AM-101 Clinical Trial — Participants Updates and Discussion

[Jeffrey F]

Hey @JohnK I was just wondering if you had any popping of the ears. Whenever I burp it feels like my eardrums are popping and I was wondering if something was wrong with them lol. Im just hoping the injection sites are healing okay.

 

[JohnK]

I notice more clicking when I'm swallowing. Maybe it's popping? Hard to tell exactly.

 

[liquefact]

About to undergo the injections part of the trial in a couple of weeks and haven't read any horror story so far... Don't know if I want to... glub!. Just reading
@liquefact experience makes me hesitate a bit...

Hey @Joe Bananas, think of my situation as a one off. Even though i had significantly more side affects than average subject because of the injections, i still believe they're temporary and they're because of some other hidden conditions surfaced by the injections.

As i said before, i'd set my expectations to not to have a relief from the 1st round and it'd be a nice surprise if it happened. It's 19 days from 1st and 14 days from 3rd injections, still no pronounced improvement. So i believe that i'd been given placebo.

I feel like my T is returning to pre-injections baseline slowly, even though i still have some bad days (like today) driven by stress in work. 2 times since the injections, i had very good days, loudness around 3-4, annoyance lower than that. I hope i'll have more good days in the future.

The popping is still present, every time i gulp they pop. Sometimes they pop by themselves without me doing anything.

The fullness is there as well, especially in my right, not severe as the day of the 2nd injections though. Almost 3 weeks after the injections, it's weird that i still have that but i believe it's fading away slowly.

Pain is 99% gone except once in a day, i feel slight pain in my right ear which goes away after 10 secs.

Also, as my case is seen as an unexpected one among all the subjects, i've been invited to the site for another follow up visit bw 1st and 2nd. I'll raise all these concerns and have my ears checked out. I hope there's nothing wrong that'll make these annoyances permanent. I'm also a little bit afraid of the flights too because during my flight back to Seattle after injections, the poppings were crazy. Shall see what happens.

 

[JohnK]

I'm also a little bit afraid of the flights too because during my flight back to Seattle after injections, the poppings were crazy.

I also feel the flights made my ears feel worse. Not so much popping, but they got super muffled afterwards.

 

[Sebastians]

Applied for am trials in Antwerp. Got a call a few days ago to answer some generic questions and now waiting for a final yes or no.. Although already a bit hesitant after some stories i read here. Will keep you people posted on any development.
Good luck to those enrolled!

 

[Charlie396]

Waiting to hear back to see if I'm accepted.

Only thing I'm afraid of is while checking past medical records they might frown upon seeing the word 'anxiety'

 

[liquefact]

Update:
It's been 21 days after the 1st and 16 days after 3rd injections.

I've been to the site yesterday for an extra follow up visit because of the not completely closed eardrums in the 1st follow up visit. I believe this was unnecessary because, the first follow up visit happened 3 days after the last injections because of the timing with the holidays. Normally it happens ~1 week after the last injection and it was normal for the eardrum not to close completely after 3 days. Still i complied with their request to have my ears checked and ask questions about popping/fullness.

I was a little bit afraid of the flights because of the excessive and painful popping of the ears during my flight back home 3 days after the 3rd injection. This time, i had almost no popping during flight because of the pressure changes, which is very welcome.

Doctor examined the eardrums and saw that they were completely closed, as expected. The fullness is like 30% of what i had after the injections, so i'm not much concerned about it, the doctor told me that this was within the expected limits as well.

About the poppings, doctor did not have much idea. It's not as extreme as before, so i might say that it'll on the way to be gone but still it's very weird that something related to eustachian tube surfaced after opening a hole in the eardrum. Doctor says that all the injections, successive flights and everything put a huge burden on my ears and it'll take some time to resolve.

About the Tinnitus, i had some more spikes in the past 10 days. I believe all of them are because of some extra stress at work. I also had a very good day, hardly noticing the T during the day as well. The main difference with before is, my T was pretty much stable before injections, was not seeing any spikes like the ones i see after it. This difference might be attributed either to the drug (it's doing something) or not (the injections disturbed the stability of my T). I still believe i got the placebo as most people start feeling the improvement after ~2 weeks.

