Otonomy Starting Phase 1 Trial in 2015 for Tinnitus

#61
Gave a call to Otonomy where they took my name, #, and email address. I would like to be on their clinical trial if I meet their criteria.

Silverstein Ear Inst. in Florida called me back on my inquiry there and I brought up Otonomy and he (resident Dr.) said they would be conducting trials there. They (Otonomy) could have trials near to MN....just don't know yet.

I would like to go to FL though as it's warm and humid there and I like seeing the ocean.:)

I was doing pretty well lately on Gabapentin 600mg x 3/day plus Klonopin .5mg, but if I fall asleep I usually wake up with noise.:(

Looking back at @attheedgeofscience thread on Otonomy, I could have signed up there but I called beforehand not seeing that link.
 
#62
just1morething said:
Looking back at @attheedgeofscience thread on Otonomy, I could have signed up there but I called beforehand not seeing that link.
Click to expand...
I am not sure members would know which link you are referring to (I do have more than one post within this thread, haha...). :)

This is the one:

www.tinnitustalk.com/threads/otonomy-starting-phase-1-trial-in-2015-for-tinnitus.9017/#post-93572

And I suspect that you have the following webpage in mind:

https://www.research.net/s/Otonomy_SignUp

I don't believe the trial has actually started yet. The idea is to have a Q&A-session with Otonomy as the clinical trial date approaches (something which they are open to). [USERGROUP=11]@Team Trobalt[/USERGROUP] will keep the forum up to date. Promise.
 
#63
I bet 10-15 years from now we would all be laughing reading these comments and our tinnitus would have reduced a great deal! Maybe that seems a lot of time but its gonna happen for sure . Something will definitely come up to help us cope wayyy better. I can't imagine that all the efforts ,research and enthusiasm would yield nothing and we would be back to square one. Doesn't seem likely to me. At least something has to come up from all this!!
 
#64
here is a new document that a pretty good overview of the entire pipeline of Otonomy. Pages 5, 20, and 25 specifically relate to OTO-311.
 

Attachments

  • Otonomy Overview Presentation (July 2015).pdf
    4.1 MB · Views: 182
#66
OTO-104, which has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)...

I think the same will happen with Autifony if phase 2 is successful in the UK and trial would open in the USA.
 
#69
markoana said:
Does OTO-104 is gonna have impact on t. also, or it just vertigo part of maniere's d.?
Click to expand...

I don't think so. OTO-104 is a steroid injection through the tympaic membrane. Not sure what implications this has for T. It has merit if MD is indeed caused by autoimmune of inflammatory mechanisms, which could very be the case. Unfortunately the physiopathology of MD (if it even is a thing) is largely unknown at the moment.
 
#71
So, if OTO104 is approved to fast track realise, there is high possibility that OTO-311 is gonna have same treatment by FDA... But, why one more stuff for just for acute stage, whyyyy :(
 
#72
dan said:
OTO-104, which has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA)...

I think the same will happen with Autifony if phase 2 is successful in the UK and trial would open in the USA.
Click to expand...
FDA sees that this shit is getting out of control and we need solutions today and not tomorrow.
 
#73
markoana said:
So, if OTO104 is approved to fast track realise, there is high possibility that OTO-311 is gonna have same treatment by FDA... But, why one more stuff for just for acute stage, whyyyy :(
Click to expand...
because it is easier to stop a weed in the beginning than after it has grown into a 20-foot monster.

the-little-shop-of-horrors-giant.jpg
 
#75
markoana said:
But its hard to read that u are out of the game for cure that is developing.... Hate it, and if they stop it at the root, we all gonna be marginalized...
Click to expand...

You're pretty much right about that. If a cure for acute tinnitus ends up being really successful I can't see companies keep working on something for chronic sufferers. The future market becomes inexistant.
 
#76
Nucleo said:
You're pretty much right about that. If a cure for acute tinnitus ends up being really successful I can't see companies keep working on something for chronic sufferers. The future market becomes inexistant.
Click to expand...
Judging by AM-101, NMDA drugs only help a small number of patients and only provided some relief - not a cure.
 
#77
"There's no money to be made if pharmacies charge the same amount for a pill that will cure as they do a pill that treats the symptoms, therefore, there is no money to be made in a cure—and there's the contradiction. Because of this fact, big pharma only has two options if it wants to continue making massive profits: Charge disgustingly high prices for their cures, as is happening with hepatitis C, or don't produce cures at all.

It's no secret or controversy that major manufacturers are making a killing in the business of treating symptoms. Taking diabetes into consideration, global insulin sales are now $15.4 billion annually. If big pharma isn't in it for the money, if it truly is about saving lives, then why are some cures only available to the wealthy?"

http://anonhq.com/chris-rock-on-big-pharma-no-money-in-the-cure-the-moneys-in-the-medicine/
(for the record my dad has Hep C and said there is no way in hell he's paying $85K for a cure. By the way he also have extreme T, diabetes and heart disease)
 
#78
dan said:
Judging by AM-101, NMDA drugs only help a small number of patients and only provided some relief - not a cure.
Click to expand...

Yeah but I believe this is because of the flawed AM-101 study design. If the mechanism of action that Auris Medical themselves proposed is true, I do not think NMDA antagonist will have any effect if taken after 1 or 2 months. It needs to be taken a few hours after the traumatic event at most I feel. According to a recent report that was posted in the AM-101 thread, the average time after onset for the trial participant was 2 months. I don't think it is reasonable to expect stellar results that way. One can only imagine what the results would be if that figure was 48 hours instead.

However, the problem with that is that it would probably be very hard to get enough participants within such a narrow time frame. People don't get to see doctors within 48 hours when it comes to tinnitus, let alone enroll in a clinical trial.
 
