Siponimod for SP

[Doodlebug]

My neuro has approached me to join a study he will be conducting with siponimod for SP MS.

He was still waiting approval so couldn't tell me much. A quick Google tells me that this drug may be headed for Phase III which I'm thinking he's doing (?).

Only thing he could tell me is that they are looking for 1500 participants, the longest it would run is 22 months. It will have a 2:1 placebo ratio, 2 getting the drug & 1 not.

Confused if I should join because my disability is slowly deteriorating. I'm on Rebif (even though it technically isn't for SP). My Mri has come back clear 2 years in a row. My husband thinks I shouldn't because the Mri came back clear.

The nature of SP is that it slowly gets worse. Right now I only have full use of 1 arm & 1 leg. Don't really want to risk losing them but I think MS and life in general is a crapshoot.

[Myoak]

Hello Doodlebug,

Thank you for posting. I’m sure others are contemplating participation in an up-coming trial with siponimod. It is a S1P receptor agonist very, very similar to fingolimod (Gilenya) but “Siponimod is a better-tolerated drug from a cardiac standpoint, hopefully without sacrificing efficacy.”

http://www.medscape.com/viewarticle/773842

“S1P receptor agonists are a whole new kettle of fish when it comes to talking about therapies for multiple sclerosis. They have a potential for a dual punch that none of the drugs have had to date. They have the effect in the periphery of trapping activated lymphocytes in lymph nodes and preventing them from gaining access to the vasculature and possibly penetrating the brain.

But on top of that, these drugs have been shown to penetrate the blood-brain barrier and act within the brain. We have not proven that effect in humans yet, unless you buy the atrophy data as perhaps a suggestion of that effect. We are trying to latch on to that as a potential effect, but certainly in animal models these agents go into the brain, act on the same receptors that are on the lymphocytes, internalize the receptor, and trap it in the lymph node in the brain cells, such as the oligodendrocytes that make myelin.

They stimulate these cells to become quite active in extending processes, which is exactly what we want in multiple sclerosis. We want these cells to reach out and remyelinate, if possible, some of the damage. If that pans out, we will have drugs with dual roles.”

For more information check out the following link:
http://www.medscape.com/viewarticle/...l&uac=168339PZ

When the site comes up click on the video at the left titled, “A Promising New Approach in MS Therapy”.

Doodlebug, make sure your husband is aware of this info. Please understand neuros and researchers believe w/o treatment MS is slowly causing damage even during relapse. As you said, “The nature of SP is that it slowly gets worse. Right now I only have full use of 1 arm & 1 leg. Don't really want to risk losing them but I think MS and life in general is a crapshoot.” I couldn’t agree with you more.

The Phase 2 trial of siponimod appears to have had five dosage arms (.25mg, .5mg, 1.25mg, 2mg, and 10mg) and two placebo arms. Form what your doctor said I’m guessing the Phase 3 trial may only have two dosages and one placebo. He could tell you what those dosages are.

I am thankful, as many are for those willing to participate in trials. Every MSer and caregiver appreciates the courage it requires and the future benefit many may receive from it. Thank you for considering participation.

Best to you and your family!

[NYJenn]

I am currently being screened for participation of this trial.

[Myoak]

Fantastic Jenn, I hope everything works out.

I made an error in my previous post by saying, "Please understand neuros and researchers believe w/o treatment MS is slowly causing damage even during relapse." I meant to say causing damage even during remitting. Often subclinical, so treatment should be a high priority.

The siponimod trial has promise, including with SPMS. But every person is unique and must make an individual decision about treatment with the help of doctor and loved ones.

Best wishes!

[Doodlebug]

Myoak--good throughts. I couldn't see the links you posted. It kept asking for your login & password. You brought up some good points that I need to think about.

[Myoak]

Doodlebug,

Sorry about the delay in my response but you will need to register at that site to access articles. The site is safe and reputable. Good luck!

[Doodlebug]

NYJENN--

What have you gone through so far with the screening? I don't have another appt. till October. My neuro is still waiting for protocols.

MYOAK--I watched the videos and it has me rethinking to possibly join. Still researching. I have till October to decide.

[peter3756]

siponomod trial

Hi guys this is the first time i have posted a message, I have been on the trial drug for 7 months now, hopefully the real thing and not the placebo, thinking I am on the drug the only difference so far for me is that I am feeling more tiredness.
As for the MS I have SPMS and may have worsened a little bit, but after having it for 21 plus years its understandable.
Hopefully a cure of some sort will be found in the near future take care all.

[Lynn1962]

Should I join the trial for siponimod?

My neuro sent me a packet of info to see if I want to join this trial.

I haven't read it yet-too busy with holidays, etc.

I suppose I better do some research and read the packet and decide soon.

Please keep posting updates on how you are doing on this trial.

Thanks and Best of Luck and Health to you for participating in the trial.

Lynn