AM-101 TACTT1 Results Released

[bedouin]

@bedouin It took about 2 weeks for my ears to feel unclogged after my injections.

@earsnothappy . Weren't you concerned about that? I feel like I need to hold my nose and blow to unclog. Did you do that gently maybe ? I'm just afraid i'm going to put pressure on the perforation and prevent it from healing. How is your T now after injections? Better / Worse? Because things feel muffled i'm panicking that it has affected my hearing. Did those thoughts cross your mind? And have you had your hearing tested since the injections?

The T is still ringing off the hook but maybe I got placebo in both ears. Was it painful for you because I see the follow-up real drug is 3 months of it. Strength!

 

[bedouin]

Stress also raises the T --> So i'm trying to understand how that fits the model with glutamate that has been mentioned here. Anyone hazard a guess?? In today's life, unless u go live on a mountain top then maybe you can keep your T low but for a city rat like myself, stress is unavoidable. Guniea pig unfortunately u remain rodent status it would seem.

 

[earsnothappy]

@earsnothappy . Weren't you concerned about that? I feel like I need to hold my nose and blow to unclog. Did you do that gently maybe ? I'm just afraid i'm going to put pressure on the perforation and prevent it from healing. How is your T now after injections? Better / Worse? Because things feel muffled i'm panicking that it has affected my hearing. Did those thoughts cross your mind? And have you had your hearing tested since the injections?

The T is still ringing off the hook but maybe I got placebo in both ears. Was it painful for you because I see the follow-up real drug is 3 months of it. Strength!

I wasn't particularly concerned as I read the informed consent form, discussed my concerns here and with my ENT. All comments including from my ENT were that the side effects were temporary, plus another user on this site stated that his ears were clogged for 2 weeks. I just did my best to not let it bother me and believed it was just part of the process.

I've had 2 test since my injections. Both tests showed lowered tinnitus volume, and currently it's at about 50% the loudness prior to the injections. I am hopeful that I may regain silence.

All my hearing tests that I've taken have variances in the frequencies that I can hear. There is a basic pattern, but they do vary from test to test, sometimes as much as 15db in certain frequencies. The tests I've had were done at two different facilities, so maybe there's a difference in the equipment or the way the headset was sitting on my ears.

The annoyance level has also decreased with the volume, though not as much as the volume as I find the frequencies that my tinnitus are at particularly difficult to ignore.

Due to my not knowing if I received the drug or the placebo I must refrain from saying the drug is working.
I certainly wish I could know if I received the drug or not when considering taking part in the follow up trial if my tinnitus is still there. Though I am in the current mindset that I should take advantage of every opportunity that I have as I may regret not participating.

Apologies for so many words.

 

[locoyeti]

Update:
It's been about 10 days since my last update, and I have had maybe 3-4 'not so good' days. The volume of my T is still the same as it was since my last update (which was much improved since before my AM-101 shots).

I put quotes around 'not so good' because they weren't necessarily that bad, they consisted of 2 or 3 spikes during the day which lasted a few hours (the volume of the spikes were still lower than before my shots, and they did not feel as intrusive). My baseline T loudness was elevated relative to my good days, and I could hear it in both ears, though still louder in my left. My good days have been very good, I could barely notice the T most of the time, and it would disappear in my right ear, and be extremely faint in my left.

The fact that the volume has decreased rather dramatically has been very helpful to me, because the T is no longer as intrusive. How much effect the AM-101 has on this is debatable (maybe it was tincture of time), but it is a fairly stark contrast to the volume I heard before the shots. Another remarkable development for me is that I feel almost no hyperacusis at all anymore. I originally did not know I had hyperacusis (I would characterize it as mild and episodic), but after the shots I notice more and more that loud noises no longer bother me (I live in a very noisy city). Maybe this too is TOT.