If i ignore the up/down spikes, my T is either roughly at the same level of pre-injections or it's louder but i've accepted this fact. After some time, it's hard to remember the previous demon i had in my head and compare it with what i have right now. I/We seriously need some objective measurements on the T level.

The next visit (the regular one, 2nd Follow Up) will be 10 days later i hope all these will be resolved by then.

 

[JohnK]

I believe all of them are because of some extra stress at work.

You think you got stress at work? I just found out my team is getting downsized!

In other news, 6 days out from my last injection (of the 1st round). Muffledness is gone, T is back to normal with no weird behavior. I'll be flying to San Diego for my 1 week followup tomorrow morning.

I've cut off alcohol and caffeine entirely. Can't be too safe.

 

[liquefact]

You think you got stress at work? I just found out my team is getting downsized!

I think i have yeah, if i'm fired from this work, i'll need to find a new one in a very short time, otherwise i'll need to leave the country (on H1B visa). Do you know how huge stress this causes on one especially if you have invested so much? Whenever i have too much workload, i develop stress; whenever i have stress i have a T spike at home that day, guaranteed.

 

[JohnK]

(on H1B visa). Do you know how huge stress this causes on one especially if you have invested so much?

Yes, if only because my coworker behind me now finds himself in this boat.

As a side note, he had stress tinnitus for 2 months but it went away. lucky bastard.

 

[liquefact]

Yeah the lucky guys are the smarter ones at the same time IMO, as i was really stupid not protecting my ears during >120db concert. I'm also unlucky because the two guys that i went to that concert together do not have T at all.

Not condemning the past though, i'll get better eventually. You'll too.

 

[Jeffrey F]

1-week update after Real drug (round 2)

Tinnitus from a 6 down to a 5-5.5

Ear fullness after injections gone away
Ear popping after injections gone down.
Eardrums have healed after injections though I have small blood clots (probably what is causing the popping as my ENT said)

 

[JohnK]

Just finished my 1 week followup. Ears have healed up fine, hearing is fine, T currently unchanged (back to where it started, around 5)

How many weeks in have successful candidates noticed improvement?

 

[liquefact]

@JohnK, no fullness/popping left as well?

2 days ago in my follow up visit i asked the doc about when should i expect some improvement after the injections if i'm given the real drug and his answer was ~2 weeks after the last injection. So probably it's still too early for you.

 

[Hotaru]

Do they really force you to take birth control while you're doing this?!

 

[Markku]

Do they really force you to take birth control while you're doing this?!

According to the exclusion criteria (which you are referring to I assume):

1. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
2. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;

Likewise, on the AM-101 study site it states:

Women who are able to become pregnant must take a pregnancy test before they can take part. During the clinical trial they will also have to use a reliable method of contraception. Pregnant or breastfeeding women may not take part in the study.​

I believe this to be the case because the hormonal changes that occur during pregnancy could potentially skew the results.

Nonetheless, I'm going to confirm this with Auris Medical. I will update in this thread.

 

[JohnK]

So mysterious. I wonder what it's doing for those 2 weeks.

Did any people with good results drink alcohol during this trial? I could use a drink but don't want to jeopardize it...

@JohnK, no fullness/popping left as well?

No fullness, although on the flight there and back I noticed more ear popping than I'm used to. Could just be my own increased awareness of physical sensations post-T... Why, it's also how I discovered I had "suddenly got" eye floaters

 

[Joe Bananas]

Did any people with good results drink alcohol during this trial? I could use a drink but don't want to jeopardize it...

Don't know but I used to hang out with some guys who consumed Ketamine via nose or even injected in club environments. The alcohol just seemed to increase the K effects. Lol

 

[Markku]

Do they really force you to take birth control while you're doing this?!

I believe this to be the case because the hormonal changes that occur during pregnancy could potentially skew the results.

Nonetheless, I'm going to confirm this with Auris Medical. I will update in this thread.

So, foolish of me, I totally forgot about the embryo/baby!

Auris Medical's comment:
"This is standard language that applies essentially to all clinical trials as a precautionary safety measure to protect the embryo / baby. This does not relate to hormonal changes."​

 

[Hotaru]

So, foolish of me, I totally forgot about the embryo/baby!

