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Thread: Use of 4-ap ( fampridine )

  1. #31
    Tigger, I believe that the trial has started randomizing patients in at least 50 of the 75 or so centers. It is the biggest chronic spinal cord injury trial that has ever been carried out. Several people have already reported having started on these forums. Wise.

  2. #32

    I just

    got a letter from Craig. Trial's starting now.

    Onward and Upward!

  3. #33
    Thanks, Chris. Craig is indeed one of the centers that was amongst the first to start randomizing.

    In addition to the phase 3 clinical trials, people who have participated in previous Acorda trials are eligible to join an open-label trial where they will get Fampridine SR on a long term basis (free).

    Wise.

  4. #34
    mkowalski, clinical trials are "powered", i.e. are designed to have just enough subjects, to establish statistical significance. If a substantial number of subjects turn out to have taken 4-AP and had to be disqualified, this would reduce the statistical significance of the finding. Also, in most FDA "registration trials", unless it is agreed upon beforehand, dropping out subjects from the trial after randomization may not be allowed.

    Actually, this is something that really concerns me about spinal cord injury clinical trials. If a therapy works only on say 30% of people, it takes a large number of patients to show that the treatment is effective, even if the treatment is very effective for the 30% of patients. If there was some way of identifying 4-AP responders before randomization, that would greatly improve the likelihood of clinical trial success. It is one of the reasons why Acorda is choosing to do the clinical trial only on people who have some motor or sensory function below the injury site... because Acorda believes that there are more 4-AP responders in the incomplete population. In some ways, 4-AP itself may be that tool for identifying people who are most likely to respond to remyelination therapies that will be coming down the pike.

    At the present, we are trying to develop gene expression tools to see if we can identify rats that are most likely to respond to regenerative therapies. This may allow us to be able to identify people who would be most responsive to certain regenerative therapies. This is an approach that may make clinical trials more efficient.

    Wise.

  5. #35

    Wise?

    Isn't the quality of 4-AP going to be less consistent or potent at a compounding pharmacy than the Fampridine-SR will be?

    Jan

  6. #36

    still waiting...

    for an answer, Dr. Young.

    Thanks,

    Jan

  7. #37
    Senior Member Jeff's Avatar
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    Jan

    Dr. Young had this to say about compounded 4-ap:

    Originally posted by Dr. Young:


    4-aminopyridine is not a miracle drug. It should enhance the conduction and the synaptic activity of existing connections. You are already over the recommended level of 10 mg capsules four times a day. Are you taking 15 mg immediate release capsules? If so, I would not advise you to go up higher. By the way, are you still taking the drug that you got three months ago? One reason that the effects is diminishing may be related to the short shelf-life of the compounded drug. Many pharmacies mix the drug with dextrose and I have heard that this reduces the shelf-life of the drug so that it loses potency over a period of weeks or months. If you are still taking the old drug, you should first try with a new batch before increasing the dose.

    If you are taking time-release capsules that have been compounded, I really do not know the characteristics of these formulations well enough to say anything. It is possible that the so-called time-release formulation of 4-AP made by compounding pharmacies are not only delaying but reducing the overall absorption of the drug. That is one of the problems with a non-FDA approved compounded drug. Every pharmacy probably has a different formulation and the quality control is unclear.

    Wise.
    http://carecure.org/forum/showpost.php?p=69078

    ~See you at the SCIWire-used-to-be-paralyzed Reunion ~

  8. #38

    4-AP & AD's

    Since I spent my entire day of yesterday with shiver, goose bumps and cols sweats, I was wondering if the mix of 4-AP & AD makes thing more risky??? Sorry if I sound toooo dumb but if 4-AP is supposed to even increase heart rate and AD's too, dosen't this turn u into a time bomb????

    ...It's the heart afraid of breaking,that never learns to dance... It's the dream afraid of waking that never takes the chance... It's the one who won't be taken, who cannot seem to give, and the soul afraid of dyin'... That never learns to live...

  9. #39
    Jan, sorry...

    The 4-AP that is in clinical trial is a sustained release formulation that has been extensively tested and validated to result in extended and stable levels of 4-aminopyridine with twice a day treatments. The Fampridine SR formulation also have long shelf half-life.

    The 4-AP that is available from the compounding pharmacies come into two forms. The immediate release form has a short half-life and needs to be taken 3-4 times a day and has peaks and troughs that may produce side-effects and may be less efficacious respectively. I understand that some compounding pharmacies provide a "time-release" version of 4-AP but I don't think that these have been tested to ensure that they do provide appropriate or stable levels of drug. The stability of both the immediate release and the timed release formulation are not known. Earlier tests done several years ago suggest that immediate release 4-AP mixed with dextrose (sugar) has a short shelf-life and loses potency over several weeks.

    Wise.

  10. #40
    Polett,

    You need to identify the cause of your AD (autonomic dysreflexia). Have you ruled out urinary tract infection?

    What is the dose of the 4-AP that you are taking? Have you reached the 10 mg four times a day level? While 4-AP can increase heart rate and blood pressure when it is taken in overdose, I have not heard that it aggravates AD. To my knowledge, 4-AP does not cause AD.

    Wise.

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