AM-101 Clinical Trial — Participants Updates and Discussion

I didn't vote a lot worse, just worse. More or less not as good as I was before the real drug.

 

I think that you hearing things differently will pass if it was from the drug. I do hope that if you are still playing in a band (just going by your picture) that you always are wearing custom fitted ear plugs. To me having tinnitus and playing in a band is like handling dynamite while holding a lit match.

 

I lost my career in drumming.I wore ear protections for years much more so than any of the other teachers I worked with or musicians I played with. I always wore protection, probably would have been better off if I hadn't. I would like to think you are right, but unfortunately I feel it is here to stay.

 

@amandine

Yes, I was right on the cusp of the 12 month limit and narrowly managed to get into the trial. I live in Switzerland and am lucky enough to be just down the road from a hospital running the trial and as it's just 30 minutes on the train I never asked about hotels etc. I believe I get a fixed amount per visit plus I can submit any travel/parking receipts at the end of the study for reimbursement. However these are going to be very minor costs so maybe not relevant to your situation.

 

@BuzzyDave

Thanks for the info on expenses.
No not the same as for me who has to travel very long distance and stay overnight but concurs that expenses are normally covered and not the bullshit i hear in france
thanks
PS Are you not ocncerned by the non reports showing improvement but by some reports showing no effect or worsening effect?
amanda

 

Great to hear. I thought you said in a previous post that you had heard that it was different in different centers. I am glad that you have confirmed this is not the case. Remuneration should be consistent across all centers. Good luck!

 

Hey Mikey Cliff. That is awful. So sorry to hear it is worse. I can relate to a career being trashed because of t. And a career in music too. I used to play part-time. Have had to give it up. If you don't mind me asking how did you get T? Was it from drumming? You said you wore ear plugs. You are the first person I have heard from that said they regretted going for the 2nd injections. Because that is the real drug. Is it any better now? I go for my 2nd set Nov 4th and a bit concerned now.

 

@bedouin

Have you found personal positive improvement stories from people who had the real drug either first time or afterwards in the 2nd set of injections?
I have not found any positive lowering reports yet.
In fact, on the contrary - I have seen only reports of it spiking the T.
But maybe I havent seen what you have read?
It said on AM trial report from phase 2 that it can make the T worse in 10% of people participating altho whether this is permanant or temporary I am unsure. So few people taking part ad on this forum.....yes no positives....are all the 10% on this forum?
Please can you send links or info to poitive reports from am 101 if you have any please?

 

Anyone been kicked off the studies and why?
Have heard some horror stories of people being kicked off for no good reason and without much care or consideration for the person kicked off.
To know why people being kicked off or refused may help someone to stay on.....

 

@Mikey Cliff Thanks for taking the time to post, much appreciated.

 

@NewGuy

I know that you are due back on the 30th.
Just wondered how your T is now - hopefully it has gone back down now (or not?).
Please let me / us know how you are?
Sorry to pester you about this but real interested....as you know, I am trying to see if i can do these trials but not terribly sure about it. I know that you are an incredibly strong and positive person hence you went ahead without having a problem making up your mind yes or no.
So for someone like me who is undecided and feeling very vulnerable at the moment, an update as to how things are would be very welcome even tho I know that what happens to you may not happen to someone else....thanks

 

@Mikey Cliff Is your tinnitus noise induced? And if so, has it been from a sudden acoustic trauma or from noies exposure over the years?

 

Hi amandine. When i made the decision to take part, I asked around on the forum as well as looked at the phase 2 results. I saw that people spiked immed after having the injections. But it came down in time. This is the first time I have heard of someone who's t has increased with Mikey Cliff. It's a bit worrying because i go for my 2nd injections on 04/10. I think it was locoyeti that said he had had a +ve improvement after the injections. More so with the first ones and then a bit less after the 2nd ones. You'll have to search the original AM101 thread for his submissions. Also cullenbohannon who had gone for them and said it was worth going. He had found it beneficial. There were a few others as well that helped me make up my mind. StayPositive was also one of them. Safety was effectively ruled out in phase 1. That should encompass no increased t nor hearing loss. I think search the original thread and you will find all the ones i looked at to make my decision. The phase 2 results also showed no permanent increase in t nor hearing loss.

 

I think that was Soulstation. His case was rather bizarre around travel arrangements. The post-mortem was "Get everything in writing" before you make the long journey. So if the trial doctor says its ok to take a taxi home to your bnb after the injections, then get it in writing, including everything you discuss telephonically, write it down. Get the doctor to sign off on those things before you make the long trip.

Soulstation had no leg to stand on at the end of the day and the doctors decision to refuse him entry onto the trial was final. AM made a formal announcement to TT that Markku posted which said in a nutshell "We back the doctor". Contact Soulstation for all the ins and outs. You have probably read it as it is that which you are referring. It was a weird one. I haven't heard of anyone else being kicked off it, other than people just not getting through the screening because they don't meet the eligibility criteria.

