AM-101 Clinical Trial — Participants Updates and Discussion

Hi,

I am starting this thread to unclog the info thread.

I would like to see people who have taken part in the AM-101 study give updates and answer questions to people who are curious how the process went for us.

I had my injections 4 days ago and things are going well for me, still have a full feeling and my tinnitus is all over the place. Last night my ear started to drain. Some of the earache feeling went away.

If anyone has questions feel free to ask.

 

@NewGuy
glad to hear you are feeling a bit better. Is your hearing good? When you say that your T is all over the place, is it louder also than before or is it going up and down at will? Has the numbness gone away from your ear cos i remember you said that it had remained numb for the whole time of the injections. Has the eardrum hole healed up? Think you are due back in about a week. Does your T make you nervous at all or is it really quiet so it doesnt disturb you.....glad to hear you are ok ish....tho.....was a bit worried there when did nt hear from you for a few days....

 

I have completed my follow up open label injections. It's been about a week, but I still have the post injection tinnitus spike. I'm hoping that starts going down soon. Will post updates as I progress.

 

@earsnothappy sorry, can you explain what "open label" injections are?

 

It means the medicine was really the medicine, no chance of placebo. Double-blind testing is over, so they are compensating people who got the placebo by letting them try the real deal.

 

After you go through the study where you may have got the real drug, you are able to go back 3 times and get the real drug. Its a win/win after first round.

 

It goes Up and down in volume. Mostly on the higher side. The numbness was something that you don't feel, it is just the in the eardrum and has to do with if they can re-inject without re-numbing. I still have a hole, it takes a week or to for that to heal. I am still getting some draining. It stil has a full feeling, should go away in a week. I go back on the 30th. All on all, things are good.

 

@OddV
Good luck tomorrow, hope it goes well!

 

My injections start on Nov 3rd 2014.

 

@NewGuy
Glad to hear things are getting better..
Please keep telling us how you are getting along. I really hope it is going to get rid of your T. You are making me brave enough to go for these injections. Although Autifony should be starting theirs soon and that is pills and more inclusive to participate but only in UK.

 

Did the original injections spike your tinnitus? Did you get any hearing loss? Also do you know if you can be back on anti-depressants after the study and still get the open label injections? Also, how many times did you have to visit the clinic?

 

I am on the first round of injections and my T has spiked. I have hearing loss in the sense of the clogged / full feeling. My ear is itching like crazy so I believe that the hole is healing up.

 

That's understandable. The spike I think is because of the muffled sound. Hopefully, your hearing goes back to normal. More hearing loss with tinnitus is scary! Anyway, hope you got the actual drug and not the placebo? Do they ever tell you after 90 days if you got the placebo or not? Seems silly they would want people to get the drug twice and more perforation?

 

@Danny Boy
Yes you have expressed something that I have been thinking about .
So do they tell you whether you got the placebo or not when it comes to the open trial after the first 90 days? dont think so, The people who administer the injections dont know.
So you make get the drugs again round 2.
I think that everyone who took part in the first round of injections is entitled to be in the open trials and get the meds for certain.
So you may get the drugs x 2. Plus as you said more holes and numbing and trauma to the ear.
Do they do a follow up after this second lot of injections or is that it .

 

@amandine attaching the PDF I was sent from Addenbrookes hospital in Cambridge, UK. I've been accepted at Guy's hospital, London - the form I signed was identical apart from the location and study doctors.

When asking if I would receive the real drug after if I received the placebo:

I was also told verbally at my first visit that this would be straight after the existing trial. It's not clear whether I would get the opportunity if I got the real drug straight away - I was just happy to get it at all!

On a side note, the doctor, nurse and audiologist(?) I saw were all super friendly and very professional. It restored a little of my faith in the NHS after being burned by GPs multiple times - National Health Service (NHS) is massively underfunded nowadays so not their fault anyway.

 

Just got back from the study site, long day with a 6 hour round trip driving.

Arrived a bit early and met the VERY nice clinical trial nurse. She had me sign the consent form and then began a long series of questions. At some point, I was taken for a hearing exam (they did do bone conduction as well).... Then back to the room where I answered more questions.

