AM-101 Clinical Trial — Participants Updates and Discussion

[amandine]

@OddV

Yes i am worried about @bedouin as well.
Not like him to disappear is it?

1,200 pages!! assuming that we only need to skim these pages...to check the names off. But still way too much.

How about you send me the first 300 pages and you do the next 300 pages?
Then we can see about the rest.
Or better still:
can you put it online here broken into 100 page units perhaps.
Ask for 10 other participants to help go through 100 pages each = 12 people incl you and me.
Then each one notes the names in those hundred pages, sends the names to Markku or posts the names in a list online. Can Markku allow us a space to do this?

Then with 12 lists of names, we can check these against each other and come up with one final list of names.
Just an idea cos 1200 pages is daunting but 100 pages per person less so.
Or 50 pages x 24 helpers
Or 25 pages x 48 helpers.

It is not impossible to ask for this help as there are over 5000 members here....99 percent get it for free so a little payback (maybe not with money now but) with a bit of work....

Is it not worth perhaps putting out a call for help generally and maybe having the space in a special section here which can be deleted afterwards.

I dont think that i can look through 600 pages and I dont think that you could or should either. Far too much to ask anyone really.

This all off the top of my head - dont want my laptop to explode but 600 pages of data....which i wont be reading, only noting the names on the posts which presumably you will be doing too.

By the way, what will be the value in the end of this data collection. To know if it works or not this am 101? to get an idea of the efficacy. Cos we would need to note also how long the person had T, how severe is / was it, and what was the cause of their T. Maybe that data is jumping the gun a bit and in the beginning we only need to know what has happened to them but without then follow with the extra date I cannot see that it is doing very much except satisfying curiosity.
I would be very interested in the results IF we can get in touch with these people.
Like i said, I am willing to help BUT can we also get some more people involved to break this task up a bit please.
Anyhow, looking forward to hearing from you.....

Anyone out there willing to help with this task?
Can @Markku or you or me put out a special call to arms please on a seperate thread?

 

[OddV]

Continues to be on Odd day (pun intended)... Ear got real hot for about a minute and then the volume of the T dropped again... Just went to the market and walking around all the noises, I couldn't even hear it. Right now, the loudness is fluctuating between a 2 and a 5. This is the quietest it's been since onset.

Keeping my fingers crossed that this is my new normal or I continue to improve. I was able to pop my ear today for the first time since the injections.

 

[marqualler]

@OddV That sounds encouraging. Hope it at least maintains for you!

Things seem to be slightly better--went to yoga today and didn't really hear the T at all and more importantly had a lot of fun and felt great. If nothing else, it seems to be at a level that I can live at. Waiting to find out if I am eligible for the study right now and also weighing getting a tympanoplasty which could help any T amplified by any conductive hearing loss (pretty sure I have a little considering my eardrum is a little damaged by my infection). But playing with my 1 year old makes it hard to focus on the T at all, which is nice.

 

[amandine]

@OddV

Glad to hear the good news. Hope it keeps up and keeps going down.
Havent heard from you re my post yesterday.
Please understand me, I am not saying that I am not happy to help with the sorting of names in the thread.
I was only saying that 600 pages is a bit much for anyone to go through including you.
Was wondering if we cant spread this out a bit and get a few more willing helpers with this project. It will get done more quickly that way hopefully although of course it depends on the speed of the volunteer work.
Please get back to me
thanks

@earsnothappy
how are you doing please re am 101

 

[OddV]

Sorry @amandine ... Got busy last night with the kids and stuff... Not sure I can split the PDF, I might just have to send the whole thing to,you and we agree on pages. I'm heading out in a bit and probably won't get to it today. Do you have Dropbox? If so, send me a PM with your username and perhaps i can share it there.

T was back up to a 6 this morning .

 

[amandine]

@OddV

That is not such good news...but all the fullness and stuff from the injections has gone yes? has the electrical sound gone?

