AM-101 TACTT1 Results Released

[attheedgeofscience]

@attheedgeofscience did you have any luck in getting AM-101 off trial? When did you try and do you think the answer would be different now?

I'm getting concerned that I might be DQ'd because the Urgent Care place I went to put down sinusitis instead of ear infection on my medical forms.

You can try to contact Dr. Michael D. Seidman at the Henry Ford Medical Hospital. His department is part of the AM101 trials, and he is willing to perform the AM101-procedure off-trial (provided AM is willing to release the drug). They have been exploring this since early summer according to my information. I don't know what the conclusion is/was. I doubt that they will have been successful, however.

 

[OddV]

You can try to contact Dr. Michael D. Seidman at the Henry Ford Medical Hospital. His department is part of the AM101 trials, and he is willing to perform the AM101-procedure off-trial (provided AM is willing to release the drug). They have been exploring this since early summer according to my information. I don't know what the conclusion is/was. I doubt that they will have been successful, however.

Thank you.

 

[NewGuy]

Update- just got done with my second injection, my eardrum was still numb so they just injected into the hole that was from yesterday. No pain what so ever, just some popping from small air bubbles in the fluid.

 

[amandine]

@NewGuy
I dont know how you can be so brave! Ear still numb and just a few pops from air bubbles!! My god, it is so scary!! Maybe I am just a big wimp but I hate going to the dentist as well. Make a terrible fuss....so heaven knows how I will allow someone to come near me with a big needle ready to go into my ear!!!! Just thinking about it I am starting to shake! And you are so blase about it - I truly admire you.
However if I can get the info from the study centre and confirmation for first appt, then I shall go and have it done as there seems little out there otherwise that can help. Today is a loud day and yesterday was silent - weird.
Did you go alone? Or with a firend, relative or partner? If you did it alone, drove their or took the train and then the whole injections thing alone.....I am just not that brave these days.....I am I guess a weak person....although I was always considered the strongest one before the T...
Finally the one thing that I dont get....that AM are not asking people who have unilateral T for MRI tests and results. This is considered to be the most important and immediate thing to get done when T is only in one ear to rule out awful possibility of nasties. Seems strange to me that they can assume reason for T - I know that participant says it is due to acoustic trauma but how can AM be sure of this - surely they should be more responsible and ask for proof of no nasties? Anyway it is just what I think. Did anyone out there have an MRI before they did these AM-101 trials?

 

[NewGuy]

@amandine
Don't let my words seem scary, they are just the details of the procedure, truth of the matter is the people at the study site are very nice, talk and joked with them the whole time. As for the needle, I don't don't know what it looks like, I didn't look at it. I did drive here and go through this on my own. I don't look at it as a scary thing, I look at it as a good thing. Its a chance for us to get some relief. If you were strong before, don't let T break your spirit, keep strong. It sounds like things are already looking up for you, your getting sleep, your having good days with your T. And your trying to do something about it and not just give up, that is something I admire Keep strong and things will be just fine.
Please make sure you let us know if you get in the study.
P.S. this is way easier than going to the dentist

 

[amandine]

@NewGuy
thanks for those kind words. I however feel pretty ashamed of myself for being so useless. I have already said that if I get onto these trials there is no way that I can go there alone. So you can see how pretty useless I am.
Funny tho that I was always the one who never drank alcohol or used meds. By the way, I am not using any meds at all and I have to say that my body feels better for it.
And I did manage to sleep last night - but when the T was so loud this morning I spent the day in bed till dark again.Just my whole life seems to have been consumed by this T and even tho the TV is on now I am still pouring over this forum every minute....feeling very anxious altho friend here keeps telling me that as it went down on Sunday and then again on Wednesday to practically quiet, that it is a good sign that things will heal up....he says that I have to be positive and happy and do dumb things like an impossible jigsaw puzzle for example. He keeps suggesting playing playstation as a concentration thing but I hate the playstation as I am not very good hand coordination and so am rubbish at the play station so it is boring for me. I was always very academic and I always loved studying stuff and reading about all kinds of varying subjectgs and would be great in pub quizzes as someone who knows a little about lots of subjects - but now it seems that all I have left in life is this T which is completely consumung....how do you manage to be so confident and deal with everything and on your own. I am just such a scaredy cat....sorry...I know you are right about it being something good but we really dont know if we are getting placebo or not or even if the real thing will do any good at all. Please may I ask how you got your T? I am not really sure how or why mine came along suddenly.

