In an effort to help our PWS community better understand its SCOUT-015 trial, Radius Health has released several resources about the process of the study, trial sites, and about their drug RAD011 a synthetic cannabidiol oral solution, which is being studied as a possible treatment for hyperphagia and related behaviors in Prader-Willi syndrome.
Click on the buttons below to download these helpful documents. You can also find a comprehensive list of these RAD011 trial sites and their enrollment guidelines at www.clinicaltrials.gov. If you have any questions, contact scout015@radiuspharm.com.
About RAD011 and the SCOUT-015 Clinical Trial
Radius Health's RAD011 is a synthetic cannabidiol oral solution, which is being studied as a possible treatment for hyperphagia and related behaviors in Prader-Willi syndrome.
According to Radius Health, the SCOUT-015 clinical study is a "global randomized, double-blind, placebo-controlled study in PWS with around 200 patients, and a seamless phase 2/3 design to allow for evaluation of multiple dose groups and Intent-To-Treat efficacy analysis with both Phase 2 and Phase 3 cohorts." The study is looking to enroll individuals living with PWS who are between the ages of 12-65.
Currently, there are nine available clinical trial sites with more planned.
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Perry A. Zirkel has written more than 1,500 publications on various aspects of school law, with an emphasis on legal issues in special education. He writes a regular column for NAESP’s Principal magazine and NASP’s Communiqué newsletter, and he did so previously for Phi Delta Kappan and Teaching Exceptional Children.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Children’s Institute of Pittsburgh. She graduated from Duquesne University receiving her Bachelor’s and Master’s degree in Education with a focus on elementary education, special education, and language arts.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Program (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Children’s Hospital in Denver supporting families and school districts around the United States with their child’s Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.