Otonomy OTO-313 — Treatment of Tinnitus

[Mentos]

@Mentos, please don't screw this trial up.

What makes you think I intend to screw the results?

As I previously stated I will be transparent with the test coordinator about the type and duration of my tinnitus and it's up to them to consider me eligible or not. It's not stated anywhere officially they accept only acute cases.

 

[mikki_]

What were the results from the Phase I study? Any indication on improving tinnitus?

I would love to see a pointer to Phase 1 results. Is there a paper somewhere?

 

[Piney]

You should absolutely enter this trial. Whether you've had tinnitus for 4 months or 40 years, if the drug works, it works.

Frequency Therapeutics never reported FX-322 did anything for tinnitus, while Otonomy has stated so.

No one knows how well it's going to work yet, that's why they need people to try and enter the trial. They will most likely increase the number of locations as weeks go by, which they have done in all the previous trials.

I plan on trying entering the trial if it comes to the North East.

 

[FGG]

You should absolutely enter this trial. Whether you've had tinnitus for 4 months or 40 years, if the drug works, it works.

Frequency Therapeutics never reported FX-322 did anything for tinnitus, while Otonomy has stated so.

No one knows how well it's going to work yet, that's why they need people to try and enter the trial. They will most likely increase the number of locations as weeks go by, which they have done in all the previous trials.

I plan on trying entering the trial if it comes to the North East.

Weird. I wonder if it was revised. Just now I looked and it lists "early onset" as a requirement. One of their press releases said up to 12 months as well:

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Maybe if you call they can give more specifics on their inclusion parameters though. "Early onset" is pretty vague wording.

 

[Jack V]

Weird. I wonder if it was revised. Just now I looked and it lists "early onset" as a requirement. One of their press releases said up to 12 months as well:

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Maybe if you call they can give more specifics on their inclusion parameters though. "Early onset" is pretty vague wording.

"Early onset" might distinguish from age-related (vs duration).

 

[FGG]

"Early onset" might distinguish from age-related (vs duration).

I don't think so. Age-related is included in their list of included conditions:

• Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure.

 

[Piney]

These trials are always vague or confusing in the literature; even on the Clinical Trials page at times. If you meet all of the inclusion criteria, they can still reject you from entering the trial and not tell you why.

What they can't do is force people to get to the clinic and take action. Every trial has a delay or an excuse. Most trials are delayed because they have to get the candidate to travel, commit and give them the thumbs up.

The more (and faster) people enter the trial, the better.

 

[Chinmoku]

I just emailed Otonomy to ask if they have plans for trials in Europe. I got an answer saying that there will be some testing locations in Europe and instructing me to check the ClinicalTrials.gov webpage in the US (which is where I had found their email address in the first place!). However, that page only lists a couple of US locations.

How do we Europeans find out the European locations of the trials?

EDIT: The page of Action on Hearing Loss (now RNID) says the drug is only trialled in the US.

 

[Guywithapug]

Dear Otonomy,

Please hurry.

Thank you,
Guywithapug

 

[Gee82]

I just emailed Otonomy to ask if they have plans for trials in Europe. I got an answer saying that there will be some testing locations in Europe and instructing me to check the clinicaltrials.gov webpage in the US (which is where I had found their email address in the first place!). However, that page only lists a couple of US locations.

How do we Europeans find out the European locations of the trials?

EDIT: The page of Action on Hearing Loss (now RNID) says the drug is only trialled in the US.

Thanks for the info. I had sent them an email too enquiring about European locations but got no answer.

 

[Toby1972]

How do we Europeans find out the European locations of the trials?

What is your location?

Mine = Landsberg am Lech near Munich.

 

[Tezcatlipoca]

You should absolutely enter this trial. Whether you've had tinnitus for 4 months or 40 years, if the drug works, it works.

Frequency Therapeutics never reported FX-322 did anything for tinnitus, while Otonomy has stated so.

