done in your area http://www.tinnitus-study.info/

 

Two days after final injection. Tinnitus isn't that loud. I was expecting the post injection spike to be much worse. No pain in the ears. Both ears still feel a bit full but nothing major. Hearing seems ok but a little muffled from the fullness. So far so good.

 

How long have you had your T at the time you started the injections? Did they tell you how long to expect for it to start having an effect? And do you know of anyone that actually had complete relief from this?

 

Final for the double blind, or final for the follow up (guaranteed drug)?

 

I've had it for about 8 weeks at the start of injections. They didn't tell me. I didn't really ask. I heard from people online who got relief that it can take quite awhile. I don't know of anyone that had complete relief but there are people in this thread who have had relief aswell as some people on reddit.

 

Final for the double blind

 

Did you try taking anything before the injections? Or you went straight for that?

 

Well I hope you get relief. Best of luck.

How long is it till you have the chance to get the actual drug for sure?