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Thread: 4AP Trials at Kessler

  1. #1

    4AP Trials at Kessler

    I wasn't sure where to post this...

    I was at Kessler Institute(in NJ)today, and talked to the person who is overseeing the 4AP Clinical Trials.
    Here's what I was told-

    The trial that was supposed begin in Dec, and keeps getting pushed back, is a Continuation Trial. This is for those who were in a previous trial with 4AP, and didn't have any adverse side-affects. The new start date is the end of April.

    There will also be two other clinical trials of 4AP there. She doesn't have all the details yet.

    I asked her if it would be ok to post this info and she said yes. She also said to put her number if anyone wanted to call with questions.
    Sue Vhoorman RN, (973) 731-3600 (Just ask the operator for her)

    ... ...

  2. #2
    March... April... May.... pretty soon they'll switch to 2003.... 2004.... 2005.... DR. YOUNG: come on, u can do it all, tell them to set that 800 number once and for all. I don't want to call collegue pharmacy, start on my own and then c them begin the trials I know..... I know.... me and my unpatience...

    Me.

  3. #3
    JLB,

    The 4-AP trial is the pivotal phase 3 clinical trials required by the FDA for approval of the drug for spinal cord injury. The trial is new (all previous trials are phase 2 trials that have defined the optimal dose and outcome measures that are necessary to set up these pivotal studies).

    About 400 patients will be randomized by about 80 centers. Many of the centers are still geting approval from their institutional review boards (IRB). Some of the centers have received their approval and have started recruitment. A large amount of drug is being packaged and sent out to all the centers. Some final discussions are going on with the FDA to ensure that all aspects of the trial are understood and agreed upon, so that there are no misunderstanding at the end of the trial concerning what endpoints, if reached, would lead to rapid approval of the drug.

    Everybody involved is anxious to move ahead with the trial. This is by far the largest multicenter clinical trial ever organized for chronic spinal cord injury. Once initiated, the trial will require 10 months to deliver the treatments and collect the data. The goal of the trial is to collect evidence that establishes the efficacy of 4-aminopyridine for spinal cord injury so that the drug will be approved by the FDA. We must make sure that it is done properly and well.

    Wise.

  4. #4

    Dr. Young

    So by March 2003 the Phase 3 will be complete. Any idea how long after that will formal FDA appoval take?

  5. #5
    quadfather,

    In theory and legally, the FDA must respond to a request for new drug approval within 45 days or something like that. Of course, their response may say that they need some additional information, etc. which may drag out the process. That is the reason why it is very important to make sure that the trial meets all their requirements and to ensure that there are no unanticipated questions that the FDA will raise. If the trial reaches the agreed upon endpoints, the FDA can then move quickly to approve the drug.

    Wise.

  6. #6

    4 ap

    what does 4ap do for you

  7. #7
    Senior Member Jeremy's Avatar
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    Does anybody know what the results from the previous trials 1 and 2 were?

    "If the wind could blow my troubles away. I'd stand in front of a hurricane."

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