4 AP Study Requirements Loosened

[nevada]

I just returned from my final visit of the phase III study for 4 AP while I was there I was informed that they being Acorda have loosened up the requirements for individuals who may be interested in participating in the extension phase of the study which is the real drug. Just some information for those of you out there who were turned down the first time or are interested in possibly trying the drug. Their web site is http://www.acorda.com Good luck

Nevada

[This message was edited by nevada on 01-14-04 at 03:56 PM.]

[Leo]

thanks, nevada

"All you have to decide is what to do with the time that is given you."
Gandolf the Gray

[nandavis15]

I copied and pasted a reply I got today from Diane Penington from Acorda.

Hello, Nan - I'm sorry, but there is no Phase 4 clinical trial planned
for SCI (which is the indication I assume you are interested in?). We
hope to file for approval with the FDA following the analyses of our
Phase 3 data, which is now just coming in.

We will likely be doing additional "extension studies" for other
endpoints other than spasticity, but that will likely happen following
approval of Fampridine-SR. If all goes well, we could have this drug to
market in 2005, at which point in time it would be available by
prescription.

I hope this is helpful. We will continue to give you updates on our
progress as we have them.

[bruce]

Nevada, good to hear you finished the study. How did it go for you? Are you now on the "real thing"?

Nan, it annoys me to hear what Acorda tells you. I too have had contact with them and been told similar things. It really pisses me off that it takes more than a year to go from Phase III to approval, especially when the basic drug has been in use for so long. Why can't these people get off their collective butts and get it done. Last I heard it was late 2004, now it's sometime in 2005. Gad, what nonsense, IMHO.

[nandavis15]

Projectorguy: that is exactly what I thought, 2005! I am waiting to hear from Nevada on any changes from his participation in Phase 3. I wonder if contacting anyone at Acorda and/or the FDA would do any good. Probally not since we are just little fish in a big sea!I am usually not a negative person but the beaurocracy (spelling?) pisses me off. Nan

[nevada]

Hi sorry about the name it is not Phase IV but is called the extension study. I was told this by the nurse who is running the program at my site. I have three weeks before I can start the extension trial and can't wait to get back on the drug. The changes in my spasms and clonus sense finishing the study remind me why I want to try it in the first place

[THP]

I'm a T3/4 incomplete and currently enrolled in my second week of the open label phase of the 4AP study. Since taking 4AP I have experienced an enormous increase in neuropathic pain,more weakness in my legs, I can better feel my butt and my bowel movements have improved somewhat.

Week 1 - 10mg twice daily
Week 2 - 15mg twice daily
Week 3 - 20mg twice daily
Week 4 - 25mg twice daily
Subsequent weeks - 25mg twice daily

I was informed 50mg daily would be the max dosage due to a couple of previous test subjects experiencing seizures at higher doses.

My appointments for the study extend into March 2005. I'll periodically post more info as time passes and the dosage increases.

Tom

[tigger74]

I've finished phase III trial last Jan or Feb. I'm going to Dr. tomorrow to get started on the next trial or what ever it is. I should Get the real stuff in a few weeks.

Brad

[This message was edited by TIGGER74 on 01-14-04 at 07:10 PM.]

[Wise Young]

Bruce (Projectorguy), I understand and share your frustration. Believe me, if Acorda could make it go any faster, it would. I have never seen any company work so hard. To get FDA approval, Acorda has to complete two phase 3 SCI trials. It decided to carry both trials concurrently and started recruiting patients for these trials in the summer of 2003. Patient recruitment was completed towards the end of December. The trials will remain double-blinded until 6-month followup data has been collected for all the patients enrolled in the study. Actually, the results of the first phase trial will probably be available in March and the second phase 3 trial in June or thereabouts. The data has to be submitted to FDA and they usually take about 6-9 months to approve or disapprove. Therefore, the estimated date of FDA approval is early 2005. Wise.

[PN]

I just started the open label 4AP study yesterday. I am at 10 mg twice a day and I return to the Long Beach VA Hospital next Tuesday.

PN