Eventually, I was handed an electronic diary and instructed on its use (it looks like a small cell phone and is made by HTC). It was stressed to me multiple times that I will have to fill this out daily throughout the 100 days.

I then met with the ENT who will be doing the injections... He spent about 45 minutes with me and answered all my questions. He then did a quick examination and thanked me for my time.

After that, they took my blood pressure, temperature and took some blood. The clinical trial nurse then walked me to the door and asked me to report ANYTHING medical that changes with me over the next two weeks. She also told me to not take any drugs without checking with her first. She did say this was TACCT2 with a companion trial after. I will not find out if I've had the placebo.

All in all, I was there for a total of 3 hours and 10 minutes.

My first injection is scheduled for November 5th.

 

That was pretty much my experience of the screening test as well. After the injections, once per day you answer 2 questions on the HTC phone. Tinnitus loudness and tinnitus annoyance on a scale of 1-10.

I go for the AMPACT2 open-trial follow-up (real drug) on the 4th Nov. As per the snippet from @tomm consent form above, "you will never know for the full duration of the trial (I assume this involves the open trial period too) if you received the placebo or the real drug". I will ask them, when i see them next if i do get to find out at the end of the open trial, if my first injection, back in August, was placebo or real. I doubt I will ever find that out. I am just happy I get the opportunity to get the real drug in Nov.

As for any hearing loss - no long term. My hearing was tested at day 30 after the injections and presents as the same on audiogram as it was before the injections. Both audiogram and bone conduction tests showed no hearing loss. Only temporary hearing loss experienced immediately after the injections from a fullness and blocked feeling of gel in the ear. That blocked feeling goes away after a week or two and hearing returns to normal. I think it also hangs around a bit because of the eardrum perforation causing swelling and its time to heal itself.

You also have the opportunity to take part in the follow up 3 times after the initial trial injections. Each round is +-3months. So effectively if you really got benefit, you could do the initial injections (placebo or real) = 3 months and then a further 9 months of three rounds of the real drug. I am going to see if my injections of the real drug lower my t at all. If they do, then i might consider a 2nd round of the real drug. If not, then I will avoid any more eardrum holes!

 

Thanks to all - really good to get this info....

 

No change for me.

 

@James White how long ago did you receive your injections? Which trial were you part of? Did you have the option for the open label portion of the trial? Do you know if you received the placebo or not?

 

Injections in April 14, Phase 3, i didn't take part in open label, i have no idea about placebo or not

 

Just curious, is the procedure painful even if its slightest ? Can somebody briefly explain the feeling from start till end ?

 

@James White
Hi....hope you are doing ok.
Did you have all the 3 injections James and then not the rest on open label?
Or did you have one or two from the 3 injections?
Dont suppose anyone told you whether you had placebo or not?

 

My injections will start in 3 days, hope I get the real stuff. I'll post my feedback here

 

Got Tinnitus in Feb initially. This was only high-pitched static. I participated in the main trial and did not notice any changes at all.

However, towards the very end of the trial timeline I noticed new lower tones in my ear.

I then participated in the follow-up study. The lower toned tinnitus did increase in volume before subsiding. The new lower tones seem to be gone or unnoticeable now, but the initial high pitched static is still there.

So it's a combination of "No Change or Uncertain" and "Moderate Improvement".

 

I keep looking at the threads talking about this drug and I have yet to see anyone say....I am cured or wow I am 50% better. I think at best if this drug is approved will be for someone that just got tinnitus or was exposed to some trauma and does not yet have tinnitus and is given the drug to try and stop tinnitus from happening or to try and prevent it from getting worse then it could have been.

 

I think the hope for a real cure is on the potassium modulars rather than a jab at your ear.

 

3 injections, i think i'll never be told if i had placebo i phase3

 

@NewGuy
@earsnothappy

How are you doing now? Would be really nice to hear how you guys are getting on. Whether things have improved for you - do you notice any difference?
Please let us know as it has been a couple of days since your last posts and really keen as I am sure others are on this forum to know how you are following your injections. That goes for anyone who has had the injections.
I notice from @NewGuy that you are a half glass full kind of guy - from the way you write things....maybe this is the secret?