Help for those with serious OFF periods - Positive Phase 3 Results for CVT-301
 

Great news for those suffering from OFF periods


The Company plans to file a New Drug Application (NDA) in the United States by the end of the second quarter of 2017.

Acorda Therapeutics Inc - Acorda Announces Positive Phase 3 Clinical Trial Results for CVT-31

hey, where can i get some of that placebo and how much does it cost?:)

The primary endpoint of the study was the change at Week 12 in Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the 84 mg dose. UPDRS III change for the 84 mg dose was -9.83 compared to -5.91 for placebo (p=0.009).

i'm sure this will be a valuable adjunct to l-dopa, wish they had released more data. and tested it against oral C/L just too much time on my hands this morning.

i would like to see if it gives you a speedier ON after eating protein which really affects me, i have planned OFFS ( planned about 5 minutes in advance when i break down and eat that container of hummus) where i know i'll be OFF for 3 hrs. they aren't delivering the drug directly to the brain so the l-dopa molecules are still broken down in the blood/tissues and still have to play bumper pool with all those amino acids waiting in line to cross the BBB. do they use exceptionally smart l-dopa?

i recently could have used inhaled l-dopa as a diagnostic. for the first time in 14 years was constipated and coincidentally my l-dopa effectiveness decreased to the point i was off most the day, a terrible experience and it kind of snuck up on me, i had no idea constipation would have such an extreme affect and needed to end immediately, not wait for the usual "gentle" treatments where you wait a day or two. and i use my l-dopa to keep my BP down, noone giving me advice seemed to appreciate that. got to the point where i could not get ON, froze to the point where i called 911 who carried me to my son's car, drove me to an ER, waited 5 hrs to be treated and was cured in 10
minutes by an expert enema. i'm over dramatizing this a little but noone in my loop, my MDS, his nurse,my GP saw my condition as that serious and i might have panicked a little bit. that said, i learned the hard way that preventing constipation and reversing it is #1 on my list. strangely enough, youtube videos showing stretches and massages that stimulate bowel movements helped and i try to do those each morning. i believe the beta blocker that i just started caused the constipation, i stopped taking it and no problem even though i stopped taking the generic miralex(?) my md wanted me to take indefinately

having inhaled l-dopa work where oral l-dopa would imply there was something wrong with my GI tract was the last point .

This was just a report of topline results. Full results will be reporte d after all of the analyses are completed by the data management team.

They already have tested this against oral C/L and it was significantly quicker.

Preclinical and clinical assessment of inhaled levodopa for OFF episodes in Parkinson's disease. - PubMed - NCBI
https://clinicaltrials.gov/ct2/show/...cvt-301&rank=5

availability
 

This is great news but my concern is: will they limit who can get this to only those who suffer offs? I don't understand why all PWP can't have a drug that is so much faster to work (and, I would think, avoid the food/protein issues taking oral c/l does since it bypasses the GI tract). Seems like everytime I have read about an inhaled version of ldopa, there is some caveat about it only being available, when approved, to those who are really suffering severe offs. Hopefully this will be available to all PWP regardless of stage/severity of symptoms.

BTW, one of the neuros we used to see nearly laughed himself off his chair when I asked about snorting sinemet years ago. While this isn't exactly the same thing, it's the same basic concept. How the tables turn:)

The drug was only researched for off periods, sort of as a disaster recovery drug. It is not formulated for longer lasting effectiveness, like C/L. The research has shown that it can become effective in 10 minutes and last, on average, about 60 minutes (during which time the PWP would take their normal meds). That being said, once it receives FDA approval, there is nothing stopping an MDS from prescribing it for more frequent use, if they believe the situation warrants it.

l/c
 

Lots of space between the lines. Best i can do.

DX 17 years ago. Age 50.

Used this forum since 1/1/2000

survived the big computer crash.

What works for me.

carbidopa/levadopa 10/100 generic by Teva

1-1/2 by mouth every 1-1/2 hours

I use a daily pill holder I fill with a special layout that allows me to know what dose I am taking by feel without a light day or night. (I have an illuminated clock and watch for the time of day.) I place 1-1/2 tablets in my mouth (or someone else can). I don't drink water. I have learned to place the tablets in such a way as to get a full 1/2 hour of slow release action out of them if that's what I need. Also i do better with 1/2 tablet every 1/2 hour before and after eating.

SUBLINGUAL WORKS!

I gave up on agonists and slow release

I take no other pills.

would like something better for on/off.

shcq,
If you are in the mood, wondering how mobile you are after 17 years with this crap, and about major issues like sleep and anything else that is a burden....if not into it or too much for you, I wish you the best...be well...

Eric

Taking magnesium, calcium,zinc combo pills does at least 3 things to me:
strengthens my bones, reduces my muscle cramps, and loosens bowels! I'm a big believer in it.