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Oxytocin Study Research Update

We want to thank all of the generous donors for their support of the oxytocin Phase 2 clinical trial sponsored by PWSA (USA) and led by Dr. Jennifer Miller and Dr. Dan Driscoll. Both physicians are well respected leaders in the field of research for Prader-Willi syndrome.  For this clinical trial, $290,000 has been raised to date.
There has been some discussion about the reasons for supporting this particular oxytocin clinical trial when another clinical trial will soon begin by Dr. Eric Hollander in New York. That trial was funded by FPWR in partnership with PWSA (USA) as part of the best idea grants (BIG) from the Hyperphagia Conference in 2012. There was such a long delay in startup after the grant was funded, that we were not sure when the study would start, and thus were unwilling to wait, given the great potential of this medication for PWS. Therefore, we helped provide support for the Phase 1 trial of intranasal oxytocin through the NIH funded Rare Disease Clinical Research Network, headed by Drs. Miller and Driscoll. Based on the positive preliminary data from that study and the fact that we still were unsure of when the Hollander study would begin, we decided to initiate funding for a Phase 2 trial, being led by the University of Florida. While Dr. Hollander is an expert in autism, the phase 2 trial funded by the PWSA (USA) oxytocin initiative will be led by renowned experts in PWS treatment and research.
We recognize that both clinical trials should be beneficial and help us discover the answers we need sooner. Between the two trials, there will be differences in dosages, clinical sites, patients, etc. Both studies will add to our understanding of how oxytocin might be most effectively used to treat PWS.
It is an exciting time for research in PWS, and especially in clinical trials. In 30+ years with the Association, I have never seen such interest from pharmaceutical companies regarding working with PWS on clinical trials.  I have almost daily contact with various pharmaceutical companies; educating them on the syndrome, advising them, and interacting with their consulting companies. We have seen tremendous advances throughout our son’s lifetime, and this next generation will see amazing advances that we cannot even imagine.
Janalee Heinemann
Coordinator of Research and International Affairs
PWSA (USA)
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