Member- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
I'm just wondering about the optional "brain encephalography (EEG) and/or auditory brain response (ABR) tests" which are mentioned in the patient info leaflet. The leaflet implies that these tests will be offered at some hospitals but not others. Since they were not mentioned to me by the doctor at Salford, I am assuming that Salford is not among the hospitals which are performing these tests. I believe we are expecting that there will be little or no cognitive impairment resulting from use of AUT00063 because it targets a more specific group of potassium channels (compared to Retigabine), focusing on those which are relevant to auditory perception. As far as I am aware, there was no cognitive impairment reported by those who participated in Phase 1 of the AUT-63 trial.
Even so, I think these tests are potentially very important to the outcome of the trial. If it was found that AUT00063 reduced T by 50% but also reduces cognitive function by 20%, then I suspect it would not be regarded as a viable drug for most people. Therefore, it would be interesting to know which of the hospitals are performing these EEG and ABR tests and to get some information about the testing procedure.
Even so, I think these tests are potentially very important to the outcome of the trial. If it was found that AUT00063 reduced T by 50% but also reduces cognitive function by 20%, then I suspect it would not be regarded as a viable drug for most people. Therefore, it would be interesting to know which of the hospitals are performing these EEG and ABR tests and to get some information about the testing procedure.
Christian78
Member
- Dec 17, 2013
- 965
- Tinnitus Since
- (Sep 2013)
- Cause of Tinnitus
- progressive tinnitus, time of expiring in next 3-6 months
now as in trial you got 2-5/10, or in ordinary life. Does anyone has anything positive?
What Christian is asking is if you had a low T days of 2-5/10 before Autifony, so then it may not be Autifony making it lower but your normal tinnitus.
If you read flow's post you will see that he is saying that he has not started the trials yet but has a consultation this week to see about his eligibility.
Therefore he has said that his T started out as a 9/10 but went down to a 2/10 ranging to a 5/10 in his normal life. As he felt it was so low he did think about not taking a place on the trail leaving that space to someone who may be more deserving. However he decided to go ahead with the trial if he can get on it.
Hope this clarifies it a bit more.........
@Viking
think he is saying that it was 9/10 when it first started.
After that it has gone down to a more manageable 3 - 5/10 on a daily basis now.
Just wanted to clarify.
Well done @Viking for all your efforts with all those drugs and sorry to see that the Keppla didn't reduce your noise....and also sad to see that Lyrica was no good for you either. For different folks it has different effect.
I know someone personally who was prescribed Lyrica by his ENT doc. He says he has the worst T ever anyone had. He takes 300mg daily which reduces his noise to a comfortable level. He says without it he would now be buried. Sometimes he has a bad day or week and then he has to take 2 x 300mg of Lyrica which takes it down for him...but gives him side effects so he prefers to be on a lower dose.
Again an epileptic drug....
I like you Viking have also fluctuating sound but it is always loud when i wake up and then stays up all day or goes down after a shower very very low and stay down for up to four days. Then it will go up again the next day when I wake up.
I dont sleep with sound at night......is this making it worse or making it go up?
anyhow going off thread talking about me cos this is about autifony trials so apologies....
think he is saying that it was 9/10 when it first started.
After that it has gone down to a more manageable 3 - 5/10 on a daily basis now.
Just wanted to clarify.
Well done @Viking for all your efforts with all those drugs and sorry to see that the Keppla didn't reduce your noise....and also sad to see that Lyrica was no good for you either. For different folks it has different effect.
I know someone personally who was prescribed Lyrica by his ENT doc. He says he has the worst T ever anyone had. He takes 300mg daily which reduces his noise to a comfortable level. He says without it he would now be buried. Sometimes he has a bad day or week and then he has to take 2 x 300mg of Lyrica which takes it down for him...but gives him side effects so he prefers to be on a lower dose.
Again an epileptic drug....
I like you Viking have also fluctuating sound but it is always loud when i wake up and then stays up all day or goes down after a shower very very low and stay down for up to four days. Then it will go up again the next day when I wake up.
