AM-101 TACTT1 Results Released

Discussion in 'Research News' started by Hudson, Sep 9, 2013.

    1. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      Have you tried to contact Auris Medical about your questions? If you want to be in the trial I suggest you do that for the correct info.

      To answer your question about if it is in the ear or brain: When T is acute, it might be able to fix it with an injection in the ear to stop the glutamate release. T becomes a "brain thing" when it is chronic because the brain plasticity accepts this ringing caused by overactive neurons as the new "normal" state. So that's why AM-101 aims to treat acute T. No one really knows for sure if this theory is correct and I'm no expert so I don't really know if I'm giving you correct information.
       
      • Funny Funny x 1
    2. SteveToHeal
      Insomnious

      SteveToHeal Member

      Location:
      Unknown
      Tinnitus Since:
      10/2013
      Cause of Tinnitus:
      Acoustic trauma
      Would not going back on this help, if it helped you before?
       
    3. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      Prednisolone is a very strong drug and is not good for the body. On top of that it stops you sleeping. Made me feel very ill.
      It apparently acts as an anti inflammatory so there is something inflamed there. Took the drugs and after 2 days it dropped the sound to practically nothing, very low but then it came back when stopped with the drug.
      Was told to taper it, 3 pills a day for 3 days so 60mg a day, then 40mg a day x 3 days and finishing with 20mgs a day x 3 days.
      Since then loud and I have become totally agitated with it. It is obsessing my life.
      Would really preefer to be drug free and normal, Never took any kind of these drugs before and I am so distraught by this with no support unit here and not much to do to occupy myself. Was supposed to be leaving here till this happened.Now I am too exhausted to do anything.
      Betahistine - not sure what to do? Can I take it - is it worth it - can i mix it with xanax?
      Am I making this worse for myself and if so how can i change this?
      Know this is off topic but just wondered if it is ok to slip it in here. Hope it is and no one is offended by my message as I would hate to upset anything or anyone by putting an inappropiate message in the wrong place. Apologies up front if i have......
      Just appreciate a few ideas or advice or something. Please dont suggest that i speak with my doctor - tried that and he got very cross and was quite rude to me and told me to go back to england (i am in france) and I got no support or help whatsoever from him. So now I have to find another doctor.
      Would like someone to speak to someone re the trials so yes will try to find a telephone number for them or to speak maybe with one of the medic people carrying out the trial.....does anyone have the link to their number at all please?
      Thank you for reading and all advice and comments really welcome.....thank you
       
    4. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      http://www.tinnitus-study.info/

      Look there and see if you can find something.
       
      • Agree Agree x 1
    5. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      I go in for my injections Wednesday. I will post how things are going.
       
    6. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      @New Guy
      Where are you having it done if I can ask you please?
       
    7. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      @lapidus,
      Thank you for the link - I already asked to get it done In London, Paris, Toulouse and Tours.
      Tours is my nearest which is 300kms from here. I asked if I could speak to someone before I make the 600kms round trip to find out how long I need to stay there.....only way I could do it is with a camper van....and it is winter time now.
      As for their site, they give precious little information hence I asked to speak on the phone. In the end they told me that someone would call me - so far no phone call.
      Personally I am hoping that my T will go away and I wont need to do this.
      However yesterday it went down considerably and I thought great and then I didnt sleep all night and this morning it was blaring away.....but I guess that is due to no sleep as I am bone tired and cannot sleep.....amanda
       
      • Friendly Friendly x 1
    8. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      I am in the US. I have read some of your posts and I understand how you are feeling, I felt the same way. Please understand it will get better! I have had T for two and a half months and the first 5 weeks were terrible. It should start to balance out for you. If you ever need some words of encouragement, don't hesitate to ask. Just stay calm and take it one day at a time, don't get worked up and try to ignore it the best you can. I found being outside helps me greatly.
       
