Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

[111]

I hven't hearing loss

Could I ask how you actually got on the trial then with this statement please, given the strict criteria set ?

It seems you are saying you got on this trial without meeting the main strict criteria point for loss, and that is an issue / stumbling block for other people thinking of going for this trial, so could you explain how you got around this during the tests you had to have done please ?

 

[valeri]

@Hotspur

Great news!
Are you, by any chance, in touch with any other participants, any improvement for them?

 

[Juan Carlos]

Hi guys,i finish the course on Wednesday,sorry for not getting back to everyone ,but i thought in the interest of clarity it would be best to take a step back and then report when it was towards the end
Basically,i would say i have a mild improvement,say im typically a 4,which would be T annoying in a quiet room after a while?Well now i have days were i can be in a quiet room still hear the T but its not quite so strong a 3 maybe 2?
Can still hear it faintly over TV and Radio,hope this helps!
If theres any questions youd like me to ask on Wednesday and can try to crow bar them in!

hi hotspur, you are a hope lighter for millions of us. I have some easy questions
Did you ever had before a similar improvement since T set? do you think that could be placebo-effect? when will u know if had placebo pill?
I know by myself that rating T just listening to it is quite tricky, so I would trust more audiometry of before pill and after, are u going to see the results of your audiometry?

I find very weird that the one having side effects has no T improvement, and the one without side effects has some improvement... It seems that we will never have a concise solid experience about this

 

[Stina]

hi hotspur, you are a hope lighter for millions of us. I have some easy questions
Did you ever had before a similar improvement since T set? do you think that could be placebo-effect? when will u know if had placebo pill?
I know by myself that rating T just listening to it is quite tricky, so I would trust more audiometry of before pill and after, are u going to see the results of your audiometry?

I find very weird that the one having side effects has no T improvement, and the one without side effects has some improvement... It seems that we will never have a concise solid experience about this

Why is it weird? Everybody is different and it is not uncommon at all with any medication to have side effects and no effect on the problem. No one drug gives the same effect on all people. The same goes for food, exercise, life situations etc. For example I'm sensitive to coffee and if I consume I get allergies whereas patients with Parkinson actually may benefit from it. This is why its good to listen to people smarter than you but also important to listen to your body and reflect that back to doctors.
Also, once the mechanism for a disease and possible treatments are found it will be possible to analyze why and on whom they don't work in order to create alternatives.

 

[Rube]

Hi guys,i finish the course on Wednesday,sorry for not getting back to everyone ,but i thought in the interest of clarity it would be best to take a step back and then report when it was towards the end
Basically,i would say i have a mild improvement,say im typically a 4,which would be T annoying in a quiet room after a while?Well now i have days were i can be in a quiet room still hear the T but its not quite so strong a 3 maybe 2?
Can still hear it faintly over TV and Radio,hope this helps!
If theres any questions youd like me to ask on Wednesday and can try to crow bar them in!

@Hotspur did you start noticing the improvement when you started taking the once per day dose mid way through your trial? If I remember correctly about midway through you learned the correct dose was all 4 pills at one time per day.

 

[dan]

No one drug gives the same effect on all people.

Paracetamol does...

 

[Hotspur]

Hi guys,i,ll try to answer all the questions as best as i can,1 Dont think ive had as consistent improvement since before medication,most days about a 2 or 3,which i would describe as a light buzz most of the day
2It could well be placebo,i think unless i get silence then everything is a variable
3They said wouldnt tell me if i get a placebo,but surely wouldnt do any harm after results have been published?From a personal point of view would help a great deal
4 I do think the hearing test will be the good indication of any change,i apparently have quite bad hearing so will ask about any changes when i have the test
5 Again another variable,i feel it did work better with the one big dose,trial doctor didnt seen to think it was a huge deal,but obviously done it that way for a reason,it could also be that medication was just building up?
I also get the impression that this dosage is not set in stone,and like i said previously there were planning on a longer course for people that have had it longer
Hope that helps,anything else i can help with feel frre to ask,bye for now

 

[CarolinaGuy]

So Hotspur, it's hard to say whether you have really seen improvement? You wrote "Dont think ive had as consistent improvement since before medication"

 

[Hotspur]

So Hotspur, it's hard to say whether you have really seen improvement? You wrote "Dont think ive had as consistent improvement since before medication"

Most days in the last couple of weeks have been about a 2 or 3,which ive not had consistently pre medication

 

[CarolinaGuy]

Oh, thanks, that sounds like potentially quite positive news if you have had a string of good days.
Are you feeling better yourself, with these low days? Or were you already mostly "habituated"
Sounds like your T is similar to mine. Very variable. I get really good days and some really bad days.
Thanks for posting the updates!

 

[Hotspur]

Oh, thanks, that sounds like potentially quite positive news if you have had a string of good days.
Are you feeling better yourself, with these low days? Or were you already mostly "habituated"
Sounds like your T is similar to mine. Very variable. I get really good days and some really bad days.
Thanks for posting the updates!