 

[NewGuy]

@amandine
Well, your friend is right. Find something else to do, spending all your time on the forum keeps you concentrating on your T. Don't let it consume you, go out for a walk enjoy the sounds of nature, the more you stress over it the worse it is. Not sure how old you are but you have a life ahead of you, live it. I was really down on myself for awhile then decided this is just a part of me now so I have to keep going. Although its always there with me, things have been much better since I came to terms with it.
My T is from gunfire without hearing protection.
I also had the real loud days and then the quite days, then its just kind of balanced out, although I still get a bad day here and there.
Keep your head up, and don't be so hard on yourself, it causes stress.

 

[beemovie]

I see that alot of people are commenting on the am-101 trials. I know everyone wants hope but I will be shocked if this works. I say that because tinnitus is basically a form of brain damage. If you consider that tinnitus is a trait of autism, the likelihood of a cure is very far away. Here,... even children with aspergers have tinnitus: http://www.myaspergerschild.com/2010/12/aspergers-and-noise-sensitivities.html

 

[2131e]

@NewGuy thanks for all your posts here they're so encouraging. I'm not freaking out about the needle anymore.

Thanks @attheedgeofscience for your advice. I can't get to my test site in the UK for another month sadly so I'll be just past the acute stage - they're still happy to take me but who knows it might be ineffective even if I don't get placebo. I'm still leaning towards doing it and am going to talk with someone from the test site about it - if anyone has any questions they want me to put to them and post on here feel free to let me know and I'll ask them.

@NewGuy : what are the 7 drugs they test you for? Do you need to stop taking anti-anxiety medications (benzos like valium)?

I hope you get good results.

 

[SteveToHeal]

@NewGuy
I dont know how you can be so brave! Ear still numb and just a few pops from air bubbles!! My god, it is so scary!! Maybe I am just a big wimp but I hate going to the dentist as well. Make a terrible fuss....so heaven knows how I will allow someone to come near me with a big needle ready to go into my ear!!!! Just thinking about it I am starting to shake! And you are so blase about it - I truly admire you.
However if I can get the info from the study centre and confirmation for first appt, then I shall go and have it done as there seems little out there otherwise that can help. Today is a loud day and yesterday was silent - weird.
Did you go alone? Or with a firend, relative or partner? If you did it alone, drove their or took the train and then the whole injections thing alone.....I am just not that brave these days.....I am I guess a weak person....although I was always considered the strongest one before the T...
Finally the one thing that I dont get....that AM are not asking people who have unilateral T for MRI tests and results. This is considered to be the most important and immediate thing to get done when T is only in one ear to rule out awful possibility of nasties. Seems strange to me that they can assume reason for T - I know that participant says it is due to acoustic trauma but how can AM be sure of this - surely they should be more responsible and ask for proof of no nasties? Anyway it is just what I think. Did anyone out there have an MRI before they did these AM-101 trials?

If you are concerned then get an MRI done first to rule out a neuroma. They are very rare.

 

[SteveToHeal]

If you consider that tinnitus is a trait of autism, the likelihood of a cure is very far away.

I'm not so sure that is true. Have a look at the Autifony thread. It looks very promising (maybe not a cure but potentially a large reducer) with trials in the UK starting soon, targeting specific Kv channels at a neurological level which feeds into the brain's network. So it might well be that stopping it at source auditory cortex stops the feedback loop in the rest of the brain by calming down the hyperactive neurons. Hence why Retigabine for eplilepsy is being trialled here by TT members due to the nature of t being compared to mini "epileptic seizures", with some +ve results from some. I don't think being so -ve saying a cure is very far away when things are happening. Just my opinion but we need hope.

