Following Saniona’s announcement that the company is initiating its Phase 2b clinical trial for Tesomet, which is being studied as a treatment for hyperphagia in Prader-Willi syndrome, the company has launched a website to help advance testing efforts for the drug.
If you would like to participate in PWS research for Saniona’s TM006 study, this website is the perfect place to start. It provides details about Tesomet and how the drug works, along with a comprehensive description of what participants should expect if they participate in the TM006 study.
According to the website, participation in the TM006 study may last a little more than one year and includes the following parts:
Screening – Up to three weeks
Part 1 (Double-Blind) – 16 to 18 weeks
Part 2 (Optional Open-Label) – 38 weeks
Requirements to participate in the TM006 study include:
- Male or female, 13 through 65 years of age
- Diagnosed with PWS
- Have a regular caregiver
- If taking, must be on a stable dose of growth hormone, antidiabetic medications, and/or lipid-lowering medications
- Must not be taking antidepressants
Participant Journey
To learn more about the trial journey and study, visit https://www.sanionapwsstudy.com/tm006-study.
Study Center Locations
There are three study center locations for the TM006 research study, including The Sparrow Clinical Research Institute in Lansing, Michigan, Indiana University in Indianapolis, Indiana, and Rare Disease Research, LLC in Atlanta Georgia.
Find the TM006 study center locations by clicking here or on the map below.
You can see if your loved one qualifies for the TM006 research study by taking the questionnaire HERE.
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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.