AM-101 Clinical Trial — Participants Updates and Discussion

[liquefact]

After one month of my application to AM101 trials, today i've been invited for a screening next week. The 3 month window for me closes on Dec 25th so if i'm accepted, i'll barely make it.

If i need describe my T after ~2 months, i'm doing much better managing it. It may have become a little quieter over time but i it's still always hearable except the shower. Mostly my reaction changed for the good. Anxiety, depression and panic attacks are long gone (1 month ago). Also i'm not annoyed any more by T and i can even focus and listen to it without getting nervous. So i'm probably doing fine and feel like i can live with that.

The problem is, there is no guarantee that it'll stay like this. There is a good chance that it'll increase over time, maybe very slowly, or i'll do something stupid and have an increase, idk. I want to do as much as can be done at this stage so that the damage in the inner ears can be undone, even if a little. But i'm very afraid too. I hope i do not back off at the last moment.

 

[greenpointer]

I'm very close to the end of the study period for my first round of injections. I'd say I've had a slight improvement, but naturally there's no way of knowing if it was the drug, since I may have gotten placebo.

I have to decide in the very near future if I'll go for the open-label round. This decision is actually much harder than it was to take part in the first round, because the potential benefit vs. risk balance has shifted for me. The odds of benefitting have lowered (since my T is now further along and passing the acute stage), and the risk is higher because I have a slight but stubborn side effect involving a pulsing sensation that makes my T louder with my pulse. Its very faint, and not bothersome, but I'm worried it might become a problem with another round of injections. (By the way I can't say for certain it was the injections that caused the pulsing, but I first noticed it the morning before my third injection, so I'm guessing it was.) Still, I do not regret taking part in the study.

Anyways, such a tough decision because the risk vs. reward of the open-label is like dead even in my mind. I'll keep you guys posted though - best of luck to anyone else entering the trial. (PS I really wish there was a tally on this site for us to keep track of people who report improvement in the AM-101 trial, and at which phase.)

 

[JohnK]

The odds of benefitting have lowered (since my T is now further along and passing the acute stage)

Don't be so sure. @OddV had his most effective round of AM-101 injections 8 months in, IIRC.

I am like you in that if I can get in the trial, my second (and with my luck, first non-placebo) injection would be around the 6 month mark. Unless it goes horribly wrong in round 1, I don't see myself NOT doing round 2!

 

[Koen]

I got the same feeling as @greenpointer . The idea of getting placebo in the first round sucks since there seems to be a downward curve of efficacy somewhere between 3 and 6 months. And even when you do get it before 3 month, we're talking about improvements. The http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/figure/F2/ graph also had a lot of the placebo people rating many improvements. And these improvements were all within 3 months.
I am still wondering what else the injections would improve except the temporally 'chilling' of the ' glutamine storm'. I believe I read somewhere the nerves can die of from this overflow of glutamine. My feeling is that this battle is list very fast. Because they seem to assume the 'storm' passes or would the product also influence the glutamine creation.

 

[newarrior]

David:


Thanks for your various messages. Currently, we only have one clinical trial open for recruitment in the US – TACTT2 with our drug AM-101 for the treatment of acute inner ear tinnitus. Acute means: up to 3 months from onset. Please check for additional information on eligibility criteria our website www.tinnitus-study.info. From your messages I understand that your tinnitus and hearing loss have been around for much longer.


Kind regards,


Thomas Meyer

 

[JohnK]

I think they don't see themselves as saving your hairs from dying of glutamate, but rather just calming the dead screaming ones. The time limit is not "this is how long your dying hairs have to live" so much as "this is how long until the signal gets internalized in the brain and thus much harder to switch off"

(I refuse to say "impossible." Trobalt has proven that you can switch the brain part off)

 

[JohnK]

Perhaps a future treatment would be an AM-101 treatment to stop the signal coming from the ears, and then another treatment of the brain itself to tell the signal has stopped and it needs to loosen up enough to go back and check

 

[jay-alex]

Perhaps a future treatment would be an AM-101 treatment to stop the signal coming from the ears, and then another treatment of the brain itself to tell the signal has stopped and it needs to loosen up enough to go back and check

I'm inclined to agree with you, here. From the reading I've done, the best treatment for T will be multimodal. Thus, treating or repairing the inner ear followed by some sort of therapy for the brain to readjust would provide the best results, in my opinion. This is opposed to treating just one or the other. I personally believe that the best forms of treatment for T will involve fixing the original source of damage (this would generally only be individuals that suffer from T due to acoustic trauma, barotrauma, otitis media, or the like) before doing anything else.

Alternatively, the T signal could be filtered out from reaching the conscious part of the auditory cortex but that would require a tremendous amount of information on the mechanism of T and finding a way to induce a neurological change that would allow T sufferers' brains to filter this out. This "filtering" (that occurs in the TRN I believe) is what prevents some individuals for developing T. These individuals "have" it but it never reaches the higher parts of the brain. This isn't exactly proven, but it makes sense to me.

 

[Ecip]

Seems the best bet so far is MRI guided high intensity ultrasound treatments.

