AM-101 Clinical Trial — Participants Updates and Discussion

[amandine]

@OddV

I also wondered about that aspect of the report from phase 2 but that is what it says.

The improvement in tinnitus was gradual over the 90-day observation period (Fig. 3). In the first days, tinnitus loudness increased slightly as the eardrum was still open and sound perception may have been temporarily altered. TLQ started to improve in the high-dose group on Day 2, before the third injection, breaking away from the 2 other groups. At Day 90, the mean tinnitus loudness in the high-dose group was 43.2% lower than at baseline (49.5% for unilateral cases). This compares with an improvement of 17.7% (10.0%) for the placebo group.

So are we suggesting that the clinical reports may not be really accurate in their findings? Cos it is not possible?

Even tho the numbers reporting on this trial are small, no one has as yet reported an improvement after day 2. On the contrary, the reports have only been that the T is up in the beginning (and then subsides in time) plus fullness of head or ears which also subsides in time. But the T going down on day 2, that has not happened to anyone posting.

Just like the injections are supposed to be completely painless......? For some they have been painful but then again pain is different for each individual.

What do you think?

 

[beemovie]

@beemovie I've got constant tone, but with the injections and audio tests, it aggravated it... I actually remeber telling the doctor that he had pissed off my T.

That's actually one thing I didn't understand after reading the clinical paper.... How anyone could report lower T after the second injection after having your ear assaulted. They ask you "over the last 24 hours"... Not sure about @NewGuy and @bedouin and if they have single tone. I think I had mentioned before that I've set up my own parameters in regards to how loud I perceive it.

I'm doing myself a disservice right now because I'm constantly monitoring it, looking forward to getting back to work tomorrow so I have other things to focus on.

Ok, It makes sense for you because you have a baseline from prior to having the injections. Also, I was just wondering if it get louder when you yawn or does it stay the same?

 

[OddV]

@beemovie I'm trying very hard to not yawn, burp, cough or sneeze right now as it still sends a bit of pain into my ear.

When I've tried it in the past, it was a very minor increase in volume.

And for you and the sake of science, I just tried it ☺... No change.

@amandine I don't think I'd say that... The question asks you, over the last 24 hours, what's the loudest it was. I experienced what I would call a 4 the first night, but it later ramped back up to a 7...so,i reported a 7...it might just be when someone does their diary or them being optimistic.

 

[tomm]

Arrived at hospital at 1300. Had a battery of audio tests and a urine drug test. All passed. Had my ears full if cotton wool soaked in anaesthetic. Injections start in about 20 mins (about 4 hours).

 

[OddV]

@tomm please keep us updated on how you progress.

 

[marqualler]

@OddV How are things going for you? It's been a few days now hasn't it?

 

[OddV]

Still a full feeling in my head (heard this can last 2 weeks)... Loudness is up and down... Ranging from a 6 to an 8..... The annoyance of the Tinnitus is quite high right now and is causing me concentration issues. I'm having trouble putting it out of my mind. The electrical noise I described before is till with me.

Tomorrow is one week from first injection... At this point, I can't say if it's helped or not in regards to the loudness. Hopefully @bedouin can chime in on how he's doing. Today is 1 week for him getting the real drug. Also would like to hear from @NewGuy too.

 

[NewGuy]

Hey all, its almost 30 days since my first injection and today is the first day I have had more than a few seconds of clarity in my ear, not the full or muffled feeling. My T is still high most of the time, but some times I don't hear it at all. I have a constant high pitched tone, like a bell that does not stop ringing. I have hearing loss at 4500-6500k. @OddV try not to get to frustrated cause that full feeling might last a few weeks.
I will get back on after work and talk a little more, I just had a quick second at lunch

 

[NewGuy]

Great, thanks for the info @NewGuy. Good to know that they are a good place and a good doctor--I was really impressed with the nurse I talked to there. I am based in Minneapolis so it is about a 3 1/2 hour drive to Des Moines, so if I did it I'd have to be away from my family for a few days which would be tough, unless they came with me which might not be the worst thing, either. When will you find out if yours is the placebo or the real deal?

Its 3 hours for me, I am in Lincoln, NE. Won't know if its the real drug until the study is over.

