AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
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Positive news from a T sufferer who participated in the AM-101 trial (after 2 years of T):
http://www.icenimagazine.co.uk/tinnitus-patient-gratefu/
*P.S.: Read with tempered optimism because 1 good result is never the good result.
http://www.icenimagazine.co.uk/tinnitus-patient-gratefu/
*P.S.: Read with tempered optimism because 1 good result is never the good result.
Given that the AM-101 study ever only accepted patients with onset of tinnitus up to 12 months, I do wonder how he managed to get on to the trial...
https://clinicaltrials.gov/ct2/show/study/NCT02040194
a (concerned) passerby
Member
Hope it is not typo, hope it is some connection that he has in Auris, or anything else...and that AM101 can work in chronic cases (even for a small part of suffers)
btw H is definetly more easy to cure, or have relief than t...but realy glad for this guy!
Had first open label injections on Tues, and another pair today. Results so far are the same as when I did the blind study; slight increase in T vol, and clogged ears. Got third set of injections tomorrow morning, hopefully I'll see some changes but I've mentally prepared for the worst.
Got my third set of injections today. Tinnitus slightly is louder, just like before. Just like Oddv said about the open label drug, it leaked out of my ear - which the 'closed' study drug didn't, making me think I must have received the placebo previously.
Seven week update.
The last four days have been difficult as my tinnitus has been morphing and is now composed of a very high pitched tone. It is so high that at times I can feel it, but cannot define the tone. After my acoustic injury, my tinnitus was made up of a variety of frequencies that often came together as a buzz. About a month after my injections, my tinnitus volume calmed down a bit. Over the last few weeks it seems that various lower frequencies that use to make my tinnitus have been fading. Now I seem to be left with the very high frequency tones and these are rather annoying.
I cannot say it is necessarily easier to deal with. The lower frequencies acted like a masker, making the higher tones less obvious. As the lower frequency tones quiet I am left with the more obnoxious higher frequency tones. I am hopeful that they too will fade softer as that would be wonderful. It is difficult to put a value on the sound level because it is so high pitched.
Have I gotten better? I think so. I cannot hear it while showering so I suppose it has improved. My shower is my moment of peace each day. I am now three months and one week since onset of tinnitus.
The last four days have been difficult as my tinnitus has been morphing and is now composed of a very high pitched tone. It is so high that at times I can feel it, but cannot define the tone. After my acoustic injury, my tinnitus was made up of a variety of frequencies that often came together as a buzz. About a month after my injections, my tinnitus volume calmed down a bit. Over the last few weeks it seems that various lower frequencies that use to make my tinnitus have been fading. Now I seem to be left with the very high frequency tones and these are rather annoying.
I cannot say it is necessarily easier to deal with. The lower frequencies acted like a masker, making the higher tones less obvious. As the lower frequency tones quiet I am left with the more obnoxious higher frequency tones. I am hopeful that they too will fade softer as that would be wonderful. It is difficult to put a value on the sound level because it is so high pitched.
Have I gotten better? I think so. I cannot hear it while showering so I suppose it has improved. My shower is my moment of peace each day. I am now three months and one week since onset of tinnitus.
To anyone who passed the screening: Do you happen to know if you would be disqualified for taking prednisolone/methylprednisolone pills a month prior to the injections?
Recent article covering AM-101, AUT00063 and VNS:
http://www.the-scientist.com/?articles.view/articleNo/43843/title/The-Sounds-of-Silence/
http://www.the-scientist.com/?articles.view/articleNo/43843/title/The-Sounds-of-Silence/
My understanding from the study documents I signed that you had to be off of them before your initial visit and at least two weeks before your first injection.
Why? if he never reported the problem to a doctor it would be very easy to lie and get into the trial.
True, but then why tell the truth to a newspaper afterwards and reveal the lie? I'm pretty sure it's a typo.
"The hearing space is where ophthalmology was 10 or 12 years ago," says Autifony executive Barbara Domayne-Hayman. At that time, the basic research community was not that interested in certain eye disorders, "whereas now it's an extremely hot and active space. We think that hearing is going to go in exactly the same way,"
Nice and truth comparation. In 10/12 years we will have real treatment or a cure, I am sure. But, it will be almost 2030.....so far...
