AM-101 Clinical Trial — Participants Updates and Discussion

[OddV]

3rd round, 2nd injection... No different than all the others... Ear canal more tender, as usual; more painful injection the second day, as usual. Everything else the same.

I didn't have to do a hearing test today (yippie)... hearing was normal this morning, thus they (trial site) opted out of doing it... I suspect I'll have to do it tomorrow as hearing is very muffled following injection today.

For those of you considering doing it who are scared of an injection through your ear drum... yeah, it's a bit painful, but it's over quickly... it's why I recommend the stress ball to folks. To be honest, them suctioning the Emla off before the injection is more bothersome than the actual injection.

Suctioning takes about 30 seconds
Injection takes about 10 seconds

Breath deep, it will all be over soon. Then the boring ass 30 minute wait begins. Luckily, my trial nurse is a nice lady and talks to me the whole time. Also, my doctor doing the injections is awesome. He always spends more time with me than he has to and I've gotten to know him (as well as you can know any doctor) fairly well. I know where he likes to vacation, what college football team he pulls for, what type of beer he likes, etc, etc. I hope all trialees have the same experience.

After this round, I have one more round as an option. The only reason that I wouldn't do it is the time commitment. The pro's that I've experienced to date are getting to the point that they don't really outweigh the con's of the time commitment. I have to drive 3 hours each way to the site, which blows a whole day for the follow ups. I've gone ahead and booked round 4 in July and will make a decision as I get closer.

I guess my thought process goes like this. If I don't experience any more relief from this round, then why would I do round 4? If I DO experience additional relief from this round... how close to 0 am I and do I think another round would get me to 0. If it's a 1 in a few weeks, do I really need to go through the hassle to potentially get it to a 0 or do I just let nature do it's thing going forward.

Will be going on my first international flight since onset, little nervous about being in a plane for 20+ hours; should I use noise canceling headphones for that trip?

 

[earsnothappy]

3rd round, 2nd injection... No different than all the others... Ear canal more tender, as usual; more painful injection the second day, as usual. Everything else the same.

I didn't have to do a hearing test today (yippie)... hearing was normal this morning, thus they (trial site) opted out of doing it... I suspect I'll have to do it tomorrow as hearing is very muffled following injection today.

For those of you considering doing it who are scared of an injection through your ear drum... yeah, it's a bit painful, but it's over quickly... it's why I recommend the stress ball to folks. To be honest, them suctioning the Emla off before the injection is more bothersome than the actual injection.

Suctioning takes about 30 seconds
Injection takes about 10 seconds

Breath deep, it will all be over soon. Then the boring ass 30 minute wait begins. Luckily, my trial nurse is a nice lady and talks to me the whole time. Also, my doctor doing the injections is awesome. He always spends more time with me than he has to and I've gotten to know him (as well as you can know any doctor) fairly well. I know where he likes to vacation, what college football team he pulls for, what type of beer he likes, etc, etc. I hope all trialees have the same experience.

After this round, I have one more round as an option. The only reason that I wouldn't do it is the time commitment. The pro's that I've experienced to date are getting to the point that they don't really outweigh the con's of the time commitment. I have to drive 3 hours each way to the site, which blows a whole day for the follow ups. I've gone ahead and booked round 4 in July and will make a decision as I get closer.

I guess my thought process goes like this. If I don't experience any more relief from this round, then why would I do round 4? If I DO experience additional relief from this round... how close to 0 am I and do I think another round would get me to 0. If it's a 1 in a few weeks, do I really need to go through the hassle to potentially get it to a 0 or do I just let nature do it's thing going forward.

Will be going on my first international flight since onset, little nervous about being in a plane for 20+ hours; should I use noise canceling headphones for that trip?

I really appreciated it when the nurse or doctor stayed in the room while waiting. It really helped with the anxiety of getting a needle in your ear. A few times they weren't there and being alone, waiting, really sucked.

 

[attheedgeofscience]

For those of you considering doing it who are scared of an injection through your ear drum... yeah, it's a bit painful, but it's over quickly...

Thanks for the account. Just to be clear on this point regarding the injection: I assume it is just an injection and no actual cutting of the eardrum as is done with grommets, correct?

I had grommets placed as a kid, but I don't remember the actual procedure any longer (I was about five years old). For the sake of the "audience" here on TinnitusTalk, if you were to rate the pain threshold of the injection of the eardrum (after being numbed), how would the pain compare to - say - a regular blood test?

Thanks.

 

[OddV]

On a pain scale of 1 to 10, a blood test is a 1.

My experience:
Day 1 injection - 2
Day 2 injection - 4
Day 3 injection - 5

No cutting of eardrum, just the injection... He does put a control hole to allow pressure to equalize if it's not too tender.

I do 3 days in a row due to travel, if I lived local, I'd take a day between... Doc did tell me that it would make a difference pain wise to give a day between.

