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.
I don't recall the results for the earlier phases...did they show much promise? I assume they were double blinded studies.
Member
Founder
