Audion Therapeutics Trial

[Drone Draper]

They'll only do the treatment in one ear, so that's not a problem. If you have hearing loss in both, they'll use the worst one.

 

[grate_biff]

Got an email from them. They only take US citizens. Why do they have trials in London then??

 

[Drone Draper]

I don't think that's right.

"At least 40 people will take part in this second part of the study in total and the study will be conducted in the United Kingdom, Greece, and Germany."

Doesn't look like they're looking for American participants at all.

 

[gadsie]

Thank you for your email. Unfortunately, we are only able to recruit UK citizens for the early phases of the trial.


Any updates on the trial will be available http://regainyourhearing.eu

 

[Drone Draper]

Damn.

Give them my address lol

 

[gadsie]

I don't understand why, really. I even said we could pay for travel expenses etc. ourselves (because on the website they mention they cover that). Oh well..

 

[gadsie]

Give them my address lol

Haha, guess that could work.

 

[gadsie]

Does anyone here know if it could work to just give a fake address, or a PO box or something? I don't see why they would ever really need that in practice. (Hypothetically, of course)

 

[Drone Draper]

It is a weird thing. Also Audion Therapeutics is a Dutch company, after all. Why couldn't they take a resident from the country they're based?

Maybe they need you to be registered with the NHS or something, I'm reading through the Participant form I recieved and there's nothing that denotes that you need to be a UK resident.

You would probably be able to just give them a fake address, I doubt they're going to look through your credit records or electoral register to verify your identity.

One thing though, they also say they need to be able to contact your GP.

"With your permission, your GP will be notified that you are taking part in this study and the details of the tests involved and any important changes in your hearing or health. Your GP will be able to contact our team easily if they have any concerns or queries relating to your involvement in the trial."

So it might be hard to get that one past them.

 

[grate_biff]

Got an email from them. They only take US citizens. Why do they have trials in London then??

I meant to say UK citizens as well I read it wrong. Sorry!

 

[Philip83]

Drug being tested in London could be breakthrough in treating hearing loss

 

[JohnAdams]

Drug being tested in London could be breakthrough in treating hearing loss

Looks like we are closing in on a potential cure on multiple flanks.

 

[Aaron123]

Drug being tested in London could be breakthrough in treating hearing loss

Yawn. Hyped headline. No new information. Phase 1 was successful, recruiting for phase 2.

 

[Philip83]

Yawn. Hyped headline. No new information. Phase 1 was successful, recruiting for phase 2.

I know, just thought I'd share that there were some press about it.

 

[Philip83]

https://www.actiononhearingloss.org...earing-loss-to-take-part-in-a-clinical-trial/

Here's also a post about it where they officially have responded to quite a few user comments. Scroll to the bottom to check them out.

 

[Flamingo1]

You would probably be able to just give them a fake address, I doubt they're going to look through your credit records or electoral register to verify your identity.

Might be kind of hard when they ask to see your passport.

 

[Flamingo1]

Looks like we are closing in on a potential cure on multiple flanks.

Within the next two years surely we'll know whether we are or not.

 

[Drone Draper]

Might be kind of hard when they ask to see your passport.

My understanding is you just need to be a resident, not a citizen. Almost half of London where the trial is are not British citizens.

 

[Rubenslash]

Within the next two years surely we'll know whether we are or not.

As per Audion therapeutics:

The results of the phase I and II REGAIN studies will be published after the completion and data analysis of both studies; we are aiming for early 2020.

Other interesting quotes:

Thank you for your interest in our trial. We have recently broadened the inclusion criteria for participants with hearing loss of up to 20 years duration. If you are interested in taking part, please contact the REGAIN trial team by telephone: 020 3108 9344 or by email: ei-regain@ucl.ac.uk.

=> It means they believe it could still work after 20 years of damage, that's a very good sign.

The drug we are testing in the REGAIN trial is aimed at regenerating inner ear hair cells and restoring hearing in people who have acquired hearing loss later in life. With hearing loss and tinnitus closely linked, we will be monitoring the effect of the drug on tinnitus as well. Worldwide trials of novel drugs for tinnitus are being initiated; it is too early to tell if they will cure tinnitus.

