Announcement

Collapse
No announcement yet.

The 4-AP List

Collapse
X
 
  • Filter
  • Time
  • Show
Clear All
new posts

    The 4-AP List

    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.]
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
    usc87.blogspot.com

    #2
    The list - Great idea

    PN, Thanks for the info about your 4-AP trial. This is great information, I think it should have it's own catagory, Dr. Young, if possible.

    Comment


      #3
      While still in rehab at the National Rehabilitation Hospital in Washington DC (July to October 92) I was in a trial, self graded, on the use of electrical stimulation on spasms. This was done using the same technique used for electro ejaculation in men. IIRCI was tested 3 times. To me, no real difference and definetly NOT worth the embarassment and needing to take a prophylactic to avoid dysreflexia.

      In late 97-early 98 at the Medical College of Virginia in Richmond I was in Acorda's 2A cross-over trial of 4-AP (Fampridine) that was made by Elan as a sustained release formula. I also knew which weeks I was on the drug and which I wasn't and the test was blinded. Defintely helped those horrible nightime repetitive spasms I used to get. Much better strength and endurance too. Ditto on the bowels and also could go longer between caths. Trial with before and after testing was 10 weeks. EKG and blood and urine work on each visit. Slight problem falling asleep while on the drug but otherwise no problems. I went to the compounded formula through my physiatrist after the trial was over and been on it since. With the compounded formula I've had severe heartburn several times if not taken with food. I also get my 4-AP from a pharmacy that only makes compounded drugs such as specialized chemotherapy drugs, modified drugs to remove allergens for some people such as dyes or inert ingredients and they can turn kids meds into popsicles if need be to get them into the kid. I recommend finding a doctor who can follow you while on 4-AP if you try it. Has anyone asked what specialty the doc who prescribes for College Pharmacy is in?
      Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

      Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

      Comment


        #4
        NT-3

        I agree this list is a great idea! I have not thought of this study until I saw this thread.

        During late 2000 into early 2001 I participated in a study by a pharmacuetical company named Regeneron. The nature of this study was to decrease the amount of time we spend doing our bowel routines.

        IMO I was receiving the actual dosages of the medication and not the placebo. My BM routine would take upwards of 1 1/2 to 2 1/2 hour's to complete, in order for me to feel secure about complete evacuation.

        After being on NT-3 for a couple of weeks I noticed a substantial reduction in the time it took to be completed with bowel care. Towards the end of the study I chronicled a dramatic reduction in bowel care.

        I had reduced my BM care to a mere 15-20 minutes, TOPS! This to me is a leap forward in increasing the quality of life for the spinal injured. I know we all want a cure, however; making things a little easier on us is not necessarily a bad thing.

        As far as side effects are concerned there were none that were harmful IMO whatsoever. I had no signs of side effects which were: diarhea(before getting use to med),bloated stomach,dizziness, and maybe a couple of others I cannot remember. As I said I was not concerned considering I did not have any.

        I have provided a link below from the company website that offers a brief summary of the study.

        http://graphics.regeneron.com/research/researchNT3.htm

        I offered my account of this study, so that we can know that there are other studies going on that we may not be aware of that necessarily are not the cure.

        Comment


          #5
          Taiwan

          I had rod removal, scar tissue removal, cyst removal, decompression, laminectomy and drug cocktail procedure done by Dr. Cheng in Taiwan on October 17, 2001.

          My injury was July 17, 2000. T4 motor complete, sensory slightly incomplete.

          Results of surgery: no real functional gain. I have regained a small patch of sensation on stomach and one of my knees.

          Very glad I went, I had to get opened up anyway (for rod removal) so why not try to fix the damn problem at the same time.
          "Oh yeah life goes on
          Long after the thrill of livin is gone"

          John Cougar Mellencamp

          Comment


            #6
            Mkowalski99: I think that Dr. Cheng may offer us the best chance at some recovery and I hope that you, Vgrafen and others will keep us updated on your results.
            Good Luck!