I dont sleep with sound at night......is this making it worse or making it go up?
anyhow going off thread talking about me cos this is about autifony trials so apologies....
Sorry for musundertundig. I was talking about my "single" experience. It is clear that the drugs in general have subjective response. Some are positive, others not, others 1/2 or need dose adjusting. I was not talking "about all". I apologize for this musundertundig.
Sorry
best wishes
No need to apologise. I didnt post what I posted cos I thought that you had said anything wrong - not at all! I was just posting that some one else had found Lyrica to be helpful. However I did point out to this person that Lyrica can be very very dangerous and he should consider not being on it full time - but he said if he goes off it then he will kill himself with the noise. So viscous circle really........but Lyrica can be so dangerous in that it can cause worsening T and it can cause damage for liver etc....
Viking I am so sorry if I made you feel that you needed to apologise!! sorry...........
SteveToHeal
Member
Apoogies in advance if this has already been covered....
I applied to get on but knew about the hearing loss requirement. So when I got my ENT to refer me to UCL and so as not to waste my/their time and money (and go through the whole emotional fallout), I sent through my audiogram first. I only have high frequency hearing loss. After they spoke to their audiologists, they told me straight up I would not qualify. I am also taking Sertraline anti-depressant (because t has made me so "blue") and was told by Nottingham this was an exclusion drug.
But now i read the forums and some ppl say say taking an anti-depressant is not always an exclusion. So wtf?
However, my main question is this. Of the 3 or 4 ppl that have been accepted, did you guys all fit the hearing loss criteria? Very NB info for me.
I phoned Newcastle and they said they might amend (or do away with) the criteria in Feb because as of yet, not one person is eligible. The thought of tampering with meds again (coming off to get on the trial) and only a 50/50 chance of the real drug, no follow-up, for the sake of my sanity, i'm bowing out of trying any further to get on this phase. T is loud today. Yesterday was soft. Sleep gets it down but u never know day to day. Russian roulette. One of these days it will be with a f***ing loaded gun !!!
Hopefully phase 2a is a resounding success and phase 3 opens up before the end of the year, with no hearing loss criteria and we all stand a better chance of returning to silence and getting our lives back!
I applied to get on but knew about the hearing loss requirement. So when I got my ENT to refer me to UCL and so as not to waste my/their time and money (and go through the whole emotional fallout), I sent through my audiogram first. I only have high frequency hearing loss. After they spoke to their audiologists, they told me straight up I would not qualify. I am also taking Sertraline anti-depressant (because t has made me so "blue") and was told by Nottingham this was an exclusion drug.
But now i read the forums and some ppl say say taking an anti-depressant is not always an exclusion. So wtf?
However, my main question is this. Of the 3 or 4 ppl that have been accepted, did you guys all fit the hearing loss criteria? Very NB info for me.
I phoned Newcastle and they said they might amend (or do away with) the criteria in Feb because as of yet, not one person is eligible. The thought of tampering with meds again (coming off to get on the trial) and only a 50/50 chance of the real drug, no follow-up, for the sake of my sanity, i'm bowing out of trying any further to get on this phase. T is loud today. Yesterday was soft. Sleep gets it down but u never know day to day. Russian roulette. One of these days it will be with a f***ing loaded gun !!!
Hopefully phase 2a is a resounding success and phase 3 opens up before the end of the year, with no hearing loss criteria and we all stand a better chance of returning to silence and getting our lives back!
@SteveToHeal
Cant remember who it is but one person posted on this thread that he was surprisingly not given a test for hearing whatsoever and was on some medication too and this did not stop him from being accepted onto these trials.
Go figure?
Maybe your mistake was to offer them the hearing test up front? If they dont ask, dont give?
Or maybe different rules apply for different clinics which will already throw the results into mayhem....
Cant remember who it is but one person posted on this thread that he was surprisingly not given a test for hearing whatsoever and was on some medication too and this did not stop him from being accepted onto these trials.
Go figure?
