MemberWhat?????
What happened to 4 weeks?
Soooooooo disappointing!
The ratio should be the other way around if they really wanted a cure
Same here Martin!
Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus
- Thread starter attheedgeofscience
- Start date
What?????
What happened to 4 weeks?
Soooooooo disappointing!
The ratio should be the other way around if they really wanted a cure
Same here Martin!
FounderNot all 4-week treatment periods start at the same time, I would guess.
And processing the results will take a while.
Late 2015 earliest or sometime in 2016 we can hope for the results to be published.
I meant for the whoooooooooooole trial and analysis to be concluded and results posted for public.
So technically we have to wait another year or so to find out if this drug works or not?
This is only phase 2 so I can't help but wonder how likely we are to see this one available in the near future.
By the time other phases are completed, and that's providing this one shows results, it's not unrealistic to say 5 years at least.
All in all call me negative but this doesn't sound promising at all
This is only phase 2 so I can't help but wonder how likely we are to see this one available in the near future.
By the time other phases are completed, and that's providing this one shows results, it's not unrealistic to say 5 years at least.
All in all call me negative but this doesn't sound promising at all
So technically we have to wait another year or so to find out if this drug works or not?
This is only phase 2 so I can't help but wonder how likely we are to see this one available in the near future.
By the time other phases are completed, and that's providing this one shows results, it's not unrealistic to say 5 years at least.
All in all call me negative but this doesn't sound promising at all
Valeri, while it is true that the trials each last 4 weeks, and may start at different points, Autifony have not indicated any dates yet for Phase II. 2015/2016 is a good guess, but it is only a guess from tinnitus talk members.
Let's all make sure that speculation on this thread does not come across as fact regarding these trials. Autifony in their communications seem to be proceeding with cautious optimism. And so should we.
Well, the phase should be much quicker than Auris..Mainly because Auris had to wait 3 months to see if their drug worked, Autifony only need 1 month...
SteveToHeal
Member
Guys!!!
It's live: http://www.autifony.com/autifony-tinnitus-study-uk-sites.asp
Probably just updated now as I clicked as html was all over the place. Now in tabular form. Guts must still be updating it as i type. All those in the UK, choose your region and make the call!
It's live: http://www.autifony.com/autifony-tinnitus-study-uk-sites.asp
Probably just updated now as I clicked as html was all over the place. Now in tabular form. Guts must still be updating it as i type. All those in the UK, choose your region and make the call!
Does anyone have an address that i can give so that I can take part in these trials please? I am a UK cititzen born and bred but am stuck in france. Will happily come over and stay to do these 4 week trials. Can register to get a GP no problems wth my NH number etc....Can anyone at all help me out please? Steve once mentioned to me that perhaps I should put a call on out on this forum. I know this is a big ask but can ANYONE help me out - I have no one else to turn to except the people on this forum. Please can someone help me........
I know that some of us may get the placebo and there is no follow up realdeal drug being offered as yet. And also 4 weeks may not be enough. It may require more ongoing drug. We dont know do we?
OR has anyone read that 4 weeks is sufficient to re sort the potassium channel where it has gone wrong. I would rather do this than injections in ears that have so so success reports. I am afraid of the 10 per cent chance that the injections can cause deafness.
So please is there one kind soul out there who can help me out so that I can register. Otherwise I think that i fit all the trial criteria.
Hoping to hear a positive response as this is sent out as an urgent and desperate request.
thank you
aplogies to mods if I should not have put this post on here.....but so desperate to get on these trials, dont know what else to do or how to get any help to get on this trial....
Ny T is pretty bad so I really need to try for some kind of solution......
I know that some of us may get the placebo and there is no follow up realdeal drug being offered as yet. And also 4 weeks may not be enough. It may require more ongoing drug. We dont know do we?
OR has anyone read that 4 weeks is sufficient to re sort the potassium channel where it has gone wrong. I would rather do this than injections in ears that have so so success reports. I am afraid of the 10 per cent chance that the injections can cause deafness.
So please is there one kind soul out there who can help me out so that I can register. Otherwise I think that i fit all the trial criteria.
Hoping to hear a positive response as this is sent out as an urgent and desperate request.
thank you
aplogies to mods if I should not have put this post on here.....but so desperate to get on these trials, dont know what else to do or how to get any help to get on this trial....
