Loobie's second shot update

Loobie · Post by **Loobie** » Sat Jan 06, 2007 10:45 am

Hello all,

I still haven't the foggiest if this is real or placebo effect. However, I have a small update that I'm trying not to get too excited about. Although I have RRMS, everything about my progression has been a bit odd. Allow me to explain:

My first symptom was ON. It was (and is) not typical. My eyesight would only get bad when I exerted myself or got heated (it doesn't take much heat). This was perceived by me as good at the start. I had my 20/20 eyesight most of the time and I could always just chill out and relax for a while and I would 'go back to normal'. 5 years later my vision is worse and it has never decreased in intensity or severity, it has only increased. I can still get back to normal in one eye, but not the other and definitely not for very long anymore.

This has also been the same for my bladder and bowel issues. They have progressed really slowly, but I have never had a remitting time. By that I mean that once I get a symptom, it stays for good. I guess I should be thankful that I am not progressing rapidly, but for me anyways, all symptoms become permanent in terms of their level of disability. Now I'll get to the point.

Since the onset, I have had severely interrupted sleep. I literally have not slept longer than 2 hours at a time for 5 years. My usual night consists of getting up to go the bathroom at least 4 times a night and sometimes it's so often I feel that I didn't get 30 consecutive minutes. My bladder symptom is that I only void a very small amount many times per day (and night) and my bladder is never empty. I have sort of gotten used to the limited sleep. However, last night I slept all night. The reason it is so significant to me anyway is simply that I have not done that for five years. I'm not talking a maybe I forgot one night scenario, I mean it is the ONLY time I have slept all night in that long. It would be as earth shattering for me as if I actually peed for longer than 3 or 4 seconds.

It has been two weeks since my second injection. I'm trying to not get too excited about this, but I can't hardly help it. It may be nothing and I will probably just chalk this one up as that wiley old bastard MS screwing with me, but man do I feel rested for the first time in a long time. I'm showing my sensitive side again, but I cried in bed when I woke up and realized it was starting to get light out. I was very confused at first actually but it was fleeting once I saw the clock.

In the words of a good friend; I'm so happy I could just shit.

Stay tuned. Tomorrow I'll either say "just kidding", or "it happenned again!....yipee skipeee!

Lew

sh8un · Post by **sh8un** » Sat Jan 06, 2007 11:33 am

Hi there,
That's great news...I could hardly get through the post. I was really excited for you. I guess we should not get too excited but I couldn't help it either.
NN

Lyon · Post by **Lyon** » Sat Jan 06, 2007 8:29 pm

Hey Lew,

I'm with Neda. Even though I was 100% sure I'd be hearing this kind of thing and even though the things you're saying are hardly conclusive proof, it sure is giving me butterflies in my stomach to hear it from a real person as it's happening.

I don't think it makes or breaks the situation if tonight doesn't go exactly the same as last night, but let us know.

Thanks for the updates. As I mentioned, my wife doesn't really have any symptoms to dissapear but of course we want the MS disease process to stop. The updates of others is about the only way we are going to be able to maintain surety that we are on the right track.

Bob

connieb · Post by **connieb** » Sun Jan 07, 2007 5:10 am

I'm really excited for you-- and I don't want to help it!!!

Even one night's respite (remission?) happening after five years of nothing else helping is an encouraging sign! Also, (and this is based on nothing more than personal experience recovering from illness) sometimes recovery assumes an "off again," "on again" pattern, so I wouldn't get too depressed if it you experience more sleepless night over the next few days.

Loobie · Post by **Loobie** » Sun Jan 07, 2007 6:47 am

Well last night was OK. I actually have an umpire's clicker that I started to use years ago when this all started so that I could keep track of my "nightly goings" per my urologist. Last night I was up 3 times. I haven't used it for a while since I just gave up on it and figured I better just accept it until I get to the point where I feel I need to IC. I laid back down and slept for about an hour and a half after my usual rise time which is also atypical of my sleeping abilities.

I don't know...hell, while this is going on, my left eye is staying "out" almost all day which would indicate a worsening there, but I also have a head cold so my sinuses are all packed up and I know that can affect vision. I'm not making any moves until I feel I'm over the cold, but if I get over that and my left eye is staying fogged over even when I'm not hot, I may have to get unblinded and make a decision. I want so bad to stay in this trial, but the one thing I don't want to do is screw my eyes up permanently.

Therein lies the quandry; this could all be happenning anyway and do I pull the trigger and go on the 'roids as a just in case? I'm absolutely torn. I really can't think of living blind. Maybe that's why it is such a struggle for me since I'm seeing it in those absolute terms of "do this and you see, don't and you are blind". I know myself and I can definitely screw with my own mind. I think I need to keep a close eye on it (pun intended) for about a week and bring it up to my DR. I hesitate because the medical field tends to kneejerk back to known treatments and I'm scared they are going to say steroids straight away since that is a fallback position they have been using for years when ON flares up.

My desire would be to get unblinded and make sure I am getting the real stuff to see if it helps, but I doubt my DR. would do that since they can't say that they think Tovaxin would do anything yet since it isn't FDA approved and the results are not 'official'. Oh well, it's my life and I could always refuse steroids, but I don't think I could coerce them into leaving me in the trial and giving me the goods if I'm not already getting them. I hope I get over this cold and things calm down for me.

