Phase III: Dexpramipexole

[KC2U2]

Go for it! Hope for great success for the trial

 

[StillSteve]

Go for it! Hope for great success for the trial

Thanks. I will post updates here.

S

 

[Bhappy]

I too heard about this study. I emailed the contact and was told the information will be coming soon. I think they are still getting organized because I heard it's supposed to be a world-wide 800 person study. Let's hope all interested get into it.

 

[kelly]

Is anyone here already taking Mirapex?

 

[arwaxru]

I went to U Miami neurology yesterday to see if I could join the phase 3 trial. They participated in the phase 2 trial of dexpramipexole and were very encouraged by what they saw in their few patients. I took all my records, including the "raw data" from my 2 EMG's, a disc with my MRI's, and a stack of lab results. I expect to be tested further, randomized, and enrolled next month.

 

[KC2U2]

I expect to be tested further, randomized, and enrolled next month.

Congrats, keep us updated

 

[rms000]

I emailed them twice but have not gotten a response. Is there another email I can try? Also, any idea who is doing the study in Atlanta?
Thank you.

 

[sadiemae]

Emory is doing it

 

[arwaxru]

Here is the link to all 83 centers that will be enrolling.

Phase 3 Study of Dexpramipexole in ALS - Full Text View - ClinicalTrials.gov

I encourage all who meet eligibility criteria to contact the group nearest to them. The faster the study is fully enrolled, the faster we all get an answer.

 

[Alyoop]

The huge AAN conference has been on in Honolulu, where 10000 neurologists have been hanging out. That may have been why things have been a little bit behind. Bet you get contacted now they are back home

 

[arwaxru]

From the consent form:
They are looking to enroll 800 patients over the next 18 months.
Visit at the site every 2 months, remote (home) visits other months.
Blood work, EKG, PFT, strength testing, questionaires
If on Rilutek, must be on for 60 days.
Twice per day dosing.
Three patients (of 182) had major complications in Phase 2 - unknown if related to drug - were low white blood cell count, inflamed pancreas, and sudden death.
You will get the drug at the end of the study period while the FDA reviews the results.
Must avoid preganancy. . . . or causing one.

 

[HelenL]

during the study they'll also do ekg's to ensure your heart is ok, and also check for a certain type of white blood cell. Evidently the med can cause this type of white blood cell to decrease too much, so they have to make sure it's at the right level to begin with.

I had my 2 1/2 hour initial visit yesterday, and assuming that my bloodwork comes back ok, will be starting the med in a week or 2. Also, you cannot take more than 5g of Creatine daily, or more than a certain amount of Vitamin E (I think it was more than 1000 mg, but not sure).

LOTS of questions about ALL your health issues, no matter how small, so try to remember when they started! Good luck to everyone!

 

[StillSteve]

I talked to the doctor in charge of this trial in Minneapolis yesterday. She's reviewed my records, and feels that I will be a good candidate, and I'm hopeful my start date will be the first week of August (see the update I just posted--when and if it gets through moderation, {sigh}--at the end of the thread titled "Forego riluzole for a chance to enter Dexpramipexole study now?" for an explanation of the delay).

The doctor mentioned to me than only 40-some of 800 slots worldwide have been enrolled. Only two enrolled so far in Minneapolis (and another two, I think she said, at the Mayo Clinic in Rochester, MN).

She mentioned that Biogen has made the commitment that anyone who completes the trial will, at the conclusion of the trial, receive the drug until such time as it makes it to market.

My fingers are crossed for all of us (those eligible and those ineligible who may be helped if the drug makes it to market).

Sign on if you can!

 

[Alyoop]

Steve, I work with Biogen on a new MS therapy. They are a very good company and every time my patients come to the end of the extension study, they do an amendment and it just roles on for another few years. They certainly can be trusted ( unless the drug is solstice of course). Congratulations, I had a feeling the recruitment would be slow.
Aly

 

[rmstudier]

I've read that experts believe this drug may slow progression 30 to 40%. Is anyone optimistic that progression might be stopped? I'm in discussion with Minneapolis, but unsure about it becase of long days to travel there.
Thanks