AM-101 Clinical Trial — Participants Updates and Discussion

[amandine]

@James White

But

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

So you still had the full quota of injections. But made no difference to you. All the injection hole, the T spike following injection etc...has all gone away and you are the same as before the injections?
You are from Toulouse and therefore the trial study was in your own city so not difficult to get there. I am wondering why you didnt go for more having already suffered the initial 3 injections which must be the worst thing. Hope you dont mind me asking and please tell me to bxxxxxr off if it is none of my business and you would rather not answer this.

 

[cullenbohannon]

quick summary for me, ive written a lot about am101 experience so ill keep this short, After my injections i had louder t for a while because of the liquid in the ear and my ear drum felt numb for a while after. After about two weeks i thought i had a change it was lower and more tolerable, but now i really don't know, my T gets louder some days and quieter on others. All in all im happy i went through with it. It is a common procedure, and has an established saftey profile from previous phases. Wish i could definitely say it was quieter or louder, but im not sure.

 

[amandine]

@cullenbohannon

My T seems to be up for 2 days then real quiet for third day and then up again.
Does this up and down without the injections.
As yes have not had one person (i think) that can say yes definite improvement post injections - even those who had follow up injections so they know they got the real deal.
Doesnt seem that promising for am-101 as I would have thought that by now there would be at least one person with a good positive report saying improvement by now....what do you and others think?

 

[tomm]

@cullenbohannon

My T seems to be up for 2 days then real quiet for third day and then up again.
Does this up and down without the injections.
As yes have not had one person (i think) that can say yes definite improvement post injections - even those who had follow up injections so they know they got the real deal.
Doesnt seem that promising for am-101 as I would have thought that by now there would be at least one person with a good positive report saying improvement by now....what do you and others think?

Admittedly it's not a great sign. Best thing would be to assess the results from those people who got the second round of the real thing.

 

[cullenbohannon]

Yes unfortunately we have not been to lucky here on TT. But I do remember seeing a reddit user who had great success with it. I think we are much to small a sample size to make a conclusion one way or another.

@cullenbohannon

My T seems to be up for 2 days then real quiet for third day and then up again.
Does this up and down without the injections.
As yes have not had one person (i think) that can say yes definite improvement post injections - even those who had follow up injections so they know they got the real deal.
Doesnt seem that promising for am-101 as I would have thought that by now there would be at least one person with a good positive report saying improvement by now....what do you and others think?

 

[amandine]

@cullenbohannon

Put out a search on dr google to see if there were any success stories re am-101 phase 3 injections and came up with nothing.
If you look at the results from phase 2, it says that in some patients there was a 50% decrease but 10% of people suffered an increase - I think that subsided afterwards. Yes a permanent 50% decrease would be fantastic - but none of their results seem to be spectacular.
I am interested to understand why people think that Autifony in UK would be good - for me it is the fact that it is pills and not injections - but otherwise I have no idea.
Do you or anyone know why Autifony would be a good one as opposed to A Medical?
Love to hear from you and all
thanks
amanda

 

[amandine]

@cullenbohannon

I have looked for ''reddit'' but cannot find it.
Do you have a link please.
thanks
amanda

Yes unfortunately we have not been to lucky here on TT. But I do remember seeing a reddit user who had great success with it. I think we are much to small a sample size to make a conclusion one way or another.

 

[cullenbohannon]

When I get a chance I will give you my thoughts on autiofony. I would suggest reading over @benryu posts. He explained it well I think.

For the reddit link check the first page of the am101 thread.

 

[amandine]

@cullenbohannon

thanks for that - will have a look
Please do send me your thoughts on autifony on forum or personal conversation - whatever you feel better with. Would be very interested to know. I take it your thoughts on am-101 are not that positive then?
Thanks
be well

 

[amandine]

@cullenbohannon

Went to have a look for the reddit link on first page of am-101 and then found there are several threads with am-101, please can you tell me which one I need go to?
thanks
amanda

When I get a chance I will give you my thoughts on autiofony. I would suggest reading over @benryu posts. He explained it well I think.