 

@bedouin

No I had not read @Soul Station report being kicked out of the am 101 trials. This is news for me. Trying to get anything in writing in france is impossible and even getting a response to email or phone is down right pretty impossible. However looking at the threads to decide whether it is worth all the anguish or not. Would you say having read it all, that it is more positive than not. By the way, are you in the States?
Also I had not read that people had a positive result but then had not read all of the am 101. Maybe i should go and have a look at the posts that you mention.
I was referring to another case when someone was kicked out but will not mention name or anything cos that is up to the person nvolved and I am NEVER one to discuss other people unless they wish for that to happen. If he or she posts about this or has posted about this it is up to them and until I see a post from this particular person then I will not discuss - only to say that I am aware of another person being kicked off in a very very bad unfeeling way....

 

It was very difficult for me to come out with that post as I don't want anyone to refuse getting the injections because of my experience. I really wanted to say no change or unsure but I would be lying if I said other. All I can say is that it has been well over a month since the real drug so i would be silly of someone didn't try the injections and some time later my T magically disappeared or got better. The trial coordinators said they had not read about anybody becoming worse, however I would imagine those people withdraw which means their data is not recorded in the trial. Think about it, you have to finish to have your data recorded. Anyone who might have had an adverse reaction are likely to withdraw and their data doesn't count.

Thanks,

 

Hello everyone.

I finished my first three injections about a month ago and just finished my last visit. From the initial three injections I presume I got the placebo because there was no change at all in my tinnitus. I opted to go into the open label study and got my first injection of that study. From my understanding it is 100% chance of getting the drug.

This time compared to the first seems a lot more painful. During the first three injections, I was 100% back to normal within a few hours. This last injection has my ears feeling very full, and I had a bad headache all night. Could be the result of getting the real drug. I go in for my following two visits in this week and I will report back.

I didn't vote yet because I am hoping this open label works. For my first initial, it was the same.

 

Any idea why? Is there anyone else that reported pain and no-little-pain between the first and 2nd set? Could it be the placebo does not hurt? Real drug does? Or maybe the 2nd set is because you have already had a needle through the eardrum and there is some residual weakness from the 1st set. All hypothetical meanderings here!

 

Just to say that @NewGuy said that he had fullness of ears after his first 3 injections, some earache and that his T went up also. However I dont know any more than that.

 

To all you AM-101 participants. I had T onset on September 22 due to a middle ear infection. The tone/volume has been consistent since that day, however, I think I'm getting use to it. I would rate it a 6 or a 7 on loudness/intrusiveness scale.

I made my way into the AM-101 trial and my first injections are next Wednesday. I'm trying to make up my mind if this is worth the risk or not.

@attheedgeofscience I appreciate everything you've posted to this board and would like to have your feedback on the above.

@bedouin would you do it again?

All others that have received the injection, I would appreciate your feedback. @Dr. Nagler Would appreciate you weighing in as well.

I've read as much as I can...nervous about this making it worse since I think I've partially habituated.

 

Just to clarify worse for me: my left ear seems to have gotten a new tone during the second visit for the real drug. It's difficult to tell if it was completely new or just exacerbated by the procedure. Like I said previously, if I didn't hear certain sounds differently I would have voted differently. Could have been from AM-101 or could have been something else. With that: I had a really good day today with the T as loud as normal. I also didn't smoke a cigarette for the first time since I bought a pack the day that horrible ENT doctor said there was nothing I could and for me to turn on a fan.(insert angry face) Today I drove home without my fan on and was able to take my mind of it like it was never there. I ate my dinner and watched NCIS when I got home with no masking on and enjoyed it Like I didn't have T. All this on the same day I stuck my finger in my left ear and said "yep definitely different than before the real drug." It hardly bothered me today, in fact my eyes gave me more anxiety that my T today. (been battling with floaters and what not). So for those who are worried, I would day give the trial a shot, it's easy for me to say I regret the decision to go through with it, but what if it had made me better? For some it will be difficult, believe me I cried like a baby after the last injections and boo whooed when I got home for the next couple of days as the spike was incredible. That will likely happen so be prepared to battle an increase for a short time. My situation is rare and it is likely that individuals going through the trial will have a different experience than mine. Iv'e been changing my diet and cutting out the alcohol. T pretty much turned me into a bigger drunk than I already was. So hopeful these things will help, as well as, a continued search to becoming healthier and getting my life back.

Peace and chicken grease,
I'm out

 

OK. Here's my svelte 226 lbs. of weigh-in ...

Clinical trials are very important. Incredibly important.

If you are enrolling in the AM-101 trial because you are eligible and are interested in contributing to the body of scientific knowledge, then I say: "Go for It."

But if you are enrolling because you firmly believe that AM-101 is The Second Coming, then I say: "Take a Pass."

