AM-101 TACTT1 Results Released

[Fish]

It is ok Brian I figured somebody might ask that one day. To answer your question, visiting this forum has become sort of a daily routine to me, among other websites. I met really many nice people here and I like to know how everyone is doing. Besides that, I can follow the news on AM-101 and other treatments.

I can honestly say that tinnitus doesn't bother me at all. As I said before, it isn't completely gone but it's so quiet I forget about it completely during the day. I really hope it stays like that...

If it has any impact on my life, it's only that I'm way more cautious, I avoid loud places and always carry earplugs with me.

 

[attheedgeofscience]

This is the power of the double blind placebo study. They give the drug to one group of people and a placebo drug to another group. Neither of the groups know what they got (double blind). Then they have to find the difference in cure rate (here probably som kind of reduction parameter) between the two groups to be statistically significant in order to claim the study to be succesful.

Double blind is when neither the doctor nor the patient knows whether the real drug or the placebo is being administered.

 

[urtica]

They sucked the numbing fluid out with a sort of vacuum cleaner. really horrible noise!! She did it just the first day, the other two days she stuffed a cloth soaked with the numbing liquid in m ear wich was ok. On the third day she also used a spray which made a loud noise as well. all pretty unpleasent.

btw: It's improving. Right now my T is back at the level it has been before the trial. Let's see if it keeps on improving! But right now, it's not bothering me much..

 

[JohnDoe]

They sucked the numbing fluid out with a sort of vacuum cleaner. really horrible noise!! She did it just the first day, the other two days she stuffed a cloth soaked with the numbing liquid in m ear wich was ok. On the third day she also used a spray which made a loud noise as well. all pretty unpleasent.

btw: It's improving. Right now my T is back at the level it has been before the trial. Let's see if it keeps on improving! But right now, it's not bothering me much..

Hi @urtica, thank you for keeping us posted. I have a few more questions:

- Does your hearing still feel different than before? Are there any other sensations regarding your ear that may be relevant?
- Do you have Tinnitus in one ear or both?
- Were you afraid before getting the injection? What were some of the risks talked about?
- When will you know if you received the placebo or the real drug?

Thank you for your time.

 

[Johno]

Double blind is when neither the doctor nor the patient knows whether the real drug or the placebo is being administered.

Hey man, what's new? Give us some news about your stem cell experiment, please

 

[tom68]

OK quick update, yesterday I went down to my doctor's surgery and left im a letter asking him to put my name forwards for the clinical trial - as the guy running the trial asked. I'll go back and check if he's done it tomorrow.

 

[Hudson]

They sucked the numbing fluid out with a sort of vacuum cleaner. really horrible noise!! She did it just the first day, the other two days she stuffed a cloth soaked with the numbing liquid in m ear wich was ok. On the third day she also used a spray which made a loud noise as well. all pretty unpleasent.

btw: It's improving. Right now my T is back at the level it has been before the trial. Let's see if it keeps on improving! But right now, it's not bothering me much..

How long was it between your injections and when it decreased back to your old level? Your continued input is greatly appreciated.

 

[tomytl]

Now recruiting in the US
http://www.aurismedical.com/p/news/news_43.php?lg=en

maybe some useful news

 

[nills]

"We expect results from both TACTT2 and TACTT3 trials in late 2015."

My god, they should hurry up a bit ...

 

[cullenbohannon]

I've sent them an email for the north American trials. Hopefully they get in contact with me . Seems to be the best chance we have.

 

[Mark Washington]

cullenbohannon. Hey I got a site in NJ, if you would like there contact information i can give it to you. Message me if you would like it sir.

 

[Erlend]

"We expect results from both TACTT2 and TACTT3 trials in late 2015."

My god, they should hurry up a bit ...

LATE 2015??? Jesus christ. Let's hope that's a type o

 

[Hudson]

LATE 2015??? Jesus christ. Let's hope that's a type o

It's not. Phase III trials can take a long time. I've said previously that the best shot for approval of this drug, assuming efficacy is shown in Phase III, is in 2016.

 

[NeoM]

I read clinical trials take about 10 years on average for them to complete.

