AM-101 Clinical Trial — Participants Updates and Discussion
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Hi guys, new to all this and very worried. Never been a musician, not really into music or concerts, ipods or any other type of earphone devices. It only took 2 and half ours in an open bar with very loud music (i did not even want to go but wife and friends want it to. Thank god nothing happen to her) to take my peace away (three days later tinnitus started). I have been quietly reading all threads and since my tinnitus began one month ago this forum has been very helpful. I am a probable candidate for AM 101 in USA, i have been in talks with the clinical trial people and i am planning my first visit to their office. I want to ask any of you that already went through the trail if by any chance you know if they allow for participants to have supplements or herbal medicine like Valerian root for example. I know that they probably test for benzos and anti depressant but do they test for anything else? How did you guys cope with no being able to sleep (i have spent up to three days without sleeping before i collapse in exhaustion for only a couple of hours and cycle begins again). I am scared of taking any sleep medicine for fear of being DQ from the study. How did most of you guys got through once and some of you even through 3 cycles. Need serious help. Because i have to decide for this injections or the retigabine way. Any suggestion or comments will be appreciated.
When tinnitus started, I had a great difficulty in getting sleep. I barely slept only for a couple of hours and if I woke up, it would mean not being able to sleep again. This is mainly due to the fact that at first you are in a state of shock listening to that unnatural sound in your head, and that shock is mostly responsibly for causing a great deal of anxiety which leads to sleeplessness. It may take some time to get used to the idea of sleeping with this. At the beginning I only slept getting sleeping pills. I had to sleep to go to work. Melatonin, valeriana and such light pills didn't do anything. At the very begining while in the hospital (with intervenus corticosteroids to no avail) they gave me stendon and lexotanil but I still couldn't sleep! I only could sleep with stilnox, sometimes I even had to take 2 of them to sleep.
A couple of months to 3 months after onset I could sleep with no pills. But I had done HBO (may have helped lowering my T a bit), took some antidepressants (cut it because they did nothing to my T, only helped a bit to sleep), and tried Neurontin and other pills only to help with my T that also bring sleep as a sideffect (no benzos though). It was a smooth transition, now I am able to sleep without any pills, I have gotten used to it. I think sleep is something you habituate after some time. It is the day that bothers me most...
You know, after some time your T may reduce some, your brain may adjust some, it will be easier to sleep. Just don't think about it when trying to sleep. Do what you used to do before to go to sleep. It probably wont work at the begining but later on you will catch the old sleep routine of yours again. Relax. Our only hope is if it subsides on its own (it is early for you). Not much you can do, only in acute stage (first days) you must take corticosteroids and perhaps do HBO therapy. Unless they can find an underlying cause of your T, but you have to be really lucky with choosing a real expert on T, and I am afraid they are not so many and not everywhere... Then again, acoustic trauma is an untreatable cause, and you may just have to join the club and wait for those potentially promising therapies to come.
Get off the herbs, not sure they check but you don't want to DQ because of it...
For sleep, use this.. https://play.google.com/store/apps/details?id=com.tmsoft.whitenoise.lite mix crickets, water and wind.... Crickets are key... Enya also helps
For sleep, use this.. https://play.google.com/store/apps/details?id=com.tmsoft.whitenoise.lite mix crickets, water and wind.... Crickets are key... Enya also helps
thanks both of you for the advice i will be sure to download the white noise from the play google store. I am sure my wife and dog will be thrilled by the sounds tonight but what the heck as they say in the marriage vows for better or worse. OddV i know that you went through countless sets of injections and you must have been a newbie at the first one otherwise they would not have taken you, how did you deal with all the anxiety and lack of sleep before and during the trial. Just with the white noise thing? Were you able to sleep during the period of injections?
Hopefully i will be accepted into the program (they will tell me next week were i have to go for the first visit and 15 days later zappp... in the ear and maybe get well in the first round) i am keeping hopes up and if not i will at least try the second round 90 days later.
Two more questions OddV are you allowed to fly after the 10 day visit (in pressurize cabin of course)? How does the electronic diary thing work, is is wifi or hsdpa 3G or LTE in nature. Is it tie to one carrier or can you take a trip if you had a plan vacation during those 90 days. I know is something i can ask them directly but i dont want them to think that was either taking benzos for the first part or that i will leave in a trip during the trial. I rather ask you and if you dont know i will stay put for the 90 days. Thanks in advance.
Hopefully i will be accepted into the program (they will tell me next week were i have to go for the first visit and 15 days later zappp... in the ear and maybe get well in the first round) i am keeping hopes up and if not i will at least try the second round 90 days later.
