AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
Which country is this guy? I am in US but as far as I know they accept up to 3 months?
It was a guy in the EU applying for the phase 3 trial. Half of the people are 0 - 3 months and half 3 -12 months. I am not sure what country it was but I will try and find out. Maybe the US is different laws.
Also, is the US in phase 2? If so, then it is 0 to 3 months only. Phase 3 looks in the 3 - 12 months.
Member- Jul 16, 2014
- 113
- 34
- Tinnitus Since
- 02/06/2014
- Cause of Tinnitus
- Labyrinthitis (Inner ear infection)
Ive just applied for this guys! they have emailed me back saying what hospital would i like to be seen at. Fingers crossed i can get in there for a trial! Just hope i dont have the placebo!
I think is phase 2 only in US.I wonder if they will start a phase 3 .Thanks for the reply ...
There is a Phase III trial taking place in the US and Canada, but it is only open to patients who have had tinnitus for three months or less. There is a follow up Phase III trial taking place here as well, where patients will have the opportunity to receive the treatment for up to 12 months from their tinnitus onset, but those patients will have had to have participated in the first Phase III trial.
- Jul 16, 2014
- 113
- 34
- Tinnitus Since
- 02/06/2014
- Cause of Tinnitus
- Labyrinthitis (Inner ear infection)
My guess is that the earliest AM-101 could be released would be 2016, and late 2016, at best.
You live in the UK, so you have the opportunity to take part in the AM-101 trials if your tinnitus is less than a year old.
The Autifony AUT00063 trials are taking place up in Nottingham as well, you could look into those if you don't want to take part in AM-101.
- Jul 16, 2014
- 113
- 34
- Tinnitus Since
- 02/06/2014
- Cause of Tinnitus
- Labyrinthitis (Inner ear infection)
I have had T just shy of 3 months. What one would you recommend I take part in? Or should I try and go for both? Thanks. Caff
I would take part in the AM-101 trials first if it were me. Your tinnitus is more or less acute still in my opinion, and the target for the Autifony trials is "chronic" tinnitus, although they don't want people who have had it for more than a year though.
- Jul 16, 2014
- 113
- 34
- Tinnitus Since
- 02/06/2014
- Cause of Tinnitus
- Labyrinthitis (Inner ear infection)
I respect the heck out of Hudson, but I have to disagree. The Autifony trials start in September, so it's just a short wait, and to me it doesn't look like AM-101 does much more than turn down the volume in those people it helps at all. AU00063, the Autifony drug, targets the hyperactive nerve channels responsible for the tinnitus quite specifically, and is aimed at getting them out of their "stuck" mode and operating properly. Myself and a number of other posters are considering trying another drug with a similar effect, Retigabine. AU00063 is supposed to be the sniper bullet compared to Retigabine's shotgun approach, and seems to be well supported by the latest theories.
Problem with signing up for AM-101 now is that it would presumably disqualify you from participating in the AU00063 trial, since they want to be sure it's their drug that is effective. I tried to sign up for AM-101 months ago, but we are so near the Autifony trial now that IMO it's worth the wait. Here in the US, we are not getting a tinnitus trial for Autifony, rather they are trying it for hearing acuity. I'm not as confident that I'll be able to get into that one, so I'm considering Retigabine. If I were anywhere in the U.K., I'd be content to wait for Autifony. They will have several sites participating, partially run through UCL, so it should be easy to get on board.
The only caveat for you may be that there is a rumor they may seek patients with under 6 months duration, not that the drug will be limited to those patients, but because it may be easier to reset them to a healthy state. We'll hopefully get the full criteria soon.
I can see both sides of the argument, but just for me, I'm much more hopeful AU00063 will be a cure. AM-101 seems destined to be consigned to an early intervention, worth trying for new cases but outclassed for sufferers with more than 3 months duration. Just my opinion, mind. YMMV.
Problem with signing up for AM-101 now is that it would presumably disqualify you from participating in the AU00063 trial, since they want to be sure it's their drug that is effective. I tried to sign up for AM-101 months ago, but we are so near the Autifony trial now that IMO it's worth the wait. Here in the US, we are not getting a tinnitus trial for Autifony, rather they are trying it for hearing acuity. I'm not as confident that I'll be able to get into that one, so I'm considering Retigabine. If I were anywhere in the U.K., I'd be content to wait for Autifony. They will have several sites participating, partially run through UCL, so it should be easy to get on board.
The only caveat for you may be that there is a rumor they may seek patients with under 6 months duration, not that the drug will be limited to those patients, but because it may be easier to reset them to a healthy state. We'll hopefully get the full criteria soon.
I can see both sides of the argument, but just for me, I'm much more hopeful AU00063 will be a cure. AM-101 seems destined to be consigned to an early intervention, worth trying for new cases but outclassed for sufferers with more than 3 months duration. Just my opinion, mind. YMMV.