            PN
            The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
            --General George Patton

            Complex problems need to be solved collectively.
            ––Paul Nussbaum
            usc87.blogspot.com

            Comment


              #7
              Bumped up by request.
              The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
              --General George Patton

              Complex problems need to be solved collectively.
              ––Paul Nussbaum
              usc87.blogspot.com

              Comment


                #8
                The List

                I would be interested in reading posts from folks at Project Walk, as well as any other program that utilizes physical therapies, gait training, non-traditional techniques, etc.

                Comment


                  #9
                  LJ, thanks for the suggestion of creating a separate forum for this... however, because of the number of forums already, I am a little reluctant to create a whole new forum. Once a forum has been put to the bottom of the page, nobody goes to look at the forum any more. The Cure forum is the most popular of the forums and so I think that this topic is a good idea. One possibility is that we can make this into a "sticky" topic... i.e. a topic that stays at the top of the forum for say 2 weeks. This way, everybody who comes to the Cure Forum will see it. Another possibility is that we can move this to the Trials forum and make it to the top of that forum.

                  Wise.

                  Comment


                    #10
                    STAT study

                    I did the VA research trial in Houston that measured gait training on a suspended treadmill system vs. between parallel bars. I won the lottery and got the treadmill. I started in Feb. 2001. I'm a C5-6 incomplete and did receive methylprednisone at exactly 8 hrs. post-trauma.
                    The trial required 60 visits w/ 20 min on the treadmill each day, not counting testing and evaluation days. The criteria for this study: injured between 6 and 24 mo's, between 18 and 65 yrs of age (I think), some knee reflexes apparent, cervical and thoracic injuries only. My improvement was tremendous. I don't know if that is due to the specialized therapy, or the normal progress of an incomplete doing vigorous therapy 5X weekly at 6 mo's post. I rolled in and walked out. (I should qualify that-I walked out very slowly, using a walker, and not very far). It was definitely the biggest burst of improvement since my injury, not counting the initial dissipation of spinal shock. They did mega-testing;for endurance, sensation and especially muscle function. That was done by attaching electrodes to points on my legs to measure firing, as well as standard PT evaluation (push, Beth, push!)If anyone wants the scientific results, I can probably get them. I was lucky to get into this trial, and can't believe I got paid a token amount as well. Betheny

                    [This message was edited by Betheny on Nov 11, 2002 at 09:46 AM.]
                    Blog:
                    Does This Wheelchair Make My Ass Look Fat?

                    Comment


                      #11
                      Betheny: Thank you for contributing to this topic, and congratulations on your recovery. I have to chuckle when I think that they actually paid you to participate in your own rehab program.

                      Dr. Young: I agree with you. The Cure forum has the most traffic, and I like the idea of a "sticky" topic that will keep it up at the top for two weeks.

                      Schmeky: I did e-mail a person who is doing his therapy at Dragon's Way, and I asked him if he or anyone else would share their results, good, bad, or indifferent. I am aware that Dimitry went to Russia for embryonic stem cell injections, and Bilby was part of another medical procedure in the United States that used fetal pig cells transplanted into the damaged area.

                      PN
                      The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
                      --General George Patton

                      Complex problems need to be solved collectively.
                      ––Paul Nussbaum
                      usc87.blogspot.com

                      Comment


                        #12
                        OK, I have made this into a featured topic. Will take down in about a week.

                        Comment


                          #13
                          Mike:

                          That took courage. Reaching for the star of our dreams always takes courage. Perhaps one day I'll have the courage to reach for my star and be rewarded with the beautiful things of my fondest dream. I hope.

                          *************!

                          James Kelly
                          James Kelly

                          Comment


                            #14
                            Pep84

                            Is it possible at this point for someone to get NT-3 or is it still in the experimental stage? Sounds like a lot of people could benefit from this stuff.

                            "Life is about how you
                            respond to not only the
                            challenges you're dealt but
                            the challenges you seek...If
                            you have no goals, no
                            mountains to climb, your
                            soul dies".~Liz Fordred
                            "Life is about how you
                            respond to not only the
                            challenges you're dealt but
                            the challenges you seek...If
                            you have no goals, no
                            mountains to climb, your
                            soul dies".~Liz Fordred

                            Comment


                              #15
                              Curtis, NT-3 must be given intrathecally or intraventricularly to get to the spinal cord. Wise.

                              Comment

                              Working...
                              X