Phase III: Dexpramipexole

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how does a person enroll for study?
 
smwelder,

Looks like a couple of months before they'll enroll, but I emailed them and they did respond. I'd suggest contacting them and letting them know you're interested, can't hurt.
 
"Looks like a couple of months before they'll enroll, but I emailed them and they did respond. I'd suggest contacting them and letting them know you're interested, can't hurt."

Whom did you email. Of the 2 contacts shown, the second one (the webpage of Empower) has just some old one page inoformation. I suppose you did to the email address given or any of the testing locations? TIA
 
Vanderbilt University is going to do a trial. I talked to a person there and she said it looks like it will start around May or June. I don't know if all locations will start at the same time or not. Mom's next clinic will be around then so I'm hoping they will be enrolling at that time.

According to clinicaltrials.gov there are two locations in Ohio for you OhGosh.
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States

If you go there and do a search for Dexpramipexole it will give you more information about the trial.
 
Thank you for posting this! My neuro at Massachusetts General will be offering this trial, and I've been planning to sign up, but I hadn't yet looked at the details. Now I see that bothersome labs can be an excluder, and my liver function was way high on my last blood draw. I've come off of Rilutek to see if that helps, but I'm going to email my Dr today to make a plan that will increase my chances to qualify for this trial. Thank you!
Sue
 
Hi, can someone explain excactly what this drug does? :)
 
Are trials dependant on the doctor or hospital we use? Are there costs for the trail if someone gets involved?
 
Michael, the trials are not dependent on the hospital or doctor you use, although you may want to discuss participation with your doctor. Your only costs for the trial would be transportation and hotel if you need to stay overnight depending how far trial site is from your home. Some trials will pay you or offer mileage reimbursement so don't be afraid to ask.
 
Kevin pardon my stupidity. If someone wanted to get information and or apply do you contact the trial directly or go thru your own personal doctor? Sorry for the questions.
 
I reached out to Biogen/IDEC regarding testing protocol, as I plan to be a participant, if accepted, and will need to travel.

Dan

Dear Dan.

Many thanks for your inquiry regarding dexpramipexole (KNS-760704) As it appears you are aware, a Phase 2 clinical study of this compound has been conducted with potentially promising results. On the basis of this data we are planning a Phase 3 clinical study (The EMPOWER Study), which will allow us to better understand the potential efficacy of this compound in ALS in a larger number of patients treated for a longer time. An important part of this study will also be to determine the safety of longer term dosing in ALS patients.

We anticipate the Phase 3 study will start in the April timeframe. This is an estimate however , the actual time at each location will depend on how long it takes the team there to get the necessary legal and regulatory approvals in place, which is to say the study could be starting at different time at different locations. As a policy Biogen Idec lists all of our clinical studies on Home - ClinicalTrials.gov . We would suggest that keeping abreast of the information on that web page would probably be the fastest and most accurate source of news about the study. Specific information about participating centers (locations and name) will be posted once those sites have the necessary approvals in place. In the meanwhile we have listed planned locations on the site.

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

Ultimately the individual doctors who are participating in the EMPOWER study would be responsible for and make the decision regarding the patients they enter into the study (that is, there is no application process directly to Biogen Idec, everything is based on the judgement of the doctors using medical criteria we have defined for the study). They can also discuss some of the specific questions you have about eligibility, travel etc.. Those who would be open to taking self referred patients wil provide a means to contact them on the website, once they have their approvals in place. Please keep posted there as information is updated in the coming months.

We understand the urgency you feel and share you hope that this and other drugs in testing for ALS will offer hope for ALS patients and their families. Please do not hesitate to contact us if you have further questions.

Kind Regards.
S Purdy
 
I saw my doctor at the U of MN ALS clinic yesterday, and he feels that I will be a good candidate for this study and is encouraging me to apply. One of the study locations is the other ALS clinic in Minneapolis, and I do intend to contact them next week after my (initial) visit to the VA clinic on Monday.

S
 
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