This Is MS Multiple Sclerosis Community: Knowledge & Support

Does anyone know if Novartis has published the protocol for the arm of the FTY 720 study involving primary progressive patients? Where I can look it up? The trial should start recruiting in January so surely the information is somewhere!

PS: Do you guys agree the research looks good?

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Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />

Smiling,

I don't recall seeing anything about the details of the trial for PPMS. I posted a radio show with Dr Freedman (radio show in March 2007) where he mentioned FTY 720 being trialled for PPMS. You could ask your neuro or e-mail Novartis. I'll post anything I see.

For the first time there are a few drugs being trialled for PPMS. I think the Rituximab PPMS trial is due to report in the first quarter of 2008. In the UK there is a cannaboids trial, but a few years from publishing results. There are also quite a few neuro-protective drugs being tested and, of course, various stem cell trials.

Best of luck

Ian

Thanks for your comments Brom. What drugs do you feel are at the top of the heap for neuroprotection. Copaxone? Minocycline? I was hoping to see those Rituxuan results last month but heard that Genentech made an internal decision to extend the trial, keeping results blinded just a little longer. Why do you think the CEO would choose to do that? I am sure it was something other than just to frustrate me.

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Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />

I don't know much about the FTY720 for PPMS trial either. The only place I've seen it even mentioned is in Art and Hollie's notes from ECTRIMS. It isn't in clinicaltrials.gov, or mentioned anywhere on Novartis' website. I hope it starts soon though. Since it might halt and help reverse neurodegeneration, I think it's promising.

I'm a newbie to both is site and to to MS as I received my diagnosis of RRMS in November, 2007 from Dartmouth Med Center. I have been evaluated by their MS Clinic and was given information Refib & Copxone. They also suggested to consider applying for an opening in the FTY720 phase III trials. I have the applications and information and was told I met all initial qualifications but would need to get initial approval first by their board then Novartis approval after testing completion. I guess they are interested as I am newly diagnosed and to date, untreated with anything. As I am a newbie and have no available local support (to my knowledge), does anyone have any suggestions? This decision is rather confusing and intimidating. Anything such as suggestions or anything else will be appreciated.

Thanks

Hammer

My wife was offered a place on the FTY720 trial, in the end she said no because of the hypothetical risk of PML. If you get as far as receiving the consent forms and other legal docs there should be a warning about this. She is now trying out antibiotics, following Dr. Wheldon's protocol.

For what it's worth, from what I've read I think that FTY720 sounds like it will turn out to be a far better treatment for MS than Rebif or Copaxone, with the added advantage of coming in tablet form. But if I remember correctly there is a 33% chance on this trial of being on the placebo, and then after a year you would be reassigned to one of 2 treatment doses of the real thing? Maybe somebody who knows more about it could clarify that?

Antibiotics also show a great deal of promise, but they are less mainstream, so most neurologists probably wouldn't prescribe them, you'd have to find an open-minded doctor or someone who's research interests lie in that direction.

Or simply take Rebif or Copaxone, which could* reduce the number of relapses you have, and sit tight until the results come through for the effectiveness and safety profile of the new and hopefully better treatments. It's a damn hard decision to take, good luck with it whatever you decide to do.

*I think that a subgroup of patients don't respond to these treatments, or only initially respond? Again someone with more knowledge could comment?

Take care
Billy

Hello Bil,
I am in that FTY720 trial and have completed one year of it. It is after 2 years that you get offered the real medication. I don't even know what dose they will offer me but the neuro said that they will not leave me without it.
So far, so good. No side effects at all. No great gains either but no relapses. I could be on the placebo arm of the study.
Take care all, Carole

Hi Carolew! Is two years the length of your trial? That seems like an awful long time to go on a placebo in a trial for a drug that seems to have such positive results. I read that in the Phase II trial, after six months those on the placebo were re-randomized into either the 1.25 dose or the .5mg dose. I wonder why in Phase III, the wait for those on the placebo is so much longer?

The heart, lungs and retina all have sphingosine-1 phosphate receptors. I would think that there's where we would find some possible side-effects with this drug. There sure isn't much listed on the drug safety profiles I have come across. This is all I have seen --- upper respiratory infections, dyspnea, diarrhea, nausea, decrease in heart rate, decrease in expiratory air flow. What I have missed?

Have the doctor's visits while you have been on this trial been fairly easy?

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Primary Progressive, Onset 10 years ago at age 42, diagnosis 6 years ago, Vit D, Chinese Herbs, Exercise, yoga. So far tried antibiotics, fumaric acid and 4AP. Currently participant in the FTY720/PPMS Trial.<br />

HI smiling face, yes the study is 2 years long. Some neuro refused to do it just because of the placebo arm which meant that a patient could be on nothing for 2 years.
I didn't mind because I have never taken anything anyway. Only my lipitor (but that is another subject)
The one side effect that I may add is the risk for macular edema.
The doctor's visits were fairly easy for me. At the ophthalmologist's office though, they insert a lens (like a mini-microscope) right on to your eyeball. It is easy for me because I wear contact lenses every day but for others, it is tricky I hear.
The visits are frequent in the first year but slow down in the second half of the study. They do pay for your transportation and give you 50.00$ per visit...
The one thing with a study is that you never get your results back. The doctor doesn't get them nor you, unless there is a major problem.
Hope that answers your question, take care , Carole

Hi Carole

Good for you that you're already halfway through the trial. I hope the 2nd year is trouble free for you.

Happy New Year!
Billy

thanks Bil, I am hoping do too and same for all of us... Carole