One other thing I forgot to mention is that hearing distortion is significantly down. Right now, dare I say it, very few sounds actually bother me.
Glad you are doing better, my friend! Also awesome that you get another 6 months!! I go in for my 6 month on Jan 4. Hopefully I get extended. They keep saying they haven't heard anything, so we shall see next month. I will also agree that my ear sensitivity is much better. No more hyperacusis in the bad ear. Still get the fullness on occasion, but tinnitus is having more good days this week. I might even go duck Hunting on Friday. I will post more after my visit. Y'all have a Merry Christmas!
Yes, I don't really understand how and when they decide to extend someone, but I'm rooting for an extension for you. Have a happy holidays everyone, and try not to think about this disease for just a bit!
Yesterday was my day 270 visit to the clinic. No improvement at all for me. I have 2 more phone calls over the next two months and my last visit will be April, 2024. FYI - I misunderstood the what the TWELVE MONTH OPEN LABEL EXTENSION was. It does not mean we are on it another 12 months - it means we are on it A TOTAL of 12 months. Also, my clinic clerk told me of the 22 people who started in the trial at my clinic only 5 are left, that includes me. Those that dropped mostly said it did not help them. Do the math- this drug is worthless and likely won't make it to approval. We are shit out of luck again.
I don't think it's helping me, either. It's not hurting me, as far as I know, so I keep going. The audiologist said my hearing had improved from when I started in April of '23. So maybe it's helping that?
Yellowman, that makes a lot more sense, they extended me for 6 more months (ending in July 2024) and I was wondering how they chose to extend patients for longer. It seems they're not, you either get extended for another 6 months for a total of a year or you don't and you stop at 6 months. In my experience I think it's helped me. Major changes for me are less ear fullness, and a small decrease in tinnitus. But the big one is my hyperacuity to sound. I can actually listen to music. I can tolerate a bass line and it sounds 95% normal. What I've noticed on this journey is that the only things that help me have anti inflammatory properties. Steroids, this drug, and LDN have all made a difference in their own way. The only non pharmaceutical that seems to have helped me is jaw exercises for my TMJD. I'm beginning to think that my chronic issues with my jaw might be my underlying cause.
My last visit for the drug trial was supposed to be last week. I decided not to go since the drug did nothing for me. I called the clinic and told them that I would send any leftover drug and the paperwork by mail. I just got tired on the 1 1/2 hour drive. Of the 23 that started in the trial only 3 were left since I dropped out. Keep in mind I no longer have vertigo thanks to Betahistine, I was hoping for some tinnitus relief. BTW- I am still using the Lenire, 10 weeks on it no improvement yet. Will post more on that titled conversation at a later date.
To my understanding, the primary endpoint of the SPI-1005 trial is vertigo control, with tinnitus reduction as a secondary endpoint. Remember that tinnitus is often a side effect of permanent damage to the inner ear that SPI-1005 is not designed to reverse; it is meant to prevent. As such, I understand if the drug did nothing to reduce your tinnitus, but you may very well have been a positive responder if you did not experience further fluctuations or worsening of symptoms on the drug (due to SPI-1005 itself or Betahistine). Though tinnitus isn't desirable, in my view, persistent tinnitus may indicate a separate issue, possibly your brain's response to prior damage (from a Meniere's attack or otherwise) rather than SPI-1005's failure to prevent inner ear damage. This, though, is concerning. There have been 20 dropouts?
Yellowboy, I am sorry this drug did nothing for you. Hopefully the Lenire device kicks in for ya. I am guessing SPI will finish the study even though many have dropped from the trial. Will the info they have received from Phase 3 be enough to get it approved? That is the big question for sure. If it's not, I am guessing that it's over as these drug trials cost big bucks. SPI-1005 has helped me with vertigo, hyperacusis, hearing improvement and some Tinnitus improvement. I was 6+ months on the real drug to see significant hearing improvement. My doctor will be prescribing Betahistine for me as I will be off the trial drug in July and have no desire to go backwards in regards to vertigo. Y'all have a Blessed day!
Glad it's helping Mark, but not so glad that you will have to stop it in July. Hopefully the Betahistine helps you. Interested to see if it makes it to market, If I could just quiet my tinnitus by half I would feel like I got my life back.
This is puzzling to me. Remember, the Phase II results showed as much as 90% improvement compared to Placebo in some categories.
I do remember remember reading they were fairly high in positive results. I got my hopes up, unfortunately .I don’t get it to be honest with you.
I wanted to add something - I asked my clinician if she thought the drug would be approved, she said she would be surprised if it was. When I asked why - she said the company was being accused of some ethical violations. She did not elaborate any further.
It would be necessary to know with certainty what type of ethical violations it has violated and why, if that is true, it has been given authorization for phase 3. I would be surprised if they did not approve a medication that is giving very positive results in those patients for whom It has worked and not only on vertigo but also on hearing. The only thing we can do is wait to know the final results.
I think the drug has been helpful for me, but my clinician did mention that they are seeing more prevalent cases of liver function issues as the trial has gone on. Perhaps it’s due to dose and the dose doesn’t really need to be so high, but we’ll see how it all plays out.
That would be a compelling reason not to approve the drug or to limit it only to serious cases. The benefit/risk factor when approving new treatments does have a lot of weight when approving their sale. But we need to wait to know the data from the entire trial and, if there are liver problems, to know what they are exactly: Are they mild or serious? How often? Can you consume and monitor liver function annually without risk? etc All medications act on the liver to a greater or lesser extent, this one was no different. I give just one example of an approved medication with an impact on the liver that requires annual monitoring by blood tests of liver function: Medications for high cholesterol.
You’re exactly right that the liver has to process it. They told me that most half their dose and everything has come back into normal range. Personally, I had to stop for two weeks because my AST and ALT (these are the primary liver function tests) were three times the normal range at my 6 month check up. HOWEVER, I was hospitalized shortly after due to a major bacterial infection of my liver. That was likely the cause of my elevated test results.