 

[OddV]

Day 3... Doc opened a new tube of emla and coated my ear canal, pain wasn't as bad as day two.

Same ole same ole... Very full feeling, very muffled... T slightly increased.
I go back next Friday for follow up.

 

[Jokko]

But in don't understand this med is only for acute tinnitus of too for chronic tinnitus? AM-101

 

[OddV]

So, I go for my 1st checkup tomorrow.

Going into the injections (3rd round) I was about a 2 or 3 on loudness.

As of yesterday, I'm sitting at a 1 on loudness. Stress normally spikes it, I've been super stressed this week and have had no spikes. I'd compare it to when you turned off an old CRT TV and the buzz that was barely audible at that point.

Keeping my fingers crossed.

 

[skoupidis]

Keeping my fingers crossed.

We all do that for you! And for us, hopefully in the future. Although you got lucky and was accepted into trials. We have the same onset you know, but I will be much more chronic when and if I ever manage to do the injections.

 

[OddV]

What I've noticed is that each round has cut it roughly 40% to 50%...

If I maintain the 1 for the next 90 days, I don't think I'll do the last round. Based on my experience, it would take it to 0.5 on loudness... Is that worth the pain and time commitment?

 

[skoupidis]

What I've noticed is that each round has cut it roughly 40% to 50%...

If I maintain the 1 for the next 90 days, I don't think I'll do the last round. Based on my experience, it would take it to 0.5 on loudness... Is that worth the pain and time commitment?

Just rap it up and take it for home. Then I will write you my address so you can send it to me. The difficult part for me will be to find a capable ENT to do the injection without destroying my eardrum.

 

[attheedgeofscience]

What I've noticed is that each round has cut it roughly 40% to 50%...

If I maintain the 1 for the next 90 days, I don't think I'll do the last round. Based on my experience, it would take it to 0.5 on loudness...

Very informative. Especially considering that you believe you had the placebo in the first round (i.e. the trial itself). What you are suggesting is that AM-101 remains potent in the later stages of tinnitus onset. Again: informative.

Would you be kind to inform the forum as to whether you received the injections bilaterally (in the post follow-up study)? I realize you may have stated it before. I apologize, if so.

Is that worth the pain and time commitment?

Only you can decide. And you are the expert by now! Personally, if the risk is low - and which seems to be the case - then I would probably at least consider it.

How did your eardrum look a week post-intervention?

Thanks.

 

[OddV]

@attheedgeofscience unilateral (left ear only)

Ear drum fully healed 8 days later sans a small blood clot.

Hearing was slightly deteriorated, but that's normal at the first checkup.

Hey, is Esketamine addictive? I'm kinda craving another shot right now.

Have to do a pros cons list to do it again, the time commitment is huge with me living 3 hours away.

 

[shantelle]

Anyone have any positive outcome on this trial? Ive signed up for it near my area. I have 3 weeks of Tinnitus caused by loud club in vegas.

 

[Nucleo]

Anyone have any positive outcome on this trial? Ive signed up for it near my area. I have 3 weeks of Tinnitus caused by loud club in vegas.

Someone correct me if I'm wrong but I do not recall anyone saying their symptoms completely resolved after the injection. If we take for granted the proposed mechanism for tinnitus generation by Auris Medical is correct, I would at least expect some.

 

[Sharpfire]

I'm booked in for a screening session on the 26th, then the first injection i think 2 weeks after and I'll report back with all the details etc. Would have been much earlier (i.e around now / last few weeks) but I'm currently doing academic exams so need to wait till they're over.

 

[Frances Lynn]

I'm new to this forum and fairly new to T. Hard to get used to. I'm supposed to be screened next week to see if I'm eligible for the 3rd phase of the trials. Has anyone participated in phase 3? What was your experience like?
The Auris website has info on the clinical trials. Thanks for any light you can shed!

 

[Calories]

I live in India, is there anyway I can get into the trials?

 

[Carm]

I live in India, is there anyway I can get into the trials?

Simply put: no.

 

[Jokko]

Hello guys, I joined the trial in swiss! my tinnitus started 17.01.2015 also know I'm in the fresh post-acute phase maybe this drug (am 101) can kill my mild tinnitus forever.

