I've recently begun the process of getting into my 1st clinical drug trial. This trial is for NP001 from a company called Neuraltus Pharmaceuticals. This is one of two recently developed drugs based on the ability to use sodium chlorite as a mechanism for changing the brain's messaging when it comes to cell death. Essentially this treatment flips a bit that tells the brain to not be so aggressive when recycling cells.
My Nerosurgeon at the University of Minnesota, Dr. John Day, is working with the study coordinator to assist me in getting into the trial. If accepted, I will receive five weeks treatment spread out over several months. It is a double-blind placebo controlled test so there are chances that I might be on the high, low or no dose schedule.
Looking at the reports at PatientsLikeMe.com for those already in the trial shows a strong statistical significance for those who appear to be on the different schedules. Regardless of which test group I am in compassionate case policy says that if they find the drug is doing well all test members would be provided early access to the drug once the trial is complete.
About Me
- dta
- Fridley, MN, United States
- I was diagnosed with ALS in October 2010.
The onset presented itself as Bulbar, starting in my throat. As a result I am now trached and use a vent (although my lungs are still strong). I have also lost significant muscle in my both hands, arms and shoulders and can no longer walk. My posts here are typed with my eyes starting in 2012.
4 comments:
My father recently was denied for this trial, as his lung function was only at 50%. Would you recommend going to china and/or receiving medicine? Thanks!
This is a very exciting clinical trial. On Friday I am going for an interview with the doctor in charge of the NP001 phase 2 clinical trial at Columbia Presbyterian Hospital in New York City.
I was diagnosed on December 2, 2010. My condition is limb onset ALS, which is progressing quite rapidly. Today I am going for my next to last clinical visit for the trial of another molecule based drug- NOGO-a. I believe it is a great thing to participate in a clinical trial. And there are altruistic satisfactions-you are playing an active role in the fight against the disease, hope that potentially you may be helped by the drug and, most importantly, you receive a lot more hands-on treatment than you would otherwise.
I found out about NP001 after following some links from Dudley Clendinen's article in the New York Times, "The good short life" July 8, 2011. (http://www.nytimes.com/2011/07/10/opinion/sunday/10als.html?pagewanted=all). This led me to a posting comment by Ben Harris, an ALS patient who is already participating in the phase 2 trial of NP001. His remarks are provocative and incredibly hopeful ("…After only one day of receiving the drug I noticed significant improvements in my condition…").
David, I wish you all the best and hope that you are tested with the high dose.
Andy Heimer, Paterson, New Jersey.
@tarnett I'm sorry your father was denied. There is hope that this drug will move through Phase 2 quickly and the entry requirements would change for Phase 3.
As to going to China, I'm due to write up a retrospective -- which I will begin work on, but the short answer is: if your father can get around without a chair, it may be helpful. I found it to be while I was there. You should plan to be there for at least 3 months -- and ideally not alone.
However if you have TCM practitioners in your area I would consider starting there first.
I have a lot more thoughts I will post in the retrospective, feel free to contact me directly at alsinfo@davidtanderson.com if you have any specific questions.
@Andy thanks for the good energies and the info. It is an exciting trial and I agree about the service and treatment benefits. I wish you all the best in your treatments and encourage you to remain positive.
Just found your blog again. Thought I had bookmarked it.
This sounds so promising!When will you know if you're accepted into the trial.
Do you remember my friend Barbara from NYC who, at 48, was dx'd with lung cancer already metastasized to her brain? She got compassionate entry into the Iressa chemo study. She didn't make it, but they gave her 3-6 months upon original dx, and she lived for 5 years.
Thinking of you often,
Hugs
Susan
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