 

[JC81]

Quick update, I have felt alot better down to like 1-2/10 most of the time. I decided against it at this point and will wait to see what happens in the future with treatments or possibly when AM-101 is approved, on the market and closer to home... Considering there are reports in this thread of people having improvement 8-12 months out it's a possibility.

I would say I feel like I am around where I remember my ears being? So maybe I have had a bit of it in the past. I don't know, it seems like a lot of time and work which wouldn't be easy for me to coordinate, as well as the possibility of getting a placebo. I know that tympanic membrane injections are considered safe but I just don't feel that great about it for potentially no treatment the first time around, and I know my horrendous luck......

I am trying to get an ENT appt, its not easy around here. I don't know if I have some neck strain or jaw issues that contributed to it. Lastly, I will certainly be listening to music lower, wearing ear plugs to any loud events I go to and trying to exercise more so that I can ride out the years in comfort until a commercial treatment is available.

Other info- I have been taking NAC 600mg 1x daily, Magnesium Oxide 500mg 2x daily, Vitamin C 250 in the afternoon 500 at night, Zinc 50mg 1x daily, Fish Oil 1200mg 2x daily, 1x Multivitamin.Trying that plasticity website once daily seems to help some. Also I have been trying to keep my neck straight not strained and not to have an clicking in my jaw or popping from chewing too fast. Keeping occupied has been an amazing amazing amazing relief for me. While I hear it from time to time during the day, at night when I try to sleep and ambient is low I hear it but it is quiet enough I don't need to mask.

I had some dark thoughts, none ever suicidal, mostly just the oh man if it's X loud I could deal with it and eventually I will die when I am 70 righ? Then I'll have peace? Then the thought of 53 years of listening to it would start the loop again for me. DONT do it!!!!

I wish every one good luck and will say a prayer for all of us and a treatment or cure sooner rather than later.

 

[Ecip]

Quick update, I have felt alot better down to like 1-2/10 most of the time. I decided against it at this point and will wait to see what happens in the future with treatments or possibly when AM-101 is approved, on the market and closer to home... Considering there are reports in this thread of people having improvement 8-12 months out it's a possibility.

I would say I feel like I am around where I remember my ears being? So maybe I have had a bit of it in the past. I don't know, it seems like a lot of time and work which wouldn't be easy for me to coordinate, as well as the possibility of getting a placebo. I know that tympanic membrane injections are considered safe but I just don't feel that great about it for potentially no treatment the first time around, and I know my horrendous luck......

I am trying to get an ENT appt, its not easy around here. I don't know if I have some neck strain or jaw issues that contributed to it. Lastly, I will certainly be listening to music lower, wearing ear plugs to any loud events I go to and trying to exercise more so that I can ride out the years in comfort until a commercial treatment is available.

Other info- I have been taking NAC 600mg 1x daily, Magnesium Oxide 500mg 2x daily, Vitamin C 250 in the afternoon 500 at night, Zinc 50mg 1x daily, Fish Oil 1200mg 2x daily, 1x Multivitamin.Trying that plasticity website once daily seems to help some. Also I have been trying to keep my neck straight not strained and not to have an clicking in my jaw or popping from chewing too fast. Keeping occupied has been an amazing amazing amazing relief for me. While I hear it from time to time during the day, at night when I try to sleep and ambient is low I hear it but it is quiet enough I don't need to mask.

I had some dark thoughts, none ever suicidal, mostly just the oh man if it's X loud I could deal with it and eventually I will die when I am 70 righ? Then I'll have peace? Then the thought of 53 years of listening to it would start the loop again for me. DONT do it!!!!

I wish every one good luck and will say a prayer for all of us and a treatment or cure sooner rather than later.

I would also recommend pycnogenol to you, as well as vinpocetine. Both are shown to increase blood flow to the inner ear and have helped some peoples tinnitus. Vinpocetine works similarly to gingko biloba but has a faster effect (7 to 10 days vs 4 to 5 weeks, respectively).

 

[PnL67]

AM-101 is it working on hyperacusis ?

 

[Silvio Sabo]

While talking to a site coordinator, I was told they've treated 3 patients so far. One had total elimination of T. Here's hoping...

3 chronic patients?

 

[JC81]

I would also recommend pycnogenol to you, as well as vinpocetine. Both are shown to increase blood flow to the inner ear and have helped some peoples tinnitus. Vinpocetine works similarly to gingko biloba but has a faster effect (7 to 10 days vs 4 to 5 weeks, respectively).

Thank you I will take a look into it and maybe order a bottle of it.

Edit- I cant change the post above any longer but it should read 43 years lol I am 27 now.

 

[JohnK]

3 chronic patients?

No, 3 acute patients that met the inclusion criteria.

 

[ali can]

Hi. I wonder That have mild T maybe ı can only hear it at night but ı have anxiety and 1/10 is it worth that ?
is there a chance to gone completely I want to participate for AM101

 

[JohnK]

I wonder That have mild T maybe ı can only hear it at night but ı have anxiety and 1/10 is it worth that ?
is there a chance to gone completely I want to participate for AM101

The answer to both your questions (is it worth it and to make it gone completely with AM101) is: probably not.