For the reddit link check the first page of the am101 thread.

 

[OddV]

@cullenbohannon

Went to have a look for the reddit link on first page of am-101 and then found there are several threads with am-101, please can you tell me which one I need go to?
thanks
amanda

http://www.reddit.com/r/tinnitus/comments/1m1kiy/follow_up_on_am101_study_i_participated_in/

 

[amandine]

@OddB

Good of you. Thanks.
amanda

 

[amandine]

Looked at reddit. thanks.
Is that it? Only one person who had one injection in the phase 2 trials of am-101 has reported any success? Surely there must have been more who took part who could declare success if it was a good drug, especially as the phase 3 has been running a little while now..with the 3 injections at the higher dose of phase 2. All very well what the company blurb is- but I would have thought that we could have heard from more people with success following the injections.....or am I being a bit too impatient....

 

[James White]

@James White

But
So you still had the full quota of injections. But made no difference to you. All the injection hole, the T spike following injection etc...has all gone away and you are the same as before the injections?
You are from Toulouse and therefore the trial study was in your own city so not difficult to get there. I am wondering why you didnt go for more having already suffered the initial 3 injections which must be the worst thing. Hope you dont mind me asking and please tell me to bxxxxxr off if it is none of my business and you would rather not answer this.

Well, enduring the trial is a lot of my time and it's kind of stressful. I thought i would give one chance to being in a trial but you always have this idea in mind that it may harm you so that's why i didn't take the 2nd chance.

My tinnitus is annoying but it's not extreme so i thought i would wait for the study results and see how AM101 works on a lot of people when it's released to the public. The other thing is I suppose my tinnitus comes from audio trauma but it's hard to tell.

 

[amandine]

@James White

Thanks for your reply.

I am more than 300kms each way from my closest study sites. I have tried Tours and the chap there says they are full up which I dont believe. I think it is just he does not want an english person there.
So the other option is Toulouse.
My problem is that I am trying to speak to a trial coordinator from Toulouse (or anywhere in france - just does not happen, cannot get to speak to anyone) to find out if my travel expenses will be covered incl hotel whilst i need to stay in Toulouse.
From the AM website it says that AM cover all reasonable travel expenses and I know that in the UK and in the States that travel and hotel is covered - in uk up to 60 pouonds per night for hotel and max for petrol but not sure what that is.
I need to be able to pay to go and come back and stay overnight which I cannot do without reimbursement.
Why oh why can I not speak to anyone there?
i shall try contacting using the lady's details from Toulouse that you sent me.
As you did the trials in Toulouse, do you know the trial coordinator phone number and name please?
Do you know whether your expenses or experses were covered / reimbursed?
I freel a lot like you - my T however is extremely intrusive and I really dont know how to cope with all of this and am beginning to fall apart here.
I am however dubious as to how good am-101 really is as have not seen any real positive results being reported from participants altho it may be a bit too early for that yet. But I am afraid like you of of any harm being done to me and too would find the whole experience of going there and having the injections and going thru the whole trial etc...incredibly stressful and debilatating - however if it could get rid of this T then of course it would be worth it. I am just worried about the T going up due to the trial and other problems etc.... Other people have reported that their T went up in volume after the injections like @NewGuy but dont know if it went down yet for him.
So all in all I am scared to be part of the trial but am also scared to not take part as I cant live with this T as it is so intrusive as to me having no quality of life left anymore and I am hanging on by my finger nails to sanity now.