Ny T is pretty bad so I really need to try for some kind of solution......
by the way, is it proven in the autifony trial before ths one that there are no side effects? anyone? thanks
anyone willing to let me register from their address OR let me stay with them for the duration? I shall willingly pay towards my stay there. Or does anyone have an empty flat or house or room that I can stay at for the duration of thses trials.
It is my intention anyway to return full time to UK but just need some help now for these trials and will be able to find my own housing etc.. after this - just need an immediate solution to get on these trials.
thanks
@Rube
By the time it expnds to USA it will be too late.
They are taking people from 6 months to 18 months only.
When someone calls to find out about getting on these trials, can they please post the questions and criteria they are asking for. So far I fit the criteria but I and others I am sure would like to know what restrictions there are that we may not be aware of.
thanks
anyone willing to let me register from their address OR let me stay with them for the duration? I shall willingly pay towards my stay there. Or does anyone have an empty flat or house or room that I can stay at for the duration of thses trials.
It is my intention anyway to return full time to UK but just need some help now for these trials and will be able to find my own housing etc.. after this - just need an immediate solution to get on these trials.
thanks
@Rube
By the time it expnds to USA it will be too late.
They are taking people from 6 months to 18 months only.
When someone calls to find out about getting on these trials, can they please post the questions and criteria they are asking for. So far I fit the criteria but I and others I am sure would like to know what restrictions there are that we may not be aware of.
thanks
It's a very good news for UK citizen.
I can't participate to this trial...
because:
- I am not UK citizen!
- My hearing is not bad enough (less than 20 dB loss) on my audiogram. And yet I hear really worse than before my last NIHL. If this inclusion criteria number 4 is respected, I do not see how they will manage to find enough people. Does participants must have a hearing loss of at least 20dB for each frequency referred to validate this criterion 4?
"4. Sensorineural hearing loss (Pure Tone Average (of thresholds at 250, 500, 1000, 2000 and 4000Hz) >20 and <60 dB Hearing Loss (HL)); If a hearing aid or sound generator user, then confirmed consistent daily usage of the device over past 6 months; "
Here are all the criterias:
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB
That's why i have begin to started Trobalt trial...
Very good luck for the AUT00063 trial participants
I can't participate to this trial...
because:
- I am not UK citizen!
- My hearing is not bad enough (less than 20 dB loss) on my audiogram. And yet I hear really worse than before my last NIHL. If this inclusion criteria number 4 is respected, I do not see how they will manage to find enough people. Does participants must have a hearing loss of at least 20dB for each frequency referred to validate this criterion 4?
"4. Sensorineural hearing loss (Pure Tone Average (of thresholds at 250, 500, 1000, 2000 and 4000Hz) >20 and <60 dB Hearing Loss (HL)); If a hearing aid or sound generator user, then confirmed consistent daily usage of the device over past 6 months; "
Here are all the criterias:
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB
That's why i have begin to started Trobalt trial...
Very good luck for the AUT00063 trial participants
@amandine
The selection criteria can be seen here
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB
I just phoned the contact number and was told that I need to get a referral from my GP if I want to be considered for selection. They took my details and asked me a few basic questions (How long have you had tinnitus for? etc..). They say that I need a referral before they can give further consideration to my application. TBH, I think my chances are slim.
The selection criteria can be seen here
http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2014-002179-27-GB
I just phoned the contact number and was told that I need to get a referral from my GP if I want to be considered for selection. They took my details and asked me a few basic questions (How long have you had tinnitus for? etc..). They say that I need a referral before they can give further consideration to my application. TBH, I think my chances are slim.
@amandine
They told me that they are only recruiting 10 people from this particular hospital and you have to assume that of those 10, 5 will be given the placebo. I also got the impression that priority may be given to people who are already ENT patients at the hospital. To be honest, I may also find myself ruled out because I have a history of depression though I am not sure if I would score >11/21 on the Hospital Anxiety & Depression Scale. Still, I will try to get a referral and see what happens.
They told me that they are only recruiting 10 people from this particular hospital and you have to assume that of those 10, 5 will be given the placebo. I also got the impression that priority may be given to people who are already ENT patients at the hospital. To be honest, I may also find myself ruled out because I have a history of depression though I am not sure if I would score >11/21 on the Hospital Anxiety & Depression Scale. Still, I will try to get a referral and see what happens.