Maybe your mistake was to offer them the hearing test up front? If they dont ask, dont give?
Or maybe different rules apply for different clinics which will already throw the results into mayhem....
Hello chamferman great to hear that you are on the study, do you mind me asking what hospital it was that you went to, I have an appointment at Birmingham this week, ideally the UCL in london would have been far better for me but they seem to have not to get their out patients organised yet, so I am going to go to Birmingham any way as I contacted them before the London details became live, just wondered.
Hope it is all ok for you. ?
Quater 3 or Quarter 4 of this year would be my guess. This trial isn't supposed to last that long, and they'll need a little time to do data analysis.
The inclusion and exclusion criteria for the AUT000063 trial have been published and are freely available at the WHO Clinical Trials web site and elsewhere. See http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB.
Inclusion criterion 4: "Sensorineural hearing loss (Pure Tone Average (of thresholds at, 500, 1000, 2000 and 4000Hz) =20 and =60dB Hearing Loss (HL))"
Exclusion criterion 5: "Severe hearing impairment such that verbal communication is unreliable."
From this, we can infer that in order to get on the trial it is necessary to have some hearing loss but not too much. In my earlier posting, I stated that I was given the impression that insufficient hearing loss wouldn't necessarily be a barrier to participation in the trial. I told the doctor that I didn't think I had much (if any) significant hearing loss in the mid-range frequencies and she didn't seem too concerned about that. Neither did she seem too concerned that I had recently been on Prozac for several months. I cannot say for sure whether I would have been ruled out if I was still taking Prozac but I didn't get the impression that I would have been automatically ruled out because of that. The doctor did seem concerned about my high blood pressure (exclusion criterion 20 concerns blood pressure) and there is still a possibility that I might be ruled out due to failing to meet the blood pressure requirements.
I should emphasise that I have not yet completed the screening process and I have not yet been formally accepted on to the trial. As far as I'm aware, only one forum member has a guaranteed place on the trial (@chamferman) and he has already begun taking the drug (or placebo as the case may be). The second part of the screening process does include a hearing test and I am due to attend the hospital for hearing test and other tests next Monday. There are still a number of factors which might still cause me to be ruled out.
@SteveToHeal - Given what you have said about your difficulty in getting on to the trial, it does seem as if there may be some inconsistency in the way that the inclusion and exclusion criteria are being interpreted at different sites. We can only speculate about why that might be. It is possible that each site has quota of places to fill and some sites are finding it easier to fill their quota than others (Salford have 10 places, apparently). Therefore, for anyone who is desperate to get on to this trial and gets told by one hospital that they are ineligible, it may be worth approaching other hospitals.
Inclusion criterion 4: "Sensorineural hearing loss (Pure Tone Average (of thresholds at, 500, 1000, 2000 and 4000Hz) =20 and =60dB Hearing Loss (HL))"
Exclusion criterion 5: "Severe hearing impairment such that verbal communication is unreliable."
From this, we can infer that in order to get on the trial it is necessary to have some hearing loss but not too much. In my earlier posting, I stated that I was given the impression that insufficient hearing loss wouldn't necessarily be a barrier to participation in the trial. I told the doctor that I didn't think I had much (if any) significant hearing loss in the mid-range frequencies and she didn't seem too concerned about that. Neither did she seem too concerned that I had recently been on Prozac for several months. I cannot say for sure whether I would have been ruled out if I was still taking Prozac but I didn't get the impression that I would have been automatically ruled out because of that. The doctor did seem concerned about my high blood pressure (exclusion criterion 20 concerns blood pressure) and there is still a possibility that I might be ruled out due to failing to meet the blood pressure requirements.
I should emphasise that I have not yet completed the screening process and I have not yet been formally accepted on to the trial. As far as I'm aware, only one forum member has a guaranteed place on the trial (@chamferman) and he has already begun taking the drug (or placebo as the case may be). The second part of the screening process does include a hearing test and I am due to attend the hospital for hearing test and other tests next Monday. There are still a number of factors which might still cause me to be ruled out.
