Well I got my last injection today. It was uneventful as they all are. My coordinator told me that they had to color the placebo too as people were peeking and they are different colors. Hell for all I know that's just what they told me to make me not turn around. Now comes the six months of waiting to get into the extension. I get an MRI in four weeks and then some more at six week intervals after that.
Based on what's been going on with me as I've expressed in my exercise and relapse post, my Dr. thinks I had a relapse. He said for the things to be there when exerted that were not there before when I was exerted means some significant change has occured even if I didn't have a "knock down" relapse. I keep going back to the fact that at rest, I feel pretty normal except for my bladder. But since it used to just be my eyes when exerted and now it's eyes, legs, balance and everything else, he said I'm just exacerbating injury that's already there from a relapse.
They are very worried about relapses and had discussion of taking me out of the trial. I told them over my dead body as I think this new vaccine approach is our best shot at stopping MS in it's tracks. They apparently won't dose you if they think you are having a relapse.
Sorry no earth shattering news, but this drug (or placebo) is not 'active' and there really isn't much to tell. I sure hope there is after the extension starts!
Last (booster) shot today!
Thanks Lew,
I think that's the only kind of attitude you can take for a clinical trial like this. Go into it with hopes that not too much damage will happen during the year that you might be on placebo but at the same time hope like heck you will be on the real treatment and not the placebo.
My wife goes in next Wednesday for her second treatment but it shouldn't be quite such a long day this time without the MRI.
At this point she's the only person in the Michigan trial. I'd like to think that would up her chances of being on the "real thing" but I suppose they do the randomizing in Houston so that your odds are consistant regardless of the state you're in or the number of participants in that state.
Bob
I think that's the only kind of attitude you can take for a clinical trial like this. Go into it with hopes that not too much damage will happen during the year that you might be on placebo but at the same time hope like heck you will be on the real treatment and not the placebo.
My wife goes in next Wednesday for her second treatment but it shouldn't be quite such a long day this time without the MRI.
At this point she's the only person in the Michigan trial. I'd like to think that would up her chances of being on the "real thing" but I suppose they do the randomizing in Houston so that your odds are consistant regardless of the state you're in or the number of participants in that state.
Bob
Good luck Lew! I hope you'll be ok for the remainder of the waiting period, and that it was the placebo you were takiing and you'll get real thing with excellent results in six months.
Take care, Ewizabeth Previously Avonex, Rebif & Copaxone RRMS ~Tysabri, 31 infusions, ended 9/09. Starting Copaxone 12/09, waiting for Cladribine to be approved in 2010.
Hi Lew,Loobie wrote:I had to sign a "new" ethical review board sheet and this time I read it cover to cover.
I go to my wife's appointments with commitments that I'm going to be aware and ask questions, but because we are driving such a long way the trial staff are trying to cram as much as possible into the appointments which makes for a long day and quickly tires me out. Last time we had to be in Saginaw at 7:30AM for an MRI, which is almost 2 hours away, and we didn't leave Saginaw to go home until about 3PM.
They did have her sign some new paperwork last time. I'll have to go through it and see if the form you mentioned is among that stuff.
Bob
Good luck Lew,
Thanks for the update. Mucho admiration for your persistance and "stick to it" approach. Great message for the rest of us. For general info, I got the same "flip of a coin" paperwork. I have to think there must be a more sophisticated method of determining who does and who doesn't or I would be applying for the flipping position. I was also told that a relapse stops your participation for a period of time which I can only assume is based on the lenght of exaserbation? It seems there was a few month waiting period after remittance but my mind isn't what it once was. I am also more than a little confused how attack and remittance are determined in this trial or in general. I have never been given any clear answers about either, from anyone since my diagnosis.
All the best,
Lars
Thanks for the update. Mucho admiration for your persistance and "stick to it" approach. Great message for the rest of us. For general info, I got the same "flip of a coin" paperwork. I have to think there must be a more sophisticated method of determining who does and who doesn't or I would be applying for the flipping position. I was also told that a relapse stops your participation for a period of time which I can only assume is based on the lenght of exaserbation? It seems there was a few month waiting period after remittance but my mind isn't what it once was. I am also more than a little confused how attack and remittance are determined in this trial or in general. I have never been given any clear answers about either, from anyone since my diagnosis.
All the best,
Lars
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Loobie
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Lars,
The relapse question is hard for me to. Obviously there has been disease activity or I would have nothing to aggravate when I get hot. I just wish (and absolutely don't at the same time) that a relapse would be more noticeable. I know, be careful what you wish for, but the circumstances being what they are right now, I would really like some more definitive stuff happening. This has been the absolute longest six years of my life, but November will come.....
My coordinator told me that Opexa has not released the protocol, or haven't developed it yet, for the extension. I hope they are just hanging on to it until it gets closer to time because I don't want to wait! I was one of the first entered into the IIb so hopefully Shannon will have all that stuff figured out by Turkey day (in the USA).
The relapse question is hard for me to. Obviously there has been disease activity or I would have nothing to aggravate when I get hot. I just wish (and absolutely don't at the same time) that a relapse would be more noticeable. I know, be careful what you wish for, but the circumstances being what they are right now, I would really like some more definitive stuff happening. This has been the absolute longest six years of my life, but November will come.....
My coordinator told me that Opexa has not released the protocol, or haven't developed it yet, for the extension. I hope they are just hanging on to it until it gets closer to time because I don't want to wait! I was one of the first entered into the IIb so hopefully Shannon will have all that stuff figured out by Turkey day (in the USA).
I've wondered that too. I don't know if the year starts running from when you register and are accepted into the trial, or if the year starts running from the date of first dosing?Loobie wrote:My coordinator told me that Opexa has not released the protocol, or haven't developed it yet, for the extension. I hope they are just hanging on to it until it gets closer to time because I don't want to wait! I was one of the first entered into the IIb so hopefully Shannon will have all that stuff figured out by Turkey day (in the USA).
Bob