Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
MemberI would wait for a statement from Autifony,i spoke to a nurse on the trial about a month ago who knew nothing about another phase
Does anyone know if the list of questions has been answered?
Markku answered this earlier in the thread:
https://www.tinnitustalk.com/thread...ng-loss-and-tinnitus.6516/page-63#post-121734
Unlike AM-101, which takes 3 month per a person. Autifony only needs one month. So the results are quicker and the trials are far faster.
No wonder they don`t know ... it`s all good and on track ... good riddance to Autifony .. and us ..
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
some drugs on field of neurology can be fast tracked
and to add, we are 150 000 million people who need that drug because there is NO OTHER TREATMENT, SO I AM SURE THEY WOULD SEE IT, OTHERWISE WE STEAL IT AND SEND TO CHINA TO BE COPIED.
jeannie
Member
- Nov 2, 2013
- 429
- Tinnitus Since
- 2013
- Cause of Tinnitus
- Noise-induced, Ear Infection, Medication... Who knows?
so one person says phase 3 in august and one says they didn't know there were any phase 3??? both were in the trial??? well.that don't sound good as august is approaching us....
There is absolutely no way phase 3 trials are starting in august. Phase 2 isn't even done and they have trouble recruiting participants.
- Jan 25, 2013
- 3,544
- Tinnitus Since
- 2008
- Cause of Tinnitus
- TMJ disorder, airplane barotrauma, noise exposure.
I suppose that's because of the strict criteria they must meet, not lack of volunteers.
@Nucleo is Correct. I'll post this again so people don't keep rehashing this and coming up with their own theories. Peter Harris from autifony told me in an email they will compile the phase 2 results by END of first quarter 2016. THEN based on those results they will decide what their next step is. No amount of wishing, hoping, praying, cursing, crossing fingers is going to make the process move any faster. Sit tight and wait, that's all we can do for now. Or if you can't wait get your hands on trobalt or keppra. It's not that hard to obtain.......
How do you take it? 250mg twice per day or one 500 mg tablet per day? What's your height/weight if you don't mind me asking. Just trying to get an idea of effective dose vs. weight. Thanks!
The way things are going i may offer to do it again for them!
Hi guys, the results will not be out in August. I am due to go for a screening for the phase 2b trial on 6th August. If I get through I will be taking the drug (or placebo) for 28 days so that's well into September. Rube is correct, it'll be next year before they compile the results.
I will, of course, keep everyone posted as to whether or not I get on the trial.
I will, of course, keep everyone posted as to whether or not I get on the trial.
Dubbyaman
Member
Thats what pisses me off about all these new promising approaches Dan. The crappy criteria.
Somehow I knew it would be end of Q1 2016, just like last year phase1....so basically May 2016.
noisebox
Member
- Jul 4, 2015
- 319
- Tinnitus Since
- 04/2012
- Cause of Tinnitus
- West End show. Came back 2015 vitamin D overdose prescribed
You would imagine that even with the criteria there would be enough volunteers, but its not exactly been made public. If they put it on national news I'm sure they would be full.
noisebox
Member
- Jul 4, 2015
- 319
- Tinnitus Since
- 04/2012
- Cause of Tinnitus
- West End show. Came back 2015 vitamin D overdose prescribed
At least we know some facts about dates. maybe phase 2b is what we thinking is phase 3, the one Mrs D said she signed up for. Maybe just maybe if phase 2b is 3 then by early 2016 they will at least know the outcome.
Please ask loads of questions when you go and get back to us, please please.
I take two 250mg tablets in the morning. For some reason, I was able to save some money on 60 250mg tablets, versus 30 500mg. I'm 5'8" 155lbs. I don't if it matters, but I'm athletic and have high metabolism, so my body fat is very low.
It has actually featured in national and local newspapers,the hospital i went to were inundated with calls when the story came out, but very few were eligible due to having it too long
Well, I guess they didn't know there are people with tinnitus with great hearing and hidden hearing loss....I mean trobalt worked for me, therefore Autifony would too. Foolish I say.
- Dec 24, 2013
- 933
- Tinnitus Since
- (1956) > 1980 > 2006 > 2012 > (2015)
- Cause of Tinnitus
- Ac. Trauma & Ac.Trauma + Meds.
