Recruiting AM-101 in the Treatment of Acute Tinnitus (TACTT3)

What does "empirically driven" mean? Just for the layman or dumb farmer that still watches "Green Acres" reruns everyday. I don't recall the results for the earlier phases...did they show much promise? I assume they were double blinded studies.

 

Watie, if you PM me I can give you some of the contact information for KUMed in KC, Kansas.

 

I will PM you as soon as I figure how to do that. lol I got message from Jake and he gave me an e-mail address for KU Med center to try. Thanks for the help. I have never tried to PM on TT before. Its probably easy but still working on it. Again thanks

 

@watie - Your not the Wichita Lineman are you?

GLEN CAMPBELL - WICHITA LINEMAN

 

No but I wish I was. He probably made enough money to try any treatment out there.lol

 

I got an e-mail back from the recruiter at Auris and they're going to have trials at a New England site - I'm already planning on joining the trial for the later stage (4-12 month) group.

If anyone wants me to update this thread when that happens let me know.

 

Huh I just posted to you on another thread....I was told there were no post-acute trials in the US soon. Thanks. Will check this out.

 

It appears they changed their minds. They updated the clinical trials site with a TACTT3 trial.... which allows for participation of up to 12 months of onset. This is separate from their "Post acute" trial that they have had on clinicaltrials.gov for quite a while, which, to my understanding, was and is only going to be performed in the EU.

 

@Champ Keep us briefed

 

@Champ - Go ahead, make my day!

 

Thanks Hudson: So you are saying that trials involving participants whose onset occurred more than three months ago will only be in the EU? Sorry, confused.

 

LadyDi,

Originally, (for the last year, since MArch 2013) Auris Medical only had two trials listed on clinicaltrials.gov that were upcoming and for AM-101.

One was the Treatment of Acute Onset Tinnitus TACTT2, I believe. The other was Treatment of Post Acute Tinnitus Onset. The second was supposed to be their trial dedicated to post acute studies, which would only be performed in the EU.

Recently, out of the blue they posted a new trial:

http://clinicaltrials.gov/ct2/show/NCT02040194?term=am-101&rank=1

AM-101 in the Treatment of Acute Tinnitus 3 (TACTT3)
This trial will take place in the United States as well, from what I have been told. If you scroll down through this particular trial's data to look at the inclusion criteria, you will see this statement:

"This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of repeated intratymanic AM-101 injections in the treatment of acute peripheral tinnitus (up to 3 months (Stratum A), or between 4 and 12 months (Stratum B) from onset)."

What this says is that Auris will accept people into this particular Phase III trial if they are in the "post-acute" stage. They will be divided into Stratum B.

From this I can only deduce that Auris will accept people up to 12 months of onset in the United States for this particular study, assuming the patients fit all other inclusion criteria.

I have no idea about their reasoning as to why they added more Phase III trials suddenly, other than they are probably building as strong of an evidence case as possible as soon as possible so they can proceed with the regulatory approval process. If they were to perform this trials serially as opposed to in a parallel nature, it would take several more years to wind their way through the regulatory approval process to get a product to market.

Long story short, yes, they are accepting patients (you have to find a participating site somehow) into this trial beginning in February here in the US.

EDIT: I'm only speculating here. This may also mean that to participate in the post-acute stage, you have to have completed their Stratum A "acute" portion of the trial first. It does not say. You can email the folks at Auris if you have any more specific questions than that. That's the best I can do.

 

Appreciate this greatly. I am seeing my doc, who is part of the U Miami research team for AM-101, next week. I can ask him about inclusions and if I need to have been in Stratum A.

U R the. best, Hudson!

 

I live in Miami, anybody know where I could sign up for an am-101 trial? Any info would be greatly appreciated!

 

I scheduled an evaluation on 28 April for this trial right in my back yard in Havertown, Pennsylvania. If I go through with this I'll be sure to post my entire experience here. Here's hoping I don't chicken out! *



*significant possibility

 

Hmm...I wonder if they will expand to include those of us who have only vague theories as to why our tinnitus started. I'm half-an-hour or less away from a participating doc, but the only evidence I have for NIHS being the cause is that Frozen was the last movie I saw before the whining started, and I now get pain when my daughter plays "Let It Go" backwards on YouTube.

 

Do you think they'll still let me participate even if I'm all the way in Miami?

 

Please do and Good Luck Jake

 

Are there any trials in the NY, NJ, PA or CT area?

 

Think I saw a participating doctor in nyc ...not sure who it is...

 

Thanks! Close enough!

 

Best wishes to all who are accepted and take the plunge. I will be looking forward to reading all reports as things progress. God bless you all.

 

How do you get enrolled in this? Just contact them via www.tinnitus-study.info or do I need to go to http://clinicaltrials.gov/ct2/show/study/NCT02040194?term=am-101#contacts and use the contact info there?

 

For people's info, I went through http://www.tinnitus-study.info and have received correspondence from two different study sites.

 

Hello all,

This is my first post. I'm participating in the Am-101 trial (both the 3 month and 4-12 month stages). So far, so good. My general impression is that I am slowly seeing some overall improvement, but no instant cure. Healing well from the injections and no hearing damage--not bad for a middle-aged lady. I will let you all know how it comes along.

 

How big of an improvement would you say you've achieved?

By the way, post here to share your experience.

https://www.tinnitustalk.com/threads/am-101-participants-updates-and-q-a.6558/page-24#post-124878

 

I got noise-induced T which started a little less than 3 weeks ago. I've been contacted to possibly participate in the AM-101 trials. My T is constant and really low, I only notice it when it is really quiet. But nevertheless, I cannot get to sleep at night and my hearing is a lot more sensitive. Do you all think AM-101 could work for me? Would you all go for it if you were in my situation?

 

If we want to follow the key words "TACTT3" and "results", maybe we have to wait for the official results expected in early 2018:
https://clinicaltrials.gov/ct2/show/NCT02040194
https://www.tinnitustalk.com/threads/am-101-clinical-trial-—-participants-updates-and-discussion.6558/page-77#post-229907
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2240001

If you are interested in AMPACT2, the open-label extension study of the Phase 3 TACTT3 clinical trial, see:
https://clinicaltrials.gov/ct2/show/NCT02040207
https://www.tinnitustalk.com/threads/auris-medical-reports-key-results-from-keyzilen®-am-101-ampact2-open-label-extension-study.21359/
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2263955

 

Are these trials still going? I sent a message to Auris Medical one or two days ago and have not heard anything back. I am in day 45 of acute tinnitus.