Thoughts:
After reading @benryu 's posts, it seems as though the effects of AM-101 may not work past 2.5 months. Perhaps I got the actual drug and not placebo when I got my first shots 2.5 months after onset. But I did not get the same stark contrast that I have had since getting the AM-101 shots 5.5 months after onset. I don't know how to explain this improvement. Is there a way that the esketamine diffuses past the cochlea, into the cochlear nerve and beyond? If so then might it have some inhibitory local effect on the neurons, perhaps explaining the decrease in volume? If anyone can explain the mechanism of how I have gotten such improvement, I'm all... ears.

 

[David S]

I just heard the follow up where you get the real drug is 18 injections (9 each ear) !!! 3 rounds of 6 spaced over 3 months. IS that what other people on the follow up have been offered. I'm going to have a pin cushion for an eardrum. Not to mention the pain factor.

Did anybody else hear anything about this. Rememer form Trial 2 that the 3 x 0,81 mg showed much better inprovment? Are that about to increase that even futher?

 

[Matt h]

Hi, everyone
Matt from Uk on day 70 after 101 trial and have now had dates through for second phase of am 101 must admit even if i had placebo i am 100 times better, i have calmed right down, changed diet no Diet drinks or msg foods, really took advice from ENT specialist that i had to be in the right frame of mind for drug or placebo to work.
Really making good progress now and looking forward to treatment. I would recommended going on the trial to anyone if nothing else it gives you a focus, and a sense that your going in the right direction and the care i have received and been superb, has given me a new purpose, coming of anti depressants this week and looking again to life even with my T , you have to be positive have a purpose and cut out the stress, look after yourself and plenty of rest!!

 

[dboy]

Hi, everyone
Matt from Uk on day 70 after 101 trial and have now had dates through for second phase of am 101 must admit even if i had placebo i am 100 times better, i have calmed right down, changed diet no Diet drinks or msg foods, really took advice from ENT specialist that i had to be in the right frame of mind for drug or placebo to work.
Really making good progress now and looking forward to treatment. I would recommended going on the trial to anyone if nothing else it gives you a focus, and a sense that your going in the right direction and the care i have received and been superb, has given me a new purpose, coming of anti depressants this week and looking again to life even with my T , you have to be positive have a purpose and cut out the stress, look after yourself and plenty of rest!!

Matt, congratulations! Could you clarify whether your improvement is due to your tinnitus loudness going down (possible effect from the drug) or whether it is simply that you have attained a positive mindset and are less bothered by it? I was not quite clear. Thanks.

 

[NewGuy]

Hi everyone, I hope I am posting on the right place, I have been browsing this thread and wondering the best place to sign up for the AM-101 trial? I am in my first month and feel for anyone who has put up with this for years. Any help in the right direction would be greatly appreciated. Thanks in advance, and its nice to be part of a group who knows what I am hearing, or not hearing. My wife does not understand which makes it a bit tougher to deal with.

 

[locoyeti]

Welcome Newguy, since you have gotten this recently I would definitely sign up for the AM-101 trial. I would read over this thread and other resources so that you can be better informed. If you go on Auris Medical's website they will have a section that details the trial locations.

By the way, I've been PM'ed that it was not clear so I will clarify:
I have gotten two rounds of treatment, the first round was the TACTT2 in which I may have gotten placebo (40% chance), and the second round was part of the AMPACT follow up in which I received the real AM-101 drug.

@Bart Marien and @StayPositive , how are you both doing? Any effects with the AM-101?

 

[NewGuy]

Welcome Newguy, since you have gotten this recently I would definitely sign up for the AM-101 trial. I would read over this thread and other resources so that you can be better informed. If you go on Auris Medical's website they will have a section that details the trial locations.

By the way, I've been PM'ed that it was not clear so I will clarify:
I have gotten two rounds of treatment, the first round was the TACTT2 in which I may have gotten placebo (40% chance), and the second round was part of the AMPACT follow up in which I received the real AM-101 drug.

@Bart Marien and @StayPositive , how are you both doing? Any effects with the AM-101?

Thank you, do you feel it has helped you? I signed up on their website so I hope to receive a response.

 

[locoyeti]

Thank you, do you feel it has helped you? I signed up on their website so I hope to receive a response.