    9. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      @amandine I found that alpha lipoic acid really helped to calm the spikes and balance to a tolerable level. I take 600 mg a day.
       
    10. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      @ NewGuy
      Hi thanks for your post.
      I just looked up alpha lipoic acid and was wondering - on the report from wiki it says that its sales description as an anti oxidant has just recently been challenged. That it can cause the stress reaction and is used for losing weight in the states. Side effects of alpha lipoic acid may include headache, tingling or a "pins and needles" sensation, skin rash, or muscle cramps.
      So i was wondering if it would be okay to ask you; for how long have you used it and have you had any side effects as above or anything other side effect? When you say it controls the spikes, does it keep your T down all the time or do you only take it when you have a spike?
      off to try and get some sleep.
      have a good night
      amanda
       
    11. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      @NewGuy
      Sorry forgot to ask, if your T is under control then why are you going for the am 101 trials - injections in ears over 4 days!! Yuch!!!!
      I would be happy if my t would feel like yours....it is just so intrusive.
      Yesterday it was great, low and really felt good.
      Stayed up till 5am and then went to bed with talk radio on next to me. Probably big mistake cos i didnt sleep good , maybe an hour or two....absolutely bone tired today and the T is blaring from the morning...so again it is bad....and yesterday so good....
      If you are going for the trials when you are so well with it, then I have to go and do the trials cos I am feeling distinctly unwell with it all. Main problem is that I cannot sleep but if this were under control then i think that the t would get much much better...
      off to bed
      good night
      amanda
       
    12. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      I have been using the lipoic acid for 1 month and have not had any side effects. I take one 600mg pill every morning, not just on the days that I have spikes. I cant say that it lowers the volume of my T, it just takes the edge off so it is not so intrusive. Some days I wake up and my T is not a bother at all, yet it is always there. To answer your question as to why I am going to go through with the study, because my T is always there, I am willing to try things that will reduce or remove the ringing I hear.
      A big part of my peace with T is acceptance, this is something that has happened to us, as bad as it is, things could be much worse. The way I see it is I still have my vision, I still have all my limbs, I am still able to work, I can still play with my kids. I try to stay busy with anything I can as it keeps my focus off of the ringing. This is just one more thing I carry with me in life, but life does keep going.
      I see you said you had a good day yesterday, I had a series of good days then bad days for awhile and the bad days started to get fewer and fewer. I hope this is the case for you as well, but sleep is a factor in that, do what you can to get enough of it, I used white noise at a very low level for awhile and now do not need it. Try to keep your stress down, its not good for any part of life but really effects T. Also if you drink alcohol, make sure its worth it, I love to have some drinks from time to time, it makes me forget about my T for the night . The down side is the next morning my T is louder, no matter if its 1 beer or 18 beers.
      I read that you have to travel quite a distance to go to the study center. I do as well, its about a 400 mile round trip for me. If you decide to take part in the study be aware there are some guide lines that can get you rejected. If you decide to take the lipoic acid don't tell them you take it to help with your T, you use it as a daily vitamin. They don't want you to take anything to help with the T. They also test for 7 different drugs including marijuana, cocaine, and anti-depressants. They will compensate you for your travel, pass or fail.
      I hope I answered some of your questions and helped in some way.
      If there is anything else you would like to ask me or something I can help with, please just let me know.
       
    13. earsnothappy

      earsnothappy Member

      Tinnitus Since:
      May 2014
      Just finished my first round of shots in my follow up open label trial. Everything went well. Will post updates as things progress...
       
