This Is MS Multiple Sclerosis Community: Knowledge & Support

I started the screening process for the Phase IIb trial in Jan of 2007. I received my first vaccine in March and the last vaccine on 9/21/2007.

In July of 2007, I had a major exacerbation which was treated with 3 days of IVSM.

The trial ended for me on April 1, 2008. Two weeks later, I had another exacerbation which was treated with 3 days of IVSM.

I was dx'd with RRMS in March of 2001 after my second exacerbation in 2 months. Since that time, I've had a history of 3-4 exacerbations year. My MRIs showed lesions in my brain only but 2 neuros are convinced that I have one on my spine that just isn't showing up on MRI b/c of my symptoms.

I started on Betaseron in May of 2001. In 2003, I added subQ Methotrexate to the Beta for a year to see if that would stop the 3-4 month relapse cycle. That experiment failed. We also tried pulse steroids for a year prior to that time and that failed.

In January of 05, I started on Tysabri and had two infusions of that before it was pulled from the market. After waiting for 4 months, I started on Copaxone and had a bad reaction to it so stopped that.

The 3-4 month relapse rate continued, no matter what. I started looking for clinical trials, different treatment options, and continued with pulse steroids. That's when the Tovaxin trial became available.

I went from 3-4 exacerbations a year to one. 75% reduction. In addition, spasticity was more manageable, almost negligible, cognitive issues were almost non-existent, bladder problems (retention) were no longer a problem, dexterity in my left hand was better (I am right handed), I did not notice any difference in fatigue but I have decreased the provigil from 400mg daily to 200 mg daily, decreased pain meds for neuropathic pain from daily to once or twice a week.

I am now starting to go back to my MS issues pre-Tovaxin vaccine. Fatigue is taking over. I am once again battling spasticity and my left hand is not being very cooperative. I am having trouble with my eyes, nystagmus, to the point that I am seeking a referral to a neuro-opth, and the neuropathic pain is knocking at my door again.

I have tested negative for MRTCs at least twice since April 1, 2008, and am currently waiting for the results of redraw #3.

I consider myself a success story for Phase IIb. As I have said in other posts, this is the first drug that has worked for me since my diagnosis to slow down the relapse rate.

I don't know the scientific reasons for this, some of you are more in tune with that data than I am and have been given a lot more information from your PIs than I have.

My only hope is that I can continue in the trial. Otherwise, it's more steroids for me and probably very soon.

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

Hiya.
What does your MS-specialist neuro make of all of this? I'd be curious for a medical interpretation. Sounds great that you've done so well on it compared to where you were and odd that you'd be doing worse if you were in fact not producing the MRTCs. To my narrow mind, it means that you're producing MRTCs for which they are not testing or something else (B-Cells? Space Twinkies?) is doing the damage.

Guess there's always act of God.

Please keep us posted. We're all pulling for you and it seems you should be a posterav8rgirl for the trial.

best,
patrick

I tested negative again. Just got called a few minutes ago. That's #3.

I've not talked to her about any of this as I have nothing to tell her...I have no information to give her. Except that my relapse rate has decreased for which she is thrilled!

Since I am not allowed to obtain an MRIs outside the study we have no concrete information to go by. Unless I cheat or pull out of the study, I don't know what my MRIs look like...is this drug working for real or am I in remission?

My next appt is now Jan 6th for monitoring. Blood draw and EDSS only.

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

Are you in the study at Evergreen in Kirkland as well with the lovely and talented Shalom, or is there another study hub for the Pacific NW? If you are a Seattleite, let me know if you plan to attend the local MS society chapter's Ladies Night on 11/15.

.

There's no rule saying you can't get an MRI on your own. I got two during the study that I paid for.

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http://myhopefuljourneyintoactualmsreco ... ogspot.com

it was made VERY clear to me that any procedure I had would not be condoned per protocol and be cause for expulsion from the trial. That included MRI...in fact and MRI was specifically listed among other things that I could not have done. The clinical trial doc has been very clear on what I can and cannot have done and anything that my regular neuro wants to do must be cleared with him prior, that includes med changes, procedures, etc.

I have been having severe leg cramps/spasms this past week. Friday night, they were so intense that ended up with bruising on my calf. On Monday, I emailed the clinical trial nurse coordinator informing her of the new problems and ask for ideas. Doc wrote an rx for a medication that I cannot take, long story short, we ended up with me taking .25 mg twice a day of klonopin in addition to the 1 mg I already take.

As luck would have it, I had a regular follow up appt with my local neuro and after a thorough neuro exam she wants me on 3 days of IVSM. She is going to chat with the clinical trial doc and find out if I can have an MRI, 3 days of IVSM, add quinine to help with the spasms, and if she can have a copy of my last MRI from the trial to compare with. I should know something by tomorrow or Thursday.

In the meantime, I can barely walk the spasms are so bad. Can't feel the tuning fork on my toes of either foot, no reflexes, numb hands...fatigue is off the scale. And taking klonopin during the day, I might as well just sleep. It's better than baclofen or Zanaflex!!

And I am still testing negative for MRTCs....makes one wonder doesn't it...

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

Cheryl, I can't seem to find the post you wrote and that I FINALLY have a reply for; I'm sorry to stick it here on this thread... but maybe it'll keep the discussion floating! We need consistent answers!!!!



Cheryl, I hate to sharpen my fangs before lunch but I can't resist: your site coordinator is a beeeeeeech. A lying one, at that!

How do I know this, you may ask? 'Cause yesterday, during my exciting day, my neuro pulled up two sets of my MRIs: one was the preliminary (May 2, 2007) and the other one was from my Week 52 (May 7, 2008). I'll give details in a separate post.

All kidding aside, that site coordinator needs to put some common sense to work here.

IF a subject has been on Tovaxin and the MRIs show continuing problems, that person should be given the news as soon as possible in order to make an INFORMED decision.

That IS what “open label” is supposed to mean, right?

Would you like to borrow my flame-thrower?

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Jane the Pain

Maybe that's where the confusion lies. You can't get to Opexa's MRI's of your head, but how could they tell you you can't lay in the tube on your own dime? MRI's don't change anything. That's like them saying you can't get your picture taken during the study. I can understand the banned substances and what not, but not that you can't get an MRI if you pay for it yourself.

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http://myhopefuljourneyintoactualmsreco ... ogspot.com

Here, I happen to have a few spares today ...

I am so confused.

I don't think a flame thrower would help....

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

I violated protocol ONE time during the trial by having a procedure done outside the trial and had hell to pay for it. Got the riot act read to me as well as my neuro. It was made VERY clear to me that absolutely NOTHING gets done without his ok...even if I pay for it and my insurance WILL pay. They did before.

So, been there done that...

And, when my ENT doc wanted an MRI for a severe sinus infection a year ago, neuro said NO. He would have the other neuro in the office read the MRI for NON-MS related pathology. That's how it's been the whole trial.

I follow directions.

I have been a very good patient, following everything to the letter.

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

I got to look at mine too. With my doc. It was part of our evaluation process about whether I should go forward.

I feel cheated and deprived. I wanna see mine!

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“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford

that would be because you have been. Wanna come to my next appointment and look at mine? At least it's something.