Otonomy OTO-313 — Treatment of Tinnitus

Could you get in the trial? I tried to check EMA and other websites but I couldn't find in what other EU countries they had trial locations. For sure in Romania there wasn't any. I can't find where to look for the information.

 

You can find info about study locations here:

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Please note that this study is in "Active, not recruiting" state, meaning that they have fully enrolled enough people to conduct study and will not enroll new ones.

 

As a cool little aside, the beta version of clinicaltrials.gov has a map which you can zoom-in/zoom-out of (hold ctrl and use your mouse wheel). It looks like there's 31 trial sites in the US and 17 in Europe.

Oddly I don't see anything about the higher dose or bilateral trials. Those should each be recruiting 12 patients, though they're most likely already filled up too.

 

Inclusion criteria was only for tinnitus duration up to 1 year. I have had mine for 7 years already, so they did not accept me (I checked with them).

 

This is so unfair! You have Germany with 8 spots, and only 3 European countries only, while there are so many other countries. No diversity for the study whatsoever. Is is Otonomy who chooses the locations and the trial criteria?

How can they tell for how long you have had tinnitus? There is no subjective measure to it.

I suppose you can't go to other countries to take part in the trial?

If only they were up for compassionate use when the results come out in August!

 

I guess the 'how can they tell how long' is down to honesty on the part of the participants. I was rejected from the trial for the same reason. I also tried to enroll in the OTO-413 trial for hearing loss, but my tinnitus precluded me from that one! I also tried to enroll in the latest FX-322 trial where tinnitus was not an exclusion factor but failed to meet the acceptance criteria (was not told why).

In my case, I was asked for medical records both for OTO-313 and FX-322 (sorry for not mentioning).

 

I’m sure you have to sign releases for medical records. I’m sure they just don’t take people’s word for it. If they do, that’s dumb. Someone like me has a documented history of when their tinnitus started.

Maybe we should ask @Sentinel if they asked to view his medical records.

Or @LostinTX, did they ask for medical records or did they just take your word for it?

 

Even if they don't check it's really important that people abide by the rules of the study. The current theory is that this drug only works for people who've had tinnitus for a short time. And based on the results from Phase 1/2, it only works for about half of these people (at its current dosage). If a bunch of people who've had tinnitus for several years joined it could mess up the results.

My personal belief is that this drug will work regardless of the timeframe (dosage and tinnitus cause I think are the limiting factors), however, that will need to be verified through their trials. I'm guessing that if they find no drop off in effect for the 6-12 month group they'll open it up even more in Phase 3.

 

Yes, you sign a release to have your medical records reviewed. They can find out how long you've had tinnitus and if it's bilateral/unilateral based on what is in your records.

 

Some people with tinnitus never go to a doctor, and others haven't gone to a doctor at the onset of their tinnitus. Or their tinnitus can go away and come back months later.

And not all doctors register their patients in a computer. Family doctors record your diagnosis if you come back after being seen by an ENT doctor, for them to prescribe medications only.

 

Then maybe they don't invite you to take part in the trial.

 

Right. They just find someone else who has a documented history.

 

Just hold on boys for one to two more years. If it works in Phase 2b, I think they will hurry up to get it on market, and I personally think that it doesn't matter how long you have had tinnitus, it will work for any duration.

 

I was asked a question and answered it. Yes, they require a medical history in writing backing up the information you are providing. They will not take you otherwise. And actually, when I met with the researcher, I was told someone previous to me lied about their history. The medical records did not back up their information and they were not invited to the study. It just wastes more time for the clinical study when people try to lie to get in.

 

@Ela Stefan, I understand what you're saying but, for the purposes of this study, they need to have documentation and records to fit their criteria.

We probably have a better chance at the drug passing trials if this criteria is met and this is the best way to go about it.

It looks like they filled all the spots so a lot of people do have medical records that indicate when their tinnitus started.

 

Is anyone here intending to apply for compassionate use for OTO-313?

 

Absolutely if it becomes an option at any point. This was their response to my inquiry a few months ago:

Thank you for your interest in Otonomy’s investigational drug for tinnitus, OTO-313. At this time, we do not have an expanded access program that allows patients to have access to our investigational products prior to FDA approval. If we reassess our approach to expanded access programs, we will provide that update on our website, https://www.otonomy.com/patient-resources

 

They did, I signed a release and sent them over and also provided some supplemental audiograms I had done outside of my healthcare network with a specialist.

 

Is there any significance to Otonomy starting Phase 3 trials early, before Phase 2 results are made publicly available?

1) To use the funds they have up
2) They expect high levels of efficacy and are confident in this product

 

They've said they'll be releasing the data for the Phase 2 trial in August. They need to plan Phase 3 now to be able to hit the ground running as fast as possible.

The study takes 16 weeks and they did a press release announcing the competition of enrollment on February 22. They probably didn't do this release the day the last patient enrolled - my assumption is they waited maybe a week or so after the person was dosed to be able to confidently say they were done. 16 weeks + February 22 = June 14. I'm not sure how fast they would get the data after the trial ended - maybe a week or so. Whatever the case, Otonomy either has the data right now and is currently crunching the numbers, or they'll very soon be getting it. My guess is the former. If I remember correctly, they took 6 weeks to sift through the data from their Phase 3 trial of Otividex (which sadly failed). 6 weeks from now would put us at July 31st (so basically August).

 

To find where clinical trials are conducted, go to:

https://clinicaltrials.gov/ct2/show/NCT04829214

Scroll down to bottom and there is a "study locations" and a whole list of US and European sites.

 

I wonder why they aren’t providing compassionate use and what would change their mind down the road?

 

Safety I guess.

 

Let's pray to God they do it if they have positive results...

 

Might be financial. Perhaps they want avoid leaking any info on efficacy of their drug? If results would be not so great and info would leak - their stock would drop like it did with FREQ. Just my thoughts here, I obviously could be wrong.

 

Hopefully compassionate use is a future possibility. So far the presented results have been positive so if this result is equally so then people can receive aid more quickly.

 

Because offering compassionate use can negatively affect their trials. They need this drug to hit the market or they are going under. I think this drug has a good chance to pass. They are also more serious about not giving compassionate use when they know the drug works and they just have to get around the FDA. They are not going to compromise the entire drug to help a few people out. Hopefully it comes out and helps everybody.

 

OTO-313 Phase 2 is completed on clinicaltrials.gov

 

Yes, I saw that they completed the trial on June 30th.

Of all the research threads here, this is the one that I reckon may bear the most fruit in the shortest timeframe. I have little confidence in Dr. Shore's device.

 

We have Dr Susan Shore, XEN-1101, SPI-1005 and OTO-313, all completed Phase 2. Dr. Susan Shore will have the shortest timeline, I'd say followed by SPI-1005. That trial is already designed, only 200 participants with estimated completion of June 2023. Easier to get participants for a pill than for an injection through the eardrum!