Masitinib

[Kippy]

Does anyone know the criteria for getting involved in the Phase 3 study for Masitinib?

I know it's for primary or secondary progressive MS, with no recent relapses, but what about age and general health?

[Redwings]

Clincaltrials.gov currently lists 14 studies for masitinib but, strangely, the MS study isn't among them. The phase 2 study isn't even listed.
[url]http://www.clinicaltrials.gov/ct2/results?term=Masitinib[/url]

The manufacturer might not have released the recruitment details yet -- I certainly couldn't find them anywhere. The age and health requirements will probably be similar to most other studies: male or female OK, age between 18 and 65 and not have any other complicating health conditions or be taking any other medications that might contaminate the study data. Anyone with another autoimmune disease or diabetes or a blood disorder can probably plan on sitting this one out. That would knock out concurrent use of immunosuppressants, Tysabri, Gilenya and the chemo agents and require some washout time. It might also knock out the CRABs. That might also disqualify meds like hormone treatments, as sex hormones are the subject of other MS studies and could involve variables that the study design isn't set up to account for. There might be an EDSS guideline as well, since disability will most likely be one of the outcomes measures.

Again, it's very strange that these masitinib studies aren't registered with the FDA/NIH since US law requires that all studies carried out in the US be registered and meet a boatload of requirements.

[NYJenn]

Masitinib is now going to phase III trials. They are starting to recruit MS patients with primary progressive or secondary progressive MS.

I am also curious about this drug. It seems promising.

[Kippy]

I contacted the people in charge of the trial nearest to me and am waiting for a return call. I'll let you know when I hear something. This could be exciting, even though I'm probably too old for the trial.

[Redwings]

Thanks for following up, Sparky10. The study wasn't listed just 2 days ago. The minimal exclusion criteria really open it up to a wide group of potential participants.

[Kippy]

I spoke with a woman at the Providence, RI site that will be doing the study. There is no age limit, gladly. I've also e-mailed my neurologist to see what he has to say about this trial, and me.

There could be some side effects such as rashes and nausea. There are also weekly blood tests which possibly could be done at a local hospital and then they would be reimbursed by AB Labs.

More to come!

[drmarc]

I found the study on the government website...

http://www.clinicaltrials.gov/ct2/sh...lerosis&rank=1

I put in Masitinib and Multiple Sclerosis in the search area.

drmarc

[Kippy]

My neurologist doesn't think their former studies were well done for MS. I guess the med is a cancer drug. He did tell me, though, to find out more about it. I'm waiting for the information from the company.

[lbwillis75]

Has anyone received any information about getting into this clinical trial? I emailed the information site and faxed a letter to the Neurology Foundation who will be doing the study in Providence, RI, but have heard nothing back. I'm excited about this trial because I live 7 miles from Providence and could actually participate in something that could help us.

[Kippy]

I called and spoke to a nice lady who asked me some questions and then sent me a packet of material. Since I'm seeing my doctor tomorrow, I'll show the packet to him. I had e-mailed him information about the trial, and he hadn't been impressed, but that could be because he's not participating in the trial!

Why not try calling the Neurology Center in Providence?
Good luck!

I'll keep in touch with this site and let you know what's happening with my attempts to get into the trial.

[lbwillis75]

Which Neurology Foundation location did you call? I tried the main phone number for the Neurology Foundation at RI Hospital, but the receptionist didn't have any information.

[Kippy]

That is the one I called. The Neurology Foundation, Inc. at 2 Dudley St., Suite 555, Providence, RI. The woman I spoke with has a first name that sounds like Brigit. If you still can't get anyone, please let me know.

[lbwillis75]

Thanks. I called but I found out that I am not a candidate. I was recently diagnosed with Primary Biliary Cirrhosis so I am excluded. Welcome to the world of auto-immune diseases! I wonder if people with one auto-immune disease are more likely to develop another auto-immune disease?

[Smilingface]

Carolinas Medical Center in Charlotte, NC is currently enrolling for this study. Here is the info. in a study synopsis they published:
A 96 week study with a 2/3 chance of receiving Masitinib and 1/3 chance of receiving placebo.
A total of 450 patients will take part in this international study.
Masitinib is one of the enzymes that plays a basic role in the transmission of signals between cells.
This study is for patients with PPMS or Relapse-free Secondary Progressive.

[Kippy]

I decided not to apply for the trial because my neurologist said that it could affect my heart. After reading all the information that came with the packet about the trial, I discovered that the meds could have irreversible cardiac affects. That did it for me.