Member2016 should be listed in their webpage. They obviously donät have the timeframes for the 3rd trial as they do not know whether the drug will make it there or not. Im just assuming based on how long it is taking Auris Medical and considering that in the 3rd phase there might be trials in other countries as well.
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
2016 should be listed in their webpage. They obviously donät have the timeframes for the 3rd trial as they do not know whether the drug will make it there or not. Im just assuming based on how long it is taking Auris Medical and considering that in the 3rd phase there might be trials in other countries as well.
No, I can't find any timelines listed on their website or on the NHS Clinical Trial criteria. No timelines have been announced for Phase II and up. Not sure where you got the 2016 date. Plus, I cannot see locations of UK trials posted yet either.
If someone sees different, please let us know.
Phase II UK trials will be 4 weeks each. That's all I've got.
Been doing a bit of research on FDA rules and regulations. It struck me today that I've never actually read that a person can't obtain a prescription for a non-FDA approved drug in another country and have it filled by import. Basically, the FDA and Health Canada says it's illegal to import unapproved medication, but a 90-day supply for personal use will usually be overlooked.
I have a number of relatives in Maine, where a recent law allows for the importation of drugs from the UK, Canada, and a few other countries. There's even a British online pharmacy, http://www.greatbritishdrugstore.com, taking Maine prescriptions (sadly they do not appear to stock Trobalt/Potiga).
If Autifony has a successful phase II clinical trial and moves for fast-track approval, perhaps American patients might be possible to bypass, temporarily, the wait for FDA approval. The key criteria would seem to be a reasonable expectation that the drug is safe. I wonder how big a clinical trial has to be for the FDA to consider the safety standard met?
I have a number of relatives in Maine, where a recent law allows for the importation of drugs from the UK, Canada, and a few other countries. There's even a British online pharmacy, http://www.greatbritishdrugstore.com, taking Maine prescriptions (sadly they do not appear to stock Trobalt/Potiga).
If Autifony has a successful phase II clinical trial and moves for fast-track approval, perhaps American patients might be possible to bypass, temporarily, the wait for FDA approval. The key criteria would seem to be a reasonable expectation that the drug is safe. I wonder how big a clinical trial has to be for the FDA to consider the safety standard met?
Just need to have accuracy of information regarding the trials. There are no dates so far. That was not reflected in your post on a public forum. If you are guessing 2016, best to include that in your post, rather than state the absolute.
With all due respect there is a lot of guessing on this board regarding dates, scientific data etc. so I doubt my guessing will make it any worse
- Mar 18, 2014
- 58
- 48
- Tinnitus Since
- 3/2010
- Cause of Tinnitus
- Noise exposure, drug combo?
I agree, this is hopeful, all it takes is for one drug to hit the market, then a lots will follow, look how many antidepressants there are now, a certain drug may not work for one person, but if there are a lot of options then one can usually find one that works for you. This is hopeful.
so u guys are saying Aut00063 is not gonna work with everyone? so most of the people who are waiting for aut00063 is gonna be disapointed if it does not work its gonan suck if this pilld oes not work for me cause then we gotta wait another 1 or 2 years for the next drug and that prob wont work on half the people either this waiting is just stupid the other day i acually had a rope and it was tied to the door and i was so close to just saying fuck im gonna hang myself i was so close to just killing myself cause i really dont wanna go any further with this stupid noise it ruins your life so why even keep going if aut00063 does nto work for me then its prob the end for me they need to get there shit together if they want to stop all these suicides from killing there self cause of this tormented fucking noise
If you are having suicidal thoughts I do advise you to see a psychiatrist who might be able to help you.
SteveToHeal
Member
Sure. Most t people have some form of hearing loss but their criteria of it being >20db at 500kHz intervals across the whole hearing spectrum is too stringent. Let's hope they relax them as has been intimated.
really? is a psychiatrist gonna make my tinnitus go away? a psychiatrist will not help me at all the only thing that will help me is a damn pill that makes the T go lower and hardly noticeable or a damn cure they need to get something out fast cause its just not me there is hundreds of suicide from tinnitus
I really think our emotions are running away on us a bit here, we should wait till at least we get some results from these latest trials before we start freaking out about who it will work on.
I think bottom line if you have Tinnitus from noise trauma, it will work, Tinnitus from injury or anything else maybe 50/50.
This is just my opinion and is only based on what I have read about Autifony and the science behind it.
Then again I could be wrong, but it doesn't do any good worrying about what if's either.
I think bottom line if you have Tinnitus from noise trauma, it will work, Tinnitus from injury or anything else maybe 50/50.
This is just my opinion and is only based on what I have read about Autifony and the science behind it.
Then again I could be wrong, but it doesn't do any good worrying about what if's either.