 

[SteveToHeal]

I see that alot of people are commenting on the am-101 trials. I know everyone wants hope but I will be shocked if this works.

However, i do hear you re am101. The results are not astoundingly great as we would have wished for.

 

[amandine]

@SteveToHeal
It is not that I think that I have anything wrong apart from the T, it is just that the ENT people said it is necessary and reading on the web, when there is unilateral T, then it must always be an MRI first. Obviously I am wrong as so many people are not having MRI's.
Yes the efficacy of AM-101 does not seem to be that great WITH a 10% chance of the T going up.
One of the conditions is that the T is maskable....well any T is maskable with loud enough external noise so how do they judge that? Or are they only interested in those who have very low inobtrusive T? And isn't that entirely subjective by the sufferer (as our dear Dr tell us all the time?)
Also they have to inject thru the ear drum and from what I have read, the inner part of the ear drum never heals properly. Is that incorrect ?
Yes Autifony seem to be targeting a brain problem rather than an ear problem.
Wonder if it is possible to do both am-101 and Autifony?
I just want it gone but am a bit skeptical about am-101....if anybody knows more and can suggest or show that it is really worthwhile then I shall do it....I know it is my decision and all that but I am trying to make a decision with no knowledge of facts really....

 

[amandine]

@2131e
Sadly I cannot get to speak to anyone at the test sites.
Well yes I would like to know, is it mainly for those with low or non obtrusive T?
What are the risks ie deafness etc...from the injections?
What are the real risks for T to go up from these injections?
What is the level of reduction in T that they are expecting comparing their phase 2 trials?
Is it true that the eardrum (inner side) will never heal properly after these injections?
How soon after the injections should one begin to feel a difference? if any?
If they know that it does not work after the 3 months then why are they still carrying out the trials on people who have had it 3 months to 1 year? Or is it not yet fixed in the brain until 1 year?
thanks.....

 

[SteveToHeal]

It is not that I think that I have anything wrong apart from the T, it is just that the ENT people said it is necessary and reading on the web, when there is unilateral T, then it must always be an MRI first. Obviously I am wrong as so many people are not having MRI's.

What i meant is have an MRI to rule out acoustic neuroma. You don't know if you have one until you have the scan. It can be a cause of t but very rare.

Yes the efficacy of AM-101 does not seem to be that great WITH a 10% chance of the T going up.

I don't think that is right.

One of the conditions is that the T is maskable....well any T is maskable with loud enough external noise so how do they judge that? Or are they only interested in those who have very low inobtrusive T? And isn't that entirely subjective by the sufferer (as our dear Dr tell us all the time?)

Yes. It's the tinnitus masking level. There was a post a while back or just go and look at the phase 2 results and you can see what the average was. From memory here but it was in the region 25 to 35 db MML. Std audiology. Use a tone as the masking sound and increase the gain till you can't hear your T anymore. Yes. It is subjective. That's why the results are far from perfect.

Also they have to inject thru the ear drum and from what I have read, the inner part of the ear drum never heals properly. Is that incorrect ?

I don't think so.

Yes Autifony seem to be targeting a brain problem rather than an ear problem.

IMHO it's all inter-related.

Wonder if it is possible to do both am-101 and Autifony?

No. Go check the eligibility criteria off Autifony. Can't have had any other T treatment within 30 days of taking the "wonder pills".

@SteveToHeal I know it is my decision and all that but I am trying to make a decision with no knowledge of facts really....

I'd say do the research and make a call. Nobody will take the responsibility of making the decision for you. Medical trials are a gamble. Some of us are bigger gamblers than others. Unfortunately it's the nature of the beast. Good luck!

 

[SteveToHeal]

What are the risks ie deafness etc...from the injections?

No reported cases. Read this: http://journals.lww.com/otology-neu...afety_of_AM_101_in_the_Treatment_of.4.aspx#F1

Well yes I would like to know, is it mainly for those with low or non obtrusive T?

Read link above. Explains the enrollment criteria.

What are the real risks for T to go up from these injections?