I think so, but I would read through this thread completely to get a clearer idea.

 

[bedouin]

I wasn't particularly concerned as I read the informed consent form, discussed my concerns here and with my ENT. All comments including from my ENT were that the side effects were temporary, plus another user on this site stated that his ears were clogged for 2 weeks. I just did my best to not let it bother me and believed it was just part of the process.

I've had 2 test since my injections. Both tests showed lowered tinnitus volume, and currently it's at about 50% the loudness prior to the injections. I am hopeful that I may regain silence.

All my hearing tests that I've taken have variances in the frequencies that I can hear. There is a basic pattern, but they do vary from test to test, sometimes as much as 15db in certain frequencies. The tests I've had were done at two different facilities, so maybe there's a difference in the equipment or the way the headset was sitting on my ears.

The annoyance level has also decreased with the volume, though not as much as the volume as I find the frequencies that my tinnitus are at particularly difficult to ignore.

Due to my not knowing if I received the drug or the placebo I must refrain from saying the drug is working.
I certainly wish I could know if I received the drug or not when considering taking part in the follow up trial if my tinnitus is still there. Though I am in the current mindset that I should take advantage of every opportunity that I have as I may regret not participating.

Apologies for so many words.

It sounds like you are having success with it and got the real drug. How long from time since T onset till the injections? A 50% reduction tells me you are probably in the less than 3 months category. Thanks for the info and keep going strong. Good luck with whatever you choose re the follow up.

 

[bedouin]

Update:
It's been about 10 days since my last update, and I have had maybe 3-4 'not so good' days. The volume of my T is still the same as it was since my last update (which was much improved since before my AM-101 shots).

I put quotes around 'not so good' because they weren't necessarily that bad, they consisted of 2 or 3 spikes during the day which lasted a few hours (the volume of the spikes were still lower than before my shots, and they did not feel as intrusive). My baseline T loudness was elevated relative to my good days, and I could hear it in both ears, though still louder in my left. My good days have been very good, I could barely notice the T most of the time, and it would disappear in my right ear, and be extremely faint in my left.

The fact that the volume has decreased rather dramatically has been very helpful to me, because the T is no longer as intrusive. How much effect the AM-101 has on this is debatable (maybe it was tincture of time), but it is a fairly stark contrast to the volume I heard before the shots. Another remarkable development for me is that I feel almost no hyperacusis at all anymore. I originally did not know I had hyperacusis (I would characterize it as mild and episodic), but after the shots I notice more and more that loud noises no longer bother me (I live in a very noisy city). Maybe this too is TOT.

Thoughts:
After reading @benryu 's posts, it seems as though the effects of AM-101 may not work past 2.5 months. Perhaps I got the actual drug and not placebo when I got my first shots 2.5 months after onset. But I did not get the same stark contrast that I have had since getting the AM-101 shots 5.5 months after onset. I don't know how to explain this improvement. Is there a way that the esketamine diffuses past the cochlea, into the cochlear nerve and beyond? If so then might it have some inhibitory local effect on the neurons, perhaps explaining the decrease in volume? If anyone can explain the mechanism of how I have gotten such improvement, I'm all... ears.

I think you got the real drug at the 2.5 month point as you say. You felt a large difference. Which is fabulous. Would you have had suck an improvement placebo?

Then at 5.5 months, you definitely got the drug, but by then it was too late. It sort of fits the picture that benryu was painting.

 

[Matt h]

Matt, congratulations! Could you clarify whether your improvement is due to your tinnitus loudness going down (possible effect from the drug) or whether it is simply that you have attained a positive mindset and are less bothered by it? I was not quite clear. Thanks.

Hi,
I think its down to possibly both my T was a lot better and that just lifted my mood and gave me time to focus, that it was not going to destroy my life. Which as you know it can do, i have had two bad days from work related stress, since i made my first post but i am sure it will back off if i do the right things.The worst thing for my is the emotional roller coaster i.e good to bad day ratio but i am having more good days than bad, hopefully they will tell me if i had drug or placebo but the trial team seem a little unsure i they find out themselves.
Matu

 

[earsnothappy]

It sounds like you are having success with it and got the real drug. How long from time since T onset till the injections? A 50% reduction tells me you are probably in the less than 3 months category. Thanks for the info and keep going strong. Good luck with whatever you choose re the follow up.

