What I mean is you have a specific statistical chance of it helping you based on the previous trials. Then you layer on the 50-50 chance of getting the placebo or the real thing. So from a clinical trial perspective it decreases the chance that the trial itself will help a participant. Of course, once you go through the 90 day duration you have access to the real drug so your chances of getting some relief feasibly go up to the percent that's been reported through the previous trials. My taking one for the team comment comes back to this. It's an investment in time and money and the trial needs to be completed for this drug to get FDA approval. The sooner it's completed with positive results the sooner it will come to market.
Regardless whether you get the placebo on first visit, after the first 3 months you will receive the drug for a minimum of 6 months to a year. I would call today and ask them in regards to the antivirals/Canada residency.
Give Claire a shout if you have questions. Very friendly and knowledgeable. Claire Cinnamon Clinical Research Coordinator|DaVinci Research [email protected] 916.938.0601 – Direct 916.374.6730 - Main 916.596.4034 - Fax davinciresearch.net
Thanks, I'm going to give a few of the sites a shout and see what they say. You never know what can happen! I am conscious of throwing too much at this disease and not knowing what makes a difference. I'm 5.5 weeks into the antivirals and while I think it's helping, it's still early days.
Agreed. Too many changes leads to not knowing which one works for sure Since 2018, I have tried the following: very low sodium, no processed foods, water pills, accupuncture, vestibular therapy, Chiropractic and upper cervical, homeopathic, JOH, vestibular migraine diet, pycnogenol along with numerous other supplements, etc ... I have had head and neck injuries, bad TMJ, and the list goes on. I recently learned that my father had Meniere's. I remember him telling me not to use q-tips because they destroy the hair in your inner ear and that is what causes issues. Back in those days I don't think Dad understood what the doctor was telling him. Haha. Have a blessed day!
You sound like me, but I've only been treating this for 8 months. I notice the absence of prescription antivirals in your list. Is there a major reason why you haven't tried it?
Ahh .. antivirals. Tried to get them, but unfortunately I take phenytoin from an injury back in 96'. Antivirals have a negative effect. I was going to switch up to a new gen replacement that I could take antivirals with. Then, selected for the trials so no new anything for me for the next 6-12 months. My ENT told me that I didn't need antivirals as they were not proven and it would act as a placebo! Hahaha what a joke some of these dudes are. I know more on Meniere's than some of them. Sad ... Anyway, my family doc will prescribe if needed after this trial and prescription change if I ask. If SPI-1005 is not effective for me, I will know in the not too distant future and start the next plan of attack!
We've all become experts so to speak. As a rule, I don't try to play "Google medicine", but when you do enough reading you can certainly form some pretty good opinions based on quality facts. I told me current ENT that I didn't know much and he said "no, you know a lot more than the average patient". I wish I didn't have to, but it's the only way to advocate for yourself, and if I didn't I would be sitting here since December having done nothing because my last ENT tossed me out of his office for asking too many questions. LOL. At the same time he's working from a definition of Meniere's based on a textbook from the 1960's.
I have been through a few ENTs. I live between Carson City and Reno. None here really have much experience treating MD. Probably not that many cases around here. Who knows?? Keep us posted on the antivirals. I am interested as that will be my next big thing if SPI-1005 doesn't work out. Time will tell.
Don't want to stray off topic here but my ENT tried an antiviral on me (at my request- not his recommendation). I was only on it for 2 weeks. I am getting the impression that you folks have been on them allot longer. Have they been helping and in your opinion was 2 weeks long enough to know if they would help me?
In my opinion 2 weeks is nothing - not even close to a fair trial of it. Sorry for being blunt, but our condition didn't instantly transpire and it will take time to see improvement across a range of the symptoms that characterize Meniere's. The theory goes, for those that subscribe to the viral theory, is that the virus is attacking (yes I know I'm oversimplifying things) the inner ear cells and the associated nervous system. When the body is under attack/injured it results in inflammation. These things combined cause the variety of symptoms that we experience. So to effectively provide lasting relief, presumably, a few things need to happen. One, the source of the symptoms needs to be neutralized. Since viruses can't be killed like a bacteria can, the best we can do is try to suppress its replication. You do that and the body has a chance to recover through the normal mechanisms that our body uses to heal. Decreased inflammation should result as well - inflammation being a normal bodily response to injury. Second, our inner ear is complex. It's vasculature is complex and is characterized by relatively low blood flow compared to many other areas of the body. Which is why people talk about taking supplements to increase inner ear blood flow. Third, we just don't know how entrenched the virus is in our inner ear. You could be on the threshold of symptoms which is why some might obtain relief sooner than others. We just don't know - we are all different. For me, I noticed a change in one of my symptoms at about the 1.5 week mark, and that was what I call less swallowing dysfunction. My ears often clunk or crack every time I swallow and that decreased by about 70%. That alone was a revelation. Lately, I would say my tinnitus has decreased by about 30%. I have days where I swear I'm hearing a bit better, but I don't have an audiogram to prove or disprove it. I'm just completing 6 weeks on 3g/daily of Valacyclovir. Lastly, I know of at least 2 people that are on this board that took 3g/daily Valacyclovir for a year or more. One had full relief and full recovery of hearing by the end of the year. Another, took 6 months to get the vertigo under control and had hearing recovery by the end of the 1st year. This is not clinical data, but it goes to show that it can take time and progression might not be linear.
On the topic of this thread, I've contacted a few of the locations for the clinical study and some of them are only recruiting local participants and others don't care where you come from as long as you commit. They also told me that taking Valacyclovir does not exclude you from the study.
I’m surprised there is no one on here that was in phase 1 or 2 of the trial that can share what affect the drug has ! Anyone??
Good point. We know it made it to phase 3 because of compelling evidence of its effects. We also know that people who gain relief often disappear from this forum. Perhaps it's a positive.
Gaining relief and disappearing from Meniere's forums happens quite often.. When I was feeling almost normal for 18 months, I rarely visited the forums. I think the anxiety level I had just thinking about MD kept me away. Too many bad memories haha. Hats off to those like JOH that keep at it!
Yes but if they were in trial in earlier phases they still can't get it. You would think some would still be on here. It was stopped for a while due to covid (damn !). I did a search on the trial, there are allot of posts in it going back several years. Some people mention being in the trial (one person both phase 1 and 2) but I can't find anyone who posted any results. I got tired of looking I might add !
I'm enrolled in the study, so we now have 4 people on this forum participating in the phase 3 trials. This is going to be a large financial and time commitment for me, but you only live once, and it's important to me. We'll see how it goes, but regardless, I'll be taking the real drug come late July.