This Is MS Multiple Sclerosis Community: Knowledge & Support

I’m trying to decide if I will participate in the phase III clinical trial of FTY720. I need to decide now, even if the clinical trial should only begin in March. That’s because there must be a 3 month wash-out period (no interferon or glatiramer acetate) before the screening visit for the Phase 3 FTY720 study. I’ve been on Copaxone for 4.5 years but I had 2 relapses this year. Like most people here, I would love to be on a more effective medication than the current ABCR.

I already know that the phase II clinical trial had some good results and I am already aware of the potential benefits. I need you guys to help me out by briefly discussing the KNOWN risks of FTY720. I know that some new problems will probably emerge with more people taking the medication for a longer period of time and we will have a better idea of the risks vs benefits of this drug, like all others, at the end of the phase III trial.

I have some questions about the KNOWN risks of FTY720;

I read that 13 out of 1600 patients in the transplant group developed macular edema. I also read that they were taking a higher dose of FTY720 than the ms group (1.25mg and 5mg). I know that 5mg will not be used in the phase III clinical trial of multiple sclerosis (it had more side effects and didn’t seem to be much more effective). My question is the following; does anyone know how many mg of FTY720 the transplant group was taking?


Aside from macular edema, other unique side-effects seen with this medication were bradycardia and dyspnea. Any comments on these 2 possible side-effects?


I don’t think that there have been other serious side-effects reported so far aside from macular edema, bradycardia and dyspnea but if you have heard of anything else, I would love to hear about it.

Thanks

I would jump on it. I was waiting for it and the neuro cancelled out on me.

Carolew, I read some of your posts and you really seemed interested in participating in the phase III clinical trial of FTY720. It’s unfortunate that this trial will not be done in Ottawa.

Your are absolutely right Flip and, guess what I did? I called the Montreal Neurological Institute and got my name on their list! They are starting in March '06. Hopefully, I will be able to participate. I actually live in Gatineau, so I am a Quebec patient. We may meet in Montreal.

I registered today in Montreal for it , I am all excited at the thought of using something that may just work....

I’m also registered for the Fingolimod clinical trial at the MNI. We might indeed run into each other!

Flipflopper, how far along are you in this study??? I am registered but I have no news from the institute itself. I am suppose to meet Dr. Lapierre but no news yet. How about you?
Carole

I have been impatient to see this clinical trial begin! It hasn't even started yet.

I have been asking questions to the clinical research unit manager at the MNI in the last few months since nobody has been officially assigned to this clinical trial yet.

Here is what I know

The MNI will be conducting both of Novartis Phase III trials

- FTY720 vs Avonex -> will last one year.
- FTY720 vs placebo -> will last two years


I was told last month that for the FTY720 vs placebo trial they need to get the Ethics Board approval to do the study and that this should probably be done in April.

-> They need to explain that it is ethical for a patient to be without medication for 2 years (when we have some medication available with limited efficacy).


I e-mailed a question again last week. I wanted to know if there had been someone assigned to the study yet. I am thinking of joining the FTY720 vs Avonex trial. Here is the answer I have received:

“No, I have not assigned the FTY vs Avonex study yet since I have still not received the protocol from Novartis.”


I hope that this answers your questions!


If you happen to find out when this trial will begin, could you please post the information here or send me a PM?


I have already asked many questions to the clinical research unit manager but I am still very curious to find out exactly when this trial might begin.

I really appreciate your message Flip. My neuro here in Ottawa also wants to do the Avonex vs FTY720 study but he said the same thing: no protocol yet and still not approved by the ethics committee. I think we will have to be patient here. I am willing to participate in any of those 2 studies. I just want to go ahead with something!!! So take care and will keep in touch. Carole

Sad news Flipflopper: they called me yesterday (they may have called you too), that study will not take place in Montreal either. For the same reason: they don't like the placebo arm of the study which could leave a patient without treatment for two years. The next best thing will be to wait for the other study with FTY720 vs Avonex. He said the protocol was expected this week. Then, it's the ethics comitee and then recruiting.... everything takes so long when you are waiting.... Carole

Thanks for the info Carole!

I did not receive a call from the MNI. I did mention that I was more interested in participating in the FTY720 vs Avonex trial so perhaps that's why nobody has called me.

I have to say that I am surprised that the FTY720 vs placebo clinical trial isn't done in Montreal. From the way my doctor was talking, I really thought that the ethics board would approve the placebo arm of the study in Montreal.

I guess it doesn't change much for me. One thing to keep in mind here is that Novartis will probably allow the participants from the clinical trial to take the medication (FTY720) once the one year clinical trial is over and until the medication is approved. At least, that's what I am hoping for. Once someone is finally assigned to the clinical trial, that is the first question I will ask!




I agree!!

Carole,

In case you haven't heard anything from the ms clinic in a while, I just thought that I would post the bit of info I received from the MNI last Friday about the clinical trial.

Essentially, I was told the following;

“If everything goes well, the study will be reviewed by the Ethics Board on June 22. If accepted, we should be able to start recruitment in July or August. This will depend on the contract being finalized and when Novartis holds the Investigator's Meeting.”

I guess that somebody will soon be assigned (or has already been assigned in Ottawa) to this clinical trial to answer questions and enrol patients. Hence, from now on, it's probably useless for me to write what I find out about the clinical trial.

Hello there Flip,
I got a call about 3 weeks ago from the MNI and they told me that an independent clinic here in Ottawa was doing the study!!!! It is with Dr. Christie and I called her right away to get my name on the list. Well, the week after , they called me to say they had a meeting that weekend with NOVARTIS. After, I rechecked with them. The study will be taking place. My appt with her is only in July and I am now so discouraged by the time it takes to get a darn study going, it's not funny!!
Anyway, I am doing ok, will try to enjoy my summer and will see if this 'dream study' will ever take place. We have to keep the faith but at times, it is very difficult. Hope you are well and, keep me posted please on anything you find out ok? Thanks, Carole
PS I was amazed by the fact that the greatest neurologist form MS in Ottawa (Dr. Freedman) did not tell me or know that someone else would be doing the study that was refused to him. Is the competition so bitter?

Of course, I’ll keep you posted on what I find out about this clinical trial. You do the same ok?






Well, I was a patient at the ms clinic in Ottawa for 2 years and I have been a patient at the ms clinic of the MNI for almost 4 years. Personally, I really prefer the ms clinic of the MNI on every level! I’ve always had better and more complete answers to my questions in Montreal. That is of course just my own personal opinion.

Finally, I met my new neurologist Dr. Christie. She wants to do the phase lll study on FTY720 but, she thought me something new. There is a problem with possible bradycardia that I didn't know about. Therefore, they have to give the first dose in clinic but if it causes bradycardia, they have to give the second dose in a hospital setting. That makes it a bit more complicated if you are a neurologist in a private clinic. Anyway, I an on the list, that is all I wanted and the bradycardia doesn't scare me away. It will take some time to organise all this and I am ready to wait. She thinks they removed the 5 mg dose /arm of the study because of that and the possible macular edema ( that , I knew about)
So, fingers crossed that this study will actually take place.... sigh... Carole