Large Scale Test of AM-101

Thanks to Sally's thread over clinical trials on the other board i noticed this one: http://www.clinicaltrials.gov/ct2/show/NCT01270282?term=tinnitus&rank=81

That is alot of testing sites. It i a good sign for AM 101. This drug is supposed to target "Tinnitus following acute acoustic trauma, acute otitis media, middle ear surgery or inner ear barotrauma; with onset less than three months ago." which is a limited goal but still encouraging. Research is ongoing.

 

Hi,

I am looking for people who took part in this (or past) clinical trial on AM101. I just got tinnitus for 2 months now and am accepted to take part in this trail, but I am hesitant. I found very contradictory reports from people who took part in this trial on the web. For some, did nothing. For some, it improved and for others, it worsened the tinnitus. The latest scientific report I found on the web was at this conference international conference on tinnitus in june 2012 in Bruges and the results are not earthbreaking... Would be great if some of you who took part in this trial could share their experience...​

 

sansa said,

"...with onset less than three months ago."

----

uh hmmm so with FDA approval 5 years from now, i guess we are all "in the money" !

ok, sorry for being so selfish, and argumentative, ...im bummmed out

good luck
mock turtle

 

Hi MT,

Five years? If we're lucky. But there's still hope. The FDA is holding a public hearing (Feb. 4th and 5th) for creating "An Alternative Approval Pathway" to expedite drug approval for populations with "Unmet Medical Need." Though the deadline for testifying is past, we should keep track of the hearing. There'll be public transcripts available. Here's the announcement. (Wish I had found it earlier!)

"The Food and Drug Administration (FDA) is announcing a public hearing to obtain input on a potential new pathway to expedite the development of drugs, including biological products, for serious or life-threatening conditions that would address an unmet medical need. The drug's safety and effectiveness would be studied in a smaller subpopulation of patients with more serious manifestations of a condition. Such a pathway could involve smaller and more rapid clinical trials than would occur if the drug were studied in a broader group of patients with a wide range of clinical manifestations. The labeling of drugs approved using this pathway would make clear that the drug is narrowly indicated for use in limited, well-defined subpopulations in which the drug's benefits have been shown to outweigh its risks. The purpose of the public hearing is to obtain information and comments from the public on the need for and feasibility of this pathway and its potential advantages and disadvantages." (https://www.federalregister.gov/art...-drugs-intended-to-address-unmet-medical-need)

Do you think the ATA will be testifying? Political advocacy is part of their mission. Of course, an equal problem is the paucity of clinical trials. A current check at clinicaltrials.gov reveals only 38 open studies, five of which have an unknown status.

Anyway, the FDA's recognition "unmet needs" sounds promising...let's hope it helps us!

 

jazz...well done...thanks vey much for your searching for all this information

i remember that the FDA did something like this for , uh was it hep C or maybe it was HIV or what ever

yes , sure does make sense when people are desperate and sufferes would be willing to sign a release for example, "to boldly go where no one has go before" kinda like a pioneer, blazing a trail for others...willing to take the risk, like an astronaught

i recall reading a month ago, or so, twin brothers who somewhere in europe, applied to their government for approval for assisted suicide because they were going deaf and blind and they argued that they had no quality of life left

certainly these two brothers should have been offered some advanced, promising, risky procedures....like a drug given to mice that re grows stereo cilia...or a drip of lidocaine thru the round window

i hope nobody gets the wrong idea...as tinnitus sufferers i think their are lots of things we can do, even with very very bad T, that makes it so we dont never ever have to go down the "irreversible path"...for example, heavy medicative drug use especially benzos, or ssri s, or even alcohol, is preferable, i think, to more drastic measures

thanks again Jazz for your links

best wishes
mock turtle

 

We are definitely people with an 'unmet medical need' but do you think they will see T as being in the 'serious' category?

 

"Serious," yes, life-threatening, no. Diseases with serious "quality of life" issues are considered major health problems--especially when there are so few therapeutic options. Just ask the ATA. For the past several years, the ATA has partnered with the defense department for tinnitus research, for the disease is the number one cause of service-related disability (http://www.ata.org/advocacy/successes). I would be surprised if the ATA wasn't at the hearing, advocating for shorter clinical trials.

 

Glad to help!

 

Lets hope they are and they put forward a good argument.