AM-101 Clinical Trial — Participants Updates and Discussion

@Danny Boy

I think it was a 6, and now i think it's a 3 or 4, however depends the mood ..

 

Any reduction is good even at 30-50% percent as ur have from ur 6 to 3

 

You've done a very good job of describing the effect. I concur with how you've put it in words.

 

Quite interesting. Not only does the AM-101 works in some cases, the effect has specific characteristics, which I think adds a lot to its credibility.

Within a few years, a drug that actually lowers T (for many) will likely be reality, then.

Thanks for your sharing of information.

 

We have a drug that lowers tinnitus, trobalt. We know there's gonna be a drug which lowers tinnitus, Autifony's new drug. Some woman on the trial has had her tinnitus reduced by 75% which is far more impressive than even AM-101.

 

That's good news, kind of regret not doing the trial now.

 

I've had my tinnitus reduced (so far) by 75% while I've been on the AM101 trial and more than likely AM101 will be on the market far more quickly than Autifony's drug. AM101 is in its last phase, Autifony is only in phase 2.

Would I rather take a pill than getting my ear drum punctured? Of course, but if AM101 hits the market, I guarantee you people that are distressed are going to be using it.

 

That's a limited timeframe for AM-101...Plus it doesn't cure hyperacusis....Anyhow, it only works within 3 months maybe 6 months or a year? But after that, the drug is useless. So by the time it comes out, I won't have that chance. Also, in some people it has worsened tinnitus, so really, it's not the bees knees just yet.

 

Is it the bees knees for everyone... You're probably right.

However, what I quoted above from your previous post... I don't think you can state that yet... It hasn't been tested post 1 year.

So, until it hits the market and chronic sufferers try it, I don't think you should state it so absolutely as "it's useless".

 

I'm not saying it's useless...I'm saying that since there's a time-limit, that'll be useless for people after 1 year. It won't be out for a few years anyway.

 

It might not be useless even after 1 year. If the mechanism proposed by Auris is right, then it is indeed possible AM-101 is effective even after tinnitus has been there for a while. Remember, the 3 months limit was chosen to maximize the chances of success of the trial while also not locking every potential trialees out due to time constraints...

It is always better to treat an ailment early than late I agree, but I am still curious to see how AM-101 remains effective after the 3,6 or even 12+ months.

 

As mentioned above the 3 month limit was chosen to maximize the chances of success. I firmly believe that it might work for long time sufferers, depending on dosage, and how long you're using the drug.

If the drug shows promising results in people that just recently got tinnitus, than the next step should be testing the drug on people who's had it for years...

 

There is no next step. Phase 3 is the final phase and phase 3 is only designed for people up to an year. So who really knows if it works longer than a year?

 

My 3 month window will be over soon... If this works for less than three months.. then sadly I would miss this boat... In India, we get nothing to help us with T..........

 

You are right when you say that we just don't know.
I just wanted to add here that in Europe it is up to 12 months as everyone knows. Plus I am sure that there are potentially a few or many who went into the trials who had it for longer but said that they had it for less time. We don't know that either.
Plus it has been shown to be effective by those who received the real drug for sure (after the initial injection when they didn't know if they had placebo or real drug) who by that time had passed the 12 month mark. Some reports from some people who received the real deal after they passed the 12 month mark..... (as they were accepted to take part in the trial before the 12 month mark but had passed the 12 month mark in order to receive the real deal drug for sure). Some yes have said that it made them worse and some said it made them better. So some have had improvement after the 12 month mark as they received the real deal after the 12 month mark.

Just like some have taken Retigabene and Keppra and had improvement and no real side effects and some have taken RTG (and Keppra) and had huge side effects........yes you are right in that we just don't know but I don't think this 3 month window or the 12 month window is to be taken that literally - just a thought on this and nothing more......I for sure don't know and can concur with you definitely on that. None of us know but all of us live in hope......

 

The next step is for it to be approved and go o the market... What happens then? Chronic sufferers going to their ENTs and convincing them to use it on them... THAT is the long term trial.

 

It'll mostly be licensed up to an year, I guess...But let's just wait and see.

 

And if it's successful how long till it comes out to the market. Would it take years to manufacture.

 

To manufacture no, but to get FDA approval yes.

 

Why do you thing it will only be available to people up to 1 year tinnitus?

They set a limit for the trial only. If it hits the market, anyone could use it. The question is will it work? We don't even know it works for non chronic patients...

What is chronic anyway? It is a ridiculous notion to arbitrary say that past 1 year tinnitus becomes chronic. If there is such a thing... For me all T cases are chronic after the first couple of days by which normal hearing isn't restored and T remains.

 

I totally agree with you, Skoupidis!
According to the most credible T. expert in Norway it takes 5 days for brain in rats from damage to their haircells to they could monitor the firing of neurons from the brain that we perceive as sound(Tinnitus).
He says that the brain is maybe in a thought of a holding pattern before it starts firing.
Now the same time frame may not apply for humans, but I think that for those of us who suffers from noise induced T. knows that it doesnt take that long. F. ex. after a concert.
Most commonly this fades away over time.
But what he also says, that is interesting, is that we can take a lot of damage to the inner haircells without developing T., as long as the outer haircells are more or less intact.
Now, Im only guessing here, but maybe this AM-101 injection only gets to the outer HC as they, by the name og them, seems more exposable than the inner HC. But I dont even get what this drug does exactly. Does it heal the cells or sedate them?

Ehh, So what is my point here.. Maybe I dont have one. Guess Im just hoping for someone smarter than me will pick up on something and explain the mechanisms back to me/us!

Well, the time frame of which we are receptive to the drug I guess was the point. Why would this change after a year if the neurons firing starts just days after HC damage?

 

It's not even known what it does exactly. All we know is that it acts on NDMA receptors.

 

Ive been talking with the nurse that is helping me as im signed ip to start the trail soon. And from what i understood from her its sorta like a anti-inflammatory/steroid that is administered straight to the middle ear. As the trails started the dose has gotten stronger and they have seen promising results. The people that it gets worse is only temporary she said. She said in 3 months time that if i dont notice a improvement in the t that they would than give the real drug..

 

Thats assuming i would got placebo. And as far as i know the 3 month mark or the first 12 months is just to cap the trails.

 

It's in phase 3, the last phase before FDA approval. They want to be finished with this phase by October 2015.

 

Not sure but the lady i spoke with said she figures at least a year before it goes to market

 

Oh wow. That quick eh?
We are lucky their active compound Esketamine is not a new compound and was already studied for other applications. It was even fast-tracked for the treatment of depression.

 

@shantelle, @Nucleo and @OddV , I think that that's the month they wish they are able to file the result and apply for approval. FDA approval cycle may take up to 9-12 months even though everything is in order.

 

That's my understanding @Zechariah

 

20 days post first injection in the first round, definitely no significant changes in tinnitus, probably got placebo. Hopefully there will be changes with the second round injections (real drug).