      • Informative Informative x 2
    14. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      Hi New Guy,
      Thank for your post re the trials.
      Seems you have done really well regarding this torment.
      I am not doing so well but different lives etc....
      Please may I ask you whereabouts are you having the trials done? Also, please can you explain the time frame to me? I am not getting any info from any of the centres that I have contacted which include London, Paris, Toulouse and Tours. I understand that it is 4 injections over 4 days....but that is all I know. So in the beginning did you stay near the clinic as I woud think that it is impossible to do 400 miles round trip each day over 4 days...
      How soon after your first interview did the injections start?
      Do you know if you got placebo or the real thing?
      Or did they tell you that you got placebo and that is why you are now having follow up injections in the open label trial?
      Or was there any improvement with the first lot of injections?
      After the initial 4 injections, when did you have to go back? How often over how many weeks?
      Please if you could give me any detailed info I would really appreciate it as I am getting nowhere with trying to get info from the actual clinics themselves. The actual people carrying out the trials are far to busy apparently to speak with me and all I can get is someone who answers the phones and passes on the messages.
      ok so looking forward to hearing from you
      thank you
      amanda
      Did they explain any possible dangers associated with the injections?
       
    15. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      @amandine
      I have not got the first round of injections yet, I go in tomorrow. It is 3 injections over three days, so I will be staying in a hotel close to the study site. They do reimburse for the hotel room and miles traveled. After you pass first screening, you have to keep a electronic journal for two weeks and then you go in for injections. I believe 10 days after injections you go back for a follow up and then again 30 days after that. I think it is 100 days before you go in for second round of injections if you choose to. Second round you are insured the real drug. I will not know if I get the placebo or the real drug the first time. I will keep you posted on how it goes. I am in the midwest, here in the good old U.S.A.
      I hope this helped. Please let me know if there is anything else I can help with or answer for you.
       
    16. 2131e
      Wishful

      2131e Member

      Location:
      Hobart
      Tinnitus Since:
      19/2014
      Hello everyone, I read the clinical trial paper from phase 2 of the study. At the conclusion of the study (I think 100 days), they noted that in a minority of participants, 10% reported increased T. Of course this was on a subjective measure only, and it is likely that T severity was shifting on its own as all the participants were in the acute stage. But I'd be interested in how those who did get the injections balanced that (admittedly small) risk against the possible benefits of doing the trial? I'm considering it but hesitant because of the chance of T getting worse.

      I don't want to scare anyone off so if this concerns you after reading this I'd encourage you to not take my word for it but to read the paper yourself and make your own decision. I'm hoping so much that everyone who has gone through with it gets the result they want...... a real reduction in their T.
       
    17. attheedgeofscience
      No Mood

      attheedgeofscience Member Mighty Benefactor Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Resolved since 2016
      Cause of Tinnitus:
      See information page
      If you worry about side-effects, then you will never ever be able to set your foot inside a hospital or your local GP's office; everything that is done in medicine has risks. Experimental medicine or not.

      Here's what I'd be (more) worried about if I were you: by continuously reflecting on whether to go through with the treatment (or not), you are quite possibly reducing your chances of a good result. At two months post onset, you are already in the late treatment stage.

      Here's how I view the situation: think about the unique chance of getting treated/cured - a chance that many members on this board don't have (either because they are not nationals of a country in which the clinical trial is taking place or because they don't fit the profile for inclusion/exclusion criteria - most commonly because they have had tinnitus for "too long").

      Act with haste and determination. Or don't act at all.
       
      • Agree Agree x 4
    18. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      Hi all,
      Well now I am in a real quandty. My T went down on Sunday just gone and then went up back to normal for 2 days and today wednesday it is really really low.....I am hoping that maybe it is just healing itself maybe or am I being ridiculous!?
      It is incredibly low today....
      Spent the night some of it asleep but as usual woke up after a few hours sleep but wasn't able to get back to sleep.
      However had bird song playing on laptop next to me all night. Even now birdsong playing but very low volume. Could the tweets of the bird have an effect?
      Anyone else experience their intrusive T go down so much like this before?
      Want it to stay down forever....has anyone else experienced their T diminsih and then disappear?
      thanks all and would really love to hear comments and experience....if it is like this then I could handle it and get back to normal which means getting me back......
       