 

[papu]

As promise here is my experience. Started two months previous to injection with bilateral tinnitus due to acoustic trauma. Started my first round around the second month mark. Tinnitus approximate loudness between 7 and 6. Annoyance about a 5 to 6. Had my injections in both ears (three in each one in a period of 5 days with a day of rest in between). At least in my case it was unpleasant and uncomfortable but not really painful. To be quite frank i found the 30 minutes not swallowing experience more bothersome and uncomfortable than the injections. Once again this is my experience and everybody has a different pain threshold. The eardrum was fully closed and heal each time that i went to do each eardrum shot (in other words closed in two days). Left ear became unclogged while they were doing my right ear, right ear usually took a day. No real hearing loss during the 200 hearing test that they performed (just joking but they were lots of them) and no real changes in the oculus or VR gear test pseudo device during the entire period (nistagmus test). Had the usual spike described by all that's why i did not report sooner or vote otherwise i would voted slight or moderately worse. Spiked all the way to 8/9 range for a few days, but did not get alarmed because it was described in all post before. As of now i think i am about 5/6 in loudness which i do not consider enough of a change, so i am thinking placebo like oddv in the first round which is completely in the realm of possibility before a lot of people start saying that it does not work or say that the trail is a failure. I personally will do the second round and hope for an oddv effect (yes that's what i am calling a 50% reduction in tinnitus after real drug, in honor of oddv and all his previous post and information that help me a lot through the process). For now i will vote no change after first round.

So i finally leave you hoping for an oddv effect next round I will keep you inform.

 

[ruben ruiz]

Are people getting better or not? I cant tell reading this thread, I see one person saying its positive.

 

[papu]

7 out 14 got better or 50% thats how the vote stands
If it was the treatment or not nobody knows, i am sure the jury still out on that one, thats what the trial is for. You are only seeing a glimpse here of all the candidates and i think this thread is more to describe the process for people considering going into it at least thats how it help me. For me i was unchanged in the first round but it could have been placebo (40 % chance, no small odds). In the second round i will receive guarantee the drug and then I will make my mind whether it work or not at least in my case. For other participants like oddv and laika it definetly had a positive reduction in their tinnitus. Just my 2 cents hope it helps you somehow. In conclusion nobody really knows at this stage. I went in to the trial expecting nothing and hoping for the best.

 

[Frances Lynn]

I like to hear from OddV, NewGuy and Romain about their progress. I've read though the forum twice and saw several finishing up with the real meds but didn't see updates. My life as taken a downward turn due to this but reading about trying to have a more positive frame of mind has helped. I appreciate everyone who contributes. I'll be screened this
Wed. but don't know if I'll qualify as due to the anxiety I think my blood pressure has gone up. Thanks folks and keep the thread going.

 

[papu]

What I've noticed is that each round has cut it roughly 40% to 50%...

If I maintain the 1 for the next 90 days, I don't think I'll do the last round. Based on my experience, it would take it to 0.5 on loudness... Is that worth the pain and time commitment?

Here you go frances

 

[shantelle]

I have a question about this trial..i am signed up and waiting to go through it..but if they say its fir the first 3 months...if i do land up getting placebo and than eventually getting the actual drug...wont it be past the 3 month point by the time i get the actual...will it be still effective? Its a shot in the dark but im willing to try anything in the early stages. The lady i have been talking with in the trail says results are promising...so what if i just wait until it comes out on the market...how far away is that you guys think? This is for the am 101 trial if i forgot to mention.

 

[OddV]

@shantelle... In my situation, I decided to get on the trial as soon as possible... That way, when I got guaranteed real drug I wasn't too far past 90 day mark.

Super stressed at work lately, I will not give an update until next week. My 30 day check up is on the 29th.

 

[shantelle]

@shantelle... In my situation, I decided to get on the trial as soon as possible... That way, when I got guaranteed real drug I wasn't too far past 90 day mark.

Super stressed at work lately, I will not give an update until next week. My 30 day check up is on the 29th.

Ok good to hear..i think i will most likely go ahead with it. Have you started the trail yet?

 

[Sftoon]

Quick question, I have been accepted for a TACCT3 trial but don't have a date for initial screening yet. My GP has just prescribed me mometasone nasal spray for the tinnitus (which I think was caused by noise trauma) after noticing what he thought was an inflamation behind my eardrum. I've asked the study centre whether I'm permitted to take this but they do seem to take a while coming back with responses to questions. Its a steroid spray and my T has only been around for 3.5 weeks so I am keen to take it, but not if it risks my trial participation. Anyone have any thoughts on whether it would be wise for me to take the mometasone before hearing back from the study centre?

 

[Romain B.]

@Frances Lynn

Hello,

I must report a bit positive response to am-101 2nd round injections, it's very strange the perception of T after injections (real drug), i mean you feel something good, something quieter than before but you don't really know what. The perception is different for sure.. It's like a mix between habituation and effect of the drug. But so far i do not regret it. I would do it again cause i m sure it did something, even a bit ! Not cure but something quieter in a way.. It's a subtle change but really appreciated !!

 

[Danny Boy]

@Frances Lynn

Hello,

I must report a bit positive response to am-101 2nd round injections, it's very strange the perception of T after injections (real drug), i mean you feel something good, something quieter than before but you don't really know what. The perception is different for sure.. It's like a mix between habituation and effect of the drug. But so far i do not regret it. I would do it again cause i m sure it did something, even a bit ! Not cure but something quieter in a way.. It's a subtle change but really appreciated !!

So how loud was your tinnitus before AM-101 and where is it at now?