Nothing in the report states that except a temporary increase. However, I did see someone a while back saying that he had the injections and it was 10% louder. Perhaps just check with him if it has come down by now.

What is the level of reduction in T that they are expecting comparing their phase 2 trials?

I don't think anybody knows that. That is why they are running the trial 3 - 12 month to see. We'll only know once the results of phase 3 are out.

How soon after the injections should one begin to feel a difference? if any?

Have a look through this thread again. Some guys reported a reduction. I just don't remember how long after the injection, they got that reduction. The cycles are 3 months long. Some reported no improvement.

If they know that it does not work after the 3 months then why are they still carrying out the trials on people who have had it 3 months to 1 year? Or is it not yet fixed in the brain until 1 year?

I don't think they don't know it works past 3 months. It was something that benyru (where is that guy?) mentioned (got his inside info from source/auris) but then that was disputed by another member (also from source). So i'm also a bit unsure myself to believe if it works past 3 months or not? From what i have read tho, it does seem to look like efficacy reduces after time since t onset. The hypothesis is that it gets fixed in the brain past this point and where the Kv channel stuff comes into play. To make it all well :=) However, it's all a hypothesis at this point.

The bottom line is there is only this tinnitus targeted drug out there at the moment for consumption via clinical trial. Until Autifony starts up.

 

[OddV]

http://journals.lww.com/otology-neu...afety_of_AM_101_in_the_Treatment_of.4.aspx#F1

@SteveToHeal thanks for that link... Based on reading that, I believe that both @NewGuy and myself are the type of people that this drug could help early on. I had concluded that from reading this thread and other places, but that report pretty much cements my conviction that this is a good avenue for me at this time.

I hope that Auris has a compassionate use program.... I'm going to contact them next week to find out, but I *think* those programs are limited to life saving or severe diseases per the FDA.

 

[2131e]

@2131e
Sadly I cannot get to speak to anyone at the test sites.
Well yes I would like to know, is it mainly for those with low or non obtrusive T?
What are the risks ie deafness etc...from the injections?
What are the real risks for T to go up from these injections?
What is the level of reduction in T that they are expecting comparing their phase 2 trials?
Is it true that the eardrum (inner side) will never heal properly after these injections?
How soon after the injections should one begin to feel a difference? if any?
If they know that it does not work after the 3 months then why are they still carrying out the trials on people who have had it 3 months to 1 year? Or is it not yet fixed in the brain until 1 year?
thanks.....

@amandine

i spoke today with the AM101 trial doctor:
1. think it is designed for anyone with T, of any loudness/intrusiveness level
2. forgot to ask. i'd look at the scientific papers. there are a few cases of 'clinically significant' hearing loss. no cases of going deaf.
3. I asked about this: the doctor I spoke to says he's not at all worried the drug/procedure increases T, however he thinks it is possible people end up thinking their T is louder because they are asked to fill in a diary and they therefore end up focusing on their T all the time. He thinks cases of increased T post treatment are essentially induced by the patient's increased focus on T
4. didn't ask
5. they said this is a possibility but he said he isn't 'worried about it' because the needle is so small. he says the procedure involving injection is rather standard and not high risk.
6. didn't ask
7. no one knows. they haven't tested this. all they know is that if you treat rats with AM101 4 days after you give them noise induced tinnitus, the rats are cured. No one has any idea if that means it will work in humans, let alone what a 4 day time frame in the case of rats translates to in human terms. In the paper on the efficacy of the second AM101 trial they say in the last paragraph that the 3 month window is 'arbitrary anyway' and therefore AM101 should be tested over longer timeframes. Basically no one knows.

In terms of eligibility, you need to have T that is constant, not induced by infection, not be pregnant, not be on drugs (at least, not within 2 weeks of having the blood test, which is during the appointment just before the 1st injection.... there is an initial consultative appointment before that where they give you a diary device to fill out but where there is no blood test) and no history of mental illness in the last 6 months (at least, these are all the criteria I remember from our conversation)

 

[OddV]

@2131e they are accepting patients with T brought on by inner ear infection, just FYI.