      • Hug Hug x 1
    19. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      @NewGuy
      Hi - thanks for the explanation. Do they reimburse you for the hotel and travel for each of the times that you have to be there? So for the first time to register, be accepted and then blood tests....then next time to have your injections...then next time you go back for check etc.....? So for all the times that you have to be there?
      Did not know that this is possible as only heard this from you.
      thanks
       
    20. attheedgeofscience
      No Mood

      attheedgeofscience Member Mighty Benefactor Hall of Fame

      Location:
      Denmark
      Tinnitus Since:
      Resolved since 2016
      Cause of Tinnitus:
      See information page
      As Auris Medical AG is now a stock listed company, they are required to publish financial information to the market. You can find that information via the following link or via the newsletter material in the pdf file (see attachment).

      http://globenewswire.com/news-relea...ial-Results-and-Provides-Business-Update.html

      Within the financial news release is a brief mention about the status of the clinical trials AM is currently pursuing. As with the financial information itself, it is what you would expect for a start-up company in the pharma group: no income due to no developed products (yet). It (therefore) continues to exist only by the mercy of a clinical trial success (in my opinion).

      The financial news release does not shed any light on AM's newest additions to their pipeline, AM102 and AM123. The only information on these new developments can be seen via AM's homepage:

      http://www.aurismedical.com/product-candidates/pipeline

      While I am still (slightly) doubtful about the long-term success of AM, I would like to mention that I think AM has done a fantastic job of releasing transparent and timely information about their pipeline, clinical trials, and company in general. As a comparison, I have - from a financial view-point - absolutely no idea about what is going on inside a company such as Autifony Therapeutics. I also have no idea about what AT's product is (via their hompage); only information I have been able to track down is via patent homepages and the bits and pieces released in interviews. AT remains very tight-lipped; AM is much better in this regard.
       

      Attached Files:

      • Informative Informative x 2
    21. bedouin
      Wtf

      bedouin Member

      Location:
      United Kingdom
      Tinnitus Since:
      11/2013
      It may depend on the hospital you go to but for me, they re-imbursed travel up to a maximum of £35 per one way trip (£70 round trip) and up to £60per night at a bnb. The first set of injections is over 3 days so you need to book 3 nights accommodation and get there and back eg: train.

      Just keep your receipts and submit them to the trial co-ordinator and he/she will draw it for you via hospital cash re-claim system. So sometimes you only get it back in cash the next time you visit. Visits after the first set of injections are then at 10, 30 and 84 days.

      Same procedure again re claiming travel costs back and (if required) accommodation. The best thing to do is speak to the trial co-ordinator. They will then speak directly to the trial sponsor and advise how much they are able to re-imburse you. It might be the case (doubt it tho) that each hospital might have different amounts. However, they might have different cash re-claim systems. Mine was cash. The one you're at might do it via EFT.

      However, by the sounds of it, you still need to be accepted. That is the visit 2 weeks (+-12 days) before the first set of injections. It would only be for one day. They should re-imburse you (travel and accommodation if required) for that visit too but check with the trial co-ordinator first.

      I hope that helps.
       
      • Like Like x 1
    22. bedouin
      Wtf

      bedouin Member

      Location:
      United Kingdom
      Tinnitus Since:
      11/2013
      Interesting:

      "International Tinnitus Seminar in Berlin, Germany. Anchor- and distribu-tion-based statistical analyses of clinical data support the use of a 2 point reduction on a 0-10 numerical rating scale as a responder definition."

      So only a 2 point reduction. But if it takes it from a 6 to a 4, that is still a lot :)
       
    23. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      I've had my T now for 3 weeks and 2 days, I'm seriously considering taking part in this trial. I go into the audiologist on Monday and also am doing some allergy tests, but based on my understanding, if you want this to possibly work, it has to be pretty quick. I contacted them via the http://www.tinnitus-study.info website today.

      @T-Bach... did you get enrolled via the website above? If so, how quickly did that get back to you?