No one knows how well it's going to work yet, that's why they need people to try and enter the trial. They will most likely increase the number of locations as weeks go by, which they have done in all the previous trials.

I plan on trying entering the trial if it comes to the North East.

Absolutely not, stick to the trial parameters. Don't lie about your tinnitus duration.

 

[Sentinel]

Alright, so this is my first post on this forum. I've been through hell and back with tinnitus (nothing anybody active here hasn't gone through or heard before) and mine seems to have settled enough to justify making an account so I can at least report my progress. I've had mine since late November/early December and it was originally bilateral and is now unilateral in my right with some general head hissing. The left ear had bad ETD but that's been fixed and my hearing has returned to normal and the God-awful pulsing tinnitus in that ear has gone away. I'm within the trial parameters and I'm close to one of the listed clinics so I'm going to give it a go and report back with my progress as long as I can until an NDA comes along and I can't carry on.

I spoke with the clinic operating the trial today in North Carolina and they are having me send two audiograms over and were very upfront with me on the phone about what's going on. My audiogram is normal in my right ear up until like 11.2 kHz and 12 kHz where it goes down to 30 dB and 35 dB from -5 dB at 10 kHz. Not sure what that qualifies as given that the verdict is generally out on those higher frequencies seeing as how there isn't a unified measure of what hearing loss is at that point. Anyways, I told them all my details regarding laterality and how it's affected me and I'm going to try and get in.

Even if I get the placebo at least I can do my part in this fight of ours.

I'll post regular updates!

 

[wwtsai]

EDIT: The page of Action on Hearing Loss (now RNID) says the drug is only trialled in the US.

RNID hasn't updated their clinical trial pages since at least last year. If you click on their ClinicalTrials.gov link, it leads you to the OTO-313 Phase 1/2 and not the current Phase 2.

 

[Chinmoku]

What is your location?

I'm in London, hopefully one of the two locations will be covered.

 

[Chinmoku]

RNID hasn't updated their clinical trial pages since at least last year. If you click on their ClinicalTrials.gov link, it leads you to the OTO-313 Phase 1/2 and not the current Phase 2.

You are right. How do we find European trial locations though? Are there any?

 

[wwtsai]

You are right. How do we find European trial locations though? Are there any?

I think they're going to continually update the trial page with additional locations. I don't believe the trials listed on ClinicalTrials.gov are limited to US locations only.

 

[Gb3]

You should absolutely enter this trial. Whether you've had tinnitus for 4 months or 40 years, if the drug works, it works.

Frequency Therapeutics never reported FX-322 did anything for tinnitus, while Otonomy has stated so.

No one knows how well it's going to work yet, that's why they need people to try and enter the trial. They will most likely increase the number of locations as weeks go by, which they have done in all the previous trials.

I plan on trying entering the trial if it comes to the North East.

I don't think tinnitus lasting 40 years qualifies as early onset.

But go ahead and apply.

That will probably make the recruiting phase take longer because they will have to go through all the people who obviously don't fit in the parameters.

 

[Gb3]

The left ear had bad ETD but that's been fixed

What fixed your ETD?

 

[kingsfan]

Got a canned response back from Otonomy telling me to look at the clinical trial page on ClinicalTrials.gov. Not much help there.

 

[Tanni]

Whether you've had tinnitus for 4 months or 40 years, if the drug works, it works.

I would have thought so too.

Does anyone know why they (potentially) only want to trial this on people who have had tinnitus for less than 12 months? Are they only expecting it to work for this subset of people? Are they hoping to 'massage' the results, as tinnitus is somewhat likely to improve naturally within that timeframe?

 

[Tezcatlipoca]

Does anyone know why they (potentially) only want to trial this on people who have had tinnitus for less than 12 months? Are they only expecting it to work for this subset of people? Are they hoping to 'massage' the results, as tinnitus is somewhat likely to improve naturally within that timeframe?