Two more questions OddV are you allowed to fly after the 10 day visit (in pressurize cabin of course)? How does the electronic diary thing work, is is wifi or hsdpa 3G or LTE in nature. Is it tie to one carrier or can you take a trip if you had a plan vacation during those 90 days. I know is something i can ask them directly but i dont want them to think that was either taking benzos for the first part or that i will leave in a trip during the trial. I rather ask you and if you dont know i will stay put for the 90 days. Thanks in advance.
@papu not sure about flying... I think someone else in this thread from Canada did though... I drive 3 hours each way to my site. The diary is 3G or LTE, it's suppose to sync for you but I found that I had to once sync it every day. I'll be honest, the diary is the worst part by the end of the first phase... All you want to do is stop thinking about it and this damn little electronic device forces you to rank it daily.
If you do it, commit to yourself that you'll do at least the 2nd set of injections.... The 1st set is for science, the 2nd set is for you. I rushed into to guarantee myself I'd have the 2nd set within 4 month of onset.
I've given this advice before... The 1st set, take someone with you...take a tablet or book, take a stress ball and take a travel pillow... Use the travel pillow and stress ball during the injections.
As far as sleep, at onset I had a tough time.... T put me on the floor and I couldn't sleep.... Luckily, I'm not one prone to anxiety, although I did have a couple of panic attacks.... I would sleep with headphones one and use all of my mental energy to focus on the sounds and eventually fall asleep.... The simple act of focusing will make you tired.... If your mind wanders, you'll hear the T and have to adjust your thoughts back to the external sounds. I can say that I don't mask anymore at all and fall asleep fairly quickly,
I also had H at onset, but that subsided after about 2 weeks.
If you do it, commit to yourself that you'll do at least the 2nd set of injections.... The 1st set is for science, the 2nd set is for you. I rushed into to guarantee myself I'd have the 2nd set within 4 month of onset.
I've given this advice before... The 1st set, take someone with you...take a tablet or book, take a stress ball and take a travel pillow... Use the travel pillow and stress ball during the injections.
As far as sleep, at onset I had a tough time.... T put me on the floor and I couldn't sleep.... Luckily, I'm not one prone to anxiety, although I did have a couple of panic attacks.... I would sleep with headphones one and use all of my mental energy to focus on the sounds and eventually fall asleep.... The simple act of focusing will make you tired.... If your mind wanders, you'll hear the T and have to adjust your thoughts back to the external sounds. I can say that I don't mask anymore at all and fall asleep fairly quickly,
I also had H at onset, but that subsided after about 2 weeks.
Read thru a lot of this one..
I've tried to avoid tinnitus my whole life (musician) eat plugs etc., ended up getting it in Feb 2015 from a terrible barotrauma + resultant ear infection. ear infection cleared up, tinnitus remains.
I'm 20 minutes from an AM-101 trial site and have spoken with the ENT running it out here, at length. Very smart guy, German dude.
I can't decide whether or not to join it. It's a major hassle / takes up a bunch of time, and the thought of piercing my ear drums intentionally 9+ times sounds just plain dumb, not to mention miserable + can I still travel?? Further - who knows if this will just make it worse, my T is currently mild and despite causing a little anxiety / being worrisome in the mornings and at night, is not ruining my life or anything.
At the same time - I only have a couple more weeks to decide. Efficacy is highest within 90 days. What if I'm missing my chance for lasting relief? I don't fully understand the idea of T moving from the cochlear nerve "into the brain" and thus becoming permanent...
He described T as a result of frayed nerve endings spitting nonsense instead of being controlled. Ersketamine is like a "reset button".
Feel free to ask questions or answer mine!
I've tried to avoid tinnitus my whole life (musician) eat plugs etc., ended up getting it in Feb 2015 from a terrible barotrauma + resultant ear infection. ear infection cleared up, tinnitus remains.
I'm 20 minutes from an AM-101 trial site and have spoken with the ENT running it out here, at length. Very smart guy, German dude.
I can't decide whether or not to join it. It's a major hassle / takes up a bunch of time, and the thought of piercing my ear drums intentionally 9+ times sounds just plain dumb, not to mention miserable + can I still travel?? Further - who knows if this will just make it worse, my T is currently mild and despite causing a little anxiety / being worrisome in the mornings and at night, is not ruining my life or anything.
At the same time - I only have a couple more weeks to decide. Efficacy is highest within 90 days. What if I'm missing my chance for lasting relief? I don't fully understand the idea of T moving from the cochlear nerve "into the brain" and thus becoming permanent...
