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

[amandine]

Is placebo in trials always "sugar pills" or can the placebo be another drug (that is harmless but can give some side effects) ?

In short the answer is sugar pills. If it was another drug then how could they know what was going on? In other words how could they say placebo (meaning no drug) ex percentage effect against the actual drug?
Placebo must be sugar pills - maybe the coating gives effects...I dont know.

However it is well known that the mind is a powerful thing and effects on the body can be created by the mind.......so if the person thinks they are getting a certain drug which will help them then they can create effects simply through the power of their own mind. That is why they do double blind trials to establish certainty whether the real drug administered has a definite effect or not.
Sorry for the long winded answer.

 

[Zimichael]

Hallo Mark! Yes i'm on trial but if it don't give some positive results i will abandone. Does anyone know what are the side effects of a placebo? The doctors do not say anything. They only say: "write your questionnaire and if you feel bad call us". I've done a lot of tests before enrollment, EEG even ... I'm a bit sad.
Thank you

Remington... You are apparently new to Tinnitus Talk as a member, but not sure how long you may have been watching as a visitor. No matter, but indeed, if you are in the Autifony trial then that makes you a VIP around here! Big time.

So a very, very brief note to you on a potentially encyclopedic subject...

I'm not sure if you have been following the Retigabine thread (monstrously long) or the whole "Kv ~ Potassium Channel Modulators" discussions (which include Keppra and Flupirtine), but summary point is, the Potassium Channels approach to tinnitus treatment is hugely relevant and important to many of us.
Trouble is, the medically approved drugs available to us in this class are not "designed" for tinnitus per se, and are more like shooting at a target with a shotgun from a long way off. What you are getting (if not placebo) with AUT00063 , is the equivalent of a laser guided bullet heading straight for the "tinnitus zone" target. That is, if we are to believe Autifony, and the thousands of hours that have been spent going over this subject. To date, there is no reason not to believe them, but there is nothing like "facts on the ground" to bear that out... = YOU! And people in the trial - of which we have so very, very few TT folks getting it for something so very, very important,

Here's the relevant part for you as I see it...

Autifony is giving you one smacko level dose of 800 mg a day, if memory serves. Now to start at that level on one of it's "sister", shotgun drugs like Retigabine say - though it is in a slightly different sub-class...would probably plaster you to the wall! I have taken Retigabine myself and the side effects get pretty intense for most once getting up over, say 300 mg total per day. It's best to taper up slowly to allow the brain/body to get used to the stuff, etc. etc.
Remember, we are talking shotgun approach though v. laser guided bullet with the Autifony's drug, so the side effects of the AUT00063 were hopefully going to be more or less non existent...well, except on the tinnitus of course.

However, I can readily foresee, that for some people a slam in "full dose" of any Kv potassium channel modulator, no matter how targeted, could be a bit of a "shock" to the system. Retigabine users have been all over the map, with some unable to even cope with 50 to 100 mg, while others sail along, reaching 1200 mg/day. It's very individual.
So please bear that in mind.

If you are having the side effects you reported I would guess you are on the real drug, as "confusion" for instance is a very, very well known result with Retigabine. Thus I encourage you to hang in there and you may find it easier to adapt to the drug as the days go by. You must of course make your decision on this, but I hope this note helps you to stick it out as many, many eyes, and hopes, are on this trail.

Please keep reporting to us and tell us how it's going.

Thanks much, Zimichael

 

[Remington]

Hallo guys:
I read a lot of success/improvement stories with trobalt during this summer and after this trial i want try it. One year ago i was responsive to tegretol 200mg. It's an old antiseizures drug and it work a lot on my tinnitus (on v.scale to 7/10 to 3/10) but with a lot of heavy side effects.

About this experimental drug i'm taking sure a placebo but the strange fact are the experience of some side effects. No change in tinnitus and sometimes it worse. Before taking this pills, i hadn't any worsening (gift). I'm on 22 days.

Good luck at all guinea pigs

 

[Remington]

Remington... You are apparently new to Tinnitus Talk as a member, but not sure how long you may have been watching as a visitor. No matter, but indeed, if you are in the Autifony trial then that makes you a VIP around here! Big time.

i don't wont to be a useles vip, i know the tt forum more than 1 year. I'm searching for others people on trial with my side effect, then i've subscribed to tt forum! sorry

 

[RCP1]

3 folks on the trial now - All with Placibo ? 1 in 8 chance of that.