I can tell you that being in this trial has put me on DEFCON 4 in terms of paying attention to every little thing that is going on with my body. I really don't like it since I feel like I'm becoming obsessive about it and over reacting to things that I wouldn't have given much thought to a few months ago. I really need to go take my Ritalin (ha) and quit being such a spaz.

Can you guys tell I'm really struggling with this? I just read this post and I'm all over the map. I really need a drink. It's noon somewhere isn't it?

sh8un · Post by **sh8un** » Sun Jan 07, 2007 8:32 am

Hi Lew
So much to think about. What I was thinking as I was reading the post is that the good thing is that you can always drop out of the trial if your vision is compromised. You have to make a decision with the info that you have right now. I mean, if Tovaxin does work, then it will be available soon anyways. It should become available within the next five
years for sure. It will get fast tracked if does work. Also, there is the fact that you might be able to try to get into the phase three trial again later too. Even though you will still not know if you are getting the real thing, you will still have a chance to. I know it is hard but try to calm down because the tress can't be helping you either. Hope that whether is good where you are and that you can get out for a little walk.
Take care,
NN

lyndacarol · Post by **lyndacarol** » Sun Jan 07, 2007 8:33 am

Loobie, I probably have no right to horn in on this thread--my "hook" is insulin, as you know.

I believe that inflammation (mucus) acts as carbohydrates (which turn into glucose, which stimulates the pancreas to secrete more insulin) in the body. With that angle and your current head cold and packed sinuses, could you and your doctor address the inflammation? Would that interfere with the Tovaxin trial? I wouldn't expect so. Maybe something so mild as meclizine would help.

At least, it might be something to try first. As you can guess, I think steroids do more harm than good in the long run.

Lyon · Post by **Lyon** » Sun Jan 07, 2007 9:31 am

Hi Lew,
I was thinking last night after I posted that I did get a little carried away with my excitement and hopefullness.

Not to find fault and not that everyone else isn't going to be the same thing upon starting treatment but with your microanalyzing every aspect, yeah the placebo effect might be capable of about anything.

You have got a lot to consider and the seeming progression of your ON sure puts a sense of immediacy on the situation which sure isn't enviable.

All I can say is that I wish you the best in your decisions and as I mentioned before, contact the trial coodinators for your area and let them know what's going on and what your considerations are.

Bob

connieb · Post by **connieb** » Sun Jan 07, 2007 6:54 pm

Would they allow you to take steroids and stay in the trial?

Lyon · Post by **Lyon** » Sun Jan 07, 2007 6:57 pm

connieb wrote:Would they allow you to take steroids and stay in the trial?

According one of the trial coordinators in Michigan, yes

ewizabeth · Post by **ewizabeth** » Sun Jan 07, 2007 9:10 pm

Lew,

My neuro told me that I can stay in the trial, and have treatment, even in a relapse. But they need to know if I have a relapse, that's crucial. I hope you're feeling better soon.

hmtucker · Post by **hmtucker** » Mon Jan 08, 2007 5:37 am

Lew,

As you go through your decision process I think that talking to your study coordinator would be a good move. If he/she is aware of how things are going with you he/she can fill you in on exactly what your options are that allow you to stay in the study. This is definitely a situation where there is no such thing as too much information! In other posts, you indicated that other physical things were going better for you. Is that still the case?

A question that I have been wondering about is as we all go through the study are we "allowed" to find out the results from our own personal blood draws? If we ask are they required to tell us whether they can still detect MRTCs? If so then at 6+ weeks you should be within the time range of Opexa's previous reports that by 5 weeks after the initial Tovaxin treatment no detectable MRTCs were found. That could be a big piece of information for your decision process.

Take care,
Mike

Loobie · Post by **Loobie** » Mon Jan 08, 2007 5:46 am

Mike,

That is a very good question and I will ask it. I have a call in to my research coordinator right now and will ask him that. I've decided not to post any info. for a while concerning my physical situation. There is a lot going on with me right now physically and I have been posting what's been happening, but I can't tell if I'm having a relapse or if this stuff is just messing with me. Lot's of things are happening; both good and bad, but I need to give it some time and not be so quick to evaluate what's happening without giving it a little time.

Lew

flipflopper · Post by **flipflopper** » Mon Jan 08, 2007 2:11 pm

It sounds like you have already received great advice!

Loobie wrote: I've decided not to post any info. for a while concerning my physical situation. There is a lot going on with me right now physically and I have been posting what's been happening, but I can't tell if I'm having a relapse or if this stuff is just messing with me. Lot's of things are happening; both good and bad, but I need to give it some time and not be so quick to evaluate what's happening without giving it a little time.

This appears to be a very good way of approaching this. But, once you figure out what’s going on, let us know how you are doing.

Best of luck to you!

IHaveMS-com · Post by **IHaveMS-com** » Thu Jan 11, 2007 8:38 pm

A question that I have been wondering about is as we all go through the study are we "allowed" to find out the results from our own personal blood draws? If we ask are they required to tell us whether they can still detect MRTCs? If so then at 6+ weeks you should be within the time range of Opexa's previous reports that by 5 weeks after the initial Tovaxin treatment no detectable MRTCs were found.

My experience is, they will not answer these questions. I asked these same questions. I asked to see my MRIs. Even when the study is over, they will not give you specific information. Only the general results of the study.

Since everyone receiving the mid-dose in my study had their MRTCs drop to zero, I know the mid-dose dropped my MRTCs to zero. If they told you what your MRTC count was, that would tell you if you were receiving the drug or a placebo.