Sorry no Dropbox......
look forward to hearing from you

just been looking... to find names on phase 2
Fish took part in phase 2
2 injections and then refused more as his t went thru the roof but died down. since then noticeable improvement and he was one month in.
well at least it is started .............lol

 

[OddV]

Fullness was a 4 out of 10 yesterday... Still about the same today. It's not back to where it was before the injections... I test every morning eating something crunchy.

Electrical sound is still there, but it's diminishing as well. On Tuesday, I would have said it was a 9 out of 10...today, about a 5 out of 10.

Long story short, my ear (minus the T) is not back to where it was prior to the injections. I'm trying to have patience (I'm not very good at that) as people have said it takes 2 to 4 weeks to get back to baseline. I'm only on post injection day 9.

 

[tomm]

Interesting people are reporting differences in their T and head after the procedure. If you'd have wiped my memory now I'd never have been able to work out that I had the injections.

May mean you've been given the real stuff.

 

[amandine]

Wonder if it would be possible for people to post how long ago they had their injections on each follow up post. It is just that it is difficult to remember everyones timeline. So for example, when you post, at top or bottom, please state your injections were on which date......will also make it easier to collate the info too....to make sense of it....easier...for future data as discussed so far between OddV and myself....

Hope you dont mind me asking for this....??

thanks

 

[earsnothappy]

@earsnothappy
how are you doing please re am 101

I'm having my ups and downs. I'm waiting until the end of the trial (for me is mid January) to report my status due to how much it's changing on nearly a daily basis at this point. If my status stays consistent for a week or so before then, I'll post an update.

 

[bedouin]

Hey all

Apologies for the disappearance. Just moved house and no internet. Tethering at the moment but should be fully back up and running on broadband Weds this week.

Currently I am Day 14 after the first injection (Day 1) of the real drug.

The weekend was good t wise but unfortunately i doubt it is due to am101. Last week Mon to Fri, i pretty much had two ok days and 3 loud days. Not sure why the 2 ok days. One thing is for sure, if i get good "enough" sleep, t the next day is softer. I think we pretty much all experience that and nothing to do with am101. More to do with nervous system downtime, immune system having rested, brain being reset in REM and thus neuronal brain network quieter and calmer overall.

Anyway, by Friday I was going out of my mind with t. During my last batch of injections I asked the trial co-ordinator if i could take ad's and anti-anxiety meds to take the edge off. They said no, as it interferes with the trial. I asked about sleeping tabs. They said ok but not all the time, which is sort of open ended. Anyway, i'm in the business of doing what i can to get through a day. Without having any sleeping tabs at hand, I took Alprazolam Friday night and have been taking it every night since then.

Alprazolam is a benzodiazepine used for the treatment of anxiety disorder, panic disorder, with or without agoraphobia, and anxiety associated with depression.

I put my t being lower (Sat/Sun) down to this and not am101. When i say down - maybe down to a 5 or 6. For me, it is when it hits 7, it's annoying and starts to become disabling. Above that, it's curl up in a ball and want to die. No way am i sitting with 9/10 t 24/7 for any longer. I will go insane. However, this morning it is back up to a nasty 8/10. All i can do is mask it with Steve album or any masking sounds of ocean I have handy.

I remember reading that benzos lose effectiveness over time. They are also addictive. So as soon as i can get a drs appt, i'll be getting some sleeping tabs. Then i'll still be in limits of the study to continue but to be quite honest, if i don't see a huge improvement soon, i doubt i'll be going for a third round of injections. I'm already over 12 months and I think it is as benyru said and that am101 is only effective in the first few months or even weeks of getting t.

I hope I am wrong. If guys are getting improvement in 3 < t < 12 months, then i am wrong and maybe it just has not worked for me.

I think Kv channels is the answer t0 long term T. If you look at the Retigabine thread, lots more ppl currently on the internal trial and getting results (t actually lowering as a direct result of dosing), albeit with side effects. From what i read on am101, ppls t is up and down and all over the place.

