And how! We're all pulling for him, and everyone fortunate enough to be part of this trial. Best of luck!!
AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
And how! We're all pulling for him, and everyone fortunate enough to be part of this trial. Best of luck!!
Got the third injection this morning, nothing out of the ordinary so far. It's evening now and the ear still feels full. Nothing left to do now but wait. 
Got the third injection this morning, nothing out of the ordinary so far. It's evening now and the ear still feels full. Nothing left to do now but wait.
Are you in the 1 - 3 month's group or in the 4 - 12 month's group @StayPositive?
I'm still doubting if I should apply for the AM-101 trial. I might have the opportunity, but I'm crippled by fear.
MemberDo it man, I would give my left testicle to be in your spot ... you are only couple months into this T thing, you don`t want to end up 6 years later cursing you didn`t do it. it`s a no brainer imo!
I don`t know if you realise that fear is the worst advisor in the world.
hej! just to let you know.
Yesterday i had the last injection of the follow up study! So I got the real drug now for sure. Unfortunately they would only inject it to my already treated ear, so I have to to all the study with my untreated ear as well. The injections were pretty easy, unpleasent, but nothing to be afraid of. Today my ear ist sill cloghed.
I'm noticing a slight difference to the last trial (which could have been placebo). After the first injection my T got loud because of the the gel but the it got quieter although my ear is still full of gel. Maybe it's really working or I'm just relaxed and therefore not worring about the T. Because if I'm treating my T or have the chance of the T getting better, I'm much more relaxed and almost not noticing it.
I'll keep you guys informed!
Yesterday i had the last injection of the follow up study! So I got the real drug now for sure. Unfortunately they would only inject it to my already treated ear, so I have to to all the study with my untreated ear as well. The injections were pretty easy, unpleasent, but nothing to be afraid of. Today my ear ist sill cloghed.
I'm noticing a slight difference to the last trial (which could have been placebo). After the first injection my T got loud because of the the gel but the it got quieter although my ear is still full of gel. Maybe it's really working or I'm just relaxed and therefore not worring about the T. Because if I'm treating my T or have the chance of the T getting better, I'm much more relaxed and almost not noticing it.
I'll keep you guys informed!
I can understand the fear but what specifically are you worried about? If you like, I can send you the list of risks that they gave me. Maybe that would help you decide.
I'm in the 1-3 month group. If I participate in the follow-up study, it will be past 3 months.
To be honest, I'm afraid of long-term side-effects. What if participating in this study cause something bad to happen (to my ears) in 5 years or more? Or what if participating will exclude me from future cures (like regrowing hair cells).
How does AM-101 work? Does it block something (like a receptor) or does it soothe something? I don't know.
I got my Tinnitus because of loud medical equipment, so my trust is a bit shattered.
@StayPositive, If you have the list of risks nearby, it might help.
Hi,
I'm also interested in the list, because they opened the trial here in Switzerland.
Good question relating to hair cell regeneration...
Dear JohnDoe,
I respect your fear highly as I think similar to you. I am afraid as well for the future, this concern has to be taken serious. Therefore I hope that some of in my opinion Knowledge Warriors on this board like @Hudson @ResonanceCEO @attheedgeofscience let their detailed light shine on this, and provide me and you with their insight!
For all members here we can be glad with the AUT00063 thing coming.
best Robb
Hey urtica good to hear. I have a month or so untill my 2nd injections so thanls for the update. I was considering not doing them because I felt pretty good. According to the study a lot of people who got the drug started to see results in decreasing the t relatively soon. That's why I question if I got the drug or not. Look forward to your updates and good luck!
@StayPositive,
Esketamine is an agent which acts upon NDMA receptors in the affected cells. As per the wikipedia page for NDMA receptors "a glutamate receptor, is the predominant molecular device for controlling synaptic plasticity and memory function." Esketamine is a noncompetative NDMA receptor antagonist. My guess is that because it blocks some voltage gated calcium channels and depresses the activity of sodium channels, that is primarily where the benefit for tinnitus enters the picture. The reason that this drug has been targeted at "acute" tinnitus cases, is that Auris probably postulates that temporarily inhibiting the hyperactivity of neurons within the auditory structure, you are hitting the "reset" button, which allows them then to plastically adapt to the new environment and be able to naturally return to a normal resting state.