 

[Neilpk]

I am sure I have read somewhere that this trial has been expanded to include people with T up to 6 months.

Is this correct?

 

[GrosBalou]

You are partly right. Most countries in Europe (if not all) accept tinnitus up to 6 month old, but in some other countries the trial is limited to 3 months old tinnitus.

Here's the link for UK : http://www.tinnitus-study.info/uk-the-study

 

[Joe Bananas]

The answer to both your questions (is it worth it and to make it gone completely with AM101) is: probably not.

JohnK, you mean there's no way for this guy's T to completely go if he undergo the AM101 trial even having such a mild T?

 

[JohnK]

JohnK, you mean there's no way for this guy's T to completely go if he undergo the AM101 trial even having such a mild T?

I don't actually know, but I wouldn't get hopes up. I have mild T, and I am trying to do AM-101, and I would LOVE if it got my T down to 0. It has for some. But I will go in assuming it will give me a decrease between 0 and 50%.

 

[JohnK]

I'm actually on a plane right now flying to a clinical trial site for my screening. Here's hoping it goes well!

 

[GrosBalou]

I don't actually know, but I wouldn't get hopes up. I have mild T, and I am trying to do AM-101, and I would LOVE if it got my T down to 0. It has for some. But I will go in assuming it will give me a decrease between 0 and 50%.

I think that's the way to go ! Plus, you're helping science
Good luck !

 

[donico]

I'm actually on a plane right now flying to a clinical trial site for my screening. Here's hoping it goes well!

Travelling overseas or in your country?

 

[Joe Bananas]

I don't actually know, but I wouldn't get hopes up. I have mild T, and I am trying to do AM-101, and I would LOVE if it got my T down to 0. It has for some. But I will go in assuming it will give me a decrease between 0 and 50%.

Hope you don't get the placebo, mate. Fuck this sci-fi shit we are going through!! Are they paying the flying/accomodation expenses for you?
I already did my screening appointment and I will have the second one plus be given the PDA next January 13. These Christmas holidays interrupted all possibilities of having them done sooner. After getting the PDA I will have to complete a daily questionary during 10 days, then January 23 I will be having the injections. Thing is I will be two weeks out of the 3 months mark by then.

 

[Bertman]

@Joe Bananas Good luck man. I tried getting in but was too late. I was two weeks away as well but I hadn't done any of the screening or anything and since that takes time I didn't make the cut. Sounds like you should make it though.

 

[Joe Bananas]

@Joe Bananas Good luck man. I tried getting in but was too late. I was two weeks away as well but I hadn't done any of the screening or anything and since that takes time I didn't make the cut. Sounds like you should make it though.

Hope so, I am not going to give up with any chance I have to get rid of this. My whole life is a complete mess now and I can't afford to deal with such an infamous source of anxiety and depression. Later on, if nothing helps, I'll have to negotiate with habituation but now is time to look for a solution. Also, my T seems to be changing and getting lower, but as I had 4/5 horrible spikes in the last two months I can't predict how it is going to behave. Now or never.

 

[JohnK]

Survived the initial screening. They took some blood, had me read and sign 20 pages worth of legalese about the trial. Sent me to a nearby audiologist to get another ear exam and hearing test.

I now have the little HTC phone device. Annoyingly it's totally locked down to the point where i can't even get into settings to add a wifi connection (which I'd like to do since I'm about to travel to Asia and I don't think the SIM card they've put in here has global roaming...hopefully it will just cache my data locally until I'm back in the USA and it can "phone home").

Hopefully the device works, no other issues crop up and I can get the injections the first week in January (and hopefully that isn't placebo!)

 

[Charlie396]

The problem is, there is no guarantee that it'll stay like this. There is a good chance that it'll increase over time, maybe very slowly, or i'll do something stupid and have an increase, idk. I want to do as much as can be done at this stage so that the damage in the inner ears can be undone, even if a little. But i'm very afraid too. I hope i do not back off at the last moment.

You pretty much described my fears exactly dude. 2 weeks in, it appears I fit the bill for a candidate from their website. The thought of being a guinea pig in a drug study just scares me so much

 

[Joe Bananas]

Survived the initial screening. They took some blood, had me read and sign 20 pages worth of legalese about the trial. Sent me to a nearby audiologist to get another ear exam and hearing test.

I now have the little HTC phone device. Annoyingly it's totally locked down to the point where i can't even get into settings to add a wifi connection (which I'd like to do since I'm about to travel to Asia and I don't think the SIM card they've put in here has global roaming...hopefully it will just cache my data locally until I'm back in the USA and it can "phone home").

Hopefully the device works, no other issues crop up and I can get the injections the first week in January (and hopefully that isn't placebo!)

John, from my understanding you absolutely have to fill the HTC questionary on a daily basis from now until they give you the next appointment in order to demonstrate your involvement with the trial. English is not my first language so I don't know if I am explaining this the propper way. The goal for them having you to fill that questionary now is, beside collecting details about your T to compare them with the post-injection ones, to see how serious you are about filling it on a daily basis, so my adivice is that better you try to fix the problem asap.
Regards, bro.