I'm going to try and get on Autifony and if that doesn't work, then see how i can procure some Retigabine and try that for the required time. My plan for the coming weeks is to get my t down to a 5 or 6 for an extended period of time with sleep, diet and exercise. If i can hit 80% success rate, then i'l be moving fwd and will hopefully give me the strength to carry on. I've still got a lot of time to decide but at this point i don't think i'll be going for any more injections.

Re the blocked feeling. I had my Day 10 follow up. Tymp test showed negative pressure in the left ear due to it still being blocked. ENT said that is normal and it will normalise. ENT can't see if holes in eardrums are healed yet because of blood crust over hole. However, they feel pretty strong when i can't resist blowing down on them to unblock them. I've only done it a couple of times but it does not feel like air is escaping through holes. It feels more like when you normally unblock your ears. I think the only difference is, they don't completely unblock (as they would with someone who had good ears) because there has effectively been a mini-trauma there (the injections) and it will take time (on natures clock) to heal before they are back to normal.

I think it is also one of the reasons that i'm not keen to carry on the am101 treatment as i find the intra-tympanic method too invasive for no improvement (hopefully yet!). If I was seeing a dramatic improvement then i'd go for another round but as of yet it just seems like a whole lot of distress for nothing. I did what I came to do and that was get the real drug. Up to now it does not look like it has done anything. It is still early days (Day 14), of 90 Days. Call be a pessimist but i thought i would see some improvement by now. I hope I am wrong.

Note: This is juts one persons experience so don't make your decision to not take part in the trial based on me.

Audio also a bit down from base line, esp in high frequencies where my t is. It was 5db's worse before and after am101. However, the day of the test, my t was a 9/10 so i could hardly hear the soft high pitched sounds. ENT said a 5db diff is test negligible and did not concern him. As far as he was concerned my audio was within limits the same. I'll see for sure on Day 35. Hopefully by then, the ears will have fully settled post-injection (no negative pressure) and if i follow my sleep plan / exercise plan, i can string days of 5-6/10 together so that loud t won't affect the audio tests. But yeah, it is a worry that it made it worse. But i'll know for sure at Day 35. I still have that echo feeling in my head when i talk, esp left side which correlates with tymp negative pressure test. The way the audiologist explained neg pressure, is that it's your eardrum sucked in. And a result of injections / ears stabilising pressure internally to naturally settle.


One day we will find silence!

~bdn

 

[OddV]

Thanks for the update @bedouin, I'm off for my 10 day in a few hours... Get the added benefit of driving in pouring rain for 3 hours today.

I can say for a fact... When I wake up in the mornings, there in no change to my T, but the last few days, it's gone down in loudness and annoyance throughout the day... I can't chalk this up to AM-101 as it doesn't make sense to me that this is how it would operate. Part 1 of the trial finishes up for me in late January and I'll make up my mind if I'll go for the real drug at that point. When I finish up, I'll be 4 months into T, so a little bit better time frame than you.

 

[OddV]

10 day went ok, the audio exam spiked my T to a 7. Still had blood clots on the ear drum, which the doctor said was causing the electrical hum....it should go away...he knew exactly what I was talking about.

I continue to wake up with a 6 each morning and it fluctuates between a 2 and a 5 during the day and the back to a 4 to a 6 in the evening. My annoyance has dropped significantly... Going into the injections, it was a solid 7.... It's ranging between a 1 and a 5 right now.

If this is my new baseline, I'll do the follow up injections.

 

[marqualler]

Sounds good @OddV--what do you attribute the annoyance drop to?

 

[amandine]

@bedouin
Just wondering how you are doing now a few days later? Hopefully things have improved for you? So shitty if they havent!
Retigabene seems to be more consistent than am 101 which maybe because other drugs for T have to lose something in strength in order to lose side effects. I dont know.

@NewGuy
How are you these days? Please do post us.

@OddV
Thank you so much for keeping your posts frequent and therefore up to date. Glad to hear that you are getting better. Maybe it does help then.

