Duke Retigabine Trial

Hello all. Had my first clinic visit yesterday at Duke. Bedlack was a gem. So compassionate and caring. Really, everyone was. This was a complete 180 degree turn around from my clinic here in WV. Anyway, I am contemplating participating in their ratigabine study which is due to start the end of September. They did tell me however:

1. I must stop taking B12 injections
2. I cannot start the Lunasin regimen
3. I have to go to the clinic every two weeks for 2 days at a time for 10 weeks
4. No guarantee that I will not be given a placebo
5. At the end of 10 weeks, the dosage is stopped - no more retigabine (even if symptoms improve)
6. No compensation or help with travel expenses, etc.
7. If I participate in this trial, cannot participate in any other drug trials

Since I am 6 hours away from the clinic, I just don't know if I have the stamina to do this trial. Also, after the 10 weeks, who knows how long it would be before they might allow this drug to be given to ALS patients and by that time, I may have progressed to the point that it wouldn't help me, let alone the cost of the hotel and travel and meals every two weeks for 10 weeks. Not sure what I should do but still considering.

By the way, Bedlack did not seem too enthusiastic over the Lunasin. He did say McDuff was only one patient and that he had suffered from Myasthenia Gravis back in the 70's so not sure how his variables are accounted for. Also, he completely dismissed the B12.

Best to everyone.

Vince

Thank you for all this info--there's a lot of it here and a lot to consider. Glad you're happy with your new clinic, Vince--that's huge!

V,

Since Retigabine is already approved for epilepsy, if you do the trial and feel that it helps, will Bedlack write you an off-label rx so that you could get it yourself?

And as much as investigators like to complain about clinical trial enrollment, when they won't pay mileage or a modest hotel accommodation for those willing to travel, I think it's totally penny-wise/pound-foolishness.

Best wishes in whatever you decide.

r

I actually asked him specifically about writing me a scrip for it after the 10 week study. He said no. There would be a period of time to collect data from all 12 facilities that will be participating in the study; specifications then have to be turned over to the FDA, etc., etc., etc.,

Vince

Pffft. Thanks, V.

hey vince, thanks for the info. been wondering how things were going for ya with the b-12. i have found out bedlack also works at durham va so i got an appointment there instead of duke but then they said it would be "skyped" first so that's were it's at now for me w/ him can't wait to meet him. also i was thinking of the lunisin study, found out it was full and held up by fda, found out more about just doing it on my own if not to expensive. yea there really was only just one person that had a reversal but hey that's something. anything else vince about studies. that ratigabine sounds sketchy. good on ya to find all this out and thanks for sharing . love ya chally

Actually Chally they are pretty excited about the retigabine as it is currently an approved drug for epilepsy. Their hope is that it will slow the excess "excitability" found in us PALS. But you know how the FDA is, before it can be approved for another condition, they will require MASSIVE AMOUNTS OF RED TAPE!

I wish you could have gone to the ALS Clinic in Duke instead of a skype visit. Personal one-on-one is much better but maybe you can after your first va skype visit. He is a pretty funky looking dude with some crazy hair and even crazier clothes but he knows what he is talking about and genuinely cares about trying to find a way to slow this crap down.

Lunasin will run you over $700 per month if you follow the Mike McDuff regimen. Too expensive for me.

Best of luck to you Chally. Keep me posted.

Vince

I just bought 300 250mg Lunasin tablets for around $190 which is close to a months worth.

hey vince, yea 700 is out for me too. but hey Music what's your take on this ? where you get that deal and how much you take daily and are you seeing any results. thinking of starting a new post or sticky about what everyone is doing on their own so that we can compare notes about our own personal studies. anyone know how to set this up? we all need action, now! love ya all chally

Chally the best thing would be for each person to start their own thread and give it a really good title with your name and what you are trialing.

Then update it often.

A sticky is a post that is designed to always stay at the top of a forum section. BUT when a new post is made to any thread it bumps it to the top again, so if you are updating your own thread it will stay near the top.

Stickies can only be created by a mod too.

I think a thread for each trial is a great idea