Dear @swc5150 ... Forgive me if I am just a space cadet and can't even do a search correctly here, but I have a bone to pick with you...actually a couple of bones. Yeah, just to make myself popular, but WTF.
1. You posted this above re Keprra...but you have not posted any such result in the two main (unfortunately competing) "Keppra" threads here on TT.
A. = https://www.tinnitustalk.com/threads/levetiracetam-keppra-—-another-possible-potassium-channel-modulator.7295/page-11
B. = https://www.tinnitustalk.com/threads/levetiracetam-keppra-worked-for-my-hyperacusis.8946/page-16
Though, you do have a post in B., the latter, dated June 2nd...then zip, zero, nada.
So, for people like me, who are trying Keppra (and who are more than eager for as much info as possible about "results"), it was just by coincidence that I stumbled on your post here in the Autifony thread! Which is "fortunate unfortunate", as I would far prefer to have had the ease of finding out about your taking Keppra, and info. thereupon, in one of the dedicated threads to it...Makes my difficult T and H screwed brain easier to grind and get some possible sense from!
Yeah, sorry, I am a "proof/science" kind of guy after decades of being thrown all over the universe by good ideas and potential cures for some chronic afflictions...T and H being the top of the list.
Anyhow...Can anyone trying, or considering trying Keppra, please report intentions and or results on at least one of the main "Keppra Threads"...Thank you.
2. OK, bone number two, and you are by no means in the minority on this, and it is an old "chip/bone on my shoulder" for sure!
So, being inquisitive and wanting to know more once I startlingly saw your Keppra comments on this thread, what did I do first off? Well, I clicked on your Profile to see who the hell you were; what kind of T and H you had; what maybe caused it and...well 100 other questions. One click. One place to get the scoop. Right???!!!
Wrong... Zip, zero, nada...nothing there.
Total info. = Male...Tinnitus since June 2012. And to the left...Joined January 24th 2014.
Well, that does not tell me very much. Does not allow me to even get the most basic sense of if my T and H have any commonality or similarity to yours, and thus if your 'reduced levels' of T and H c/o Keppra, have anything closer than Pluto in relation to mine...And thus of any use to my judgment-evaluation of WTF do I do now??? Like where to go with it - seeing as I am now on 2,000 mg total per day! And I discover you: I take two 250mg tablets in the morning. *(Same daily dose as @svintegrity funnily enough, who is ALSO getting "results"!)
Etc., etc., etc.
See the game here??? I mean, hell that is highly relevant for me trying to figure this stuff out, as MOA explanations are total zoo, and maybe I should be dropping in dose rather than upping it???!!!
All to say, that INFO is our trade here and I for one would really appreciate if we could coordinate it a bit better and people could add some basics on their Profiles to avoid huge hunting expeditions of "Postings" etc....which I do not have the energy or inclination for, given that the opportunity to avoid all that has been provided c/o Markku's great layout here on TT. Basic Profiles Please!!! The NSA does not give a shit about Tinnitus unless someone can weaponize it!
OK, end of speech...and sorry to 'pick you out' as an example here. Nothing personal so to speak. But if you feel pissed I can understand...But my goal is to handle/live with/cure/whatever, T and H in the least exhausting way possible. it is too exhausting living with it already.
Ta much...Best, Zimichael
Hi noisebox, a phase 2b trial is still a 'phase 2' trial and not a phase 3. A phase 3 trial will still need to follow this one - if the results from this one are positive. This is why some drugs crash and burn as they go through the trial phases. If the results of the current phase 2b trial for AUT000063 are not good the drug will not go on to a phase 3 trial in it's current form. This is why drugs take so long to develop and get to market - there's so many hurdles they have to get over. And if a drug does get through all it's trial phases successfully it then has to get through all the regulatory processes and red tape before it can be marketed.
This is why it takes years for drugs to get to market, if at all.
The reason the criteria is so strict is to ensure accurate and robust results - the more accurate and robust the results the more likely it is that it will get through the regulatory processes and red tape. So although it's very frustrating for us, it is actually for the best. We want to be taking the best, most reliable drug we can right ? Not some wackadoodle concoction that falls short. So let's be patient, let Autifony do it's thing and see what happens. Everything they are doing is in our best interests (and theirs too).