How are you getting along with collating the data or is it a forgotten project. I believe that @Mpt had contacts with previous am 101 participants (or was it @benryu - sorry I forgot) who have now disappeared. Is that cos they got better or bored? Wonder if he can provide data to you or on here and is he still in touch or can he get in touch or can the mods get in touch with these people.
I do keep calling for people to add data to their posts on am 101 and retigabene simply cos I feel it would make easier reading (more informative) and make it easier for data collection. However dont think I am getting very far with it so will stop asking.... anyhow wanted to know if this am 101 data collection can be progressed? Obviously you cannot do 1200 pages alone and I not 600 pages....did you find another way to transfer the data? Can it not be placed in a special place on this website where it can be sorted? Please ask the mods I guess which I expect you have already done. Maybe you have decided to undertake the whole project alone which is very brave helpful and considerate of you......havent heard so just dont know.
looking forward to replies

 

[OddV]

@marqualler I think because the T is lower throughout the day, I'm not as annoyed with it all day and can deal with it better in the evening... Not sure I can attribute the loudness drop yet to AM-101. It has to be lower I the morning when I wake up before I do.

 

[amandine]

It has to be lower I the morning when I wake up before I do.

Hi OddV

Do you mean that the T is lower in the morning before you properly wake up?
Sorry to ask ....just didnt understand.

 

[OddV]

Hi OddV

Do you mean that the T is lower in the morning before you properly wake up?
Sorry to ask ....just didnt understand.

I'm not attributing the lowering of my T to AM-101 until I experience a lowering of volume first thing in the morning. To date, I've only had one lower morning of a 5, all other days have been a 6.

 

[lapidus]

@I believe that [USER=3093]@Mpt had contacts with previous am 101 participants (or was it @benryu - sorry I forgot) who have now disappeared. Is that cos they got better or bored? Wonder if he can provide data to you or on here and is he still in touch or can he get in touch or can the mods get in touch with these people.[/USER]

It was Benryu who had contacts with people working on the AM-101 trial. Benryu is very busy with work right now but said in a mail that he probably will come back to this site in the end of December or sometime next year. This was his post:

https://www.tinnitustalk.com/threads/am-101-tactt1-results-released.1994/page-48#post-61316

 

[tomm]

First checkup visit today. Same ear tests and a blood test. Nothing special. Back in 3.5 weeks for check 2.

 

[OddV]

Back to a 6 on both scales... Fullness is basically gone (1/10).

I'm not a patient person, waiting around to see if this might work is driving me nuts.

 

[OddV]

21 days post injection today, quick status update.

Prior to the injections, I was a constant 7/10 on both loudness and annoyance.

Today (the proverbial today that is), I wake up to a 6/10 on loudness and probably a 4/10 on annoyance. During the day, it fluctuates between a 2/10 to a 5/10 on loudness and between a 2/10 and a 5/10 on annoyance. The trial asks "over the last 24 hours, how would you rate the two"... so, with that criteria, I've "stabilized" at a 6/10 on loudness and a 5/10 on annoyance.

The fullness is completely gone. I do have a weird "crack" in my ear from time to time when I yawn. The electrical noise that I complained about is also mostly gone, so I think the doc was right when he said it was due to the blood clots on the ear drum.

And, with that criteria, 21 days in, I would have to say... I got the placebo... the "change" in T, in my opinion, is just a normal change from recent onset to whatever happens when you get closer to 3 months. I don't think that the mechanism of the drug would have me waking up to louder T, it going down throughout the day, and then back up in the evening. I imagine that if I had received the actual drug and it works as purported, then I would be having lower mornings as well, this is just my opinion and is not based on any medical fact.

I communicated with the trial site yesterday. If I want to go onto the companion trial (AMPACT1), I was told that I have to agree to have the injections within 14 days of finishing the first part (TACTT2)... they did tell me, if they could get everything scheduled, that I could start on AMPACT1 during my last checkup of TACTT2.... so, I have a decision to make mid-December.

Would love to hear from @tomm, @NewGuy, @bedouin, and @earsnothappy on how they're doing.

 

[tomm]

21 days post injection today, quick status update.