Auris Medical's comment:
"This is standard language that applies essentially to all clinical trials as a precautionary safety measure to protect the embryo / baby. This does not relate to hormonal changes."​

I'm still confused. Do they make you take birth control or not? I'm not pregnant nor in a relationship(s).

 

[Markku]

I'm still confused. Do they make you take birth control or not? I'm not pregnant nor in a relationship(s).

So if you don't have sexual relations which could impregnate you, you wouldn't need to take birth control. I'd be surprised if it was otherwise, however the study site will certainly go over this with you.

 

[baz 22]

So I am about 3-4 weeks into my tinnitus and struggling. I know a few people have tried the AM-101 trial now and wondering should i try it?

I am worried about injecting stuff into my ears but I am kind of desperate at the minute. I am from the uk and I think the limit here is 6 months so I still have some time but the sooner the better right?

My tinnitus is not to bad during the day cause the background noise masks it, it is just night time that really gets me ringing.

Anyway worth trying or not?

Or should i wait it out and hopefully recover or habitute?

 

[Nucleo]

I am worried about injecting stuff into my ears but I am kind of desperate at the minute. I am from the uk and I think the limit here is 6 months so I still have some time but the sooner the better right?

The sooner the better. In my opinion refusing to get on the trial because you don't like injections is not a valid reason.

Intra-tympanic injections are performed routinely and is a low risk procedure.

This is a unique opportunity to try something to cure your tinnitus that you may never get again in your lifetime.

 

[ady]

So I am about 3-4 weeks into my tinnitus and struggling. I know a few people have tried the AM-101 trial now and wondering should i try it?

I am worried about injecting stuff into my ears but I am kind of desperate at the minute. I am from the uk and I think the limit here is 6 months so I still have some time but the sooner the better right?

My tinnitus is not to bad during the day cause the background noise masks it, it is just night time that really gets me ringing.

Anyway worth trying or not?

Or should i wait it out and hopefully recover or habitute?

It boils down to you either not doing it and risking a lifetime of afflicting tinnitus or taking the injections and possibly being cured or reduced for good for real. It isn't a choice ! do it.

 

[JohnK]

The injections aren't bad. Worth the possibility of relief from the ringing!

 

[jdjd09]

So, I'm currently in the two weeks before the shots and concerned I may have missed a diary entry. I feel like I did it, but not 100% sure.

Is there anything that will indicate you missed a diary entry? Like will the light on the phone change or will the diary indicate that?

Also, if I miss one day am I still allowed to participate? I'm really concerned about this. I feel like I did fill out the diary, but I'm really not 100% sure.

Thanks for any information.

 

[Jahhsoul]

So, I'm currently in the two weeks before the shots and concerned I may have missed a diary entry. I feel like I did it, but not 100% sure.

Is there anything that will indicate you missed a diary entry? Like will the light on the phone change or will the diary indicate that?

Also, if I miss one day am I still allowed to participate? I'm really concerned about this. I feel like I did fill out the diary, but I'm really not 100% sure.

Thanks for any information.

Same for me, I forgot it today. They accept you if you did 70% of diary entrys. So, no problem

 

[OddV]

Good luck to all the new trialees... I know it's stressful thinking about the injections, but the anticipation is worse than the actual procedure.

Just some small tips. Take a book with you and a travel pillow to rest your head on.

Here's to all finding silence in 2016!

 

[Mirage]

I've read through this thread and have two questions that I'm not seeing any clear info on:

1. For US studies, do they pay for travel to the clinical sites? If so, is it up front or reimbursed?
2. As for inclusions/exclusions, I can't really pinpoint the exact cause/timing of my "Persistent subjective peripheral tinnitus" (bilateral in my case)... I do regularly see to forget ear protection when using power tools, and operate grinding equipment for my Lapidary hobby..

So, my real problem right now is that when I answer the "What event triggered your tinnitus" question on the contact form with "unknown or other event", I'm immediately excluded.

If I specify "Acoustic trauma (e.g. bang, loud concert)", I won't be able to cite a specific incident...

Thanks!

 

[Nucleo]

I guess usage of power tolls counts as an acoustic trauma. These things are definitely on the loud side of things.

Seeing as you got your tinnitus in ''mid 2015'' acording to your avatar, I guess that means June. I do not know if they accept patients beyond 6 months in the US.