No, a psychiatrist can't make your tinnitus go away. However, he can help cope with it. Also, he can help you cope with the anxiety related to the drug (eg. whether it will or will not work).
I agree with Dan that at this point there is no reason to think such thoughts as we know very little of the drug.
The sooner you accept that it is what it is, and that you can at least go see a doctor to control your anxiety, the better you will be. No one wants tinnitus, but being hard on yourself and not gettin help will just make the situation worse. Meds are used to cope but if i was feeling suicidial, there the best thing along with counseling that will get you back to feeling good.
I would think that the science behind potassium channel openers would work for different etiologies of t. Not sure where or why just noise induced t only would be implied? The clinical criteria for this study stipulates no specific etiology.
http://www.nhs.uk/Conditions/Tinnit...7-GB&Condition=Tinnitus~quiet&pn=1&Rec=0&CT=0
Right, got that in the title reference to the study. Thanks. Then in the main body, they specify the different hearing thresholds required in the criteria, but do not specify the etiologies there. Potassium channel openers have been shown to help different etiologies. Even more so with central t rather than peripheral. See Retegabine threads and Benryu's posts. Also, when a few of us emailed Dr. Large at Autifony, he implied the trial will be opening up eventually to those without specific hearing loss. Not sure that we should rule all this out just yet.
Thanks so much for this. Note "KV3 channels are found at all levels of the auditory system." This includes the Central Auditory Cortex and areas that surround the nerve, not just to do with the nerve, cochlea and inner hair cells. Good chance that if this drug works, it will become available to all etiologies of t. Trying to keep hopeful for us all. So much speculation right now. Can't wait for the trial dates and locations to be listed and get underway, so we can find out more.
All,
Please keep me posted of any dates for this trial as I do qualify for this trial.
I have had tinnitus for 12 months
I have hearing loss.
I also live in London, so I'm all over this trail.
If I am selected for the trial I will of course post daily updates on this site.
Regards
Carl
Please keep me posted of any dates for this trial as I do qualify for this trial.
I have had tinnitus for 12 months
I have hearing loss.
I also live in London, so I'm all over this trail.
If I am selected for the trial I will of course post daily updates on this site.
Regards
Carl
jeannie
Member
- Nov 2, 2013
- 429
- Tinnitus Since
- 2013
- Cause of Tinnitus
- Noise-induced, Ear Infection, Medication... Who knows?
Eric, hang in there,, we dont need anyone else to commit suicide!!! lets hope and pray this will work, i know the sufferin,,,, i cry alot, depressed, anxiety and panic attacks and feel like im going crazy .... just dont seem fair... i think dark thoughts myself, but i have my children ,grandchildren and mother..... this is a horrible thing we have to deal with, but im just hoping something will come through for all of us in near future!!!!
thank you im hoping as well at least i dont see why it wouldnt help me cause before i got my tinnitus i was at the computer reading things like i always for about 3 hours after that i turned on the tv for about 1 hour to watch some cartoon network
and no reason at all my left ear starts ringing thought it would go away the next day but nope been 4 months and still going its just so weird how it can jsut come out of no where i have no nerve damage mabye hearling loss trying to get into a ent and i have a little tmj issue going on with my left side that i still need to check out but its taking forever to get into a ent
Hey Carl, that is great news you may participate! Thank you so much!
There is a contact email on the Autifony site and another on the clinical criteria on the NHS site. I would suggest emailing, so you can get information earlier, if possible.
I cannot find any dates or UK locations listed as yet for Phase II, just that each trial would last 4 weeks.
Lisa
http://www.autifony.com/autifony-contact.asp
http://www.nhs.uk/Conditions/Tinnit...7-GB&Condition=Tinnitus~quiet&pn=1&Rec=0&CT=0
Hi Lisa.
Thanks for the info.
I will definitely look into both links and register with them.
Then I suppose it's just a waiting game.
It all looks very promising though.
Maybe a cure for tinnitus is not that far away after all.
Then we can all live in quit quite state again.
Never though I would become a Guinea pig for drug testing, but like a lot of people on this forum, we all want to get better again.
I thought the day of popping pills and hoping for the best we're well behind me.lol.
Anyway let's hope I'm selected............
Kind regards, Carl.x
Thanks for the info.
I will definitely look into both links and register with them.
Then I suppose it's just a waiting game.
It all looks very promising though.
Maybe a cure for tinnitus is not that far away after all.
Then we can all live in quit quite state again.
Never though I would become a Guinea pig for drug testing, but like a lot of people on this forum, we all want to get better again.
I thought the day of popping pills and hoping for the best we're well behind me.lol.
Anyway let's hope I'm selected............
Kind regards, Carl.x
Carl, just a mention that Phase I has been completed, and all the safety tests for that drug passed with flying colors. So please don't be too nervous re the testing. We will keep our fingers crossed for you
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