 

[James White]

@amandine the trial coordinator number is the same as the one i gave you in private message

 

[amandine]

@James White,

Ok James thank you for that.
Do you know anything about travel expenses being payed or not?
Guess I can try the number you provided and see if I can get any answers that way.
thanks
amanda

 

[James White]

@James White,

Ok James thank you for that.
Do you know anything about travel expenses being payed or not?
Guess I can try the number you provided and see if I can get any answers that way.
thanks
amanda

Guess you should call them yeah as i didn't need travel expenses being paid so i don't really know

 

[NewGuy]

Hey all, sorry its been a few days since my last post. Well not much has changed the last couple of days, my T is still loud most of the time. I am still getting draining out of my ear, last night was a lot of fluid. I am hoping this will stop in the next few days. I go in for my first follow up on Thursday. I try my best to not pay attention to my ear, but its hard because of the full feeling. I will keep posting when I can.
Thanks

 

[amandine]

@NewGuy

Thank you for getting back - missed you!
Sorry to heat that things are not yet improved - at the study centre, did they tell you about these initial effects that you would or might have - this ear draining....full feeling.....or have louder T.? You dont mention the earache so I hope it has resolved itself?
Think you are so very brave! and such a wonderfully positive person.....
with all the very best to you
amanda

 

[amandine]

Just wondering if anyone has seen anything from @T-Bach lately? He had the injections on the am 101 trials. Last time saw any report message from him is a few weeks ago - I would love to get in touch with him again....dont know how....to see how he is getting along....

 

[bedouin]

It normally has to be motivated by the trial co-ordinator but you can get them to pay up to £60 per night for accommodation. Just clear it with him/her first. The first set of injections are 3 days, so they will normally cover 2 nights. They expect you to return home the night of day 3. However, if say, the injections are scheduled for later in the day on day 3, and you are unable to get home that night, then the trial co-ordinator can motivate the medical monitor (the person who speaks to AurisM) to pay for a 3rd night. They cover up to a maximum of £35 per journey (one-way) in travel costs. They had a £2 per day cafeteria allowance. In total those 3 things were all i was able to claim back.

 

[amandine]

@bedouin

Hi,
Just replied to your other post re autifony and october 27

You did your trials in the UK then? I just spoke to @DannyBoy who is due to start his tomorrow and he was told that they only pay up to 30 GBP for travel costs and they do not cover hotels? So don't understand what is going on? Where in UK did you have it done.??..saving me if you dont mind from looking back at your earlier posts, did you do the injections yet and how are you now?

thanks amanda

It normally has to be motivated by the trial co-ordinator but you can get them to pay up to £60 per night for accommodation. Just clear it with him/her first. The first set of injections are 3 days, so they will normally cover 2 nights. They expect you to return home the night of day 3. However, if say, the injections are scheduled for later in the day on day 3, and you are unable to get home that night, then the trial co-ordinator can motivate the medical monitor (the person who speaks to AurisM) to pay for a 3rd night. They cover up to a maximum of £35 per journey (one-way) in travel costs. They had a £2 per day cafeteria allowance. In total those 3 things were all i was able to claim back.

 

[bedouin]

@bedouin

Hi,
Just replied to your other post re autifony and october 27

You did your trials in the UK then? I just spoke to @DannyBoy who is due to start his tomorrow and he was told that they only pay up to 30 GBP for travel costs and they do not cover hotels? So don't understand what is going on? Where in UK did you have it done.??..saving me if you dont mind from looking back at your earlier posts, did you do the injections yet and how are you now?

thanks amanda

Yes - i did mine in the UK. They might have different setups re the finances at each hospital. Like i said, best speak to the trial co-coordinator about how much they will re-reimburse you. It is possible that they do it on a case by case basis. My trial co-coordinator had motivate that they cover my hotel costs. That was because I was not living close by and could not travel every day in. The most they could get was 60 GBP per night and up to a max of 35 GBP travel.

I had my first set of injections back in August. No improvement.

I go back for the 2nd set (real drug) 4-6 Nov.

 

[amandine]

@bedouin

This info re the payment for hotel and petrol or train etc....are exact the same amounts that someone else told me who is in the UK who lives 200 or so miles from the study centre.
So you are not the only one to get this payment
should be standard across all the eu countries taking part as on AM site it says that they will cover expenses (reasonable)

 

[BuzzyDave]

Hey everyone,

I have just had my first am-101 (or placebo) injection this afternoon. Really the worst thing about the procedure is that you are not supposed to swallow for half an hour while the medicine diffuses into your ear; its a bit uncomfortable whilst the goo drips down into your throat and I ended up spitting into a cardboard thingy a lot. My ear was stuffed up for about an hour afterwards but has mostly cleared already. No noticeable affect on my tinnitus so far, but to be honest today was a really good day anyway so I probably wouldn't have noticed. It certainly didn't make it worse.