 

[2131e]

@OddV aah ok - I thought the reason they asked about infection was as an exclusion criterion. I see that it wasn't.

 

[bedouin]

@amandine

i spoke today with the AM101 trial doctor:
1. think it is designed for anyone with T, of any loudness/intrusiveness level
2. forgot to ask. i'd look at the scientific papers. there are a few cases of 'clinically significant' hearing loss. no cases of going deaf.
3. I asked about this: the doctor I spoke to says he's not at all worried the drug/procedure increases T, however he thinks it is possible people end up thinking their T is louder because they are asked to fill in a diary and they therefore end up focusing on their T all the time. He thinks cases of increased T post treatment are essentially induced by the patient's increased focus on T
4. didn't ask
5. they said this is a possibility but he said he isn't 'worried about it' because the needle is so small. he says the procedure involving injection is rather standard and not high risk.
6. didn't ask
7. no one knows. they haven't tested this. all they know is that if you treat rats with AM101 4 days after you give them noise induced tinnitus, the rats are cured. No one has any idea if that means it will work in humans, let alone what a 4 day time frame in the case of rats translates to in human terms. In the paper on the efficacy of the second AM101 trial they say in the last paragraph that the 3 month window is 'arbitrary anyway' and therefore AM101 should be tested over longer timeframes. Basically no one knows.

In terms of eligibility, you need to have T that is constant, not induced by infection, not be pregnant, not be on drugs (at least, not within 2 weeks of having the blood test, which is during the appointment just before the 1st injection.... there is an initial consultative appointment before that where they give you a diary device to fill out but where there is no blood test) and no history of mental illness in the last 6 months (at least, these are all the criteria I remember from our conversation)

I am on the trial for 3 to 12 months and can say this.

1. As long as they can mask your tinnitus at a low enough and high enough level then you tick that box in the screening process tests. So a 10% tinnitus would probably only need a masking tone of 5 decibels which is too low. But a 100% might need a masking tone of 85db and too high (nobody would have tinnitus this loud)! Exaggerated to make a point! So as long as your tinnitus is discernibly maskable then you fit the criteria. They attach you to a bone conduction tone transmission head piece (basically instead of head phones it's a metal strip with one end touches your bone behind your ear, the other nothing). It's what you can have tested if you go to any audiologist surgery that they use to test if you can hear with your ears blocked. They then play tones and you tell them at what volume the tone you can no longer hear your tinnitus. That they then mark down as the masking level. Most people with tinnitus will pass this test.

2. After having the injections my hearing was as good as before. No hearing loss.

3. Tinnitus after injections was higher. Went down after a few weeks. I've had some low days, some high days after that but pretty much the same as it was before the injections. Pretty bad - average 7/10. So no improvement but could have had the placebo. My tinnitus at injection time was at 9 months. I have to agree with the doctor there. Perceived tinnitus level is possibly higher because of concentrating on it more during each day. The e-diary also asks you to report each day on tinnitus loudness and annoyance 1 to 10. So being on a trial for tinnitus and reminded every day could increase perceived tinnitus loudness and annoyance.

4. Being in the 3 too 12 month category, mine has not gone down but could have been given the placebo.

5. Procedure was painful for me, especially on day 3. Maybe because I have tinnitus in both ears. They use the same hole from the previous day which i found sensitive from the previous days perforation. Most of the pain came from when the liquid was being pushed into the ear. Like a feeling of the liquid pushing from the middle ear back against the inside of the ear drum pressure. A lot of people say it was painless for them. I can't say the same. Maybe i'm not made of sterner stuff like them ;-) But i'm still glad i went for it and winced through the pain.

6.I can't say because I felt no improvement.

7. I think they had some positive results in less than 3 months so like you said they say in the last paragraph that the 3 month window is 'arbitrary anyway' and therefore AM101 should be tested over longer timeframes. So the opportunity to participate and see!

