Clinical Trials Opportunities

Susan Hedstrom

Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.

Recent Posts

NNZ-2591 as a Potential Therapeutic for Children with PWS

Study Purpose This open-label study will study the safety, tolerability, pharmacokinetics, and efficacy of NNZ-2591 in children with PWS ages 4 to 12 years. Study participants will receive NNZ-2591 oral solution ( a ready-to-drink strawberry-flavored liquid) twice daily for 13 weeks. Every participant will receive NNZ-2591. Participation involves 5 trial visits to the study site over the course of the study. All travel and lodging expenses will be reimbursed. Enrollment will begin with children ages 8-12. After safety and tolerability data has been reviewed, children ages 4-7 will be able to enroll.

Light Therapy for People with PWS

Study Purpose Maimonides Medical Center is seeking volunteers with PWS ages 6 and up to participate in a clinical research study to see if light therapy can be used to reduce Excessive Daytime Sleepiness (EDS).

RGH-706 as a Potential Therapeutic for PWS

Study Purpose KITE PWS is a Phase 2 study to investigate the effects of RGH-706 in people with Prader-Willi Syndrome. This study is seeking people aged 17 years and older with Prader-Willi syndrome for participation and will evaluate an experimental oral drug that may help to reduce appetite. The study lasts 5-6 months and requires about 8 study visits.

CSTI-500 as a Potential Treatment for PWS

*****THIS STUDY HAS COMPLETED ENROLLMENT***** Study Purpose This is an open-label, single-center, Phase 1 study to evaluate the PK and safety of a 10 mg single oral dose of CSTI-500, a triple monoamine reuptake inhibitor (TRI), in people with PWS. The study is looking to enroll 14 individuals between the ages of 13 and 50 years.

RGH-706 as a Potential Treatment for Hyperphagia in PWS

Study Purpose RGH-706 is a once-daily oral capsule that has been developed by Gedeon Richter for weight management. The Phase 2 study of RGH-706 will evaluate the efficacy, safety, and tolerability of RGH-706 in people with Prader-Willi syndrome and will measure changes in hyperphagia, body weight, body mass, metabolism, and clinical global impression.

ARD-101 as a Potential Treatment for PWS

Study Purpose This is a Phase 2, open-label study to investigate the effects of ARD-101 in people with Prader-Willi Syndrome. This study is looking to enroll 12 individuals between the ages of 17 and 65 years. Participants will take ARD-101 orally, twice daily for 28 days.

Excessive Daytime Sleepiness Interview for People with PWS ages 6-65

Study Purpose If you are the caregiver and the parent or legal guardian of someone aged 6 to 65 years of age who has been diagnosed with Prader-Willi syndrome (PWS) and who also experiences daytime sleepiness, you and your care recipient may qualify for a 90-minute video interview that will pay you $100 for your participation.

Research Opportunities for People with Schaaf-Yang Syndrome

Understanding the Pathophysiology of Schaaf-Yang Syndrome to Improve Care and Treatment Options Dr. Fleischer at Southern Illinois University School of Medicine, in conjunction with Dr. Schaaf from Heidelberg University in Germany, is conducting a study entitled, “Understanding the Pathophysiology of Schaaf-Yang Syndrome to Improve Care

Pitolisant for People with Prader-Willi Syndrome & Excessive Daytime Sleepiness  - the Tempo Study

Study Purpose The primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.

Chronic Stress, Cognition and Food Cue Reactivity

We want to learn more about how stress affects appetite in Prader-Willi Syndrome and how different areas of the brain communicate with one another in adolescents. With your help, we can gain more insight into the functioning of the adolescent brain.

Tools for PWS Awareness

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