This is why it takes years for drugs to get to market, if at all.
The reason the criteria is so strict is to ensure accurate and robust results - the more accurate and robust the results the more likely it is that it will get through the regulatory processes and red tape. So although it's very frustrating for us, it is actually for the best. We want to be taking the best, most reliable drug we can right ? Not some wackadoodle concoction that falls short. So let's be patient, let Autifony do it's thing and see what happens. Everything they are doing is in our best interests (and theirs too).
Zmichael,
I haven't been keeping track of all threads relating to Keppra / Trobalt close enough to report my results on each, sorry. Until being called out about potassium channel modulators, it never crossed my mind to even mention it. I figured plenty of others have already covered it.
I don't know who @svintegrity is, but it's likely not a coincidence that we're trying the same does, since that what others on TT have tried as well.
If you want more details on my T, here you go... I've been a pro musician since I was 18 years old (42 now), so have had light T for years (maybe decades), but it never really bothered my until roughly summer 2012. That's when I developed a weird low pitched, variable hum in my right ear. It has since moved to my left ear, but I can make it stop by moving my jaw or twitching my face. This is actually how my right side started as well. Last summer, after a July concert we played, my left ear developed a loud high-pitched ring, that's difficult to mask (since improved, likely due to habituation). Also developed H in that ear, that gets bad when my 1 year old daughter cries, or I drive our diesel car.
I've read/heard enough testaments to Keppra here and elsewhere, and did the best research I could, and decided a couple weeks back to give it a shot, since it's safe. I got some advice from a fellow TT member on starting dosage. My T has never been as bad as many of you, and has always been pretty mask-able, so maybe that's why I'm seeing positive results? I don't know, but what I can tell you is I no longer dread my daughter crying, and have no issues in the car anymore.
At this point, I could give a shit less if anyone believes or not. I'm not trying to convince anyone to take Keppra or give anyone false hope. Amazing how people report some positive news, then get hammered for it, or get accused of lying. No wonder Corrine hasn't posted lately! At least now I know better than to report any further results going forward.
I haven't been keeping track of all threads relating to Keppra / Trobalt close enough to report my results on each, sorry. Until being called out about potassium channel modulators, it never crossed my mind to even mention it. I figured plenty of others have already covered it.
I don't know who @svintegrity is, but it's likely not a coincidence that we're trying the same does, since that what others on TT have tried as well.
If you want more details on my T, here you go... I've been a pro musician since I was 18 years old (42 now), so have had light T for years (maybe decades), but it never really bothered my until roughly summer 2012. That's when I developed a weird low pitched, variable hum in my right ear. It has since moved to my left ear, but I can make it stop by moving my jaw or twitching my face. This is actually how my right side started as well. Last summer, after a July concert we played, my left ear developed a loud high-pitched ring, that's difficult to mask (since improved, likely due to habituation). Also developed H in that ear, that gets bad when my 1 year old daughter cries, or I drive our diesel car.
I've read/heard enough testaments to Keppra here and elsewhere, and did the best research I could, and decided a couple weeks back to give it a shot, since it's safe. I got some advice from a fellow TT member on starting dosage. My T has never been as bad as many of you, and has always been pretty mask-able, so maybe that's why I'm seeing positive results? I don't know, but what I can tell you is I no longer dread my daughter crying, and have no issues in the car anymore.
At this point, I could give a shit less if anyone believes or not. I'm not trying to convince anyone to take Keppra or give anyone false hope. Amazing how people report some positive news, then get hammered for it, or get accused of lying. No wonder Corrine hasn't posted lately! At least now I know better than to report any further results going forward.
Don't let some of these miserable folks piss you off. Some people wont be happy no matter what, screw them or put them on ignore. Im happy you came back to report your positive results and Thanks for doing that.
Agree... and if you really want to see misery in motion, then have a read of the following thread from TSMB on AM-101:
http://tinnitussupport92262.yuku.co...lready-in-Phase-III-in-Europe-and-USA?page=-1
It's like they actually do not want to have a cure (even the admin "over there" seems to have that fram of mind). My goodness...
A (concerned) passerby
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