Friedreich’s Ataxia News Forums Forums Research, Science, and Trials RTA 408- MOXIe/ Reata Clinical trial

  • Shandra

    February 2, 2019 at 8:33 am

    I did Phase 2, Part 1 in August-October of 2015. That was a placebo-controlled, dose escalation study so I may or may not have been on the drug, and if I was I have no idea what dose I was on. It was also only for 3 months.

    I just screened for the extension study this past Monday. If everything looks good I’ll start in a few weeks! I’m excited because it’ll be a much different process than the first time. We are guaranteed the active medication at the most effective dose (derived from the results of the part 1 study we were in!). I know you know that but i wrote it out for others reading the forum 🙂 . There is no exercise testing in this study, so that’ll definitely be different!

    I’m excited to start hearing some results from the Phase 2 Part 2 study. I know Reata started recruiting people in 2017 and enrolled the last person in November 2018. So that means some have already finished the year-long trial and the very last person will be done this November. This is just a guess but they might be able to give us some very preliminary results at CHOP this fall? Data analysis takes awhile but I’m optimistic that in early-mid 2020 we will start hearing some full results. Remember this was a pivotal Phase 2 trial, meaning the results are intended to provide evidence for FDA approval (no phase 3 trial). We shouldn’t get ahead of ourselves but if the results trickling in now are good, we may start hearing about the potential for FDA approval next year! That’s pretty cool to me 😀

  • Chris

    February 10, 2019 at 4:02 pm

    @shandrajamie do keep us updated if the active medication is any good 🙂
    I was planning on doing this trial but it was close to the end of enrollment and I was still a temp at my job so didn’t want to start missing days here and there.

    • Shandra

      February 13, 2019 at 12:21 pm

      Hi Chris! While the trials are ongoing I can’t speak to my individual experience as that could disrupt the clinical trial process, however I can say that the published results from the Part 1 trial showed 3 months of treatment with the active medication led to neurological improvements (measured by FARS) equal to reversal of 1 year of FA progression!!! I am excited to hear the Part 2 results from the longer trial.

  • Clifton

    February 18, 2019 at 9:07 pm

    I am on moxie Phase 2 part 2. Year long trial so here till october.

  • Jessie Beatty

    April 12, 2019 at 6:57 pm

    Can you tell me where you read the published results from the part 1 trial? I have researched this a ton but want to make sure what I have read already is the most up to date info. Do you know if Dr. Lynch is involved with this study? From what I have researched this drug sounds promising. I want to be positive about this study but I am also trying to not get my hopes up:) I am new to all this, my daughter she is 9 was just diagnosed in October.

    • Matt Lafleur

      April 13, 2019 at 12:55 pm

      I am not sure, but maybe my brainy friends @shandrajamie or @jonathan can point us in the right direction?

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