As Kevin Kline once said when discovering the safe was empty... "Disappointed!"

 

[nills]

i don't wont to be a useles vip, i know the tt forum more than 1 year. I'm searching for others people on trial with my side effect, then i've subscribed to tt forum! sorry

it`s good you did so because we are craving for some experiences ... good and bad ... any chance you can ask some other trialees to subscribe at TT and share their experiences or ask your doctor to tell them to come here ?

 

[Sharpfire]

Is placebo in trials always "sugar pills" or can the placebo be another drug (that is harmless but can give some side effects) ?

A placebo is the exact same solution as the real drug, just without the active ingredient/drug. E.g. placebo = solvent mixture. Real drug = solvent mixture + drug. The solvent mixture could be anything, as long as they are the same in both placebo and real.

If someone is allergic to the solvent, it could lead to side effects

 

[amandine]

i don't wont to be a useles vip, i know the tt forum more than 1 year. I'm searching for others people on trial with my side effect, then i've subscribed to tt forum! sorry

You are not a usless vip. You are incredibly welcome. Please stay with us!

 

[dan]

I had much better for this drug....useless

 

[RCP1]

The Fat lady hasn't sung yet. Sample set 3 - Can't draw any conclusions yet but disappointing that no good anecdotes have materialized.

Lets hope @Remington can get some further info from other trialees...

This drug really is the only current hope on the immediate horizon - failure would be a body blow to many.

I for one am not writing it off yet...

 

[Mark662]

The Fat lady hasn't sung yet. Sample set 3 - Can't draw any conclusions yet but disappointing that no good anecdotes have materialized.

Lets hope @Remington can get some further info from other trialees...

This drug really is the only current hope on the immediate horizon - failure would be a body blow to many.

I for one am not writing it off yet...

So very true. Nor am I.

I am sure there has been a massive amount of background research gone into bringing this particular variant of potassium channel modulator to a human trial. GSK/Autifony could have chosen many others to test.

I just hope, like millions others, that they are on the right track.

I think I would put up with a load of side effects to experience total silence for a night at the least. It would be a rare experience. What other hope is there for us in the near future?

 

[valeri]

I don't even want to think what the future will be like for me if this doesn't provide at least a tiny bit of relief

 

[swc5150]

Don't get down yet my fellow sufferers. A couple of people reporting no improvements does not complete a phase 2 trial. Remember, the trial started in oct/nov last year, and they're already planning an expansion into the US. There's little doubt Autifony already has some results that warrant this expansion, otherwise it wouldn't be in the works. Everyone wants to hear those magic words that it works, but we just need to relax and let the trials run their course.

 

[Rube]

Don't get down yet my fellow sufferers. A couple of people reporting no improvements does not complete a phase 2 trial. Remember, the trial started in oct/nov last year, and they're already planning an expansion into the US. There's little doubt Autifony already has some results that warrant this expansion, otherwise it wouldn't be in the works. Everyone wants to hear those magic words that it works, but we just need to relax and let the trials run their course.

Seriously, let's chill with the "omg it doesn't work" nonsense. Unless you have some hard evidence, let's wait and see. So much negativity........

 

[rtwombly]

This drug really is the only current hope on the immediate horizon - failure would be a body blow to many.

I was just walking around my house thinking how quiet it still is on 150mg of Potiga every 6 hours.

Two new versions of Retigabine have been invented in the last several months, both of which are said to be less prone to side effects, and one of which is said by the inventor to be theoretically more effective on tinnitus than Potiga. Plans are to clinically trial both drugs for tinnitus.

So nobody throw in the towel just yet, 'kay?

I want AUT00063 to work too, but it's not the only game in town.

 

[locoyeti]

I was just walking around my house thinking how quiet it still is on 150mg of Potiga every 6 hours.

Two new versions of Retigabine have been invented in the last several months, both of which are said to be less prone to side effects, and one of which is said by the inventor to be theoretically more effective on tinnitus than Potiga. Plans are to clinically trial both drugs for tinnitus.

So nobody throw in the towel just yet, 'kay?

I want AUT00063 to work too, but it's not the only game in town.

where are you getting this information? please link source.

 

[Hotspur]

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!

 

[RCP1]

@Hotspur

Great news - Something positive anyway... I'll take it

Thanks for getting back

R

 

[preslys]

i would say i have a mild improvement

ammmmmmmmmmm ,When my tinnitus hears this kind of news he tries to find an other place in my body to hide.

