AM-101 TACTT1 Results Released

@Dr. Nagler Hi, i'm very new in this site and i would love some advices from you. I've had a constant mild tinnitus for like approximatively 3weeks now and considering to take part of the AM 101 trial in France. My tinnitus has been induced by a noise trauma, and I can say that this period is the harder of my life (i'm only 17). I want to know if cases like mine usually recover partially/completely from tinnitus by resting and waiting or should I do the AM 101 clinic trials. I know I sound like an idiot with theses questions but I really need help.. I'm going to the my first ENT doctor in 12 days, but I'd your professional thoughts on my case.
Thank you for reading

 

Hi Marius -

Most individuals such as yourself with mild tinnitus of relatively short duration find that it just sort of fades away on its own within the first few months. The fine folks who populate this board in general have long-standing tinnitus and are the exception rather than the rule.

At this early stage I like your idea of resting and waiting a bit. Avoid very loud sounds, of course, but also try to avoid silence. Keep some soft sounds around you as much as possible (quiet music, white noise, nature CD, etc.) Silence actually puts a strain on the auditory system as your brain turns up the gain to try to hear environmental sounds that just aren't there.

Discuss your tinnitus with your parents - not just that you have it, but also how it affects you.

It's good that you are seeing an ENT for an evaluation.

For now, I would tend to keep AM 101 on the back burner. You have several months to decide whether or not to get involved with a clinical trial.

All the best -

Dr. Stephen Nagler

 

@Dr. Nagler Thank you for reading and answering, I'm feeling very desperate those days.. Actually I don't know how to determinate my tinnitus, because I can hear it in class and even outside if I pay attention, so I don't know if it is mild.
Secondly, I was considering to do the AM 101 tests as soon as possible, because from what I've read and seen in TT and everywhere on the web, it seems to work the most for acute tinnitus phase. So if I wait I can miss a big chance ..
However, I've been told about cases where the tinnitus goes away by himself, so I really don't know what to do. I have discussed a lot about my tinnitus with my parents, but like everybody they don't know anything about this
Thank you so much again.

 

Marius, your parents may not know much about tinnitus - but they know a whole lot about you. Lean on them to help you through this. It's what parenting is all about!

Regarding AM 101, after you see the ENT and if your parents approve, there is no harm in contacting them to get more information. I just wouldn't rush into anything - but that's just one man's opinion.

Dr. Stephen Nagler

 

@Dr. Nagler I guess you're right, by the way I don't know if it's psychological (maybe acceptance) but I think my tinnitus level has decreased a bit, but I really can't say if it's pre-habituation or that i'm a lucky boy..
Thank you for your time Doctor I really appreciate.

 

Sure but you get the point. Lost career ... Jailed etc. You get the idea.

 

Hi all,

thanks for all this information, I just got an email offer to do the AM101 trial. I'm actually an Australian but studying in the UK so if they will allow that - I still have to ask - I might go ahead.

I've got tinnitus for the past month, it was mild but has been getting worse, I think because I didn't protect my ears after I first got it and went to gym classes with loud music and bars and things. Now it is making all sorts of crazy noises and at the moment I don't know what else to do but take valium to sleep. Nothing has ever made me so anxious.

I was wondering from anyone who has had the treatment -- is it really painful? Not to sound like a wimp but the idea of a needle or a scalpel in the ear sounds kind of scary. If anyone wanted to share their experience with that part of the trial love to hear it.

If I do end up deciding to participate I can keep you all informed of how it goes.

 

Here a request for some support Tuesday i had my first AM-101 injection and only one of round 2.
I decided to not continue as T increased after it and I suffer a lot lately through allergies of pollen etc.

Please answer:

- I had a half beer say o,3 liter of alchoholic strenght 2,5% and a coffee (caffein) every day after tuesday i had my first AM-101 injection would this cause any harm? Side effects?

- Also where i am worried about is if I not enough protect my ears. As travelling after injection i was briefly at railway stations and in city noise, such as yesterday outside a terrace where a baby screamed close to me and upsetted me, i hope this influences not my recovery negatively. Any advice how i should look - treat noises, I mean is it maybe better after an injection to cover up ears for such noises? (AS i just read overprotection is not causing a benefit)

- Also would any sexual acts limit my recovery as said sex - mastrubation could worsen our cause T (twice three times daily)?

- Due to my allergies could I keep taking desloratadin from Aerius (5mg once daily, have interrupted it since Tuesday)

Sorry for so many Q's it was not easy for me to take the 4 th shot of second round.
As T increase stronger this time as last time, so i think before was placebo.


Thanks for helping me out, highly appreciated

@attheedgeofscience
@Hudson
@Johno

 

No side-effects.

No damage done.

No. But you could go blind...

That would a question for the clinical trial doctors. But my opinion is that it would not interfere with the treatment in any way.


Robb, I hope you get the benefit from the treatment that you deserve. You have been through a lot recently. You will need to take me off your "communications list" as I am leaving the TT-forum. Actually my last day was yesterday, but because I was alerted to the "historic" news about the phase II trial of AUT00063 finally commencing, and no one had seen it, I decided to make a brief "return" again today...