Hi,not sure i was habituated,when i first got this a year ago it was very somatic,i dont seem to be affected by noise at all!Like yourself could be variable,but if it did stay with a light buzz it wouldnt be too bad

 

[RCP1]

This is exciting news. Particularly if @Hotspur maintains this going forward. If he gets permanent improvement from the drug that would be amazing... Or even better he may improve further... Who knows

 

[Mark662]

Even antidepressants, like Prozac, take at least a month to become fully effective, so with the trial being 28 days it is comparatively short. They are both neurological drugs but work on different mechanisms of the brain. The time period to declare Prozac ineffective is 8 weeks after starting treatment.

 

[Hotspur]

Just regarding side effects,and basing placebo or real drug on them, this is what the information sheet says of phase 1
The most common side effects were mostly mild in nature,included headache,feeling a bit sleepy or tired,feeling a bit nauseous.At most 1 in 1o felt these effects
Also 4 out of 56 who received the study medicine showed abnormal events on the heart rhythms which did not cause any symptoms.Heart experts reviewed the data and confirmed that these events were not a clinical worry and could not be proven to be related to the drug

 

[valeri]

@Hotspur

Do you know of any other participants who had any improvement?

 

[Hotspur]

@Hotspur

Do you know of any other participants who had any improvement?

Ive not met anyone else,the hospital im visiting only has time to see one person each week

 

[Remington]

user 111 why do you treat me like a criminal? I'm not deaf. I've minimum hearing loss in the same ear of tinnitus. To be more precise very small on frequencies between 4 and 5khz. Tonal, teeeeeeeeee. I've no deafness. I'm honest.
good bye

 

[RCP1]

We need to be more respectful of these guys. They are coming on here out of their own goodwill and nothing else. They owe nobody anything. @Remington thank you sincerely for your reporting to this board. Wishing you all the best in your recovery.

We really need to keep our eye on the ball here which is to keep the info coming in to us. P*ssing these guys off is the most counterproductive thing we can do. We already had this kind of thing done 3 weeks ago. I thought we had gotten passed this...? What is so difficult to understand? We have just lost a valuable trialee. They don't grow on trees...

 

[111]

user 111 why do you treat me like a criminal

So which part of my question suggested this, please elaborate ?

Lets look at the facts,

• You suddenly appear on here saying you are on day 22 of this trial, nothing from you previously.
• You got asked a genuine question by Zmichael, to clarify a few things, and you did not supply an any answers.
• I asked a genuine question in relation to information supplied by yourself, and you state the above as part of your answer.

There are people on here from the UK would like to get on this trial, but see the loss criteria as the stumbling block, you stated you had no loss, hence my question to you.

If you are genuinely on this trial then why come on here and be unhelpful and not answer questions and then be so negative to a question.

The other two people on this trial have given good concise up dates about their experiences pre and post selection, you have not supplied anything which indicates you are actually on this trial at all.

 

[Rube]

Ive not met anyone else,the hospital im visiting only has time to see one person each week

I hope u stick around to let us know how u r doing post trial.
Also u said u said last couple of weeks has been low, that seems like it coincides with when you started taking the full dose at once. That sounds like good news to me.

 

[amandine]

I can see that you are just on 18 / 19 months 'ish since your start of T so their 6 to 18 months is indeed a bit flexible....your T started in July 2013....
Please can you tell us, if it is ok with you, how is your hearing and what kind of hearing tests you had to take?
Do you know what loss of hearing they are looking for (aside from what is written on their website as it seems this may differ in practice from trial clinic to clinic).
This info would be incredibly useful for other people to get the oomph to apply to be on trials.
How long have you been on the trial so far and have you noticed any difference in your T levels yet?
We are all so looking forward to hearing your info......thank you so much for posting and please would you answer the above questions. It is incredibly appreciated by all of us.
Thank you!

@111 Just wanted to say that I asked this before zimichael back on saturday but didnt receive a reply either. I did not get upset that @Remington didnt reply to me. Why not? Because members are not forced to reply are they? If Remington wants to reply he will and if he doesnt then he wont and we must respect this. But attacking back to a member will definitely not help this situation.
Rather we should thank Remington for any info he provides and that goes for all other trialees. @RCP1 is right when he is basically saying cool it guys - lets be nice and respectful to each other and help each other with what ever we can including info from these trials.
@Remington please understand that people are hungry for info and many people want to go onto these trials. Some have already been refused due to lack of sufficient hearing loss but we are slowly becoming aware that there are different requirements at different trial clinics. That is why we ask these questions for example re the hearing loss requirement that you for example needed in order to qualify. It is not cos treating you like a criminal....it is more just a thirst for information as it may mean that more of us will qualify for the trial. Hope you understand and you stay with us. Maybe 111 phrased it in such a way as it potentially sounded a bit aggressive but I sure that was not his intention. He is suffering just as all of us are.......so stay with us @Remington please........on behalf of all of us here.

 

[rtwombly]

Even antidepressants, like Prozac, take at least a month to become fully effective, so with the trial being 28 days it is comparatively short. They are both neurological drugs but work on different mechanisms of the brain. The time period to declare Prozac ineffective is 8 weeks after starting treatment.