This hyperactivity of neurons associated to the auditory complex has been implicated in numerous studies as the most likely culprit for tinnitus generation. This can be seen further by the development of other drugs, such as Autifony's AUT00063 compound, which are drugs which directly target the sodium/calcium gated ion channels. Retigabine has also been indicated as having possible preventative effects for tinnitus, if not treatment possibilities for those who already have it as well.
You bring up a good point, that one never knows exactly what will come of a clinical trial. Safety is paramount, and has to be established before large scale clinical trials can be started. In these clinical trials, they don't simply inject the compound and send you on your merry way. They take your blood periodically, and monitor levels of the drug and it's metabolites to make sure systemic exposure is not occurring.
Ketamine has been used in medicine as an anesthetic for over twenty years now. It is delivered to patients systemically in a medical setting very often. If neurological destruction were taking place (which one would suspect at much higher systemic drug levels if it was going to happen at all) it would have been noticed already. Use of the drug in a medical setting has been well established to be safe. To top it all off, as I've said before, the amount of the drug applied in the AM-101 study is 1/1000th of that used for anesthesia. They can do this because they apply the drug locally to the middle ear, which it then diffuses into the inner ear via the round window membrane.
To tell you the truth, I honestly would be more worried about the effects of taking Vancomyacin or frequently taking NSAIDs on the auditory system than I would the delivery of this drug in such a small and controlled fashion. I don't think I can stress enough that in the over 800 individuals that Auris has already performed this procedure on, the vast majority of side effects were due to puncturing the ear drum and were transitory in nature.
As I said above though, you bring up a good point. These are clinical trials, and you sign waivers, get documentation and consultation from a medical professional about the risks, and more because it has not been approved yet. Nothing is guaranteed. If tinnitus is not that much of an issue for you, and you consider the risks to outweigh the benefits, you are not compelled to participate. I really seriously doubt that this procedure will hurt you or damage your auditory system in such a way that you will never be able to participate in any other further medical developments (none of which will be guaranteed or without the possibility of side effects either).
I understand the anxiety about the procedure. However, I would definitely take part in it if given the opportunity. I tried.
Hey Robb all the people you listed advised me to do participate and I'm glad I did. I would second most of what Hudson said. Also I would say I personally would be more worries about the side effects of autiofony which affects the brain. The best place to find out about the study in the adverse effects section in the study. No one here knows any more then what it says there. @Robb are you considering partaking?
I can't speak to long term side effects, but the following were reported in one of the previous studies, though these are specifically related to the injection itself:
Very frequently reported (more than 10% of subjects reported)
- Tinnitus louder/worse
- Delayed healing of the eardrum (more than 5 days from last injection)
- Hearing deterioration
- Redness of eardum or blood crust on eardrum
- Inflammation of the middle ear or eardrum
- Injection site pain
- Ear pain
- Ear discomfort
- Ear itching
- Headache
- Hearing too loud or distorted
- Tiredness
- Dullness
- Injection site discomfort or warmth
- Vertigo or dizziness (after procedure)
- Nausea
- Ear infection
- Skin spots
- Decreased appetite
- Stiffness
- Involuntary eye movement
- Restlessness
- Dizziness (general)
- Abnormal sensation in the mouth
Temporary, it always goes back down when you read the reviews and experiences of the people in the trial.
Which people? From where do you have this kind of information about decreasing? Do you know somebody else,who participated in this study? I would like participiate too in august in czech republic, but i have doubt about efficiency, when i see your posts. Everybody here is quiet about trials... :/
I think they only accept locals. Unless you are planning to move to Czech Republic I doubt they will accept you.
Yes.. I had same doubt, but slovak and czech language are similar.. We were one state until 1992.. I called them.. I will just pay for trials, because i dont have insurance.. Before i contacted Hungary,Poland and Austria, but they refused me..
You shouldn't have to pay for the trials. They are clinical trials... in most cases, they will actually pay you.
Keep in mind, 40% of the people in this trial will get placebo.
It is my understanding that the follow up post acute trials (of which only participants in the TACCT 2 trials can participate) will be guaranteed to get the actual drug, as they are open label trials.I dont know why.. Same said me in Hungary before results from medpro(propably they manage insurence and financing). Yes, i know.. They will pay me.. But then i have to pay for clinical trials, because i dont have czech insurence.. And same said me doctors in slovakia: You can participiate on trials in abroat, but you have to pay.. Why? I dont know.. I will call them tomorow and let you know..
Hey @gebora I got that info from here. The section about changes in t loudness. And it shows. The Changes over time.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
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