This Is MS Multiple Sclerosis Community: Knowledge & Support

I had a request to ask about the extension study after the Phase IIb for Tovaxin. I don't remember who, but someone asked if we find out about our initial trial and whether or not we were getting the goods.

Everyone in the trial gets to participate in the extension. Everyone will find out if they were getting the drug or the placebo. I think that this is important to them as well. Anyway, I just wanted to answer that. I get my last monthly dose today.

Things have slipped a bit in my vision even though everything else seems to be staying on track, so who the hell knows? I just know that short of a major attack, I'm staying in. As I go through this I find myself really wanting to get the drug, but I also feel that it is important to be in the control group. They have to show efficacy and for some 33% of us in the trial if we don't show any progression then the drug will show no efficacy. Don't take that as brave or noble or anything. I think this drug shows incredible merit to this point (at least statistically) and one year in the grand scheme of things is not that long. However, I will withdraw if something extremely detrimental happens which is why I say this is not totally motivated out of my natural (hmm, hmm) samaritan ways.

I also think that the extension study shows that the researchers feel that this drug works for a lot of people. I could be dead wrong on this, but I don't know that I've ever heard of an open extension on a double blind trial before. This could also be that I Evelyn Wood speed read most trials just to get to the stats. I'm hoping that's the case anyway.

Lew

Thanks Lew, I think it was me and to be honest, I was totally convinced that they wouldn't let us know whether it had been Tovaxin or placebo. Thank you for that information! You hit the nail on the head, who the hell knows for sure?
In my wife's case we're hoping that it's a short year and there are no major attacks. We'd pull out of the clinical trial in a heartbeat if I was convinced there were any benefit but in a major attack you can be treated with steroids and remain in the trial and I was under the impression that the crabs had to be in your system for months before they are beneficial. With that in mind, by that time the trial would be over and she would be on the real Tovaxin by the time the crabs provided any protection, so at least to my way of thinking we are in the trial through hell or highwater. I think you know of my interest in treating autoimmunes with parasites? At least with those clinical trials the participants were given the option of continuing treatment as part of a long term safety and effaciacy study which has continued for 6 or 7 years. I think it's fairly common to roll short term trials into long term for treatments which prove effective.

Thanks again Lew,
Bob

I just asked my doctor about the extension study the other day. It is my understanding that we will be eligible for the open-label Tovaxin as soon as our term is up. However, we will not be notified as to whether we were on placebo or tovaxin until everyone else in the study has completed their term.

As of Febuary 6, I have had four injections. My 5th dose won't be until May. I think I was one of the first 3 or so to receive an injection. At any rate, I haven't seen anyone on-line who has been in this particular study as long as I have been.

At this point I have both good and bad news. The bad news is that I began having a relapse early last week. This is my 3rd one ever. I was initially diagnosed 2.5 years ago after a bout of optic neuritis. Then last May my hands, feet and abdomen went numb. This new relapse is optic neuritis again. The good news is that this relapse has been relatively mild. Last time, my vision was totally shot. I couldn't even see the E at the top of the eye chart. This time my vision is only slghtly blurred. My neuro said I had 20/20 in my good eye and 20/25 in my affected eye.

My neuro, who of course is blinded, says he really doesn't have an opinion as to whether I'm on placebo or not. He says that if I'm not on placebo, this relapse doesn't necessarily mean that the Tovaxin is not working. His thoughts were that since, 1. this relapse has been relatively mild and 2. it is still pretty early in study. I could very easily have had a relapse and still be benefiting from the Tovaxin.

At this point I really don't know what to think. Frankly, I hope I am on the placebo and that everyone else is having better results. At any rate, I'm staying in come hell or high water. (Hell being another relapse and high water being November 2008!)

I hope this news isn't too discouraging but, on the bright side, I may have just reduced the odds of someone else being on placebo!

Good luck to all!

"Faith is not just believing that God can. It's knowing that He will."

Hi Heather,

We seem to be on very similar schedules. My 4th injection was Feb. 22nd. They told me that they thought I was the tenth person based on my "number" that I have to use at the MRI place. It's my initials and some numbers and it ends in 0010. Not that that matters at all, but I think you may be right in the fact that they won't let you know your placebo vs. drug status until everyone is done. That just makes more sense. I didn't dig that deep since all I asked was would we find out during the extension study and they said yes. They never told me if I would find out immediately, but I think you are right as we could start posting messages and stuff about our experiences.

Lew

Hi Heather,
Welcome to the site and thanks for posting your information. What you've been told seems correct and sensible.
Bob