@PhilB
So in other words this is going to be practically impossible to get onto?
How many are they recruiting nationwide?
I have no history of depression or anything.
I have a hearing test which shows up to 50db loss at 8 kHz
Otherwise slight dips before that on lower kHz...
Does that count?
Damn all these people so hopeful for autifony and now most cant get on it anyway....
If I had an address in england I may be very well suitable....
So in other words this is going to be practically impossible to get onto?
How many are they recruiting nationwide?
I have no history of depression or anything.
I have a hearing test which shows up to 50db loss at 8 kHz
Otherwise slight dips before that on lower kHz...
Does that count?
Damn all these people so hopeful for autifony and now most cant get on it anyway....
If I had an address in england I may be very well suitable....
SteveToHeal
Member
I phoned them and they are posting info to my sister, who lives in the UK. I have a UK passport and my sister lives up North. If i get in i'll make the trip to the UK and stay with my sister for a month. They asked how long i'd had t. Also only 50/50% chance you get the real drug and no follow up in phase 2 of the real drug. Only in phase 3.
Said there will only be a phase 3 if this phase is successful, which is standard. He also said recruiting goes on till July. And that they can take up to 28 days for the screening period. Could be less but it can take that long. So worst case scenario, we are looking at last patients results to be in end Sept 2015, say Oct to be safe. I don't know how long it will take to analyse the results? Maybe end of 2015 we'll see if 063 works? Then if so, a large roll out phase 3 in 2016, if phase 2 worked?
I asked about the hearing loss criteria and they are "looking" to take it out, which is great news. I just hope they do. It is as we guessed and that the criteria for t could be too stringent placing hearing loss criteria on top and they can't get the numbers ? However, he said until they officially remove the criteria, the hearing loss criteria stands. I will apply all the same and hope it is the case.
One thing he did say is that Autifony have high hopes for the trial and that it is exciting times for t sufferers. I'm not sure if it's just wishful thinking or if they really do think this will work! I really hope so for all of us out there.
Should have more info in a few days.
Said there will only be a phase 3 if this phase is successful, which is standard. He also said recruiting goes on till July. And that they can take up to 28 days for the screening period. Could be less but it can take that long. So worst case scenario, we are looking at last patients results to be in end Sept 2015, say Oct to be safe. I don't know how long it will take to analyse the results? Maybe end of 2015 we'll see if 063 works? Then if so, a large roll out phase 3 in 2016, if phase 2 worked?
I asked about the hearing loss criteria and they are "looking" to take it out, which is great news. I just hope they do. It is as we guessed and that the criteria for t could be too stringent placing hearing loss criteria on top and they can't get the numbers ? However, he said until they officially remove the criteria, the hearing loss criteria stands. I will apply all the same and hope it is the case.
One thing he did say is that Autifony have high hopes for the trial and that it is exciting times for t sufferers. I'm not sure if it's just wishful thinking or if they really do think this will work! I really hope so for all of us out there.
Should have more info in a few days.
@SteveToHeal
Out of interest, please say which site you called?
How will you get over the fact that you are not registered with a GP? Your T is not registered in UK. Or you can register and say that it is new maybe but that would not be fair. Or you can say that you have it since july but never sought medical help. Where will you have your hearing tests to show them....unless they remove this criteria then maybe ....they will probably do one wont they? to check?
By the time that is done will the 10 for each hospital already be filled from their ENT depts?
After all you have to get to UK, register with a doctor (which is quite easy and possible to do once you get past the long line of eastern europeans) and then apply afresh with your gp's request.
By the time you get a docs appt it may already be too late....unless you are flying over now?
I for sure would like to get onto it but is it possible?
@Danny Boy
They said that they will take people up to 12 months and only if they dont have enough people they will look at taking people 12 to 18 months.
Seems to me that this is already tied up...?
To everyone: by the way, it appears that Birmingham hospital did not know that their phone etc....is up on autifony site now.
Does not sound like it is really organised properly after all the faffing around for ages now....
Just phoned wigan.
1. 6 - 12 months and up to 18 months - no cut off at 12 months
2. Must be referred by GP or show have had appts at ENT in the area of hospital.
3. If referral only by GP but no ENT diagnosis then must attend an appt at ENT clinic first within the hospital
4. after ENT if it was necessary and successfully passed then follows
only 3 visits
first one is screening incl blood test and hearing test. This hearing test consists of checking db loss across whole range of Khz including from lowest up to 10 or 12 Khz. Then they take an average db loss from all that data - so if you have hearing loss at different kHz then this is averaged out to see if you fit the criteria for hearing loss. Blood tests results after 2 or 3 days.
