AM-101

Hey dr.

I gained tinnitus from noise exposure. I went deaf briefly, and y hearing restored.I am healthy, though tinnitus is kinda bringing my quality of life down, which has kinda of done a job on my health holistically. To say the least, i could be better. I am in my late 20s. I have a family history of tinnitus, all from noise exposure.

My biggest question is: Is the intrampypanic injections safe? I was looking to possibly take part in the AM 101 trials. My biggest concern is deafness and more prevalent is the concern that my T gets worse.

I believe the drug is probably the least of my concerns. My biggesgt concern is the procedure and what can result from that.

Also could a placebo be problematic with this type of procedure? I cant imagine sugar being injected into the middle ear would be good for the middle ear. I can see a drug being injected inot the middle ear helping out, but I see the placebo as something that can only do damage, not help.

Hypothetically: Would you advise someone to take part in this trial or are you against AM 101 trials? I know you are not my specific doctor however your opinion carries weight.

Thank you greatly for your time Dr.,

Mark

 

Hi Mark -

Thank you for your excellent questions.

Let me start with the second one first:

"Would you advise someone to take part in this trial or are you against AM 101 trials?"

The decision regarding whether or not to participate in any given clinical trial is a personal one that should be made in consultation with your own doctor. In general, however, I know how important clinical trials are and would be hard pressed to discourage a patient of mine from participating in one unless I felt that it would interfere with his or her current treatment program. I also think it is important to keep in mind that while it is natural to hope to achieve some measure of therapeutic pharmacological benefit from participating in a clinical trial, that will only happen if one is randomized to the treatment arm and if the drug being tested is, indeed, efficacious. (Regarding AM-101 the jury is still out on that one.) So while one always hopes, the main reason to participate in a trial is for the advancement of our understanding of the drug being evaluated.

The first question:

"Is the intrampypanic injections safe?"

Well, we all of course want guarantees in life - but as they say, the only things in life that are sure are death and taxes. That said, transtympanic administration of various medications is nothing new. And in the case of the AM-101 trial, I think that the chance of lasting adverse consequence would be very low in the treatment arm and close to zero in the placebo arm.

And now the unasked question:
"If you had a crystal ball, where do you think AM-101 will fit into the grand scheme of things in tinnitus treatment?"

So I do not have a crystal ball, but as I see it, the drug may ultimately be found to have a limited role in the treatment of recent onset tinnitus that is not overly bothersome. However, as far as clinically-relevant bothersome chronic tinnitus goes (i.e., the tinnitus that brings most folks to support sites), it is my feeling that once the self-reinforcing vicious circles and feedback loops that make intrusive tinnitus intrusive are established centrally in the brain, then treatment with agents administered at the ear level will have little, if any, effect. Please note that my answer is based largely on theory - and I would be thrilled to be wrong.

Best to all -

Dr. Stephen Nagler