Take care,
Jakob

 

Thank you Jakob, I am very grateful for your contribution on this Forum. You are a smart and brave independent thinking Man.

A person like you would I like to see spending time in EU council to revamp the healthcare system.

Wish you all best

(ill give you my personal email and hope one day in the future we can have a meet and greet with some other members as well maybe)

 

Update from Auris Medical

Auris Medical kindly asked us to post the following statement regarding the experience @CathodeRaySound had.

The statement begins:

We have looked into the case described by CathodeRaySound. There is no general requirement to be accompanied by someone who can drive a study participant home following the injection. However, the site in question does have a policy to require this, and routinely asks to make appropriate arrangements prior to an injection. They have the right to do that.

The investigator at the site has broad experience in clinical trials. It is his duty to select study participants in accordance with the study protocol, which includes the requirement for a patient to be able and willing to adhere to the protocol, and notably to attend also the follow-up visits. We have been informed that the investigator at the site did not feel comfortable to proceed in this case – not only for the driving issue. This decision should be respected. Participating in a clinical trial is much more than “just” getting a treatment. Other patients have been declined at other sites as well. In the end, it is the investigator who bears the responsibility for the proper conduct of the study at his/her site and for the patient’s well-being. The ultimate goal is to have a clinical trial that is properly conducted – and this is checked by regular monitoring of all trial sites and also by inspections from regulatory agencies. Participating in a clinical trial means a lot of work for an investigator – all investigators are motivated in the first place by the desire to develop a new treatment and ultimately to help lots of patients.

It is very regrettable that CathodeRaySound went through a lot of stress and got frustrated in the process. However, we trust that the investigator, considering all the facts known to him, all the protocol requirements and also based on his experience, took the appropriate decision.

 

Thank you for the feedback; however, the conversation we had only raises more questions. Now I am being told the reason was not solely due to the driving issue apparently, so now I am wondering what were the other issues for the denial of treatment? Although you do not know conclusively, your answer was, since I did not bring a driver the doctor did not trust my integrity. This detail was not specified by the study doctor. As far as I was told, I was rejected due to the fact that I did not have a designated driver, which was because at the preliminary examination I was told that cab rides and hotels can be arranged accordingly, and I clearly stated I would probably not bother asking my busy friends to be my caregiver unless it was an absolute requirement, which the study doctor seemed to initially understand. If I was under a different impression, I would not have waited two weeks to drive four hours in total only to get denied. As far as calling you (Auris) after the rejection was to find more information on other possible study centers I can possibly participate in, but it seems like I wasn't trusted to go through with the follow up visits due to the long distance of other study centers or because of the doctor's reported lack of trust in me? So my request was rejected on that front too. Perhaps what other members of this forum can learn from my experience is to fully document your conversation with the study doctor, and the trial coordinator. With that said, I appreciate Auris on their side looking into further details of my case.

 

The TT-member in question, @CathodeRaySound had arranged for staying in a hotel (and would be travelling back-and-forth using taxi, as I understand it) which should be just as good as being accompanied by a relative/friend for transportation. And in any event, that particular arrangement had already been agreed upon before the clinical trial meeting date.

There were no driving issues; so irrelevant argument. What other issues there may be, I don't know (I was not there).

Typical PR talk.

 

@attheedgeofscience

Auris is not at fault here in any way, they're just working off the information this doctor is providing them. It is only natural for them to take the word of their study doctor with the utmost certainty. The only thing I regret was not recording the initial conversation at the preliminary examination, where the doctor mentioned arranging taxi rides and hotel rooms. Did this doctor really think I would waste two weeks of careful decisions and driving 200 miles there and back alone if he told me a designated driver was an absolute requirement? It seems like the doctor completely forgot the fact that we even discussed hotel and taxi arrangements, and because of it my "reputation" was tarnished for lacking integrity and I am not given the chance to go to another study center...I should have known better and recorded everything, from what I've read online this doctor pulled this type of stuff before, and almost killed another patient due to his negligence before, if what I read was true. I don't know what else to feel or say other than this whole situation just really sucks on my part, so document your meeting with your doctors people!

 

That I am well aware of.

Most communication is (or should be) done in writing. Always have these things in writing. And in any event, a clinical trial centre in a country such as the USA, should be automatically providing you with such details in writing so that the "weak party" (= you, the patient) does not end up in an unfortunate situation.

I was not there, so I don't know what happened or the exact circumstances. I am leaving this thread; in fact, this is my last day on the TT-board.

Good luck.
________________
MODERATOR EDIT: Please do not ask ATEOS why he is leaving. He's already been asked below. He will answer if he so wishes. Otherwise this thread will get derailed from its original subject. Thank you.

Tinnitus Talk's staff welcomes ATEOS back anytime. He's undoubtedly been a really great asset to this forum and its members.

 

Off topic but before you go, why exactly are you leaving? Are you gonna come back?

 

@attheedgeofscience

Anyone? ?

 

@Rube

Due to the complexity of your issue perhaps you should speak with those ENT doctors and get some opinions from them after your MRI, you have two weeks from now to make your decision so that should be enough time to get everything checked before you make the decision to go ahead with the AM-101 treatment.