 

[john2012]

has anybody yet posted any positive/negative feedback from autifony trials
or is it too early?

 

[amandine]

has anybody yet posted any positive/negative feedback from autifony trials
or is it too early?

Pleae read the post by Hotspur. This is all we have......but better than no improvement at all.

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!

 

[Stina]

Just wanted to point out that after 15 years of arthritis and trying various combinations of treatments it is completely normal that drugs have side effects. People are different and no one drug has the same effect on everyone. Therefore after the first trials (which include ca 100 people) it is very hard to say how any of us will react to the drug or whether it will work. For example the drug I have been taking for 10 years without side effects can have quite strong side effects on many people whereas I haven't had any for 10 years and as the drug has been used for 3-4 decades now the long term effects are known. And on the other hand with the new drugs the long term effects are also unknown which is why they are not used very often (only in extreme cases). Therefore I think only time and larger trials will show the effect Autifony has and at this stage it is very difficult to make conclusive statements.

 

[marqualler]

Keep in mind that part of the trial is also to determine effective dosage and length of time to take it. Also remember the different etiologies of tinnitus. The fact that Hotspur reported some improvement is certainly a positive but the fact that the drug is even this far along is positive in and of itself. Just my two cents!

 

[rtwombly]

where are you getting this information? please link source.

I got one from ATEOS, same convo you were on IIRC. ATEOS's source was excellent. The other was https://www.tinnitustalk.com/thread...eat-epilepsy-and-neurological-disorders.7743/.

 

[Zimichael]

i don't wont to be a useles vip, i know the tt forum more than 1 year. I'm searching for others people on trial with my side effect, then i've subscribed to tt forum! sorry

@Remington ...don't worry about being a "useless VIP", as not an issue here at all. Information is our trade on TT then we sort it out and slice, dice, re-mix, whatever.

Incidentally can you please tell us how you manged to get into the trial and which location you have been going to? Who is your testing leader/researcher? We have been getting such varied reports about the different locations and 'helpful' v. 'unhelpful' locations and evaluators, it would be really good know.

Thanks much, Zimichael

 

[tshapiro]

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 thanks for taking the time to share back with the group. It is much appreciated.

All - if this drug has actually helped Hotspur - even a small amount - without detrimental side effects than this would be a huge milestone. Once the pharmaceutical industry learns of a potential mechanism to harness T than it will be a relatively short time before someone figures out how to do it more effectively. This would be the proverbial crack in the armore sort of speak and the next few years should bring more exciting breakthroughs. The road to making something better is much shorter and less risky than the road for something completely unknown. Hopefully, more positive results - not necessarily perfect results - emerge.

 

[tshapiro]

i don't wont to be a useles vip, i know the tt forum more than 1 year. I'm searching for others people on trial with my side effect, then i've subscribed to tt forum! sorry

@Remington Welcome! And thanks for sharing with the group.

 

[Rube]

@Hotspur thanks for taking the time to share back with the group. It is much appreciated.

All - if this drug has actually helped Hotspur - even a small amount - without detrimental side effects than this would be a huge milestone. Once the pharmaceutical industry learns of a potential mechanism to harness T than it will be a relatively short time before someone figures out how to do it more effectively. This would be the proverbial crack in the armore sort of speak and the next few years should bring more exciting breakthroughs. The road to making something better is much shorter and less risky than the road for something completely unknown. Hopefully, more positive results - not necessarily perfect results - emerge.

Amen brother. Just need to crack the door open a bit then we should start seeing progress snowball just as you mention!

 

[tshapiro]

Keep in mind that part of the trial is also to determine effective dosage and length of time to take it. Also remember the different etiologies of tinnitus. The fact that Hotspur reported some improvement is certainly a positive but the fact that the drug is even this far along is positive in and of itself. Just my two cents!

This is pretty encouraging - I think it increases our perceived odds that the drug could still be a winner. In other words, if it doesn't work for someone than there is the potential that they were on too low of a does.

 

[Remington]

To zimichael: I'm sorry but i can't answer to your request of name of Drs or hospital. I can only say that i live and work near Wrightington H. I hven't hearing loss or others disorders. I've concentration's problems on job only when i must read new rules about it. Sometimes problem to fall asleep. lucky this drug made me tired and i can sleep better. I'm on 23th and tinnitus this night is on vs 4/10.
Thanks all and good night