I qualify for AM-101. I'm in Minneapolis, and it would require me to go spend 5 days in Des Moines, IA. I think I could make this work with my job, but I'm wondering if people here in the community would think it's worth it?
A little history about my T. I've been in bands for most of my adult life, but had usually been careful using ear plugs at practice and whatnot. On (Thursday) July 9th I played a show in Chicago, and during soundcheck there was a snare drum hit that I thought was loud. Normally not something I'd notice. I didn't pay much attention and just kept on with my life. That weekend (Saturday) I was drunk and stressed/sad and listened to some music really loudly with earbuds while going to bed. The day after that (Sunday) I went to Murder City Devils concert and rocked out real hard (and actually saw MCD again on Monday). However, that week at work I noticed a ringing in my ears (and I was hungover so it was really prominent). Thinking it was wax (with which I've had problems in the past) I irrigated my ears but nothing came out. Well...enough time has passed now where I know I have T. I went to an ENT (a very nice, but very old man with IMO an antiquated notion of treating T) where they identified that I have hearing loss around 4300-4900 Hz. I'm unsurprised and not worried about the hearing loss. I've had 2-3 times in the past where the T was almost completely unnoticeable, but it always comes back. I've been trying to treat my T as much as I can, and today is actually one of the best days I've had in some time (did Neti pot last night, moved to a ketogenic diet, been taking supplements and drinking turmeric daily). I know habituation is possible for most (all?) people, and that some therapies such as TEMS are in the pipeline and have been shown effective. Sorry to get long winded, but some opinions would be nice. It would be quite an investment in time for me to go down to this trial, but the results I've read about make it seem like it might work for me.
A little history about my T. I've been in bands for most of my adult life, but had usually been careful using ear plugs at practice and whatnot. On (Thursday) July 9th I played a show in Chicago, and during soundcheck there was a snare drum hit that I thought was loud. Normally not something I'd notice. I didn't pay much attention and just kept on with my life. That weekend (Saturday) I was drunk and stressed/sad and listened to some music really loudly with earbuds while going to bed. The day after that (Sunday) I went to Murder City Devils concert and rocked out real hard (and actually saw MCD again on Monday). However, that week at work I noticed a ringing in my ears (and I was hungover so it was really prominent). Thinking it was wax (with which I've had problems in the past) I irrigated my ears but nothing came out. Well...enough time has passed now where I know I have T. I went to an ENT (a very nice, but very old man with IMO an antiquated notion of treating T) where they identified that I have hearing loss around 4300-4900 Hz. I'm unsurprised and not worried about the hearing loss. I've had 2-3 times in the past where the T was almost completely unnoticeable, but it always comes back. I've been trying to treat my T as much as I can, and today is actually one of the best days I've had in some time (did Neti pot last night, moved to a ketogenic diet, been taking supplements and drinking turmeric daily). I know habituation is possible for most (all?) people, and that some therapies such as TEMS are in the pipeline and have been shown effective. Sorry to get long winded, but some opinions would be nice. It would be quite an investment in time for me to go down to this trial, but the results I've read about make it seem like it might work for me.
My advice would be you have little to lose except your time. There is nothing else approved that can lower the volume long term. It doesn't work for everyone. If you read the Phase II study documents, after subtracting the placebo and those that would have gotten better without treatment it may benefit perhaps 25% of participants.
I have been through three injections and have another round next month if I want to keep going. The injections are not that painful. I would use uncomfortable to describe it. However, your tinnitus will crank up over the following weeks before calming down after 3 weeks to a month. Be prepared for very loud and annoying tinnitus for a few weeks following the injections. Mentally, I am in better shape because I feel like I am doing something about my ailment.
I have been through three injections and have another round next month if I want to keep going. The injections are not that painful. I would use uncomfortable to describe it. However, your tinnitus will crank up over the following weeks before calming down after 3 weeks to a month. Be prepared for very loud and annoying tinnitus for a few weeks following the injections. Mentally, I am in better shape because I feel like I am doing something about my ailment.
I too am on the fence about participating. My tinnitus is moderate in one ear and only very mild in the other. I have no choice but to treat both, however, because I revealed that my tinnitus was technically in both ears. Does anyone happen to know if treating my "good" ear would lead to any side effects? I understand the drug acts by blocking NMDA receptors that are being exposed to extra glutamate, what what if there isn't much extra glutamate to block? Could I be harming my ear by blocking those receptors too much?