      I fully expect the audiologist on Monday will tell me "just wait and it will go away"... well, that's not a good answer IMO.

      Lastly, I'd really like to see some sort of chart/table like the below... I just can't seem to find the information (if it exists)... does anyone know if it does?

      vqtatx.png
       
    24. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      Hi @OddV
      Very decisive and well done. I am surprised that you have been able to see an audiologist so quickly. Here is not like that.
      I was wondering, has no-one who is going for these trials been asked or suggested to do an MRI - i understand that this is a course of action if one has the T in one ear only......just to rule out any other cause for the T.
      Do they give an MRI at the trials clinic then? Or do they not need one? Confusing really as there could be any other reason for the T. I would have thought the clinic would have wanted to know the results of the MRI.
      I am confused therefore as my MRI (right ear only) is on Monday coming. Waited ages for it. By the way, the hospital is asking me to pick up some dye from the chemist that they then inject into me for the MRI. Anyone know anything about this dye they use?
      Also as far as I understand these trials are for 3 months max the best but will be used on people who have T for up to 12 months. Is this info wrong then cos I thoujght that it was correct....
      Finally I would just like to add here that today the monster has practically disappeared suddenly after being like a high pitched train volume for 2.5 months. Only loud noise exposure was a headlight still on warning siren in the car. Used normally to tell you that you have cut the engine but headlights still on. This malfunctioned and instead of going off when driving, it stayed on whilst the car was driving. Had to drive only a few times with this siren (which is now removed). That was the only loud exposure so I am guessing that mine was caused by that......no chemical exposure whatsoever but loads and loads of stress including moving house - the T started quiet the first night in new house and then really loud the next morning.......
      So back to am 101, do they need an MRI? with or without dye? thanks
       
    25. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      Great news! maybe tinnitus will go away for you...
       
      • Like Like x 2
    26. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      Not sure that I can answer this here as I think that it is not to do with am-101 and this thread is to do with am-101. But hoping that it maybe ok......
      @dan thank you - hoping....quite weird.....so low now.....wondering -- is at all possible, that it can go away now....thought it didnt really ever go away for anyone - or at least that is the impression that I got from here and the web.....made me very gloomy...e
      Maybe the times it does go away, people are so happy they dont post about it online (or just dont want to read another word about it)....dont know.
      Hoping it stays down....
       
      • Like Like x 1
    27. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      The AM-101 Phase 3 clinical program in acute inner ear tinnitus remains on track. Ramp-up of clinical trial sites in North America and Europe progressed with approximately 100 sites initiated at the end of August 2014. As previously announced, Auris Medical expects to enroll a total of 930 patients: 630 in the acute stage (i.e. up to three months from onset) and 300 in the post acute stage (i.e. onset between 4 and 12 months). The first patients that completed the TACTT trials rolled over into the open label AMPACT trials in April and May 2014.
      Auris-Medical-Holding-AG-Reports-Second-Quarter-2014-Financial-Results-and-Provides-Business-Update.

      Well guess that explains it then...690 acute patients up to 3 months and 300 post acute, 4 months up to 12.
      Thanks for the info @theedgeofscience
      anyone know about this dye for the MRI on Monday? Is it necessary?
       
    28. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      @amandine
      I was told I would get a check in the mail at my home to cover my travel. I have not got it yet but was told it could take a few weeks. I am driving to the study now and will stay at hotel for next two nights. I will give them the receipt for my hotel stay on the third day. Will keep you all posted!
       
      • Informative Informative x 1
    29. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      @NewGuy will be watching this thread for your update... did you get enrolled through the http://www.tinnitus-study.info website or some other way? How long did it take them to get back to you.

      Best of luck, I hope it works for you.
       
    30. NewGuy

      NewGuy Member

      Tinnitus Since:
      08/2014
      Yes, I went through the website. They responded back in 2 days.
       

Share This Page

Loading...