September 24, 2024
Dear Prader-Willi Syndrome Community,
We are pleased to share an update on the 12-week, pivotal Phase 3 COMPASS PWS study
evaluating the efficacy and safety of carbetocin nasal spray (ACP-101), an investigational
drug, for the treatment of hyperphagia in Prader-Willi syndrome. The study was initiated in
the United States in November 2023 and will include approximately 170 children and adults
aged 5 to 30 years of age.
Key Updates:
- *Clinical study sites in the United States, Canada, and the United Kingdom are
participating in the Phase 3 COMPASS PWS study and are accepting patients.
Additional sites are pending in the United States, Canada, and Europe. - *Participants who complete the 12-week Phase 3 study will be eligible to enroll in a
long-term, 36-month open-label extension study designed to investigate the safety
and tolerability of long-term treatment with carbetocin nasal spray.
For more information on the COMPASS PWS study, including who can participate and
which trial sites are enrolling new participants, please visit the trial website at
CompassPWS.com. The website features a “Find a Research Site” tool that is updated on
an ongoing basis as trial sites open and are accepting referrals. To be contacted about
potential participation, there is a form to fill out on the website. If you have visited the
COMPASS PWS website and registered participation interest, your information has been
appropriately recorded and passed on to the closest clinical trial site available. The sites will
determine if interested families are suitable to participate.
If you have questions about the Phase 3 COMPASS PWS study, please contact us at
compasspws@acadia-pharm.com. We remain steadfast in our commitment to pursue this
investigational treatment to address a severely unmet need for those living with Prader-Willi
syndrome. We are grateful for the community’s participation, partnership, and continual
inspiration through your unwavering dedication to your loved ones.
Thank you for your continued support.
All our best,
The Acadia Prader-Willi Syndrome Team
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.
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.
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.
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.
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.