Johno
Member
- Jan 8, 2014
- 231
- Tinnitus Since
- 6/07/2012
- Cause of Tinnitus
- acoustic trauma
AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
MemberBecause T here in Slovakia is not classified as a disease (only hearing loss is).
eastern europe problems
however in 2-3 years they might change that
lol. Heard you guys might be getting microwaves next year.eastern europe problems
lol. Heard you guys might be getting microwaves next year.
what? you mean like ovens??
Only temporarily before dropping to a lower level than they had to begin with from what i have heard
Hmm because on the trials ( http://clinicaltrials.gov/ct2/show/record/NCT02040194?term=am+101&rank=1 )
It says:
- Tinnitus loudness [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
Improvement in tinnitus loudness - Hearing threshold [ Time Frame: Day 35 ] [ Designated as safety issue: Yes ]
Occurrence of deterioration in hearing threshold in the treated ear(s)
If you read the whole topic, then you see that Hudson replied that the change in threshold is a temporary reaction to trauma which will pass in time.
I don't know. I know hearing loss was listed as a side effect, but I don't know if it's temporary because of the injection or a permanent side effect.
I think it was mentioned that this was only a temporary thing because they stick a hole in your eardrum, but this heals within a week and you'll be fine. It happend naturally often as well, and they do it all the time for other purposes.
I found another redditor who had the am101 treatment. He was online only 30 minutes ago, I think I'll be able to pass on some questions.
He has already said that: Am101 was completely nice and smooth and safe to do, just a little hole in the eardrum. The ringing became worse 24 hours after, but one week later, the ringing was almost completely gone.
http://www.reddit.com/r/tinnitus/comments/qvj88/taking_place_in_a_clinical_study_for_tinnitus/
He has already said that: Am101 was completely nice and smooth and safe to do, just a little hole in the eardrum. The ringing became worse 24 hours after, but one week later, the ringing was almost completely gone.
http://www.reddit.com/r/tinnitus/comments/qvj88/taking_place_in_a_clinical_study_for_tinnitus/
My first appointment is in 6 days at the medical center. If I receive my first injection at that time, I will let you all know how it goes! If it works for me, it will work for you guys! Heads up!
Does anyone have more information from people that have participated in the trial? I am always naturally more skeptical of the company that says it is safe than the average everyday joe who is says it safe (i.e. Joe I will believe).
However, other than that good recent post by Erlend, there really is only a limited amount information that I have found (which all kinda says it is safe in the short term). I saw that @DykeyPhillips participated and he abruptly left tinnitustalk.com, which can say 2 things, his tinnitus is no longer a concern (which is terrific), or his ear fell off (which probably is not the case because AM 101 by theory might not be in a hardcore application phase). But im sure everyone wished they can know.
I also remember reading from a tinnitustalk.com individual who stated that he had tinnitus for a few years and was in the phase 2 or 1 trial. He abruptly stopped because he thought the T got worse (which makes sense given that people who have had the drug have stated that it temporarily gets worse) but it nearly went away. He then stated that he wished that he had stuck around to get the 2 or 1 injection(s) that he missed out on due to him becoming an attrition statistic.
And that has to be some scary Sh*t if the drug makes the tinnitus worse (temporarily). I know people have described it as sort of blowing up and burning out event, but in that "week" (that erlend's post emphasized) must be some really deeply disturbing event. If it was me I would be a little perturbed in that week to say the least.
Given that the short term might be safe, do people think that the long term safety is there? The mice generally die. I just hope that a whole bunch of people in 30 years do not develop some bizzare ear/brain condition. That would clearly suck for all of x involved.
Thanks for the time
Also good luck Jake! Hopefully the future will be one that is spent with no (or a quieter) physical ringing. That would be something precious that all T folks would enjoy.
However, other than that good recent post by Erlend, there really is only a limited amount information that I have found (which all kinda says it is safe in the short term). I saw that @DykeyPhillips participated and he abruptly left tinnitustalk.com, which can say 2 things, his tinnitus is no longer a concern (which is terrific), or his ear fell off (which probably is not the case because AM 101 by theory might not be in a hardcore application phase). But im sure everyone wished they can know.