 

This makes me mad. It seems ridiculous that he should be DQ'd on this. It's admirable that CathodeRaySound has accepted Auris response so gracefully. I would not have. It is interesting that Auris watch this board so much !!!

 

All I can say is Steve Jobs dedicated his time in inventing new age electronics, phones etc. His last hours he wished maybe he would have spend more time in researching medical solutions.

The initiator of Auris Mr. Meyer has the potential to become the new Steve Jobs of the medical world.

Money is important to some such as status but making people, happy etc. have a good cause is which we live for, look at Sarkozy he wants to become president of France again having learned from his missed chances, interesting letter he wrote:

http://www.nytimes.com/2014/09/20/world/europe/sarkozy-says-he-will-seek-party-leadership.html?_r=0

I hope my of topic post is accepted, as I can't remember myself bull shitting a lot around this forum.
Maybe this post will encourage some people to think different, better whatever you want

Happy weekend all.

 

I don't get your point here?? Steve Jobs?

 

Hi Robb

What is the reference of this to my post and CathodeRayTube? Do you agree or disagree? I think the whole way he has been handled is dreadful. I would be furious.

Steve

 

You are older than me @SteveToHeal if I remember correctly - so I don't need to remind you that, the older we get, the more we become aware that there are usually two sides to every story. I have gone "public" with a number of stories on this board already but, each time I have done so, I have made sure I could back up my allegations with some kind of evidence (usually e-mails; e-mails which I have provided to Markku). I decided to do that - not because I had to, but because it strengthens my credibility. Credibililty and integrity are keywords when you work in my field (= finance). And I decided to apply the same concepts to this board. Over time, we - as members - build up a reputation because of that.

I have no idea what happened that very day. How could I...? And how could you...? We were not there. That's the problem. The very problem... But I do get annoyed the same way you do.

As far as I can tell, Auris Medical AG has proved to be a transparent and reliable partner. They have offered a lot of information on their website (unlike eg. Autifony Therapeutics). They seem to take action whenever they see discrepancies. They act swiftly. They don't want a tainted reputation on various tinnitus-boards. So yes, it is "interesting" - agreed. But in a good way, if you ask me...

Take care,
Jakob

 

@SteveToHeal

To be honest, it wasn't as graceful as it seems, when I first got the phone call from Auris this morning with their blurred explanation for why I was exactly disqualified I was quite frantic, because the doctor made me seem to them like some kind of disingenuous human since I didn't have a driver with me, when he was the one that said hotels and taxis can be a viable option. I would not have wasted my own time, and some of the money which won't be compensated going alone if the agreement was different. My only qualm is with the doctor who negatively judged my personality and disqualified me from all possible AM-101 treatments due to him neglecting his own aforementioned agreements (which I should have requested in writing). I was also pleasantly surprised when the Auris representative told me he saw my posts, I felt as if he was really trying to get to the bottom of the case; unfortunately, as he said, if the doctor is unwilling to proceed with the treatment there's really nothing they can do.

 

Hi Jakob,

Sure there are always two sides as you say .... and yes the older you get the more debates become more tedious and politics make less sense. Your senses become more finely attuned to detecting BS and that we call maturity. Innocence of youth is a blessing for hope and the curse of experience. The paradox of life. I don't know what happened that day and by any account, I am glad it was investigated.

It just saddens me that it did not have a brighter ray of light on its horizon than the PR crafted response. To me, all companies sit on the same side of the fence. Some closer to the fence boundary and some deep in secret lairs. No company or individual wants their image tarnished unless you are into self destruction. I am sure there is a reasonable explanation there somewhere. I just can't for the life of me see it.

All the best to CRT and you.

Take care.
Steve

 

STEVE a small explanation why CRT had this

first of all I fully disagree with this! In case AM-101 has a reasonable efficacy it should be rushed urgently as the potential impact on well being of a person is so important, it changes lives.

But that is USA where on a microwave they put a sticker don't put your pet in it.
The doctor there is afraid in case something to go wrong to get super sued as one member said..

I really hope CathodeRayTube will get another chance.

 

Damn! Really sorry to hear that CRT. I guess they have their reasons. I just can't see what they are. Perplexed. Sorry man. I hope you find peace and quiet in other quarters.

 

I just want to make one thing clear, my objective isn't to dissuade anyone from going through with their own AM-101 treatments. I am just reporting my experiences in order to educate myself and perhaps others that goes through a similar situation. The lesson I am offering based on my experience is to get everything on record so you're not put in an awkward situation. Use your own logic deductively and make of what I said as you will, but I know I wouldn't have put myself in this situation since I'm the one that wanted to go through with this procedure. Hopefully my posts won't make anyone have doubts about going through with AM-101, because what I've experienced is surely an isolated case.

 

Thanks Robb. I agree. It makes no sense and sadly I guess we'll never get to the bottom of it. Auris have told CRT that the Dr's word is final. I think the word flabbergasted comes to mind. I just hope he finds an alternative. CRT: Check out Retigabine and Autifony threads if you don't come right with finding another dr to give you am101. Damn!

 

No problem. It is good we get to know each other better. CRT should not give up