Clinical Trials Opportunities Archives - Foundation for Prader-Willi Research | Clinical Trials Opportunities

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 between the ages of 6 and 18 years old 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 the Treatment of Excessive Daytime Sleepiness in Prader-Willi Syndrome

Study Purpose The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with Prader-Willi syndrome (PWS) ages 6 to 65 years. Secondary study objectives are to evaluate the impact of pitolisant on: Behavioral symptoms Cognitive function Safety and effectiveness of long-term treatment Caregiver burden The study will consist of a Screening Period, an 11-week Double-Blind Treatment Phase (including a 3-week Titration Period and an 8-week Stable Dose Period), and an optional Open Label Extension (OLE) Phase. The OLE Phase will be multi-year in duration and will continue until either pitolisant is approved for patients with PWS or the Sponsor elects to terminate the study.

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.

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