 

[Stina]

well that the fact that they made it to phase III is still promising and if one wants a quality drug its logical that it takes time. scientists sleep and rest too im just happy that there is smth coming out so that in some years we can tell the newbies to try that instead of telling them to "just live with it".

 

[Amelia]

well that the fact that they made it to phase III is still promising and if one wants a quality drug its logical that it takes time. scientists sleep and rest too im just happy that there is smth coming out so that in some years we can tell the newbies to try that instead of telling them to "just live with it".

I just hope we are able to add "it worked for all of us here! It will work for you too - no matter how long you have had t"

 

[Stina]

I just hope we are able to add "it worked for all of us here! It will work for you too - no matter how long you have had t"

yes or in some more time there will be treatment specifically for us too you are still young (31 is young and I dont want to hear any arguments), years will pass quickly and before we know there shall be effective treatments.

 

[Amelia]

Lol, I turned 32 a few days ago .... Can I argue now

 

[urtica]

Hi @urtica, thank you for keeping us posted. I have a few more questions:

- Does your hearing still feel different than before? Are there any other sensations regarding your ear that may be relevant?
- Do you have Tinnitus in one ear or both?
- Were you afraid before getting the injection? What were some of the risks talked about?
- When will you know if you received the placebo or the real drug?

Thank you for your time.

- Now my hearing is allright!! I don't hear any more differences. No more distortion and no more increased T! It's been two weeks now since the injections. I think there is a really small amount of the gel left, because I can hear my right ear krackling while yawning. It keeps on improving and I think I can go to a party this weekend (of course with proper plugs). I can't wait!

- I have T in both ears, but I decided to do just one ear. If I want to I can get the real drug applied to my left ear to with that follow up study.

- I was very afraid of getting anything applied to my ears!!! But the risks were pretty minimal, since it's a standart ENT procedure and my doctor is pretty skilled. Also my eardrum healed pretty quick! Every next day it was closed again. So thats pretty safe.

They will unblind the study when they have finished it, so I think on End of 2015. My doctor (who had done also all AM101 studies before)
said: "If it's not improving, you got a placebo and participate in the follow-up study". So she's pretty positive about the drug. Also my eardrum was really sensitive after the first injection, it was iriitated, red and could not be numbed propperly. The cut and the injection the second day really hurted! She said a placebo wouldn't have that effect and another guy with the same sensitive eardrum symptom had also the real drug. So I think I got the real drug.

 

[Stina]

- Now my hearing is allright!! I don't hear any more differences. No more distortion and no more increased T! It's been two weeks now since the injections. I think there is a really small amount of the gel left, because I can hear my right ear krackling while yawning. It keeps on improving and I think I can go to a party this weekend (of course with proper plugs). I can't wait!

- I have T in both ears, but I decided to do just one ear. If I want to I can get the real drug applied to my left ear to with that follow up study.

- I was very afraid of getting anything applied to my ears!!! But the risks were pretty minimal, since it's a standart ENT procedure and my doctor is pretty skilled. Also my eardrum healed pretty quick! Every next day it was closed again. So thats pretty safe.

They will unblind the study when they have finished it, so I think on End of 2015. My doctor (who had done also all AM101 studies before)
said: "If it's not improving, you got a placebo and participate in the follow-up study". So she's pretty positive about the drug. Also my eardrum was really sensitive after the first injection, it was iriitated, red and could not be numbed propperly. The cut and the injection the second day really hurted! She said a placebo wouldn't have that effect and another guy with the same sensitive eardrum symptom had also the real drug. So I think I got the real drug.

Im dont mean to be rude but isnt part of the contract that you are willing to protect your ears afterwards? if its a loud party then things could go wrong even with plugs.

 

[Grace]

I would recomend you should to it. I'm also glad i participated. Altough it caused a lot of stress, traveling to the doctors, having my eardrum pinched, having to fill in a T. diary everyday, and two weeks of a really loud T and distorted hearing.
I don't think it's doing any worse to your ears, nothing that's not temporary. Or at least I hope so..
It gets better everyday and I think two weeks after the injection it should
have reached the point as it was before the injection. Then hope it keeps on improving beyond the point before the trial.

Btw. if you feel it didn't help, you get the chance to do the followup trial
in which you get the real drug for sure.