If you read through the disclaimer provided by your trial center there is a possibility it could get worse. Looking at the previous results of Phase II there were some people that got worse, on the order of 10%. A later dose study said there was not instances of worsening. We will never know if this was from the procedure or unrelated. Of the dozen or so trial participants I contacted by private messaging, not one of them said they were sorry they participated. Of those dozen or so people, only about 25% saw benefit from going through injections.
If it doesn't work for me I won't be sorry I participated. My take away might be proving to myself that I got through this affliction without having to resort to anxiety or anti-depression drugs. You can't be on them during the trial. There will always be time for retraining therapy or other trials, but the window for AM-101 is rather short.
Firstly, the spike I mentioned in my previous post has stopped.
Also: I don't know if this is just a psychological effect, but I feel like the tinnitus has actually dropped in volume a bit, from like a 6 to a 4. This is based on checking the volume when in bed at night, when in a part of my house where T is usually loudest, and when I block my ears with my fingers. In all of these cases, it feels like the volume has dropped a little - I did not notice such a reduction whilst I was participating in the blind study. I just hope it's a real reduction and I'm not just imagining it!
Also: I don't know if this is just a psychological effect, but I feel like the tinnitus has actually dropped in volume a bit, from like a 6 to a 4. This is based on checking the volume when in bed at night, when in a part of my house where T is usually loudest, and when I block my ears with my fingers. In all of these cases, it feels like the volume has dropped a little - I did not notice such a reduction whilst I was participating in the blind study. I just hope it's a real reduction and I'm not just imagining it!
I just sent my info through the contact form through this website.
http://www.tinnitus-study.info/ca-en-home
Reason I decided to try is because I have just experienced a spike, so I am hoping that maybe I can get it back down to where it was before. I am now just over 2 months with tinnitus. Is there any other way to contact them? Through the phone would be preferable so that I can get an answer quickly about getting in.
Thanks.
http://www.tinnitus-study.info/ca-en-home
Reason I decided to try is because I have just experienced a spike, so I am hoping that maybe I can get it back down to where it was before. I am now just over 2 months with tinnitus. Is there any other way to contact them? Through the phone would be preferable so that I can get an answer quickly about getting in.
Thanks.
Hey did anyone have an ENT that recommended getting an MRI or CT scan before enrolling in the trial? Just to make sure there's nothing unexpected going on? Mine did not, but wondering if I should.
Does anyone know if its possible to be allergic to esketamine? Or did anyone's doctors recommend getting tested for an allergy prior to receiving the injections?
@OddV @Sharpfire @bellringer @Stu
I thought id post a update. Im about 6 days post injections (second round/real drug) and im pretty sure i had placebo the first round. My spike this time wasn't close to as bas as it was the first round. I honestly dont think i had much of a spike at all. My ears are still clogged and thats possibility the loudness of my spike. Its only 6 days and the tone is definitely more favorable....the loudness or pitch is more calm and easier to ignore. The first round it took about 3 weeks for my eardrum to heal and this time around it started to heal on the 3 day (injection day). So im really hopeful as my ears are still clogged and once they unclog it should seem quieter plus the next few weeks should show more improvement as its only been 6 days. I have also finally been reimbursed.
I thought id post a update. Im about 6 days post injections (second round/real drug) and im pretty sure i had placebo the first round. My spike this time wasn't close to as bas as it was the first round. I honestly dont think i had much of a spike at all. My ears are still clogged and thats possibility the loudness of my spike. Its only 6 days and the tone is definitely more favorable....the loudness or pitch is more calm and easier to ignore. The first round it took about 3 weeks for my eardrum to heal and this time around it started to heal on the 3 day (injection day). So im really hopeful as my ears are still clogged and once they unclog it should seem quieter plus the next few weeks should show more improvement as its only been 6 days. I have also finally been reimbursed.
I've read this thread many times now but sometimes I just get lost and confused with all the names and pages and dates. Has anyone received the injections near the 3 month mark and had success? I'm approaching 3 months now and thinking about going into the trial (still emailing the coordinator). If I am a candidate I will have a very narrow time to decide so I'm hoping to get a little more insight. Also if I do get the placebo then opt for the next round then it will have been 6 months after onset. Just doesn't seem very hopeful in that regard. Thanks
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