For the screening i found that you had to say your tinnitus was constant and had a letter saying when you got tinnitus. It dos go up and own but on the whole it averages 7/10. Mine was from noise damage so i'm not sure about infection. They say acute otitis media so i think that is infection. I had to come off the sleeping tablets and anti-depressants so they could tell if the drug was working and not the tablets. I stopped drinking (don't have to) and i don't do drugs. Also the tone of the tinnitus if it changes you get asked. Mine is pretty much the same. I remember having to make sure i fit the criteria and was told by the doctor that it is very strict to get through the screening. They had had quite a few people that did not get through the screening so i made sure i fit the criteria to make the effort as a lot of people don't get the chance.

I do the follow up on 4th Nov and with the drug this time. S0 I am hoping tinnitus will go down even though i know it is longer past even the 9 months as i am desperate to reduce the tinnitus. I want to get on the Autifony trial but the hearing loss part i won't get through on but will try.

 

[NewGuy]

@NewGuy[/USER] : what are the 7 drugs they test you for? Do you need to stop taking anti-anxiety medications (benzos like valium)?

I hope you get good results.

Yes, they test for benzos, I remember seeing marijuana,meth, and cocaine. I don't remember what the other 3 were.

 

[NewGuy]

Update
Last night after my second injection before I went to bed and when I woke up this morning I have a slight pain, like an earache. Nothing that is discouraging, I am sure it is just because of all the activity going on with my ear the last couple days. I go in for my 3rd injection in just a few hours. I will continue to keep you all updated.
If anyone has questions, feel free to ask. If I miss any questions I apologize in advance and just remind me, I will answer anything.
Thanks all

 

[NewGuy]

On a side note, the study center told me they are always looking for new drugs to test and I talked to them about Autifony and Otonomy, they were interested. If they can get on the trial list for these companies I will let everyone know.

 

[amandine]

@NewGuy
Sorry to hear that you have earache....hope it is not too bad. Someone else posted here that they had pain when having the injections. Scary stuff!

 

[NewGuy]

@NewGuy
Sorry to hear that you have earache....hope it is not too bad. Someone else posted here that they had pain when having the injections. Scary stuff!

I suppose its par for the course. And remember, pain is temporary

 

[amandine]

@NewGuy
So pain is temporary but this pain is not temporary....it is there 24/7 like a torture.
Apparantly most of the participants in these trials are men. Wonder why that is? Maybe the girls are just too cautious - dont know.
I dont know whether to wait it out and see what happens - cos if the drug (s) work then they should become available to all over the next year I would have thought - no?
Have sent email to the centre in Tours for someone to call me or email me back. Could not find a trial coordinator so will be speaking (when he calls) to the chief who is in charge of these trials. Trying to ask about the expenses side being covered as money is now a real issue and there simply isnt enough to pay for the petrol and hotel cos then the account will be empty and wont be able to pay the bills. But if can claim it back?

Today it seems to have gotten a bit quieter again but not as quiet as was on Wednesday. Anyhow dont want to go on......

By the way New Guy, how are you sleeping now with all these injections and stuff going on? Hope you are getting good nights. Nobody on here has yet reported good findings or relief having taken part in these trials...but then they dont yet know if it was placebo or real. But today is your last injection and then I expect you'll be heading home....for the weekend....and then you have to be back in 7 days? for next appt?
Also,what kind of stuff do you have to fill in the diary during the first 14 days pre injection and then thru these days? Just wondering cos hope it is not too difficult as I would have to do all this in french and not my mother tongue....or maybe i can write in english and they can translate. I can speak french okayish but writing is harder......

 

[beemovie]

Does anyone know what stage is this trial in? I know in stage 1 trials the placebo rate is a very high %.

 

[OddV]

@amandine I wouldn't worry about the language you would need to report in, just use Google translate if you need to. I know you are struggling with the decision, but if you can get to the screening, I would do it 100%. Just read through this thread on how you need to present it.

 

[OddV]

Does anyone know what stage is this trial in? I know in stage 1 trials the placebo rate is a very high %.

Stage 2, placebo rate is 40%.. If you get placebo, you are invited to next stage where you are guaranteed drug... Guess this is to test effectiveness after the 3 months.