@Hudson: I got my T though a mean firecracker that got thrown at me.

Glad your improving.. Have a good feeling this drug will almost cure you

 

[Mpt]

when you say it keeps on improving do you mean your tinnitus?... how is the ringing in regards to how it was before the injections?- I'm considering taking part in the trial

 

[Mark Washington]

Uritca that is great that your T is getting better. Keep up with the posts.

 

[Johno]

Stina is right, Urtica, forget about noisy party, pubs, concerts. For sure forever. Yours ears needs more than year rest and then - avoid noise parties, pubs again. Look - i was a sportshooter before - i always wear hearing protection. But after i got T from loud motorcycle in garage, i must end my gunfire hobby. Because even earplugs and earmuffs together cannot guarantee comfort noise of gunfire for my damaged ears. Gunfire shot from .45ACP is 157Db loud, with both protections maybe 110Db - still enough for my damaged ears. Maybe with sound suppressor i can shoot ( 115Db without ear protection, around safe 70Db with double ear protection), but in my country aren't gun suppressors allowed.

 

[Hudson]

- Now my hearing is allright!! I don't hear any more differences. No more distortion and no more increased T! It's been two weeks now since the injections. I think there is a really small amount of the gel left, because I can hear my right ear krackling while yawning. It keeps on improving and I think I can go to a party this weekend (of course with proper plugs). I can't wait!

- I have T in both ears, but I decided to do just one ear. If I want to I can get the real drug applied to my left ear to with that follow up study.

- I was very afraid of getting anything applied to my ears!!! But the risks were pretty minimal, since it's a standart ENT procedure and my doctor is pretty skilled. Also my eardrum healed pretty quick! Every next day it was closed again. So thats pretty safe.

They will unblind the study when they have finished it, so I think on End of 2015. My doctor (who had done also all AM101 studies before)
said: "If it's not improving, you got a placebo and participate in the follow-up study". So she's pretty positive about the drug. Also my eardrum was really sensitive after the first injection, it was iriitated, red and could not be numbed propperly. The cut and the injection the second day really hurted! She said a placebo wouldn't have that effect and another guy with the same sensitive eardrum symptom had also the real drug. So I think I got the real drug.

@urtica,

How is your tinnitus, has it improved beyond what your "baseline" was? Glad to hear about your improvements.
Hudson

 

[Stina]

Stina is right, Urtica, forget about noisy party, pubs, concerts. For sure forever. Yours ears needs more than year rest and then - avoid noise parties, pubs again. Look - i was a sportshooter before - i always wear hearing protection. But after i got T from loud motorcycle in garage, i must end my gunfire hobby. Because even earplugs and earmuffs together cannot guarantee comfort noise of gunfire for my damaged ears. Gunfire shot from .45ACP is 157Db loud, with both protections maybe 110Db - still enough for my damaged ears. Maybe with sound suppressor i can shoot ( 115Db without ear protection, around safe 70Db with double ear protection), but in my country aren't gun suppressors allowed.

A 110 db is too loud for everyone

 

[Johno]

A 110 db is too loud for everyone

Yes, of course, but shot from pistol takes maybe 1/100 of second and healthy ears can withstand 110 Db for around 1minute before permanent damaging occurs With ear protection you should fire around 6000 shells to damage your hearing

 

[Hudson]

Yes, of course, but shot from pistol takes maybe 1/100 of second and healthy ears can withstand 110 Db for around 1minute before permanent damaging occurs With ear protection you should fire around 6000 shells to damage your hearing

I never had a problem shooting if I wore hearing protection. It didn't seem to bother my tinnitus at all. Although, I haven't had the guts to go shooting since my tinnitus got worse.

 

[Johno]

I never had a problem shooting if I wore hearing protection. It didn't seem to bother my tinnitus at all. Although, I haven't had the guts to go shooting since my tinnitus got worse.

I dont know where are you from, but if from USA - in some states in USA you can buy gun sound suppressor legaly (but suppressor must be registered and registration cost $200) In Europe i thik (but not for sure), suppressors are allowed in Switzerland and Finlandia.

 

[cullenbohannon]

Anyone have news on when they might publish the previous results in any journals?