SteveToHeal
Member
SteveToHeal
Member
Lets say you had taken part in the AM101 trial and AUT00063 proved to be successful in trials for chronic T and got FDA approval as a cure for T in year say 2016. Would the fact that you had been administered with i.t AM101 at some point, decrease your chances of AUT00063 being effective on you? Or are the Kv3 pottasium channels not affected by AM101? And therefore would AUT00063, still be effective for people with chronic T, that had had, at some point been administered AM101?
I can understand that taking part in AM101 prevents you from taking part in the AUT00063 trial. But would it also potentially make you immune to AUT00063?
I can understand that taking part in AM101 prevents you from taking part in the AUT00063 trial. But would it also potentially make you immune to AUT00063?
Where did you get the info about the AUT00063 trial phase II starting in September? Do you know if it will be only in the UK, or in mainland Europe too? Cheers.
It will only be in the UK and it is scheduled to start in september. All the info is in the Autifony thread. Read the whole thread, it's worth it
It will only be in the UK and it is scheduled to start in september. All the info is in the Autifony thread. Read the whole thread, it's worth it
Ok! Hm, I thought I did but maybe I missed that.
I guess it won't be open to none UK citizens?
This is only a guess from my side but I strongly doubt these drugs will affect each other on a physiological level as they target totally different areas of the problem, no?
That's perfectly fine and understandable if you prefer to try your luck out with the Autifony trial if you choose.
I would just caution people that I am highly skeptical that even the Autifony drug will be a "cure". We have had this discussion on TT many times before, and I think it's worth pointing out here too. Very few things in medicine are "cured". What is much more likely is an effective treatment. The difference there is any approach we take will most likely not completely get rid of the noise, but lessen it to a good degree. I could of course be wrong, and we'll be pleasantly surprised that it cures it in a good chunk of people.
Charles Large send an email to TT user Dan where he stated that phase 2 is scheduled to start september/october this year and it will only be for UK citizens. Both this thread and the Autifony thread are so long now that people get confusedOk! Hm, I thought I did but maybe I missed that.
@SteveToHeal
No they haven't published any results. The results wouldn't mean much for us anyway, as the Phase I trial was a safety study tested on healthy volunteers with no tinnitus. The best data we can find for efficacy is the animal trials that were conducted by Autifony and the results released at the 2013 TRI conference by Autifony.
I also will say that I really would be surprised if taking part in the AM-101 trial would somehow make you immune to any benefit from the Aut00063 compound or DQ you from participating in a trial. Typically with trials, they want you to have had a 30 day "washout" period between trials, so they can say with a good degree of certainty that any benefit you receive from their compound was definitely from their compound, and not from some holdover effect from your previous trial you participated in.
Quite true. The poster who says he was helped by Retigabine notes that he can still hear his tinnitus if he puts his fingers in his ears. I am certainly not planning on hitting the clubs...ever.Very few things in medicine are "cured". What is much more likely is an effective treatment. The difference there is any approach we take will most likely not completely get rid of the noise, but lessen it to a good degree. I could of course be wrong, and we'll be pleasantly surprised that it cures it in a good chunk of people.
That's perfectly fine and understandable if you prefer to try your luck out with the Autifony trial if you choose.
I would just caution people that I am highly skeptical that even the Autifony drug will be a "cure". We have had this discussion on TT many times before, and I think it's worth pointing out here too. Very few things in medicine are "cured". What is much more likely is an effective treatment. The difference there is any approach we take will most likely not completely get rid of the noise, but lessen it to a good degree. I could of course be wrong, and we'll be pleasantly surprised that it cures it in a good chunk of people.
Yeah you're correct. I think people are throwing around the word cure a bit too easy here. A cure is when you only have to take a medicine/procedure once and the problem will be fixed and never to return. There's no such thing for any disease that I can think of. We can't cure cancer but we can treat it enough to get people free from it. The medical community do not refer to people who has had cancer as "cured", the correct term is "cancer free". The cancer can still return. As for T, I don't think that Autifony or AM 101 will be cures. Autifony has shown potential to be an effective treatment based on the rat study. But even if it totally silence T you would probably have to keep taking it. Not a cure, but good enough for everyone with T if that turns out to be the case. AM 101 has not shown to be very effective yet. It will probably only work in what I would like to call "the true acute stage" where one has had T for just some days, or even hours.
I wasn't aware that anyone had actually tried retigabine yet. Do you have a link to these posts? Thanks
How the heck could you have missed that thread? And you're supposed to be staff here
It's in the Treatment section. It's the most interesting thread on TT right now. https://www.tinnitustalk.com/threads/retigabine.5074/How the heck could you have missed that thread? And you're supposed to be staff here
I've been very busy and I have had some personal family issues I've been dealing with. When I haven't been at work I've been running my mom and sister around all over the state to different family members. It's been... challenging to say the least.
SteveToHeal
Member
Yey! Got contacted today form the test unit in Austria. They only asked me briefly which one of the two test facilities I'd like to conduct the trial at. So I guess I'm not enrolled yet, but looks promising. Only kind of shitty thing is that I'm going away on vacation tomorrow for three weeks, which will make the total length of this major T-increase 4 months... Let's hope that's not long enough to engrain this spike in my brain, out of reach for AM-101
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