60 days after onset. Thanks for the support!

 

[dboy]

Hi,
I think its down to possibly both my T was a lot better and that just lifted my mood and gave me time to focus, that it was not going to destroy my life. Which as you know it can do, i have had two bad days from work related stress, since i made my first post but i am sure it will back off if i do the right things.The worst thing for my is the emotional roller coaster i.e good to bad day ratio but i am having more good days than bad, hopefully they will tell me if i had drug or placebo but the trial team seem a little unsure i they find out themselves.
Matu

Thanks & good luck with the next round of shots.

 

[Bart Marien]

Welcome Newguy, since you have gotten this recently I would definitely sign up for the AM-101 trial. I would read over this thread and other resources so that you can be better informed. If you go on Auris Medical's website they will have a section that details the trial locations.

By the way, I've been PM'ed that it was not clear so I will clarify:
I have gotten two rounds of treatment, the first round was the TACTT2 in which I may have gotten placebo (40% chance), and the second round was part of the AMPACT follow up in which I received the real AM-101 drug.

@Bart Marien and @StayPositive , how are you both doing? Any effects with the AM-101?

No effects here

 

[StayPositive]

@Bart Marien and @StayPositive , how are you both doing? Any effects with the AM-101?

Some of the additional tones I was hearing have somewhat subsided, but that may have been due to getting enough sleep for a change. My original T is the same.

 

[NewGuy]

Does anyone know the accepted level of hearing loss to still be apart of the am-101 study?

 

[locoyeti]

No effects here

Some of the additional tones I was hearing have somewhat subsided, but that may have been due to getting enough sleep for a change. My original T is the same.

Well, sorry to hear about this you guys. Its still kind of early though. I may have just gotten the real drug on the first round, but I could swear that the improvement before and after the second round was dramatic enough for me to think otherwise. I am also looking into this being maybe a trigger point / TMJD issue.

I remember delaying till the last moment possible starting the AM-101 trial because I wanted to see if it would go away on its own (I was 2 weeks away from the 3 month cutoff). I think from what I know now it might be a good idea for anyone to start the trial as soon as possible, in the off chance they get the real drug in the first round it would maximize its efficacy.

 

[lcho]

First time posting in these forums after following them since I recently began suffering from tinnitus, I'll be posting my progress with the AM-101 trial as my injections start next Monday

 

[lepli]

Good day to you,

I've just enrolled in the AM-101 phase 3 after discovering the Auris clinical trial two months ago. I'm from Belgium.

First of all, I wanted to greet people who posted their experience with the AM-101 trial (and anyone else on this forum); any good news are hopes of a better life somewhere in the future.

As mentioned in my presentation, I have a tinnitus for 11 months due to gun blast. Today, I can live with it but it remains a poison: continuous high pitch noise, sleep not as good as it was, ...

I got yesterday the device after having spent 4 to 5 hours with various tests. Injection is theorically scheduled in two weeks.

I found a few pieces of information stating that:
- AM-101 works better for <3 months trauma; meanwhile, I did not find any stats, just discussions threads;
- 0.81 mg/ml gives better results than 0.27 mg/ml but around 3-4% of patients reported 'much worse' T at 90 days for the 0.81 mg/ml. ( http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/ );

As I'll get the 0.27 mg/ml injection (or placebo ) in addition to an 11 months old T, I'm wondering if AM-101 would bring a real T decrease. I guess that 4+ months patients would have been excluded from the phase 3 if the phase2 results for such group would not have given somewhat better results than the placebo group?

Would someone have some info about these various points ? Thanks!

Lepli

 

[locoyeti]

Good day to you,

I've just enrolled in the AM-101 phase 3 after discovering the Auris clinical trial two months ago. I'm from Belgium.