He described T as a result of frayed nerve endings spitting nonsense instead of being controlled. Ersketamine is like a "reset button".
Feel free to ask questions or answer mine!
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
I didn't know pills could be injected through the tympanic membrane.
But I guess - even I - learn something new. Once in a while.
Haha...Well it's only assumptions people are making, guessing that AM-101 will be a modulator like Autifony's drug. What else could it be?
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
I understand your logic, but see this:
www.tinnitustalk.com/threads/auris-medical-am-102.7183/
(It's good to check facts before posting material on the web as... facts!).
Well, it does perforate the tympanic membrane.
As said, if I knew I'd get the real deal I'd be down for it. But with a placebo in place it's a total no-go.
Honestly, I think a placebo makes little sense given the already very strict patient selection plus the vast various causes of hearing loss + T. With this appoach their study is going to test way fewer patients with AM-101 than would be prudent for conclusive results. Especially since there's the chance of spontaneous recovery in some cases that collides with their trial.
The injection into the ear is a common procedure and should be harmless but even auris medical said that there is a risk involved in this injection and can cause hearing loss or increased T or no problems whatsoever. If you have no problems then fine but if you do get a problem you cant turn the clock back and the problem can be permanent...............or not....it is a risk that exists.
Did I read somewhere that the risks are about 10 per cent chance of having a problem.
you are thinking to commit suicide
you are not "down for" am-101, trobalt and others
What is wrong with you? you are insane if you kill yourself before trying all the options?!
honestly... if you are scared of small safe harmless intratympanic injection, you will NEVER kill yourself. you are a coward for not trying ALL options before killing yourself... sorry, truth ps. i want to die too but i would try these treatments if they was available!
It's an injection, and therefore is invasive by definition. This does not detract from it being a common and uncomplicated procedure, however.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
If @NiNyu had been referring to invasive-ness from a medical definition, then his sentence that I commented on would not have made sense. Hence the reason for my own comment.
I agree that in a dichotomy between two alternative descriptions only, an I.T. injection would be considered an invasive-procedure (as opposed to non-invasive). But/and on a continuous spectrum of varying degrees of invasive-ness, an I.T. injection would be closer to non-invasive than invasive (i.e. classified as a minimally invasive procedure).
And if readers of this forum were somehow in doubt that I didn't know the medical definition of an invasive procedure, they can check my account of my full day consultation with Prof. Jeanmonod in relation to non-invasive brain surgery:
www.tinnitustalk.com/threads/new-upcoming-treatment-hifu-high-intensity-focused-ultrasound-surgery.276/page-8#post-75063
The procedure in the above link also highlights that, just because an intervention is not invasive, does not mean it does not carry a risk.
As for AM-101, the risks involved have been accounted for in the phase-II trial papers...
...and hence there is no need for the usual forum comments such as "the procedure is invasive", "it is dangerous" or "anything to do with I.T. injections is risky".
The interested and informed reader should also have a read of my information about OTO-311 and the other use of Gacyclidine (by injections directly into the membrane of the round window of the inner ear). This last procedure represents a significant increase in the risk of the otic-intervention and hence further demonstrates the relative non-complicatedness of a standard I.T. injection. In fact, for the latter intervention the ENT surgeon would need his manager's approval before he could be allowed to go ahead with it (despite being a fully trained surgeon licensed to partake in clinical trials).
www.tinnitustalk.com/threads/otonomy-acquires-assets-and-patent-rights-for-tinnitus-program.2387/page-3#post-88374
attheedgeofscience
12/APR/2015.
Why is that the case? It seems to make sense to me, and that's how I interpreted it. It makes sense, but his "you might end up with nothing" comment indicates unnecessary worry, hence my comment that invasiveness does not detract from it being a uncomplicated procedure.
Agreed. I'm under the assumption that comments about it being invasive are relative to orally administered treatments.
The post I quoted made it seem as if you didn't. That's all I had to go by.
This is common sense.
Of all the times I've seen the term "invasive" used in a medical context, it has refereed to the medical definition. If there is another meaning present on this forum, then my apologies for the mis-interpretation. I agree that there is no need for those types of comments, as they are often not constructive and cause unnecessary panic.
Just to re-iterate, I agree that it is a well tolerated and safe procedure, but that does not mean that there are no risks. Perhaps my picture may be a tad more comprehensive. Below you can see that it was well tolerated, but still with a chance of side effects:
I don't have the full data so can't perform a statistical test, but there does not seem to be a difference between the AM-101 group and the control, suggesting that the administration procedure is responsible for the side effects under the category of "Very frequent" and "Delayed healing".
