AM-101 TACTT1 Results Released

I don't think I would wait if I had the chance to do something, even if its only a small chance. My sleep has been the same as before, no problem. As far as the e-diary, its 2 questions a day. 1) on a scale of 1 to 10 how loud was your tinnitus in the last 24 hours 2) on a scale of 1 to 10 how annoying was your tinnitus in the last 24 hours. It only takes a few minutes a day to fill out. Do not forget to fill out or you will be disqualified.

 

Stage 3

 

At best then it is 50/50 if you get the drug. Maybe less.

 

My consent form stated 40% Placebo/60% AM-101

 

Well an update,
I applied to three centres, the closest to me was Toulouse about 450kms or Tours 300kms and Paris which is really far away and also a big noisy city which is difficult to navigate.
I got a reply from Paris telling me to call to make an appt.
From the centre who sorts the applications, I received a reply email telling me that I should go to Tours as it is my closest.
So since then I have been trying to make a connection with Tours.
Finally spoke to a lady at Tours yesterday and she gave me email address to speak with the Drs involved.
So she told me to send the email to her and she would forward it. She said write in English as the Dr spoke good english so I did.
I asked all sorts of questions on the email including about the expenses reimbursement side of things. I gave them my phone number to call me or reply by email.
I got a very short email response just now.
Here it is and is so typically french....
Dear Mrs Ross,
For our center the inclusion are stopped because we have invovled enough patient and, unfortunatly ,I think that you cannot be included in this study in France if you don't speak perfectly French.
Maybe you can ask to Auris if there is a center for english speaker.
Kind regards
Dr Soizick Pondaven-Letourmy
ORL et CCF
CHU de Tours
02 18 37 05 24
The doctor is assuming that I dont speak french as I wrote to him in English but I did so cos the lady at the hospital told me that his english is great so dont need to do it in french.......
So what do I do with that? Dont even get to the first appt. So do I now apply to Toulouse which is so far away to be ridiculous.
As for England and doing the trial there, they are asking me if I am normally resident in France cos if I am then I cannot do it in England but have to do it in France.
So I am stuck ,,,,,,between a hard stone and a brick wall.
Any suggestions?

 

Apply at the next closest site, if asked tell them travel is not a problem.

 

Update
Just finished my 3rd injection and all went well. They used the same hole again and it was still numb. I have a follow up visit in just over a week. Now for the 200 mile drive home.

 

I was told its a 50/50.

 

@NewGuy

Yes it is really frustrating here. Telling them that I could travel there is exactly what I did.
I was told to apply to Tours by the central place where the initial web applications are sorted - so I got an email from central processing asking whether I can 'deplace' myself to Tours to which I replied - ''no problem''.
I heard nothing further so I called Tours hospital in order to get my appt and to ask some questions = sent the email off and that is what I got back. He didnt answer any of my questions and assumed that I dont speak french cos I wrote in english as advised to do by the girl in the ORL dept. Further. here in France. unike in the UK or the States or Australia, one is not allowed or encouraged to ask questions so that one can make an informed decision. I think that all of you who are on the trials have been able to speak with the study centre before going there. yes?

 

@amandine

Yes, the study center called me directly and I spoke to the coordinator for about 30 minutes. Since then, it's been daily emails making sure that we have everything we need to get to the screening, which has been scheduled for next week. I am in the US.

 

@OddV
Wow what a difference....if it was like that here I would have been there by now. Now how do I get to apply to Toulouse? Guess get back to central and tell them that I prefer Toulouse but then they ll just say what is wrong with Tours? Just cant get anything done here so beginning to give up on the whold thing....sad....

 

@T-Bach Can you give us an update?

 

i think it is actually stage 3 - results from stage 2 have already been published

 

Update
Drive home was fine. Earache feeling is still there and was a little worse last night and today. I didn't get the best sleep last night because of this. It is still sore and I have a very full feeling. This is normal though and should last about to weeks. My T is swinging up and down like crazy but it is tolerable.

 

This thread is a mess. Maybe it should be divided into two threads. One thread where trial participants report their experience. A second thread for information, support, and questions.

 

so how longdo they do these trials on people and if it ever becomes available to doctors around the world for tinnitus how long are we looking at?? thanks!

 

@NewGuy thanks for keeping us informed on how you're going

so you were allowed to drive home from the test site yourself?

 

Does anyone know what meds you can and cannot take on the am-101 trial?

 

@NewGuy
How are you feeling / doing now? Day leter, are things better? Please let me (or forum) know....hope you are doing ok!

 

@Danny Boy From what I've understood (and what i think), they don't want patients under another treatment (even if it's not for tinnitus, they will ask if you take meds), bu they'll only test if you take drugs like marijuana, cocaine, or benzos.
I'm on day 9 before the injections, i'll keep it posted here.

 

It is 40% placebo, 60% am101. Says so in my consent form.

 

Yes - by email or by phone in the UK.

 

They screen for any street drugs and you can't be on anti-depressants.

 

Can you be on sleeping tablets?

 

Check with the ent doctor that will be injecting you, or better still with the trial co-ordinator. They know all the exclusion criteria. They can check with Auris for you if they don't know.

I had to come off anti-depressant SNRI. I was also on another scheduled prescription med (for pain prescribed off-label to help t sufferers with sleep), which i came off as well. I can't remember them saying specifically if i had to come off those but i did anyway, as i was not going to do anything that would jeopardize me not getting on the trial.

So if you can come off whatever you are on, then do so. Would be crap if something came up in your bloods that got you DQ'd. There goes your one and only chance, if you get what i mean. But if you can't come off specific meds (if it is too dangerous to do so), then check with the trial co-ordinator if they allow it.

 

you can't be on benzos

 

Do you think zopiclone would be OK? It's not a benzo.

 

As i said above - to be sure - ask the trial co-ordinator. They will know what is on the DQ list and what isn't.

 

Hi guys, I didn't mean to leave you hanging. As @earsnothappy said, this thread is kind of a mess. I have started a new thread called AM101 Participants Updates and Q&A. I will try to post there regularly, sorry it's been a few days, I have been busy at work catching up from the time off to get the injections. If anyone has questions or has gone through the treatment, please post in the new thread, thanks-

 

I just read this, for anyone who is interested.

http://www.bioworld.com/content/auris-medical-gets-51m-hearing-disorder-drugs-1