First of all, I wanted to greet people who posted their experience with the AM-101 trial (and anyone else on this forum); any good news are hopes of a better life somewhere in the future.

As mentioned in my presentation, I have a tinnitus for 11 months due to gun blast. Today, I can live with it but it remains a poison: continuous high pitch noise, sleep not as good as it was, ...

I got yesterday the device after having spent 4 to 5 hours with various tests. Injection is theorically scheduled in two weeks.

I found a few pieces of information stating that:
- AM-101 works better for <3 months trauma; meanwhile, I did not find any stats, just discussions threads;
- 0.81 mg/ml gives better results than 0.27 mg/ml but around 3-4% of patients reported 'much worse' T at 90 days for the 0.81 mg/ml. ( http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/ );

As I'll get the 0.27 mg/ml injection (or placebo ) in addition to an 11 months old T, I'm wondering if AM-101 would bring a real T decrease. I guess that 4+ months patients would have been excluded from the phase 3 if the phase2 results for such group would not have given somewhat better results than the placebo group?

Would someone have some info about these various points ? Thanks!

Lepli

Hi Lepli,

I would double check your information because I am pretty sure that the concentrations they are using now is 0.81 mg/ml. I think you should go ahead and try, it might help and the procedure is safe enough, but you should go through this thread to check all the various viewpoints on this to come to your own decision.

 

[SteveToHeal]

Good day to you,

I've just enrolled in the AM-101 phase 3 after discovering the Auris clinical trial two months ago. I'm from Belgium.

First of all, I wanted to greet people who posted their experience with the AM-101 trial (and anyone else on this forum); any good news are hopes of a better life somewhere in the future.

As mentioned in my presentation, I have a tinnitus for 11 months due to gun blast. Today, I can live with it but it remains a poison: continuous high pitch noise, sleep not as good as it was, ...

I got yesterday the device after having spent 4 to 5 hours with various tests. Injection is theorically scheduled in two weeks.

I found a few pieces of information stating that:
- AM-101 works better for <3 months trauma; meanwhile, I did not find any stats, just discussions threads;
- 0.81 mg/ml gives better results than 0.27 mg/ml but around 3-4% of patients reported 'much worse' T at 90 days for the 0.81 mg/ml. ( http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/ );

As I'll get the 0.27 mg/ml injection (or placebo ) in addition to an 11 months old T, I'm wondering if AM-101 would bring a real T decrease. I guess that 4+ months patients would have been excluded from the phase 3 if the phase2 results for such group would not have given somewhat better results than the placebo group?

Would someone have some info about these various points ? Thanks!

Lepli

It is pretty much what I have come to learn anyway - Am101 works best for < 2.5 months :-( But its not official, so i guess it is still worth a try > 3 months... I agree with previous poster though. Read everything on this thread and make up your own mind.

 

[lepli]

Thanks for your replies. I'll check the threads for a better opinion and ask the coordinator for the 0.81/0.27ml choice for phase3.

 

[lcho]

Just had my 1st injection today, ear feeling full and slight hearing loss which is to be expected, so at the moment the tinnitus is slightly louder. Also just to clarify my tinnitus was induced by acoustic trauma.

 

[lcho]

2nd injection this morning, the feeling of fullness in my ear has increased and my tinnitus is at an all time high, although it should get worse before it gets better (if it's not the placebo)

 

[aarondowns22]

Hey icho, keep us with updates. I'm debating doing the injections. I'm at 5 weeks....

 

[Hudson]

2nd injection this morning, the feeling of fullness in my ear has increased and my tinnitus is at an all time high, although it should get worse before it gets better (if it's not the placebo)

From previous folks, I believe that the increase in tinnitus is usually a sign that you received the active drug.

 

[lcho]

From previous folks, I believe that the increase in tinnitus is usually a sign that you received the active drug.

Yeah I'm not sure whether the spike is because of the temporary hearing loss from the eardrum being perforated or not, but here's hoping I did get the actual drug! And I'll keep posting updates with my progress