Dr. Stephen Nagler

 

@Dr. Nagler lol... I'm a svelt 205.

It's a bit of both doc... I want to help out and in the process hope to help myself. I figured, initially, when I got into the trial, if this helps me great, if not, on to habituation and/or the next thing.

I am eligible... Guess the biggest concern I have is making it worse, but reading the papers on it, it seems like it is a small chance.

It's getting closer to me having to do the injections, and I usually over analyze everything, so second guessing myself.

BTW, I'm working down in the Buckhead area now, so would like to take you up on the cup of coffee sometime after I get settled in.

 

Then you have your answer.

Dr. Stephen Nagler

 

I do go back for my first follow up on Thursday. My T is still high and I still have a full feeling in my ear. It is still draining. Every now and then it starts to sound like its clearing up, and then right back to full. I take that as a sign that it should clear up in the next week or two. It is annoying but I still think its worth the try. I did get my first reimbursement check in the mail Did you find a place where you can get in for the study? I hope you did if you want to go through with it.
Also, I am glad to see all the activity on this thread, I hope it is helpful to anyone with questions, I am always willing to answer what I can. It looks as though others are to.

 

I am in the UK, as per my profile. See Location under my thumbnail pic.

At the time, after reading all am101 info, my take was that the results were fairly +ve (in my mind, not in stats terms) from the Phase 2 results. Some people had improved from the drug. The results and numbers were not astoundingly great. Still, I felt that if there was a slim chance it could help, I was going to try.

None got permanently worse from everything I had read at the time. Mikey is the first I have heard of this so that is of concern. None reported any hearing loss. So safety was ruled out. However, phase 2 was < 3 months. So there was no knowing if it could help my t at < 9 months. That is what phase 3 is all about. The 3 - 12 month range. Phase 3, they also accept a certain number of ppl < 3 months. The rest are in the post-acute phase (3 - 12 month). So after chatting to a few guys on the forum who had done am101, reading the phase 2 results thoroughly and ruling out safety, i made up my mind that it was worth the risk, that just maybe, it would reduce my t.

Probably the best explanation of am101 effectiveness vs Kv channel (Retigabine, Autifony and prob am102) stuff was scientifically explained by benyru. Again, you'll have to look through the old thread to find his posts. They are very informative. He got some inside info that said am101 was most effective in the first few weeks since t onset and tapered off in effectiveness the closer it got to 3 months. At that point tho, I was already enrolled in the trial and had decided to go through with it anyway. I think even if i wasn't, i probably still would have applied.

Subsequently, a second poster (i forget who now) also had received "good" information stating that this was not the case and that AM still had high hopes for t-reduction in phase 3 post-acute phase. Again, that info is in the old thread somewhere. So two competing sources of info. It's then left up to you decide which you feel is right and whether or not to take part. We'll only know for sure once phase 3 results are published.

 

Most probably. Given my situation yes. Ask me again in a months time after my 2nd set of injections. If it makes it worse, then obviously no. So far - after 1st set - no improvement - no change.

 

I can relate. Me too. Any connection between floaters and t? Doubt it. Just thought that was co-inkey-dink. lol. It does make things seem 10 times worse tho, that your body is well and truly packing up on you. I feel about 80 with all the complications t has caused!

Not that rare. Me too!! The 3rd day of the 1st set of injections were screaming painful so i'm not looking forward to my 6 injections (2nd set) next week - one in each ear over 3 consecutive days. Ouch! I'm not saying that to put ppl off btw. I would do anything to get rid of t and pain is transitory.

Glad you had a good t day yesterday. I've switched over to 50% habituation (sound masking on the pc) and 50% holding out for a cure. I have to say, it's a bit more of a level headspace to be in.

 

Dr. Nagler... I'm not motivated to contribute the scientific body of knowledge nor do I think AM-101 is the Second Coming. If results to this point show there is a 50% chance of helping me 50% I would do the trial. Given that standard, what does your interpretation of the the results mean for my decision?
Thank you!

 

That's a fair question.

Let me answer two ways.

Back in 1994 I'd have gladly cut my right arm off for relief. So using that as a standard, given that AM-101 is relatively safe as determined by earlier trials, I'd have considered it even if I thought there'd be only a 10% chance of efficacy. That's one way of looking at it.

The other way of looking at it is through the eyes of a guy who's been involved in tinnitus for some twenty years now and who has seen drug after drug with what truly looked on paper like real promise ... only to learn after all the studies are in that it's a bust. So viewing it that way - if 50% were my cutoff, I would take a pass.

What should you do? That's a personal decision. I'm the last person on this board who's going to tell anybody here what to do. (I'll leave that to folks who are much smarter than I.) No, I can only tell you what I would do. And I suspect I didn't do a particularly good job of even that just now.

Hope this helps more than frustrates.

Dr. Stephen Nagler