#79
Nucleo said:
Yeah but I believe this is because of the flawed AM-101 study design. If the mechanism of action that Auris Medical themselves proposed is true, I do not think NMDA antagonist will have any effect if taken after 1 or 2 months. It needs to be taken a few hours after the traumatic event at most I feel. According to a recent report that was posted in the AM-101 thread, the average time after onset for the trial participant was 2 months. I don't think it is reasonable to expect stellar results that way. One can only imagine what the results would be if that figure was 48 hours instead.

However, the problem with that is that it would probably be very hard to get enough participants within such a narrow time frame. People don't get to see doctors within 48 hours when it comes to tinnitus, let alone enroll in a clinical trial.
Click to expand...

Nucleo, Erik, are there any results of AM101 phase II trial, final results, exactly % efficiency Vs Placebo etc?

And also for OTO 104? I could not find any numbers abt that :S
 
#81
@Nucleo tnx,
English is not my mother language (as u all see i suppose lol ) so I will take a look at those tabels 2morow with more concentration...

What is your personal opinion abt result of AM101 efficiency? Is it gonna be effective after month of acoustic trauma, or more?
Because I have some bad feeling, and economicly logic that if it really works, researches for chronic t are gonna fade away, not stoped but just symbolically done by some minor researchers...
And this OTO311 is not making me happy, maybe I am selfish, but I am aware of economic fact...
 
#82
Even if AM-101 or similar drugs are effective for acoustic trauma, surgery, or ear infections if treated when acute, that still leaves a large aging population with tinnitus due to age related hearing loss, drug side effects or other reasons.

Thus drugs that can address tinnitus due to age related hearing loss (whether or not it affects hearing) or other issues will still have a large market. This is particularly true as life expectancy increases.
 
#83
Nucleo said:
Yeah but I believe this is because of the flawed AM-101 study design. If the mechanism of action that Auris Medical themselves proposed is true, I do not think NMDA antagonist will have any effect if taken after 1 or 2 months. It needs to be taken a few hours after the traumatic event at most I feel. According to a recent report that was posted in the AM-101 thread, the average time after onset for the trial participant was 2 months. I don't think it is reasonable to expect stellar results that way. One can only imagine what the results would be if that figure was 48 hours instead.

However, the problem with that is that it would probably be very hard to get enough participants within such a narrow time frame. People don't get to see doctors within 48 hours when it comes to tinnitus, let alone enroll in a clinical trial.
Click to expand...
There is so little awareness about tinnitus that most people will opt to wait 2-3 days after a concert for the tinnitus to go away - especially since in the beginning it does usually go away within a week or two- but then one day, it stays forever and gets worse and worse over time. So, yes, I think a chronic market will still exist.
 
#85
Nucleo said:
Yeah but I believe this is because of the flawed AM-101 study design. If the mechanism of action that Auris Medical themselves proposed is true, I do not think NMDA antagonist will have any effect if taken after 1 or 2 months. It needs to be taken a few hours after the traumatic event at most I feel. According to a recent report that was posted in the AM-101 thread, the average time after onset for the trial participant was 2 months. I don't think it is reasonable to expect stellar results that way. One can only imagine what the results would be if that figure was 48 hours instead.

However, the problem with that is that it would probably be very hard to get enough participants within such a narrow time frame. People don't get to see doctors within 48 hours when it comes to tinnitus, let alone enroll in a clinical trial.
Click to expand...
I read another reddit post a few days ago that mentioned the guy had got T in january and received the injections in feb/march and experienced great results.
I agree time does seem to be a factor though. I'm currently in talks with one of the coordinators of the study and will see if I am eligible, although I will be coming up on 3 months soon so it may not even be worth it if I am.
Also, could you explain your scientific reasoning of why it should be done in the first few days instead of months? Just trying to get all the info I can before I make my decision. Thanks
 
#86
OTO-311 - only for acute tinnitus? Where is this stated? I cannot find anything about only acute state in Otonomys texts on their website.

Hopefully also for chronic T ?
Thanks
 
#88
Nucleo said:
You're pretty much right about that. If a cure for acute tinnitus ends up being really successful I can't see companies keep working on something for chronic sufferers. The future market becomes inexistant.
Click to expand...
Thats not true. There will always be chronic cases. Oftentimes people don't handle medical issues in a timely manner.
 
#89
dan said:
There is so little awareness about tinnitus that most people will opt to wait 2-3 days after a concert for the tinnitus to go away - especially since in the beginning it does usually go away within a week or two- but then one day, it stays forever and gets worse and worse over time. So, yes, I think a chronic market will still exist.
Click to expand...

You may right about that. It really comes down to doctor/patient education.
 
#90
Bertman said:
Also, could you explain your scientific reasoning of why it should be done in the first few days instead of months? Just trying to get all the info I can before I make my decision. Thanks
Click to expand...
After acute noise exposure, the inner ear is flooded with Glutamate and reactive oxygen species. This is what kills the hearing cells. AM101 and OTO-113 are both NMDA drugs that block excess Glutamate and allow the ear to withstand the trauma after effects much better...in laymans terms.

Guest57247683 said:
OTO-311 - only for acute tinnitus? Where is this stated? I cannot find anything about only acute state in Otonomys texts on their website.

Hopefully also for chronic T ?
Thanks
Click to expand...
I used logical deduction.
What we know:

AM101=NMDA drug=for acute tinnitus

Deduction:
(If A=B and B=C, then A must =C as well)

AM-101=NMDA=Acute tinnitus, OTO-113=NMDA, there fore OTO-113=Acute tinnitus.

Hope that helps.
 

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