Prior to the injections, I was a constant 7/10 on both loudness and annoyance.

Today (the proverbial today that is), I wake up to a 6/10 on loudness and probably a 4/10 on annoyance. During the day, it fluctuates between a 2/10 to a 5/10 on loudness and between a 2/10 and a 5/10 on annoyance. The trial asks "over the last 24 hours, how would you rate the two"... so, with that criteria, I've "stabilized" at a 6/10 on loudness and a 5/10 on annoyance.

The fullness is completely gone. I do have a weird "crack" in my ear from time to time when I yawn. The electrical noise that I complained about is also mostly gone, so I think the doc was right when he said it was due to the blood clots on the ear drum.

And, with that criteria, 21 days in, I would have to say... I got the placebo... the "change" in T, in my opinion, is just a normal change from recent onset to whatever happens when you get closer to 3 months. I don't think that the mechanism of the drug would have me waking up to louder T, it going down throughout the day, and then back up in the evening. I imagine that if I had received the actual drug and it works as purported, then I would be having lower mornings as well, this is just my opinion and is not based on any medical fact.

I communicated with the trial site yesterday. If I want to go onto the companion trial (AMPACT1), I was told that I have to agree to have the injections within 14 days of finishing the first part (TACTT2)... they did tell me, if they could get everything scheduled, that I could start on TACTT2 during my last checkup of TACTT2.... so, I have a decision to make mid-December.

Would love to hear from @tomm, @NewGuy, @bedouin, and @earsnothappy on how they're doing.

I was scoring 7/7 (loudness, annoyance) for the week before the injections. In the past 2-3 days I'm at 5-6/6-7. Volume has gone down a bit but it's certainly still annoying. Moved into the middle of my head as well - I feel it more often than hear it now. It's difficult to describe.

I don't put the changes down to the injections - they made no difference during the injection week. My changes have come about I think due to time. I'll be coming up on 2 months soon.

 

[OddV]

@tomm I've had the "moving into the middle of my head" experience as well... It is VERY difficult to describe.

 

[amandine]

@tomm
@OddV

sounds like you both got placebo......
?? what do you guys think

@NewGuy

how are you - any change in your T??
please let us know
of course you may be doing so well that we may never hear from you again...

 

[OddV]

@amandine Yes, at this point, 21 days post injection, I would guess that I got the placebo based only on the published results from the last trial, at day 21 I should be further along than I am (see below... click the image for a larger view). My day 2, I was below my baseline (like the placebo group) and didn't get back to baseline until around day 10 to 12. By day 7, the AM-101 (high dose) group had already started breaking away from the AM-101 (low does) and placebo groups.... I did NOT experience that.

My day 7 report was "T lower in the morning, still have electrical overlay, fullness was a 5/10... loudness was 6/10, annoyance was 8/10"

Obviously, I'll re-evaluate closer to the 90 days, but my trajectory does not match up with receiving the actual drug.

 

[earsnothappy]

@OddV
It's hard to say how I'm doing.. I'd really like to wait until the middle of January to post a conclusive update as that's when my 90 days post injections will be.

Currently, I'm probably a little worse off than I was before the injections as my tinnitus spiked dramatically from the injections. Things have been improving, though very very slowly. I'm hoping that at the end of my 90 days my tinnitus will at least be where it was before the injections or better yet, improved.

 

[Marius T]

Hi guys it's now been more than a month since I got injected. First of all, injections were a bit painful and annoying. I've had a little spike after injections, which has totally gone. I've also sometimes had a pulsatile tinnitus days after injections. I don't really know if I got the placebo or the AM-101, because I've seen that I notice my tinnitus less often (only when i'm in a quiet room), and that it's maybe less intrusive wham I hear it (not sure if it's due to the injections though). I will post a conclusion of my experience on January.

 

[OddV]

@Marius T hows your T when you first wake up in the morning?

 

[Chelovek]

I too am post injections 31st October and will write a full detailed report once my 84 days are up in mid January. I can tell at this point that I did not get placebo and can report positive results but please wait for the final report.