Well typically tinnitus can only be dealt with on a pre-clinical setting as acute, since they're giving it to animals and trying to revert it. I don't think we should write off any drug, even if the drug itself is marketed as for "acute tinnitus only" since we don't really know the mechanism of action of tinnitus long term, there's a possibility it could work too. We are going to have to trial treat.

 

[Piney]

Absolutely not, stick to the trial parameters. Don't lie about your tinnitus duration.

No one said to lie. Everyone should attempt to get into the trial.

 

[Piney]

That will probably make the recruiting phase take longer because they will have to go through all the people who obviously don't fit in the parameters.

Wrong, it takes about 1 to 2 hours to go through, even if they have a hearing test.

They reach back to the company and in a couple of days you'll have yay or nay. There isn't an army of people smacking the glass door every day, but it would be great if there was.

 

[Sentinel]

What fixed your ETD?

Glucocorticoid over the counter-nose spray applied liberally for a good 3 weeks or so.

The hearing came back slowly along with the tinnitus that was basically a whirring/oscillating tone that sounded like a distant jet engine that ground down to nothing by the end. I got rid of the aural fullness and pressure too.

Also btw for anyone wondering, they do not seem to care when you got tinnitus or how long you've had it, they seem to mainly care about the fact that it is unilateral.

 

[Gb3]

Wrong, it takes about 1 to 2 hours to go through, even if they have a hearing test.

They reach back to the company and in a couple of days you'll have yay or nay. There isn't an army of people smacking the glass door every day, but it would be great if there was.

So is tinnitus that has lasted 40 years "early onset" in your opinion?

 

[Tanni]

Well typically tinnitus can only be dealt with on a pre-clinical setting as acute, since they're giving it to animals and trying to revert it.

I understand why that is the case with animals, but I don't see why that should extend to humans, unless the theory is that tinnitus lasting over 12 months is harder to treat.

I don't think it's a reason to write off the drug, but it's definitely worth questioning why any trial sets certain parameters.

Also btw for anyone wondering, they do not seem to care when you got tinnitus or how long you've had it, they seem to mainly care about the fact that it is unilateral.

That's good to hear. Good luck with your application to join the trial.

 

[Tezcatlipoca]

it's definitely worth questioning why any trial sets certain parameters.

Every trial needs parameters. Even if they suspect the drug helps with chronic tinnitus, they can't just say "everyone is welcome to come and try it". They need to establish windows and effectiveness and a whole lot of other things. It's easier to prove your drug does X in Y time than saying it does X, W, Z in any time frame.

 

[Ehren M]

Absolutely not, stick to the trial parameters. Don't lie about your tinnitus duration.

Agreed. Including parameters is crucial for making sense of data.

The trial will include around only 140 people total, with 70 receiving placebo and 70 receiving treatment. Any diligent statistician should bin samples (trial participants) by age and any other important variable (length of time with tinnitus, other diseases, etc.). Each binning procedure reduces the sample size, which will likely reduce the power of the study and increase the chances of committing a type II statistical error (meaning the researchers would incorrectly conclude that the drug does not work).

The bottom line is that lying about our condition to get into this trial could very easily cause the trial to fail.

Here's a thought for perspective:
If my memory serves me, only around 43% of participants in Phase 1/2 were respondents. In Phase 2, you'll have a 50% likelihood of receiving the treatment. Best case scenario, you would then have a 21.5% chance of benefiting from entering the trial. Honest participation, however, carries a 100% chance of helping Otonomy decide whether their drug is worth a damn We're all in this sinking boat together, friends.

 

[Tanni]

Every trial needs parameters. {...} They need to establish {...} effectiveness

How do they choose the parameters?

Any diligent statistician should bin samples (trial participants) by age and any other important variable (length of time with tinnitus, other diseases, etc.).

How do they decide what is the 'right/important' age/duration etc?

Genuine questions, open to anyone. I'm not familiar with scientific studies, so curious how parameters don't indicate who they think the drug will work for.