Another injection on Wednesday, then Thursday morning. Will keep you all informed.

 

[amandine]

@BuzzyDave

Just out of curiosity - where are you having it done - in america, europe, UK?
See you are 1 year into T - so you still managed to get in to the trials? Thought they were looking for early sufferers but then again up to 1 year maximum...so maye you got in just under the year
Anyhow, do you live far from the study centre? If you do, did you get offered any reimbursable hotel and travel costs please?
great to hear from you
thanks amanda

 

[tshapiro]

Hello, first post here. I came down with T on 10/8 after a series of loud music events. I have a screening with the AM-101 study coordinator on 11/4 in Jax Florida. I have 2 questions that hopefully some of you can help with:
1 - Is there any legitamate evidence other than Auris press releases on the potential benefits? I'm game if there is a legitamate improvement backed by some evidence that I could somehow get my hands on.
2 - I hear T in both ears, but, I understand they only test 1 ear. Wouldn't this reduce the potential benefit? If one ear bettered by 40 percent I'm thinking that could still be difficult to measure just listening to your ears.
3 - I've heard that Xanax could help lower the percieved volume and stress related. It's easy to find many people who agree to that. The study coordinator say's that I must not ever be on Xanax or I will be disqualified from the test. Is this correct? I thought I read somewhere where you could be on Xanax (or similar) as long as you stop 2 weeks prior to injections. I'd just like to get the straight answer if anyone knows.

 

[Mikey Cliff]

I have participated in the tact-1 and 2 of phase 3. I got got three injections after 2.5 months of T, and also received the real drug (3 months later) where I got 3 more injections. I regret my decision to take part in the trial after the second round and will not be participating in any more injections. My T went way up after the second round and almost came back down to normal. I got the injections in both ears. What has made it worse is that I hear fans and high frequency sounds differently now. I woke up 4 weeks after the second round and couldn't place a certain sound I was hearing. The things that gave me comfort now annoy me, total Hell. Before I went for round 2 I was starting to feel good about everything, I thought that I could live a normal life again. The second round definitely made my better ear worse and is worst than the other much of the time now. I hate to be debbie downer, but the only reason I joined was to share my experience. I hope that one day I can change my response to the survey but for now I am being honest and other people should know. It's a difficult decision to get the injections and if my hearing had not changed I probably wouldn't be regretting it so much. I know this will probably cause a stir so if you have questions please message me as there is a reason I can not go into much detail publicly. I'll do the best to share what information I can.

Thanks,

 

[tomm]

I have participated in the tact-1 and 2 of phase 3. I got got three injections after 2.5 months of T, and also received the real drug (3 months later) where I got 3 more injections. I regret my decision to take part in the trial after the second round and will not be participating in any more injections. My T went way up after the second round and almost came back down to normal. I got the injections in both ears. What has made it worse is that I hear fans and high frequency sounds differently now. I woke up 4 weeks after the second round and couldn't place a certain sound I was hearing. The things that gave me comfort now annoy me, total Hell. Before I went for round 2 I was starting to feel good about everything, I thought that I could live a normal life again. The second round definitely made my better ear worse and is worst than the other much of the time now. I hate to be debbie downer, but the only reason I joined was to share my experience. I hope that one day I can change my response to the survey but for now I am being honest and other people should know. It's a difficult decision to get the injections and if my hearing had not changed I probably wouldn't be regretting it so much. I know this will probably cause a stir so if you have questions please message me as there is a reason I can not go into much detail publicly. I'll do the best to share what information I can.

Thanks,

Woah, thanks Mikey. I'm really torn about participation after reading that. I don't suppose you got any anecdotal evidence from other participants? A lot worse permanently is not a side effect they have highlighted. 6 days to decide.