Hey guys, I know this has probably been discussed on this forum, but I've been unable to find someone other than Locoyeti who has gotten definite improvement from the injections. I know there are a couple more people that have been talked about, but can anyone tell me other people who the injections have definitely helped? Also, just because I'm new to the board, can anyone tell me what the percentage of people who have received the injections have helped vs not helped? 50/50? 60/40?
AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
MemberUpdate:
No change, still the same level of improvement after the AM-101 shots. Since the volume is lower than it was before the shot, I feel like I am habituating a lot better, my life has returned pretty much back to normal, except that I have to have pink noise around me most of the time.
Since reading up on the various science related to this, I feel as though AM-101 delivered intra-tympanically probably will not work for me at this point. I am scheduled to take my second round of AM-101 shots (3rd round overall) at the end of the month, and at this point am 90% sure that I will decline the treatment, unless anyone on this thread can provide a compelling argument for me not to.
Specifically I would like to know the answer to this:
does glutamate excitotoxicity present as
a) a domino effect, in which once a sufficiently large excess glutamate spill occurs, that critical amount is enough to set the cascades of damage in motion towards the auditory cortex? If so, then I am sure there is an attenuation in the rate of damage, perhaps due to attenuation of aberrant signals, but there could also be compensatory gain on the signal (this would explain how tinnitus in some people can get progressively worse).
b) or is it, as i think, something that attenuates after damaging some bounded number of neurons, dependent on glutamate concentration - glial buffering, or inhibitory feedback mechanisms.
c) both are possible.
d) none of the above
if a) is possible, then perhaps there is still some excess glutamate somewhere in my auditory network, in which case AM-101 might still be effective (though hard to see how the drug could work/diffuse all the way to the DCN or further).
No change, still the same level of improvement after the AM-101 shots. Since the volume is lower than it was before the shot, I feel like I am habituating a lot better, my life has returned pretty much back to normal, except that I have to have pink noise around me most of the time.
Since reading up on the various science related to this, I feel as though AM-101 delivered intra-tympanically probably will not work for me at this point. I am scheduled to take my second round of AM-101 shots (3rd round overall) at the end of the month, and at this point am 90% sure that I will decline the treatment, unless anyone on this thread can provide a compelling argument for me not to.
Specifically I would like to know the answer to this:
does glutamate excitotoxicity present as
a) a domino effect, in which once a sufficiently large excess glutamate spill occurs, that critical amount is enough to set the cascades of damage in motion towards the auditory cortex? If so, then I am sure there is an attenuation in the rate of damage, perhaps due to attenuation of aberrant signals, but there could also be compensatory gain on the signal (this would explain how tinnitus in some people can get progressively worse).
b) or is it, as i think, something that attenuates after damaging some bounded number of neurons, dependent on glutamate concentration - glial buffering, or inhibitory feedback mechanisms.
c) both are possible.
d) none of the above
if a) is possible, then perhaps there is still some excess glutamate somewhere in my auditory network, in which case AM-101 might still be effective (though hard to see how the drug could work/diffuse all the way to the DCN or further).
lcho
Member
- Sep 2, 2014
- 17
- Tinnitus Since
- 06/2014
- Cause of Tinnitus
- Acoustic trauma and prescription-drug induced
I think the connection to the DCN is not through the drug diffusing there but rather through the cessation of aberrant signaling from the cochlear neurons. [The 'aberration' here could, for example, be a lack of signals, or an excess of them]
Agreed. It might be that after your T stabilizes (usually a few months after onset), the neurons in the cochlear area might still be releasing excess glutamate - not enough to be excito-toxic, but still enough to cause a persistent hyperactivity that presents as T. If this were the case, then AM-101 might still help. It might allow some window of time for the brain to suppress/re-polarize at least some of the hyperactive neurons in the cochlear area (hair cells, spiral ganglion) which could confer some effect on the DCN and beyond. If this were true it would mean that @Bart Marien and @StayPositive did not have many hyperactive neurons close to the cochlear end. A good test of this theory would be a continuous delivery system, three successive low concentration ketamine shots may not have enough of an effect. Any thoughts?