I also remember reading from a tinnitustalk.com individual who stated that he had tinnitus for a few years and was in the phase 2 or 1 trial. He abruptly stopped because he thought the T got worse (which makes sense given that people who have had the drug have stated that it temporarily gets worse) but it nearly went away. He then stated that he wished that he had stuck around to get the 2 or 1 injection(s) that he missed out on due to him becoming an attrition statistic.
And that has to be some scary Sh*t if the drug makes the tinnitus worse (temporarily). I know people have described it as sort of blowing up and burning out event, but in that "week" (that erlend's post emphasized) must be some really deeply disturbing event. If it was me I would be a little perturbed in that week to say the least.
Given that the short term might be safe, do people think that the long term safety is there? The mice generally die. I just hope that a whole bunch of people in 30 years do not develop some bizzare ear/brain condition. That would clearly suck for all of x involved.
Thanks for the time
Also good luck Jake! Hopefully the future will be one that is spent with no (or a quieter) physical ringing. That would be something precious that all T folks would enjoy.
Also Jake I do not think that you will receive the injection at that time, because I believe it is just a screening process (which I think you stated). I think it is more probable to think that it would be in March when the needle breaks flesh. I think that because they have to screen everyone and then group people (the post acute group I do not think will be random). They could drop people out after they screen them. From what I understand these people do some hardcore screening and they will take care of you.
But be aware, just because they say everyone in the post acute group will get drug does not imply that you necessarily will get the drug. A) They could on the low give a random group the placebo. B) They can also give everyone the placebo (which I firmly doubt). It could make alot of sense for AM to give some people a placebo despite telling everyone it is the real deal. So watch for the - not so illusory- placebo effect. It is pretty easy to figure out if one has had the placebo (its also not always the case that it is easy). Rather wipe your mind tabula rasa style and see if anything is up or different with a clear head (Drugs always cause an effect while sugar can make someone a little energetic). I can imagine someone could get ear ringing (or worsening it) if they have there ear poked that would come and go as well.
Again good luck
But be aware, just because they say everyone in the post acute group will get drug does not imply that you necessarily will get the drug. A) They could on the low give a random group the placebo. B) They can also give everyone the placebo (which I firmly doubt). It could make alot of sense for AM to give some people a placebo despite telling everyone it is the real deal. So watch for the - not so illusory- placebo effect. It is pretty easy to figure out if one has had the placebo (its also not always the case that it is easy). Rather wipe your mind tabula rasa style and see if anything is up or different with a clear head (Drugs always cause an effect while sugar can make someone a little energetic). I can imagine someone could get ear ringing (or worsening it) if they have there ear poked that would come and go as well.
Again good luck
I'd assume the mice are dying because they have a significantly shorter life span than us, and my personal feelings are that how does this differ from hundreds of medications people take every day?
The trials in AM101 were previously focused on people who have had it 3 months, the 3rd trial will be for people from 3 months to 1 year. Therehope I really hope the information about the person who had had it for a few years and still participated in the trials is incorrect.
Also, if the drug is dangerous it simply won't probably reach the market.
Also, if the drug is dangerous it simply won't probably reach the market.
Mark,
phase 1 is always to see if a drug has any side effects and is/could be dangerous for human consumption or use... the fact they moved on to phase 2 and 3 excluded this possibility already. These trials are extremely regulated and I am a 100 percent sure that if something is dangerous it would n`t even have gotten to the human trials. conspiracy theories just don`t fit the profile here. Also I know which case you speak of the guy that pulled back, although I don`t remember him having chronic tinnitus for more that 3 months ... well he missed his chance. And the fact that it got worse at the beginning is normal, because the gel put in your ears makes you temporarily more deaf ... so will create more tinnitus. Sometimes because of blood pressure in the head and ear people hear this loud tinnitus sound for a couple of seconds until it fades, if you observe this process you will notice that you are not only hearing tinnitus in that ear but you are also deaf for that period of time ... 1+1 makes 2.
second. They are doing a placebo controlled trial and those that did not get the real medicine will get it afterwards. A couple of months as I remember well. I assume (which is nothing to rely on) that because of the positive effects with this group of people that got the real dose months later after the placebo, they continued on to trials with an extended period or time frame for the acute tinnitus to chronic tinnitus phase.
they also give different amounts of the drug to different people. So it is a well controlled study which will bring very clear answers to if or if not this drug will help with acute and or chronic tinnitus.