@SteveToHeal - Given what you have said about your difficulty in getting on to the trial, it does seem as if there may be some inconsistency in the way that the inclusion and exclusion criteria are being interpreted at different sites. We can only speculate about why that might be. It is possible that each site has quota of places to fill and some sites are finding it easier to fill their quota than others (Salford have 10 places, apparently). Therefore, for anyone who is desperate to get on to this trial and gets told by one hospital that they are ineligible, it may be worth approaching other hospitals.
You posted this on Jan 12th
Then today you posted this
QUOTEFrom this, we can infer that in order to get on the trial it is necessary to have some hearing loss but not too much. In my earlier posting, I stated that I was given the impression that insufficient hearing loss wouldn't necessarily be a barrier to participation in the trial. I told the doctor that I didn't think I had much (if any) significant hearing loss in the mid-range frequencies and she didn't seem too concerned about that. Neither did she seem too concerned that I had recently been on Prozac for several months. I cannot say for sure whether I would have been ruled out if I was still taking Prozac but I didn't get the impression that I would have been automatically ruled out because of that. The doctor did seem concerned about my high blood pressure (exclusion criterion 20 concerns blood pressure) and there is still a possibility that I might be ruled out due to failing to meet the blood pressure requirements.
I should emphasise that I have not yet completed the screening process and I have not yet been formally accepted on to the trial. As far as I'm aware, only one forum member has a guaranteed place on the trial (@chamferman) and he has already begun taking the drug (or placebo as the case may be). The second part of the screening process does include a hearing test and I am due to attend the hospital for hearing test and other tests next Monday. There are still a number of factors which might still cause me to be ruled out.QUOTE
Initially you gave the impression that you were accepted on the trial without hearing test required but now you are going for a hearing test.
They told you that you had been accepted bar urine and blood test results. Plus acceptance of anti depression drugs in your blood stream.
You were also told that you had been accepted even though your blood pressure was slightly high.
Now you are told that you may be barred due to your higher blood pressure.
Did you know at that stage that there was a second process to go through before being accepted onto the trials.
I can only imagine that you have been misled or the trial staff were confused themselves as to what tests they were going to do to allow or bar acceptance onto the trial?
Hence I posted to Steve that a hearing test doesnt seem to be mandatory nor certain drugs would rule him out.....
The criteria for acceptance on to these trials have been well posted and we have all read them. Many of us gloomily assumed we could not get on to the trial. Then optimism per your original post on 12th January which most definitely challenged those criteria..........and gave many of us hope that we may apply for these trials...........
Now we just dont know where it is at...
Shame that you now have to go through the hearing test plus other tests when you thought you were accepted bar only the urine and blood test results. Please can you post what happens on Monday as it really will help to clarify what these clinics or at least this clinic is / are up to regarding acceptance onto the trial.
Confused but appreciate your detailed postings and understand you can only report what you know with the information that you have at the time.
thanks
When can i take the drug their producing? That is all i want to do. Can anyone guess when i can get it? I'll be happy to pay a reasonable amount for it. When can i get it?
@amandine - OK, I guess you are right that there was a difference in the overall impression I gave on 12th January compared to what I am saying now. At the risk of creating even more confusion, let me try to explain. I came away from the initial screening appointment feeling that I had been accepted on to the trial. I cannot remember the exact words that were spoken by the doctor but she seemed to imply (i) the hearing loss requirement was not a major obstacle and I would be accepted even without much hearing loss, (ii) recent use of anti-depressants was not going to be an issue and (iii) high blood pressure was potentially a problem but they did not believe this was specifically listed as an exclusion criterion, therefore I would not be ruled out because of it. Later, I took another look at the exclusion criteria and found that blood pressure is specifically listed as potentially a basis for exclusion.