Dear Alex, thank you for your question. Any potential participant with a history of exposure to ototoxic agents, for example, aminoglycoside group of antibiotics or chemotherapy agents (cisplatin) in the last 12 months would not be eligible to participate in the trial. However, if exposure to the ototoxic agents occurred prior to the specified time-period, then participants may be eligible to participate in the REGAIN clinical trial.

Not only limited to noise induced hearing loss

 

[Terminator]

Let's hope it does not take them 20 years to take this stuff mainstream.

 

[Reinier]

"up to 20 years duration".
That gives me hope I needed. If it does not eventuate, at least I benefited from this hope.

 

[síocháin]

The rumour in the music community here was this person was doing much better with his tinnitus and hyperacusis and could work with music again like before. I managed to get in contact with him and turns out he has been a part of the Regain Project trials.

He said he unfortunately wasn't allowed to tell me much about it, but that he had some gel-like medicine injected in his ears, and it had helped him a lot. He used those words!

And also I see he is touring again, which really is a good sign!

Just wanted to post it on the forum, cause it sure made me hopeful for some relief in the near future!

 

[Reinier]

A detective should be able to find out who this person is .
On a more serious not: if something like inner ear regeneration in a person happens, how is he or she able to keep this a secret? Especially going form not touring anymore because of hearing issues to touring again.

 

[Chinmoku]

This may have been written before. While I was waiting in an hospital for a ent appointment a few weeks ago, I read a notice on the wall about the Regain project. They were looking for volunteers but they said explicitly that if one was bothered more by tinnitus then by hearing loss then this person would not have been suitable. This bothers me. Could the treatment worsen tinnitus?

 

[Lucifer]

This may have been written before. While I was waiting in an hospital for a ent appointment a few weeks ago, I read a notice on the wall about the Regain project. They were looking for volunteers but they said explicitly that if one was bothered more by tinnitus then by hearing loss then this person would not have been suitable. This bothers me. Could the treatment worsen tinnitus?

From @síocháin's post it seems to be that it doesn't since the musician was able to play music again. If this is actually true and this person did get his tinnitus and hyperacusis reduce I believe FX-322 can do the same thing.

At this rate it seems like Regain/Audion is ahead. Phase 2 results will be published next year and hopefully they go straight into Phase 3. On the other hand Frequency Therapeutics hasn't started Phase 2a and they are most likely going to have a Phase 2b.

 

[d'Wooluf]

Could the treatment worsen tinnitus?

I think they didn't want to muddy the waters too much. Their focus is on hearing loss. Someone asked them if there was a chance that their drug could cure tinnitus. Their response:

Dear Fabien,

The drug we are testing in the REGAIN trial is aimed at regenerating inner ear hair cells and restoring hearing in people who have acquired hearing loss later in life. With hearing loss and tinnitus closely linked, we will be monitoring the effect of the drug on tinnitus as well. Worldwide trials of novel drugs for tinnitus are being initiated; it is too early to tell if they will cure tinnitus.

 

[Enclave]

The rumour in the music community here was this person was doing much better with his tinnitus and hyperacusis and could work with music again like before. I managed to get in contact with him and turns out he has been a part of the Regain Project trials.

He said he unfortunately wasn't allowed to tell me much about it, but that he had some gel-like medicine injected in his ears, and it had helped him a lot. He used those words!

And also I see he is touring again, which really is a good sign!

Just wanted to post it on the forum, cause it sure made me hopeful for some relief in the near future!

The drug isn't a gel-like substance, it's a liquid:

"This is the first time the study drug LY3056480 will be tested in people. The study drug is a liquid that must be delivered to the inner ear, through the eardrum using a syringe."

 

[Philip83]

The drug isn't a gel-like substance, it's a liquid:

"This is the first time the study drug LY3056480 will be tested in people. The study drug is a liquid that must be delivered to the inner ear, through the eardrum using a syringe."

I think these are irrelevant semantics. There are also products that call themselves "liquid gel". What is that then?

 

[JohnAdams]

I think these are irrelevant semantics. There are also products that call themselves "liquid gel". What is that then?

It almost has to be a gel. If it was a low viscosity liquid it would immediately flush out through the eustachian tubes without plugging them first.

 

[Coleoptere]

It sound very positive if they have enough confidence to inject both ears.