I would think alot would depend on the rate that ketamine gets metabolized at - or rather, for how long does it stay attached to the NMDA receptors, until it is either dislodged (via thermal motion perhaps, or by some competitor molecule like, say, glutamate), or broken down by something else. For all we know, it might stay attached for weeks on end, in which case a continuous delivery system would not be needed (provided all the NMDA receptors were saturated with ketamine from the first few shots). Or perhaps its gets metabolized or dislodged really quickly (say, hours), in which case it is questionable why AM-101 only provides three shots.
@locoyeti
@attheedgeofscience
Would it in my case make any sense to do the AM-101 follow up study?
As I had some shots in June this year and have T since end of september 2013.
Some reasoning plz, as I am still doubting, as I consider the three times puncturing of the eardrum as a risk or taxation for my ear.
Also I read that AM-101 only seems to work well in cases where T persists less than 2,5 months.
Input input please
Thanks for helping me out...
I'm in the same boat. Had T coming up 10 months now. Had my first injections at 9 months (could be placebo). Will get real drug at 12 months!! Is it worth it, as you say, the three times puncturing of the eardrum as a risk or taxation for my ear and that AM-101 only seems to work well in cases where T persists less than 2,5 months?
I probably will go for it .... as there is nothing else on the horizon, other than attempting to get on AUT00063 trial (slim chance imho) and Retigabine (with what looks like some nasty side effects)
:-(
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Based on what I know now, and given that it is now a year since your onset of tinnitus, I would not bother with the next round injections (if I were you).
But the doctors at clinical trial centre must have an opinion as well. So let them have their say also. My suggestion.
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
I dont know is it worth with Am101. I use retigabine to feel better. Sure it has nasty effects but Autifony may never came out, ot they may find out that after you use it 5 years you go deaf. To get to that point they have to do this phase 3 and long term and then in some 8 years we will now if autifony works.
@bedouin @Robb
For regret minimization purposes I would go ahead and get the actual drug at least once, to see how you feel. I don't regret getting the actual drug 5.5 months in, and I feel great. I am currently mulling whether my future self will regret not taking this 2nd round with the drug (third round overall), but at least I can say that I have definitely had the drug once. We only have anecdotal feeback so far, and you may feel some improvement. The procedure is super safe, and I would not worry about the injections causing any lasting damage (the hole in the ear drum is very very small). The procedure is a pain in the ass, but it feels worse than it actually is, and has basically zero side effects.
For regret minimization purposes I would go ahead and get the actual drug at least once, to see how you feel. I don't regret getting the actual drug 5.5 months in, and I feel great. I am currently mulling whether my future self will regret not taking this 2nd round with the drug (third round overall), but at least I can say that I have definitely had the drug once. We only have anecdotal feeback so far, and you may feel some improvement. The procedure is super safe, and I would not worry about the injections causing any lasting damage (the hole in the ear drum is very very small). The procedure is a pain in the ass, but it feels worse than it actually is, and has basically zero side effects.
Thanks locoyeti. Yup. That was pretty much my plan. I am going to apply for Autifony when they open their flood gates. But with so many willing participants, I doubt I will get on. If that is the case, I will do AM101 at 12 months but only once. Not rounds 2 and 3 in fear of pin-cushion eardrum. Then see the effects. If still no shift in T, then it will be Retigabine for me.
- Dec 24, 2013
- 933
- Tinnitus Since
- (1956) > 1980 > 2006 > 2012 > (2015)
- Cause of Tinnitus
- Ac. Trauma & Ac.Trauma + Meds.
Hey sorry if I am well behind the curve here (I'm in Retig. world but try to see what is happening here when I can)...Anyway, I'm suddenly seeing these references to Ketamine so did a thread search and don't see the origins of it really, apart from that ref. to: http://www.sciencedaily.com/releases/2014/06/140617093820.htm etc.