At the initial screening, I was asked to complete two questionnaires: one on tinnitus severity and another on depression. Blood and urine samples were also taken. I would imagine that the depression questionnaire will be used to assess whether I can satisfy exclusion criterion 7 (Moderate or severe depression or generalised anxiety as indicated by a score of =11 out of 21 on the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983)). The blood and urine will presumably be analysed for evidence of drug and alcohol use (exclusion criterion 8). They won't find any problem there because I do not drink alcohol or take any non-prescribed drugs.
I was surprised not to have my hearing tested in visit 1 but it has now been confirmed to me that there will be a hearing test in visit 2. I do not know if the hearing test is being carried out as part of the selection process or in order to establish a baseline which will be used to test whether the drug causes deterioration or improvement in my hearing over the trial period. In summary, I am no longer feeling so confident of being accepted on to the trial as I was initially. However, I said on January 12th that the exclusion criteria do not seem to be quite so inflexible as the documentation might suggest. That was how it seemed when I attended the initial screening though it is clear from the comments made by @SteveToHeal that his experience has been very different from mine. This caused me to speculate that there may be different interpretations of the criteria depending on which of the sites is handling your application.
At the initial screening, I was asked to complete two questionnaires: one on tinnitus severity and another on depression. Blood and urine samples were also taken. I would imagine that the depression questionnaire will be used to assess whether I can satisfy exclusion criterion 7 (Moderate or severe depression or generalised anxiety as indicated by a score of =11 out of 21 on the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983)). The blood and urine will presumably be analysed for evidence of drug and alcohol use (exclusion criterion 8). They won't find any problem there because I do not drink alcohol or take any non-prescribed drugs.
I was surprised not to have my hearing tested in visit 1 but it has now been confirmed to me that there will be a hearing test in visit 2. I do not know if the hearing test is being carried out as part of the selection process or in order to establish a baseline which will be used to test whether the drug causes deterioration or improvement in my hearing over the trial period. In summary, I am no longer feeling so confident of being accepted on to the trial as I was initially. However, I said on January 12th that the exclusion criteria do not seem to be quite so inflexible as the documentation might suggest. That was how it seemed when I attended the initial screening though it is clear from the comments made by @SteveToHeal that his experience has been very different from mine. This caused me to speculate that there may be different interpretations of the criteria depending on which of the sites is handling your application.
We need another thread. This one is getting worn out. I'm tired of checking it. AtTheEdgeOfScience...can you create another exciting thread? Please? Something along the lines of Research that can inspire us, give us hope...perhaps we can have a thread were we can all become phds looking into Gamma, Gaba, Nuerons, Protons, Cells, you name it all the good stuff responsible for our suffering? Maybe something about the two companys that are in trials? Can we have maybe an open thread where we can start dialogue wtih members from that company? Maybe a thread for researchers to communicate there findings with us or at least to give us some idea on the progress? The worst part is that we really don't know where they are going. I think the closest thread is the one about a roundup of research somewhere in 2014. Would like to see something interesting and inspiring. I think you are best to do it AtThe...Edge.....yep.
Isabella 123
Member
- Feb 7, 2014
- 227
- Tinnitus Since
- 12/2013
- Cause of Tinnitus
- Probably traumatic noise event
Our T support group recently had a presentation by a couple of TRT therapists and when they were asked if any drug research was going on that looks promising, they categorically stated that no drug or treatment would Ever cure T. Reminds me of the buggy whip makers when word got out about horseless carriages. I believe in Autifony and that it's going to work!
Science marches on, and one day those Tinnitus Retraining Therapy charlatans will be relegated to the dust bin of medical history where they belong, along with the leeches, witchcraft, and snake oil salesmen.
TRT : Inevitable Drug Treatments
Blockbuster : Netflix
Hopefully, we will soon be resting peacefully, while TRT will be RIP.
Never say never. If you say "X will never do Y." In 99% of cases, you're setting yourself up for failure.
But as @preslys said, let's stay on topic and discuss Autifony here.
autifony is quoted in several newspapers.
http://www.hearingreview.com/2015/01/new-version-drug-studies-article/
http://www.hearingreview.com/2015/01/new-version-drug-studies-article/
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