It is unreasonable to expect me to have read all of your posts before responding to you in a thread. Moreover, that thread was created before I registered on this website, and I was unaware of its very existence until now. Nonetheless, the above mentioned procedure being more invasive relative to a standard IT injection does not stop an IT injection being an inherently invasive treatment. Again, to anybody worrying about this: there is nothing wrong with something being classified as an invasive medical treatment.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
I am not sure if you mean the raw data itself in terms of each individual who participated in the study (and I doubt that would be available to anyone except Auris Medical). But if you mean the consolidated information of the study participants, then it is available in the pdf-attachment. Interpretation and discussion of the side-effects related to the procedure of the phase-II trial can be found starting at the last paragraph of page 6 and continuing onto page 7.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
@Matt h would you be kind - for the benefit of TinnitusTalk - to share your result from the full set of 12 injections (which obviously would include the real drug). I noticed you logged in yesterday, but have not commented on any development since your post below (as well as a gentle nod from @OddV - see above):
Thanks.Completely finished my trail i have had the full 12 injections!!!
No issues
@Stink , it is NOT just one injection through the tympanic membrane it's severals with the chance of getting absolutely nothing but holes in your eardrum.
So what's wrong with you then? If you really believed in what you wrote how come you do not partake in the AM-101 study?
And why didn't you try Trobalt?
No! There's no T patient database that could exclude you from the AM-101 study or any study. And yes! Those treatments are all available even for you. You just have to travel.
As said, a placebo makes little sense due to spontaneous recovery in some cases. Period.
Of course they say that. And yet you still have to sign a form that you waive your right of compensation if anything bad should happen to you due to the procedure.
I had a hole in my eardrum once (incision) and it took about 2 weeks to heal completely.
So what's wrong with you then? If you really believed in what you wrote how come you do not partake in the AM-101 study?
And why didn't you try Trobalt?
No! There's no T patient database that could exclude you from the AM-101 study or any study. And yes! Those treatments are all available even for you. You just have to travel.
As said, a placebo makes little sense due to spontaneous recovery in some cases. Period.
Of course they say that. And yet you still have to sign a form that you waive your right of compensation if anything bad should happen to you due to the procedure.
auris medical said:
I had a hole in my eardrum once (incision) and it took about 2 weeks to heal completely.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Ninyu, @Stink has had T since 2000. The participatory criteria is 0 - 12 months in europe and 0 to 3 months in USA. Stink cannot participate in these trials as he has had it too long unless you are suggesting he lies. This may be difficult not only for him to do even if he wanted to as he may be asked to prove his doctors report but also morally he find it difficult - if he lies then it will skew the results. Is that the right thing to do? What do you think?
As for trobalt, he will try it IF he wants to and wont IF he doesn't want to...........each one makes their own decision. Ii think he was suggesting that you try these things while you can and as an alternative to suicide which is the last resort............
I was mistaken, I can do a stats test for it. I previously assumed i'd need to do a t-test, then realised that only a z-test (or chi squared) would be possible for that type of data.
Both statistical tests were two-tailed tests, and α=0.01
Tinnitus louder / worse
Using the data that 6.966 out of 86 people receiving the placebo had this side effect and that 17.982 out of 162 people receiving AM-101 had this side effect along with the formula
Delayed healing of eardrum
Using the data that 6.966 out of 86 people receiving the placebo had this side effect and that 12.96 out of 162 people receiving AM-101 had this side effect along with the same formula as above, it can be calculated there is no significant difference between the group receiving the placebo (n=86) and the group receiving AM-101 (n=162) in terms of being affected by this side effect (z=0, p=0.978).
In conclusion: Getting the placebo / real drug will not make a difference in terms of the chance of getting the above side effects.
It's the first 3 that might or might not be placebo....every other injection is the drug...if you do the entire trial, that results in 9 shots of AM-101 (75% of all shots).
What exactly are you bringing to this Q&A of the trial participants thread? You've already made it known you wouldn't participate.
Once the Internet arguing is over I would love any potential responses to my post 
I can only hear it in the morning or at night, or if I'm reading a book in the quiet / etc
most of the time ambient noise covers it up. it's mostly just saddening and takes up mental space
Spoke today with Auris M. This to talk about my experience as a Trialee again.
I remain until today still concerned what participating in this study brought me..
Just whoever reads this if your T is young under 6 months give it a go else don't bother.
I won't say the medicament is not effective but works best in initial T stages..
I remain until today still concerned what participating in this study brought me..
Just whoever reads this if your T is young under 6 months give it a go else don't bother.
I won't say the medicament is not effective but works best in initial T stages..
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