AM-101 TACTT1 Results Released

#721
DaveT said:
Hello JohnG and everyone else here, I just learned about AM-101 from here, where did you get this information that they are coming to Western Canada by middle of April? I am located in Ontario.
I just found this website recently so I am new here. I was told by my ENT to try and get used to my tinnitus and that looking for "cures" would make me lose my sanity. Do you have a link to another website or email I can contact?
Thank you!
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The AM101 trial is explained here:

http://www.tinnitus-study.info/

My experience with the website is limited (I am only indirectly involved with the trial) - however, it would seem that the Canadian rollout is still pending. My best advice is to "stay ahead of the game" and contact Auris Medical directly for more info. They will be happy to respond - but it will usually take 2-4 days (it is a small company). E-mail:

ear@aurismedical.com

Alternatively, you can ask member @Hudson - he may know something about the trial I don't.
 
#722
@Hudson Hi Hudson. I have tinnitus since last month and it is taking my normal life away. Do you know the best way to contact Auris once i am in the 3 months time? Appreciate your response .

Cheers

@JohnG I really hope you get into the program . MY best wishes for you brother
 
#723
Rog said:
@Hudson Hi Hudson. I have tinnitus since last month and it is taking my normal life away. Do you know the best way to contact Auris once i am in the 3 months time? Appreciate your response .

Cheers

@JohnG I really hope you get into the program . MY best wishes for you brother
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http://www.tinnitus-study.info/us-en-study-centers?pid=75&sid=232:havertown

Looks like the closest participating site to you is in Hovertown, PA. Contact the person located on that form and get the process rolling. I think it's worth the drive (they have trains on the east coast that will take you down there, right?).
 
#725
Just be sure you don't start taking any new psychiatric medications. Don't use any drugs either, they'll give you a UA.
 
#729
StayPositive said:
Hudson, thanks for posting that! That location (Havertown) is really close to me. I gave my info on the form so hopefully i'll hear something from them.
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I would call them. Time is of the essence with this study. The sooner you get in and get the screening process going the better. I wouldn't wait for some keyboard warrior in the office to check their email. Give them a call.
 
#730
Rog said:
@Hudson I took carbamazepine for two days last week and was the worse experince . No drugs at all. Do you think sinus will be a problem?
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No, that should be fine. Just don't start any new psychiatric medication. That means anti-anxiety drugs, or anti-depressants.
 
#738
DaveT said:
Hello JohnG and everyone else here, I just learned about AM-101 from here, where did you get this information that they are coming to Western Canada by middle of April? I am located in Ontario.
I just found this website recently so I am new here. I was told by my ENT to try and get used to my tinnitus and that looking for "cures" would make me lose my sanity. Do you have a link to another website or email I can contact?
Thank you!
Click to expand...
They told me middle of this month in BC near where I live. Don't listen to your ENT. The ENT I saw said my hearing would never get better (B.S !! I already have recovered many db in hearing and my H went away). So ENTs are completely illiterate on T. Now.. please contact Auris and see if they might be in Eastern Canada. So you won't have to schlep all the way over to our pretty part of Canada.
 
#739
Rog said:
@Hudson
Drops: 2.5 mg/mL (1 drop = 0.1 mg clonazepam). I gess is like 0.3 mg though . for 2 months.
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That's a pretty small amount for a relatively short period of time. I would try cutting back over the next couple of weeks and stopping. They won't want you to participate if you're taking clonazepam.

EDIT: Of course, if you're medically able to do that. Speak with your doctor who prescribed you the clonazepam about your desire to take part in the study.
 
#740
Hudson said:
That's a pretty small amount for a relatively short period of time. I would try cutting back over the next couple of weeks and stopping. They won't want you to participate if you're taking clonazepam.

EDIT: Of course, if you're medically able to do that. Speak with your doctor who prescribed you the clonazepam about your desire to take part in the study.
Click to expand...


I think i will do that . Thank you.
 
#741
@JohnG, I emailed ear@aurismedical.com and asked when and where they will start, I hope to get a response from them soon. I've been super active the past couple days since I found out about AM-101 and this community, so I've been trying to find out as much as possible and as fast as possible. Do you have a local number in BC or have you been communicating with Auris by email.

I totally agree with you that BC is the pretty part of Canada, I've been there many times. I might consider going there for my AM-101 trial if that's what it takes. I have family and friends there I can stay with.
 
#742
  • Improvement in TLQ from baseline to Day 90 of at least 50% was seen for 14% of patients in the placebo group compared with 42% of patients in the high-dose group
  • At Day 90, the mean tinnitus loudness in the high-dose group was 43.2% lower than at baseline (49.5% for unilateral cases). This compares with an improvement of 17.7% (10.0%) for the placebo group.
Some excerpts from the link @JohnDoe posted. I was thinking about the fact that many people get better after the T onset. The trials showed the drug at the high does to be nearly twice as effective. So that was a good start, but by how much did T improve from the two groups. Over 42% in the high does group had improvements of at least 50%, so some had more. Compared to only 14% placebo. Average improvement of 43% to about 18% (drug vs placebo). That some great information, without a doubt this drug has an effect on T. Good luck to everyone entering the trials!
 