2nd visit is first tablet and stay for one and a half hours then go home
fill in diary every day
3rd visit is to return on day 28 to take the last pill and hand in diary.
that is it
they confirmed that no side effects.
they said that even if they surpass the alloted number of people , if the person fits the criteria then they will take them as that is a good thing and the more the merrier. They said that they are open for these trials till May 2015 and that it has already been running for about a month. Cannot apply until you have had T for at least six months So it seems that the trials have already started and are currently ongoing.....and started already whilst we were waiting for info on the autifony site. So they did start in October and enrolment did start back in August 2014....guess from the patients already at the ENT depts at the hospitals.
Maybe they were looking to see if they had sufficient from the ENT depts OR they now want a much larger number of people to take part.
The impression I got was that certainly for Wigan there is no cut off number
@SteveToHeal
Out of curiosity as we are in the same boat - UK citizens but not curently in the UK
Did you tell them that you are outside UK at the moment and was this then not a problem as you are UK citizen
OR did you not mention that you are not in UK?
Cos you said that they are posting to your sister the info so it sounded like you told them that you are in USA currently.
In that case, what did they say to you re being with a GP for a referral?
thanks for letting me know
Out of interest, please say which site you called?
How will you get over the fact that you are not registered with a GP? Your T is not registered in UK. Or you can register and say that it is new maybe but that would not be fair. Or you can say that you have it since july but never sought medical help. Where will you have your hearing tests to show them....unless they remove this criteria then maybe ....they will probably do one wont they? to check?
By the time that is done will the 10 for each hospital already be filled from their ENT depts?
After all you have to get to UK, register with a doctor (which is quite easy and possible to do once you get past the long line of eastern europeans) and then apply afresh with your gp's request.
By the time you get a docs appt it may already be too late....unless you are flying over now?
I for sure would like to get onto it but is it possible?
@Danny Boy
They said that they will take people up to 12 months and only if they dont have enough people they will look at taking people 12 to 18 months.
Seems to me that this is already tied up...?
To everyone: by the way, it appears that Birmingham hospital did not know that their phone etc....is up on autifony site now.
Does not sound like it is really organised properly after all the faffing around for ages now....
Just phoned wigan.
1. 6 - 12 months and up to 18 months - no cut off at 12 months
2. Must be referred by GP or show have had appts at ENT in the area of hospital.
3. If referral only by GP but no ENT diagnosis then must attend an appt at ENT clinic first within the hospital
4. after ENT if it was necessary and successfully passed then follows
only 3 visits
first one is screening incl blood test and hearing test. This hearing test consists of checking db loss across whole range of Khz including from lowest up to 10 or 12 Khz. Then they take an average db loss from all that data - so if you have hearing loss at different kHz then this is averaged out to see if you fit the criteria for hearing loss. Blood tests results after 2 or 3 days.
2nd visit is first tablet and stay for one and a half hours then go home
fill in diary every day
3rd visit is to return on day 28 to take the last pill and hand in diary.
that is it
they confirmed that no side effects.
they said that even if they surpass the alloted number of people , if the person fits the criteria then they will take them as that is a good thing and the more the merrier. They said that they are open for these trials till May 2015 and that it has already been running for about a month. Cannot apply until you have had T for at least six months So it seems that the trials have already started and are currently ongoing.....and started already whilst we were waiting for info on the autifony site. So they did start in October and enrolment did start back in August 2014....guess from the patients already at the ENT depts at the hospitals.
Maybe they were looking to see if they had sufficient from the ENT depts OR they now want a much larger number of people to take part.
The impression I got was that certainly for Wigan there is no cut off number
@SteveToHeal
Out of curiosity as we are in the same boat - UK citizens but not curently in the UK
Did you tell them that you are outside UK at the moment and was this then not a problem as you are UK citizen
OR did you not mention that you are not in UK?
Cos you said that they are posting to your sister the info so it sounded like you told them that you are in USA currently.