 

[tomm]

I think I should fill in the proper trial note form - will do it tomorrow. Injections as they went in were slightly painful, just be calm and it's over very quickly. Had a super nice nurse who helped me stay focussed. Swallowed about 5-8 times per half an hour - hard to stop myself. Might be worth practising. Full ears for 2 hours after. Now feel pretty much back to normal T and head pressure. Don't blow your nose or pop your ears as you will mess with the hole in your ear drum.

Back tomorrow and Thursday. Based on the lack of pain and reaction it seems like I may have the placebo (?). Being at hospital for 6 hours has certainly helped me get tired out for sleep though - silver lining zzz

 

[amandine]

@NewGuy

Glad to hear that things are finally a bit better for you.
You say that you can sometimes not hear it at all but otherwise it is there a high pitched whine.
Would you say that the high pitch whine or sound that you have is the same as it was before the injections or less or different? Also, when you say that sometimes you cannnot hear it at all, would you say that it is starting to get better, go away?
Sorry to ask but i have to do these trials myself and am needing all the info and support possible please.
many thanks

 

[amandine]

@bedouin

Please let me and us know how you are getting on now since you had the real drug about a week ago. Really desperate to hear your progress news - for me cos i have to go on these trials and for everyone here.
many many thanks

 

[tomm]

Ok, so I couldn't find a retigabine type form to fill in so I'll just post an update.

Final injection of three today at Guy's hospital outside London Bridge. The study lead Mr Rupert Obholzer did my first injection in each ear Tuesday and then another ENT surgeon called Hari did yesterday and today's. Again, the care I got was absolutely first rate. The surgeons were attentive and clear despite obviously having very busy schedules for visiting wards of patients and performing serious surgery. The study nurse who organised everything for me is probably one of the nicest human beings I've ever met.

I never really got used to the feeling of the lidocaine infused cotton wool going into the ear for about 30-60 mins of anaesthesia and then being pulled out before the smallest gauge needle they make perforates your eardrum and the gel solution is injected. It's not particularly painful, but it is a very unusual experience and I wouldn't do it for fun!

I had no vertigo, pain after the procedure and after only a few hours each day I felt right back at baseline. No major change in my T either. Over the course of the week I think my brain has worked out I have more high frequency hearing loss on my right hand side and consequently my T now feels more unbalanced than it did before - volume and tone seems pretty similar. If I was to guess, I'd say that it was the placebo or has had negligible effect.

Both are obviously disappointing results but I'm glad I did it and will be returning for the 3 month AMPACT2 'real deal' trial at onset+4months and change.

The days themselves were very long, initial day was 6+ hours including tests, next days were 3-4. Do not be in a hurry. Take a book to read and some money for a snack and drink.

I overheard that the study at Guy's is almost oversubscribed - they are accepting new patients but can afford to start being a bit picky with the subjects - less than 3 months from onset. This is not the case with Addenbrookes research hospital in Cambridge.

Happy to answer any questions.

 

[OddV]

Thanks for the update @tomm your experience was a bit different than my own. I did experience some minor pain and I'm just now getting back to baseline a week later. Fullness is still around too.

I too am going to do the next part if I don't get relief this go around.

 

[NewGuy]

@NewGuy

Glad to hear that things are finally a bit better for you.
You say that you can sometimes not hear it at all but otherwise it is there a high pitched whine.
Would you say that the high pitch whine or sound that you have is the same as it was before the injections or less or different? Also, when you say that sometimes you cannnot hear it at all, would you say that it is starting to get better, go away?
Sorry to ask but i have to do these trials myself and am needing all the info and support possible please.
many thanks

Yes, the tone is the same as before.

@NewGuy

Glad to hear that things are finally a bit better for you.
You say that you can sometimes not hear it at all but otherwise it is there a high pitched whine.
Would you say that the high pitch whine or sound that you have is the same as it was before the injections or less or different? Also, when you say that sometimes you cannnot hear it at all, would you say that it is starting to get better, go away?
Sorry to ask but i have to do these trials myself and am needing all the info and support possible please.
many thanks

The tone is the same, not sure if its going away or I am just readjusting to not notice it. I am driving to my second follow up right now. I will post after

 

[amandine]

@tomm

Thanks for your update.
Just wondering - at Guys in London where you had it done, (to which i have been invited also but am still in france rather debilatated with this noise and other problems like money and lack of it..........) you said that you had cotton wool soaked in lidocaine to numb the ear pre injection. So is it that Guys are administering it differently to the other reports? Did this mean that you did not go through the sucking out of excess lidocaine - cos in the other reports, it seems that the lidocaine was squirted in the ear and then the excess sucked out (which was noisy and scary too according to the other posts).
If that is the case, then the way with the cotton wool which is then removed after 30 to 60 minutes certainly sounds easier to put up with than the squirt and removal by noisy suction.
Please could you confirm whether this is the case cos if so, I would very much prefer to have the method you have described - if I am correct in my assumption of how it was administered.
Please could you confirm re this?