@locoyeti (and @cdog) ...are you referring to Ketamine as per injection into the eardrum here above? Or are your referring to IV Ketamine, or ???? Reason I ask, is that I did a number of "Anyone tried Ketamine???" posts a while back when my doc was keen on the idea...and indeed I tried an IV grade nasal spray ("snorting it" kind of!) they made for test run. It was like being drunk on Greek Raki big time, but did not affect my T & H. However, Doc said I probably had to go unconscious for it to work. Mmmmmmmmmmmmmmm......I have not done that.....yet. (Potiga first).
I think??? you are referring to another modality though. Can you clarify for me?
Thanks much, Zimichael
I was talking about esketamine (hydrochloride), which is what they inject in AM-101 trial (if you're not getting a placebo). Esketamine is a form of ketamine.
Hey everyone, so I met with the doctor and support staff who are conducting the AM101 phase 3 trial and they accepted me as a good candidate. The only thing is, I'm terrified of this making the T permanently worse. Right now its in my right ear mostly and if I plug my left ear I can hear it. so it is manageable at this point. I've read through the 2 threads and unless I'm wrong I haven't seen enough positive results to push me over the edge to go through with the trial. Can anyone help me out, this is a tough decision????
Or I could consider trying to go the regitabine route, but there's side effects there as well. To be honest, I would be comfortable trying regitabine and if I experience significant side effects just taper off the tabs. this isn't easy at all!
Or I could consider trying to go the regitabine route, but there's side effects there as well. To be honest, I would be comfortable trying regitabine and if I experience significant side effects just taper off the tabs. this isn't easy at all!
This is my first post after being a month long lurker, and due to the relevance of your predicament with mine, I decided to go ahead and create an account. I've had tinnitus since the first week of last month, although I can't specifically point to the direct cause - it might've been one or the combination of TMJ flareup, airplane ride, right ear infection, and copious amount of stress all within a week preceding my tinnitus onset. My ENT specialist said my tinnitus is most likely due to the ear infection or barotrauma from the plane ride, and I could probably qualify for the AM-101 trial. I went through with the preliminary examination, and everything went smoothly, hearing tests showed nothing alarming and I was well within the average for my age (22). Now I am faced with the decision of going through with the injection or not. I have less than a week to make my final decision. Initially, I was quite adamant about going through with it until the specialist told me the possible risks associated with AM-101. Some of the risks discussed were hearing loss, worsening of tinnitus severity, damaged eardrum which might not heal, and vertigo. At this point my tinnitus is quite manageable, but occasionally the tinnitus puts me in a state of anxiety and panic. Like you, my concern is the exacerbation of tinnitus and the possible hearing loss associated with AM-101. There are a lot of questions I've been pondering in order to balance the pros and cons, and if it's worth taking some severe risks for a drug with questionable efficacy. My family thinks if there is even a 1% risk of developing new problems or the exacerbation of my old ones it isn't worth it, especially considering the unknown nature of trial drugs. Perhaps there are some people with personal experience with AM-101 or some well-studied people on here that can give us more insight. Some feedback would be greatly appreciated by others.
Thanks for joining and posting. I imagined everyone that did participate was definitely in the same situation we are in. Hopefully people that actually went through with the trial will chime in and give us their thoughts. But like I said, I haven't read enough positive results that i want to read to push me over the edge.
The retigabine is another option im considering, at the first sign of side effects you can taper off that and hopefully lose the side effects. If the AM101 makes T worse or messes up your eardrum or whatever, you cant get it sucked out of your ear and go back to how you were before. that's what terrifies me.
@CathodeRaySound - where did you go for the evaluation if you don't mind me asking. Im in New York city.