Do not understand which article or information you are referring to with the mice that died. Would be interesting to have a read f that one if you have a link maybe?
thanks
phase 1 is always to see if a drug has any side effects and is/could be dangerous for human consumption or use... the fact they moved on to phase 2 and 3 excluded this possibility already. These trials are extremely regulated and I am a 100 percent sure that if something is dangerous it would n`t even have gotten to the human trials. conspiracy theories just don`t fit the profile here. Also I know which case you speak of the guy that pulled back, although I don`t remember him having chronic tinnitus for more that 3 months ... well he missed his chance. And the fact that it got worse at the beginning is normal, because the gel put in your ears makes you temporarily more deaf ... so will create more tinnitus. Sometimes because of blood pressure in the head and ear people hear this loud tinnitus sound for a couple of seconds until it fades, if you observe this process you will notice that you are not only hearing tinnitus in that ear but you are also deaf for that period of time ... 1+1 makes 2.
second. They are doing a placebo controlled trial and those that did not get the real medicine will get it afterwards. A couple of months as I remember well. I assume (which is nothing to rely on) that because of the positive effects with this group of people that got the real dose months later after the placebo, they continued on to trials with an extended period or time frame for the acute tinnitus to chronic tinnitus phase.
they also give different amounts of the drug to different people. So it is a well controlled study which will bring very clear answers to if or if not this drug will help with acute and or chronic tinnitus.
Do not understand which article or information you are referring to with the mice that died. Would be interesting to have a read f that one if you have a link maybe?
thanks
Johno
Member
- Jan 8, 2014
- 231
- Tinnitus Since
- 6/07/2012
- Cause of Tinnitus
- acoustic trauma
Mice died, because was too much happy from T dissappearing and got a heart attack. It was good day to die for it. 
This guy, who pulled back after first injection (from 3) was member Fish and he regrets it, because his T after temporary worsening significantly improves.
This guy, who pulled back after first injection (from 3) was member Fish and he regrets it, because his T after temporary worsening significantly improves.
I'm just wondering that if this is so promising upcoming treatment to tinnitus that actually works, why media is so quiet about it? At least here in Finland I didn't find any news about this... How long does it probably take that this will come to the market? I know that answer to my question is somewhere in this thread but I'm hoping that someone could give me quick answer, thanks!
tinnitus is rarely spoken in any media, so any possible cures aren't spoken(for now).
If you live in BC, Canada. There will be trials happening at Kelowna and Penticton. These will be from mid to end March. One problem though. Your Tinnitus started in October, so you are past the 3 month mark of onset. You'll need to wait and see if there will be a trial for patients with an onset of 4-12 months as they are only focusing on the trial for patients with an onset of 3 months for now.
So what you're saying is if we get the placebo, we can still go back again later for another injection? How do we do this? Also how long will it take until we get the second injection?
I think all these things will be outlined in a contract that you have to sign. I don`t know what is in it or what the rules and guidelines are ... but I`m very sure that if you get the placebo in the first stage they will allow you to get the medicin later on.
Alright thanks man. I think it would be a great idea to give placebo group a second chance and would benefit the company greatly. The way I see it is, the placebo giving the company a better shot at getting the drug to the market by giving the trial a certain percentage of failure to say that they received good results at let's say 80% and the other 20% bad results, so to cover that gap of bad results, they have a placebo group at %20 making the success rate 100%. Now lets say Placebo group A at: 200 people. Non-Placebo group at 800 people. This gives the trial a sure chance of failure at %20, so to close that gap of bad results WHILST including the placebo group, they give the placebo group a second and third injection and give the trial a %100 sure success rate, giving the trial in whole a %100 chance success rate + placebo group. So this comes out to be a %120 success rate for this trial in whole, IF placebo group receives a second and/or third injection. Makes complete sense.
Hey, thanks for the response. I'm from Edmonton so I definitely wouldn't mind making the commute if they hold trials for onset longer than 3 months. I was wondering how you came across this information?
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