This is a good point. Since I started backing down on Retigabine I've noticed that I've had noticeable effect on lower doses than when I was moving up. Like, once I got the drug really pumping, I didn't need as much.

If it wasn't for the eye floaters, which are a new side effect for me, I'd be tempted to stay on the lower dose long term. 28 days may not be enough to get maximum efficacy from AUT00063.

 

[dan]

We need to be more respectful of these guys. They are coming on here out of their own goodwill and nothing else. They owe nobody anything. @Remington thank you sincerely for your reporting to this board. Wishing you all the best in your recovery.

We really need to keep our eye on the ball here which is to keep the info coming in to us. P*ssing these guys off is the most counterproductive thing we can do. We already had this kind of thing done 3 weeks ago. I thought we had gotten passed this...? What is so difficult to understand? We have just lost a valuable trialee. They don't grow on trees...

I a greeeeee. Stop pi$$ING off trialees.

 

[111]

But attacking back to a member will definitely not help this situation.

It was quite clear what my question was and the reason why I asked it, yet the reply was that I was implying the person was a criminal, go and figure that reply out for yourself.

At the end of the day if someone appears on here saying they have known about this site for 12 months, then joins and say they are 22 days already into this trail I think it fair that reasonable questions will be asked, if they don't want to answer just say so, don't imply ridiculous accusations about being criminals. At the same time I would also question what was the point of joining if you intend to answer no questions asked.


My next question would be to again clarify how they got on the trial when they say

I've minimum hearing loss in the same ear of tinnitus. To be more precise very small on frequencies between 4 and 5khz.

Yet the trial criteria says

4. Sensorineural hearing loss (Pure Tone Average (of thresholds at, 500, 1000, 2000 and 4000Hz) =20 and =60dB Hearing Loss (HL));

It would be interesting for everyone to see how someone passed the initial screening test given these results, as it might assist others to get in on this trial and broaden the amount of people who would supply genuine updated info, but I suspect we wont find out this info.

 

[Remington]

I sincerely apologize for my "sudden" appearance on this forum. I'll tell you before the next illness. I absolutely did not want to create all this noise, skepticism, negativity. I was just looking for someone who could help me better understand this clinical trial. I apologize also to other users, but unfortunately I do not have much time to reply evryoene. I am overwhelmed at work. The tinnitus today is 3/10.
kind regards

 

[Christian78]

This is exciting news. Particularly if @Hotspur maintains this going forward. If he gets permanent improvement from the drug that would be amazing... Or even better he may improve further... Who knows

Drug is not designed to be cure but to be payed and used until rest of life like any epileptic , or medicine for neural disorders.

 

[kevin b]

I sincerely apologize for my "sudden" appearance on this forum. I'll tell you before the next illness. I absolutely did not want to create all this noise, skepticism, negativity. I was just looking for someone who could help me better understand this clinical trial. I apologize also to other users, but unfortunately I do not have much time to reply evryoene. I am overwhelmed at work. The tinnitus today is 3/10.
kind regards

That is some funny shit!

 

[Christian78]

Hi guys,i,ll try to answer all the questions as best as i can,1 Dont think ive had as consistent improvement since before medication,most days about a 2 or 3,which i would describe as a light buzz most of the day
2It could well be placebo,i think unless i get silence then everything is a variable
3They said wouldnt tell me if i get a placebo,but surely wouldnt do any harm after results have been published?From a personal point of view would help a great deal
4 I do think the hearing test will be the good indication of any change,i apparently have quite bad hearing so will ask about any changes when i have the test
5 Again another variable,i feel it did work better with the one big dose,trial doctor didnt seen to think it was a huge deal,but obviously done it that way for a reason,it could also be that medication was just building up?
I also get the impression that this dosage is not set in stone,and like i said previously there were planning on a longer course for people that have had it longer
Hope that helps,anything else i can help with feel frre to ask,bye for now

Thank you for being kind and reporting your results to us. God bless you.

For rest of us if you remember dr Large wrote medicine is not totally finished and may need twitching.

Results anyway will come in summer. Preliminary maybe a bit before. And as I understood medicine could be available little bit before 2020.

So no need to pressure any participants. I think also about someone asking for details of one guy under trial who appeared suddenly i said i would make new account and come here and lift your hopes up and say I just got info from friend to come here. It would give you hope to fight on.

So there is no point of accusing anyone of anything, we can be friends here. And results will come out, whether they are good or bad.

Peace to all

 

[attheedgeofscience]

Drug is not designed to be cure but to be payed and used until rest of life like any epileptic , or medicine for neural disorders.

According to my sources, there is no definitive protocol in place at this moment. It is not known if AUT-63 will be curative or if it will require life-long suppressive treatment in order to maintain the effect.

 

[nills]

According to my sources, there is no definitive protocol in place at this moment. It is not known if AUT-63 will be curative or if it will require life-long suppressive treatment in order to maintain the effect.

Well one or the other would be great ... it is still unclear ...

if AUT00063 can bring silence until the day they find the next best thing ... great!