In that case, what did they say to you re being with a GP for a referral?
thanks for letting me know
@Danny Boy, are you sure they said 12db average hearing loss? This would be a change from the published criteria of greater than 20db and less than 60db.
Thanks Amandine. There seems to be variation though in what hospitals are telling people. Eg. 12 or 18 months.
@Rube
Thanks for saying excellent data.
My job by profession is journalist.
Now if someone can help me with an address or place to stay in england I can then try to get onto the study trial and will do a proper insider job on it getting meticulous data and posting it here (so you guys will get it way before the press gets anything - I would not report to press or anywhere else - only this forum.
Anyone got anything to help me achieve this please?
Thanks for saying excellent data.
My job by profession is journalist.
Now if someone can help me with an address or place to stay in england I can then try to get onto the study trial and will do a proper insider job on it getting meticulous data and posting it here (so you guys will get it way before the press gets anything - I would not report to press or anywhere else - only this forum.
Anyone got anything to help me achieve this please?
SteveToHeal
Member
No. I phoned Newcastle. I used to live there so maybe that is why. I already have a GP and an NHS number there so it's not a problem. Yes. I will be staying with my sister when i'm there so I gave that address. It is not a lie. And i'm in South Africa not USA. They didn't ask for a GP referral. All they said is they'll send me info in the post. That and what i wrote above.
SteveToHeal
Member
They did not ask me any of that. I am already registered with a UK GP. I think you are making a lot of assumptions. As soon as I have more info i'll post to this board to let everyone know.
@SteveToHeal
Sorry about getting your country wrong. I never knew where you are so I assumed USA - sorry again.
I am now going on what I know from conversing with a hospital
They want a registered with ENT dept in their area OR a doctors referral whereby you must go through an ENT appt in their hospital.
All the rest is as I was told today by Wigan.
Are some places dispensing with the hearing test whilst others are not?
What kind of real trial can it be if each trial centre is going under different criteria.
Even the numbers game seems to be up in the air.
Manchester 10 - Wigan as many as possible who fit the criteria until May 2015
Confusing to say the least.
What i should do is ocntact anonymously as many of the centres as possible and write down meticulously what each one says to me using the same questions. I pointed Wigan to the exclusion criteria showing on the WHO site. That is when I got the reply about the hearing test which is mandatory and apparantly they had a meeting last week and confirmed that the hearing test criteria stands.
Who knows
We need to see what each one is saying.
Or contact the medical monitor at Autifony who will be the one overseeing the criteria for these trials.
Sorry about getting your country wrong. I never knew where you are so I assumed USA - sorry again.
I am now going on what I know from conversing with a hospital
They want a registered with ENT dept in their area OR a doctors referral whereby you must go through an ENT appt in their hospital.
All the rest is as I was told today by Wigan.
Are some places dispensing with the hearing test whilst others are not?
What kind of real trial can it be if each trial centre is going under different criteria.
Even the numbers game seems to be up in the air.
Manchester 10 - Wigan as many as possible who fit the criteria until May 2015
Confusing to say the least.
What i should do is ocntact anonymously as many of the centres as possible and write down meticulously what each one says to me using the same questions. I pointed Wigan to the exclusion criteria showing on the WHO site. That is when I got the reply about the hearing test which is mandatory and apparantly they had a meeting last week and confirmed that the hearing test criteria stands.
Who knows
We need to see what each one is saying.
Or contact the medical monitor at Autifony who will be the one overseeing the criteria for these trials.
@Rube
Yes I will do this
BUT can anyone offer me a place to stay in England?
I need only to stay to get registered at gp and get referral
then if it is quick then i can stay to go to study
OR if it is longer then i can go and come back
I can ring the doctor and make an advance appt so that when i come there will be no hanging about
I have no family in UK - all died
so I need help to do this stay in uk at least intially
but can certainly do a proper job and info by gathering info from scratch thru to end of study with hospital i would potentially be with and all the rest of the study centres getting info....
Yes I will do this
BUT can anyone offer me a place to stay in England?
I need only to stay to get registered at gp and get referral
then if it is quick then i can stay to go to study
OR if it is longer then i can go and come back
I can ring the doctor and make an advance appt so that when i come there will be no hanging about
I have no family in UK - all died
so I need help to do this stay in uk at least intially
but can certainly do a proper job and info by gathering info from scratch thru to end of study with hospital i would potentially be with and all the rest of the study centres getting info....
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