Perhaps you had the pacebo cos they figure that you can have it as you re so new and it will still help you on your T day plus 4 months cos you will still be in the new range (up to one yesr)? Just a dumb thought on my part...

@NewGuy
Thanking you for your updates. Looking forward to your next one.
You are in England too. Did they squirt the lidocaine and then remove with suction or did they put soaked cotton wool in? as in Guys Hospital in London?

 

[OddV]

@amandine NewGuy is in the US (as I am), I think it's Tomm and Bedouin who are in the UK.

 

[NewGuy]

@tomm

Thanks for your update.
Just wondering - at Guys in London where you had it done, (to which i have been invited also but am still in france rather debilatated with this noise and other problems like money and lack of it..........) you said that you had cotton wool soaked in lidocaine to numb the ear pre injection. So is it that Guys are administering it differently to the other reports? Did this mean that you did not go through the sucking out of excess lidocaine - cos in the other reports, it seems that the lidocaine was squirted in the ear and then the excess sucked out (which was noisy and scary too according to the other posts).
If that is the case, then the way with the cotton wool which is then removed after 30 to 60 minutes certainly sounds easier to put up with than the squirt and removal by noisy suction.
Please could you confirm whether this is the case cos if so, I would very much prefer to have the method you have described - if I am correct in my assumption of how it was administered.
Please could you confirm re this?

Perhaps you had the pacebo cos they figure that you can have it as you re so new and it will still help you on your T day plus 4 months cos you will still be in the new range (up to one yesr)? Just a dumb thought on my part...

@NewGuy
Thanking you for your updates. Looking forward to your next one.
You are in England too. Did they squirt the lidocaine and then remove with suction or did they put soaked cotton wool in? as in Guys Hospital in London?

I would be more than happy to come visit England, if you pay the bill

 

[tomm]

@tomm

Thanks for your update.
Just wondering - at Guys in London where you had it done, (to which i have been invited also but am still in france rather debilatated with this noise and other problems like money and lack of it..........) you said that you had cotton wool soaked in lidocaine to numb the ear pre injection. So is it that Guys are administering it differently to the other reports? Did this mean that you did not go through the sucking out of excess lidocaine - cos in the other reports, it seems that the lidocaine was squirted in the ear and then the excess sucked out (which was noisy and scary too according to the other posts).
If that is the case, then the way with the cotton wool which is then removed after 30 to 60 minutes certainly sounds easier to put up with than the squirt and removal by noisy suction.
Please could you confirm whether this is the case cos if so, I would very much prefer to have the method you have described - if I am correct in my assumption of how it was administered.
Please could you confirm re this?

Perhaps you had the pacebo cos they figure that you can have it as you re so new and it will still help you on your T day plus 4 months cos you will still be in the new range (up to one yesr)? Just a dumb thought on my part...

@NewGuy
Thanking you for your updates. Looking forward to your next one.
You are in England too. Did they squirt the lidocaine and then remove with suction or did they put soaked cotton wool in? as in Guys Hospital in London?

Confirmed - they opened a little thing of lidocaine, soaked some cotton wool with it and inserted it into my ear using a crocodile tool down a funnel. Please don't focus or worry about the injections - the lidocaine doesn't do much anyway. You just need to relax and accept the short sharp scratch. Focus on how your tinnitus could get better.

I was double-blind randomised by a computer no one including the head doctor knows what I had. The only way to find out would be to have an accident that required them to release the data in case I needed medical attention. Avoiding human bias like you mention is exactly why double blinds are the most reliable test procedures.

 

[tomm]

I would be more than happy to come visit England, if you pay the bill

Anyone lives anywhere with some good views and plenty of stormy weather or near some a beach with waves I'll happily do a house swap. I could do with a holiday

 

[OddV]

Got my injections done, and the spike seems decreasing. Didn't had any earache/pain or any specific issue after the injections, and the mysterious pulsatile tinnitus is gone. I hope it's not the placebo!