@Rube
It would definitely be an easier decision to make if the anecdotal results were extremely promising; however, that doesn't seem to be the case with AM-101. The effectiveness seems to be a hit or miss, and even when it does work the drug does not seem to completely cure anyone. The treatment center I'm involved with is at the Colorado ENT & Allergy center at Colorado Springs, Colorado about two hours drive from where I live in Boulder. I'm also originally from NYC to add to our relevance.
It would definitely be an easier decision to make if the anecdotal results were extremely promising; however, that doesn't seem to be the case with AM-101. The effectiveness seems to be a hit or miss, and even when it does work the drug does not seem to completely cure anyone. The treatment center I'm involved with is at the Colorado ENT & Allergy center at Colorado Springs, Colorado about two hours drive from where I live in Boulder. I'm also originally from NYC to add to our relevance.
I haven't had my physical evaluation yet or been given the device where you have to answer a couple of questions every day so I probably have about 2 weeks to make a decision but as it is right now im leaning towards not going through with it. If I don't, I will pursue the regitabine option, autifony seems a bit too far away to wait without trying something in the meantime.
I guess us NYC'ers think alike
I had the injections. I have had a reduction in tinnitus volume and annoyance. The hearing tests I've taken also show a reduction in my tinnitus by matching volume and masking level. I do not know if I received the drug or if this is natural healing (blind trial). I'm considering taking part in the followup trial which is open label. I'm most likely going to do it as I'd rather not regret missing an opportunity. The only reason why I may not take part in the trial is if my tinnitus continues to fade away and I don't notice it when the date rolls around to take part in the follow up. I also don't know if there's a minimum tinnitus volume that has to be present (which I may be below) to take part in the follow up like there is in the initial trial.
When I first talked this over with my ENT, he believed the side effects would only be temporary and the worst thing that would happen to me is that nothing would happen (it'd either not work or I'd get the placebo). Other posters on this forum also have stated that the side effects are temporary. Esketamine is a known drug and has been around for decades. The only thing new here is that it's being used to treat tinnitus which is why they're doing the trial.
Anyone considering taking part in this trial should consult their ENT and discuss the potential side effects and if they are temporary or permanent.
Maybe it'd be a good idea to start a thread with only people that have taken part in the trial and post their current status. Or maybe there's another way for people to easily find out how many people have participated here and what their status is?
When I first talked this over with my ENT, he believed the side effects would only be temporary and the worst thing that would happen to me is that nothing would happen (it'd either not work or I'd get the placebo). Other posters on this forum also have stated that the side effects are temporary. Esketamine is a known drug and has been around for decades. The only thing new here is that it's being used to treat tinnitus which is why they're doing the trial.
Anyone considering taking part in this trial should consult their ENT and discuss the potential side effects and if they are temporary or permanent.
Maybe it'd be a good idea to start a thread with only people that have taken part in the trial and post their current status. Or maybe there's another way for people to easily find out how many people have participated here and what their status is?
@Rube
I would definitely schedule an appointment for the preliminary exam so they can help you identify your current severity of tinnitus from a medical aspect, and your degree of hearing loss, if any. They will also clarify any questions you might have, although they won't really tell you any more than what you already know. You have a two week window between the exam and the injections, so you have time to back out. Earlier you schedule the initial exam, the better, even if you're not 100% sure about going through with it. At least if you want to go through with the injections it will be sooner than later.
@earsnothappy
Thanks for the reply concerning your personal experience. The fact that your ENT thought any side effects are more likely temporary eases my mind. The AM-101 study ENT didn't seem to know much if anything about the possible prognosis of the experimental treatment, it seems like he was inducing possibilities based on other intratympanic drugs he is used to performing - perhaps it's due to the fact that I'm subject #1 in the whole state of Colorado concerning AM-101 trials, so he didn't want to tell me anything conclusively, his overall demeanor seemed to be, "who knows...I have absolute no experience with this stuff, and that's why you're here for us to experiment on."
