I thought I would start a list of all individuals who have participated in human trials, clinical trials, and/or experimental procedures, in the United States and outside the U.S., such as in Taiwan, Russia, South America, etc. Can you please include the date, location of the trial or procedure, injury level, and results, good, bad, or indifferent.

My injury level is C-2, incomplete, but I really function or qualify more as a C-5. In 1995 I participated in the Elan 4-AP double blind study clinical trials at the Long Beach VA in California, which lasted three weeks. I had no trouble differentiating the placebo from the real medicine, and at 42 milligrams of 4-AP given in a sustained release caplet, I noticed an 80% reduction in tone and spasms. I noticed that there were no side effects and I actually woke up about a half an hour earlier in the morning feeling well-rested and my bowel program took less time.

In 1997 I started the long-term clinical trials at the Long Beach VA that ended at UCLA in 2001, using the quick-release version of 4-AP. There were a lot of tests which included: EKG; EEG; glucose tolerance; full neurological exams; 24-hour urine collections; numerous blood draws; 24-hour heart monitor; four-day fasting where I could not have any caffeine, chocolate, and certain fruit; gait studies; and there may be a couple more that I've forgotten about. Within three weeks I was up to 45 milligrams per day and I took a 15-milligram capsule three times a day, seven days a week, one in the morning, one in the afternoon, and one in the evening. About twelve times throughout the three years, I did experience a little heartburn that lasted between 20 minutes and a half hour.

In my case, the quick-release formula of 4-AP paled in comparison to the Elan sustained release caplet, which is now manufactured by Acorda. The quick-release 4-AP did improve my overall sensation when it came to the neurological exams with the pin where you have to figure out which one is sharp and which one is dull. I also did better in the gait study (walking) where they taped electrodes, which measured and recorded each step, to the bottoms of my shoes. There was also a 15-minute questionnaire and the first series of questions always dealt with sexual function. In my case, the 4-AP did improve sexual function in the area of ejaculation. However, it was not what I would call "normal" either. When the trails ended for me, I went from 45 milligrams a day for over three years and when the 4-AP was gone, that was it-no more. I experienced a very mild withdrawal which occurred on the day that I had no more 4-AP. It left me feeling a little light-headed so I took one 10-milligram Valium and the next day I felt pretty much back to normal, for someone who is stuck in a wheelchair.

PN

[This message was edited by Wise Young on 01-18-04 at 03:40 PM.]