Any update?

 

[OddV]

For those of you interested, my T Tracker since onset:

 

[amandine]

@NewGuy

Sorry I got the countries mixed up!!

@tomm
thank you for the confirmation on that at Guys.

@Marius T
Yes please do you have any updates on your progress?

To everyone
I think that is a great idea! Why dont we do some house swops. Free accomodation white noise thrown in already set up!

 

[amandine]

@OddV

Sorry but I dont understand the graph u have posted - your t tracker. Please for ignorant dummies like me could you possibly explain it - what is the blue line and what is the red line and so on....afraid that the writing is too small to read on the graph.. I have increased it by 400% and it is blurred so I just cant figure it out......
thanks

 

[Markku]

@OddV

Sorry but I dont understand the graph u have posted - your t tracker. Please for ignorant dummies like me could you possibly explain it - what is the blue line and what is the red line and so on....afraid that the writing is too small to read on the graph.. I have increased it by 400% and it is blurred so I just cant figure it out......
thanks

Click on the graph and it opens up in a larger view.

Or, alternatively, click the below link:
https://www.tinnitustalk.com/attachments/ttrack-png.3680/

 

[OddV]

I should note, anything earlier than 2 weeks prior to my first injection is just me remembering based on certain events. Those 2 spikes in annoyance to a 9 out of 10 where actually while I was on steroids (not sure if it was just due to new tinnitus or the steroids themselves) and also indicate the panic attacks. Pretty much steady though at 7 and 7 up until the injections and now both the loudness and annoyance are still fluctuating. To be honest, it's pretty hard for me to separate the 2 and I could be getting them mixed up.

It's been a rough day.

Thanks @Markku for posting the link to the larger pic! Also, does TT have a list anywhere of everyone on the boards that have participated in the trial? I was getting ready to start data mining the monster thread, but didn't want to do it if someone else already had.

@amandine blue line is T annoyance, red line is T loudness. Green line is a linear trendline (just used the out of the box one in google sheets) that shows an overall trend (up or down) for the loudness. Trials ask you to track Annoyance and Loudness 14 days prior through the 100 day mark. I went back and estimated both of those measures for myself since onset (I'm kind of anal ).

 

[Markku]

Thanks @Markku for posting the link to the larger pic! Also, does TT have a list anywhere of everyone on the boards that have participated in the trial? I was getting ready to start data mining the monster thread, but didn't want to do it if someone else already had.

No we don't have such a list.

If you go through the thread (a monster task!), let me know all the names you can find. I could contact them and kindly ask that they update their current situation and what effect they thought the injections had (if anything).

Thanks!

Markku

 

[OddV]

My T is completely confusing me today. Woke up this morning at around a 6 on loudness, as I type this, it's around a 3...which,oddly enough, is annoying me more because I keep checking on it to see if I'm accurate.

If the 3 is what I eventually end up at, I could deal with this.

Still have the electrical overlay... Fullness about a 4/10.

 

[amandine]

@OddV
@Markku

Thanks for letting me know how to look at the graph. Jeez, i feel so stupid. I should have known how to do that!
Just didnt occur to me!
Thanks @OddV for your report. Seems like your T is going down. Wonder if mine will now I am 4 months in.

Anyhow, I see that you are wishing to dig up and see what has been happening to the other participants who took part in phase 2 (yes) and phase 3 (yes).??
If you need any help to get through this massive task then I am more than willing to help out.
If wanted, please just tell me which particular thread as there are a few with am 101. Post the link please. Then I could do say a certain agreed number of pages and maybe @OddV can do some more certain pages and if there are still too many maybe we can recruit another person to do some more? This way it need not be a mammoth task for one person and we can get some results.
I also have been wondering what happened to the others and assumed that it must be because they are no longer suffering and so have disappeared. Or not? We dont know. However if they have stopped posting, hopefully Markku has a way of getting in touch with them cos if they are no longer interested in this forum, how can we get any info from them. Seems the only ones who stay are the unsuccessful ones.
Anyhow, I am offering my help to find out the names and would post these to Markku.
What do you think - can you use my help with this?
Please let me know.
Thanks

 

[OddV]

Thanks @amandine... I actually downloaded the thread and have about a 1,200 page PDF to go through... Let me see if I can figure out how to get it to you and we can split up the work... It will be later today my time.

Worried about @bedouin, he hasn't checked in in a few days.