I would definitely schedule an appointment for the preliminary exam so they can help you identify your current severity of tinnitus from a medical aspect, and your degree of hearing loss, if any. They will also clarify any questions you might have, although they won't really tell you any more than what you already know. You have a two week window between the exam and the injections, so you have time to back out. Earlier you schedule the initial exam, the better, even if you're not 100% sure about going through with it. At least if you want to go through with the injections it will be sooner than later.
@earsnothappy
Thanks for the reply concerning your personal experience. The fact that your ENT thought any side effects are more likely temporary eases my mind. The AM-101 study ENT didn't seem to know much if anything about the possible prognosis of the experimental treatment, it seems like he was inducing possibilities based on other intratympanic drugs he is used to performing - perhaps it's due to the fact that I'm subject #1 in the whole state of Colorado concerning AM-101 trials, so he didn't want to tell me anything conclusively, his overall demeanor seemed to be, "who knows...I have absolute no experience with this stuff, and that's why you're here for us to experiment on."
- Dec 24, 2013
- 933
- Tinnitus Since
- (1956) > 1980 > 2006 > 2012 > (2015)
- Cause of Tinnitus
- Ac. Trauma & Ac.Trauma + Meds.
Thanks @cdog ...that "Es" was all I was after (as knew Esketamine was the active in AM-101). Ketamine is different, so wanted the 'clarification' = Done!
So we are talking another 5-6 years until Aut00063 comes avaliable to the public? thats gonna be hard if i have to live with this noise until then cause i try my best just o ignore it and its just making me feel down is there anything at all that would help me at least with he noise like any drug cause im asking my dr for some xanax monday cause i have been really depressed about this
Gave Auris a ring today, AM-101 project leader told me that there where no know serious side effects until know otherwise they would have informed participating ENTs.
Whenever AM-101 would have any significant effect for an almost 1 year T sufferer he could of course give no indication..
Add on:
Also randomly called into another AM-101 test centre and had a chat with the ENT performing it.
He had no negative side effects to report.
Out of the two patients which had T over 6 months, one had an improvement going on.
Have a good weekend fellow T boarders
Whenever AM-101 would have any significant effect for an almost 1 year T sufferer he could of course give no indication..
Add on:
Also randomly called into another AM-101 test centre and had a chat with the ENT performing it.
He had no negative side effects to report.
Out of the two patients which had T over 6 months, one had an improvement going on.
Have a good weekend fellow T boarders
lcho
Member
- Sep 2, 2014
- 17
- Tinnitus Since
- 06/2014
- Cause of Tinnitus
- Acoustic trauma and prescription-drug induced
Okay so I had my 3rd injection yesterday and the high pitched aspect of my tinnitus has already decreased in volume, and the low frequency one seems to be on and off. It's a small improvement but it's definitely done something
@Eric Fridley
Unfortunately Aut00063 will take years for it to be obtainable for most of us. Have you considered partaking in the AM-101 trials? If you've already exhausted all the other basic treatments to no avail, AM-101 might be something to at least consider. Personally, if I go through with AM-101 and I deem it to be ineffective, then Retigabine (Aut00063's bigger brother) might be my next course of action since it is already out there on the market. There always seems to be something to try, and something to do, then before you know it more options might present itself. Who knows...you might even fully habituate somewhere along your journey, and just not give a damn anymore.
Unfortunately Aut00063 will take years for it to be obtainable for most of us. Have you considered partaking in the AM-101 trials? If you've already exhausted all the other basic treatments to no avail, AM-101 might be something to at least consider. Personally, if I go through with AM-101 and I deem it to be ineffective, then Retigabine (Aut00063's bigger brother) might be my next course of action since it is already out there on the market. There always seems to be something to try, and something to do, then before you know it more options might present itself. Who knows...you might even fully habituate somewhere along your journey, and just not give a damn anymore.
yea i have had it for 3 month and 5 days after i hit the 5 month mark and its still ringing then im deff gonna get my hands on some retigabine but for right not i goto my GP on monday gonna ask him for some Xanax and see if he can get into a tmj specialist
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