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Sarepta Therapeutics, Inc. Message Board

acolonf5 2 posts  |  Last Activity: May 25, 2016 12:04 PM Member since: Jul 8, 2007
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  • The big question is what will the control group do in the EPIC trial since we know that an interim analysis showed a 79 hour length of crisis for the blended groups at 250 patients. There were two comparable trials recently (a loose term) for how the control group should perform so I looked to see what they could tell us about EPIC's control group.

    In 2007 there was a sickle cell crisis trial for tinzaparin for the management of acute painul VOC with 253 patients (126 control group). Mean age was 21.6 for the control group and overall duration of crisis was measured by number of days needed for pain to decline from highest score to less than 2 on NMS. The control group had a VOC of 4.35 days (roughly 104 hours).

    The better comparison, between 2010 and 2012, GMI-1070 had a phase 2 trial for reduction of time in VOC with 76 patients (33 controls) with median age of 22 and they actually broke out time to transition to oral analgesia (EPIC's primary endpoint). Median time was 147 hours for these 33 patients.

    These aren't necessarily apples to apples comparisons with EPIC since the median age is 15 years old in that trial, but it gives you an idea of where Mast's management came up with their 96 hour placebo assumption. To me, 96 hours makes a lot of sense based on the research that I've done on how long the placebo group should be in VOC.

    Sentiment: Strong Buy

  • Reply to

    96 hour assumption

    by blink0801 Apr 20, 2016 2:50 PM
    acolonf5 acolonf5 Apr 25, 2016 7:36 PM Flag

    If the LOS was 4.4 days, how long were the kids on IV pain medication? I'm assuming that once you get taken off the IV meds you should get discharged pretty quick, but I don't know for sure.

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