#743
cullenbohannon said:
  • Improvement in TLQ from baseline to Day 90 of at least 50% was seen for 14% of patients in the placebo group compared with 42% of patients in the high-dose group
  • At Day 90, the mean tinnitus loudness in the high-dose group was 43.2% lower than at baseline (49.5% for unilateral cases). This compares with an improvement of 17.7% (10.0%) for the placebo group.
Some excerpts from the link @JohnDoe posted. I was thinking about the fact that many people get better after the T onset. The trials showed the drug at the high does to be nearly twice as effective. So that was a good start, but by how much did T improve from the two groups. Over 42% in the high does group had improvements of at least 50%, so some had more. Compared to only 14% placebo. Average improvement of 43% to about 18% (drug vs placebo). That some great information, without a doubt this drug has an effect on T. Good luck to everyone entering the trials!
Click to expand...

I think it's important to also be aware that in the last study only 1 ear could be tested (even if you had bilateral tinnitus) as a safety precaution. I think that negatively skewed the results. The trials that are being run now give patients the option of treating both ears if they have bilateral tinnitus (or central tinnitus, whatever). I honestly believe that will lead to numbers that show an even greater improvement for people receiving the active drug. I would bet that Auris is very much aware of this as well.
 
#744
Great point Hudson. I honestly didn't even think of that. I'm actually excited for this now, i may be in the study only problem im having is my t gets affected by things like using qtips, so im worried about putting a hole in my eardrum, which i was told is about the size of a pin needle point. This is a great first step.

Hudson said:
I think it's important to also be aware that in the last study only 1 ear could be tested (even if you had bilateral tinnitus) as a safety precaution. I think that negatively skewed the results. The trials that are being run now give patients the option of treating both ears if they have bilateral tinnitus (or central tinnitus, whatever). I honestly believe that will lead to numbers that show an even greater improvement for people receiving the active drug. I would bet that Auris is very much aware of this as well.
Click to expand...
 
#745
To qualify for these trials do you have to have suffered a genuinely "traumatic" single exposure to loud noise, like at a particularly loud concert, or being near an explosion? Or could it be more just from long and steady exposure to music, fairly loud music, through earbuds, say?

I guess I'd be willing to try. It's only been little over a week. All this stuff sounds pretty encouraging, either way.
 
#746
Littlebailey said:
To qualify for these trials do you have to have suffered a genuinely "traumatic" single exposure to loud noise, like at a particularly loud concert, or being near an explosion? Or could it be more just from long and steady exposure to music, fairly loud music, through earbuds, say?

I guess I'd be willing to try. It's only been little over a week. All this stuff sounds pretty encouraging, either way.
Click to expand...
Acoustic trauma is acoustic trauma . Whether you got it from a blast or sustained exposure makes no difference to their study.
 
#747
Kimbo Slice said:
We're both at 3 months now. Would you say it is a long shot now that our useless doctors decided not to help us, or do you think we might be able to benefit from steroids still? I'm pretty desperate right now and my Tinnitus got worst today above 10000 Khz. I'll do anything to get rid of this I'm even considering HBOT.
Click to expand...
We're both SOL on that one. I am going for AM-101 as my last shot. I don't think I want to spend $150/hour for HBOT that is unproven and may not work anyway at this late a date. I'm betting on AM-101 since it is proven and acts right at the site of injury. You might want to try to get in. I too have this high pitched hissing sound non stop in both ears. I don't seem to have much hearing loss now and all I took for my therapy was NAC. I have only one option now.
 
#748
One more question then. And I apologize if it's a stupid one. What do they mean by 'acute'? Does it have to be really loud and bad, and I imagine they have a way for testing for that. Mine really isn't too bad. Though it does get a bit oppressive at night.

I guess I should just give them a call. Too bad they don't have any locations in Portland or Seattle. But SLC is not prohibitively far away.
 
#749
That just means within 3 months of onset.
Littlebailey said:
One more question then. And I apologize if it's a stupid one. What do they mean by 'acute'? Does it have to be really loud and bad, and I imagine they have a way for testing for that. Mine really isn't too bad. Though it does get a bit oppressive at night.

I guess I should just give them a call. Too bad they don't have any locations in Portland or Seattle. But SLC is not prohibitively far away.
Click to expand...
 
#750
JohnG said:
I am going for AM-101 as my last shot. I don't think I want to spend $150/hour for HBOT that is unproven and may not work anyway at this late a date. I'm betting on AM-101 since it is proven and acts right at the site of injury ...
Click to expand...

Perhaps I am confused. (Believe me, it happens more than I care to admit!)

Anyway, I thought AM-101 is still in clinical trials. How exactly is it proven?

Stephen Nagler
 

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