*****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.
Study Purpose HERO is a Phase 3, double blind study sponsored by Aardvark Therapeutics to investigate the effects of ARD-101 on hyperphagia-related behavior in people with Prader-Willi Syndrome. This study will compare ARD-101 to a placebo to see if ARD-101 works to treat hyperphagia in PWS. Eligible participants will take ARD-101 or placebo every day for 12 weeks. Participation will require 4 in-person clinical visits and 3 telehealth visits. Travel expenses and lodging for the participant and a primary caregiver will be covered. All participants who complete the HERO study will have the option to participate in a follow-up study where everyone will receive the active study drug.
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.
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
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.
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.
Study Purpose The Acceptance and Commitment Training (ACT) Study will examine the effectiveness of ACT training for fathers of adolescents ages 13-18 with PWS with the goal of improving life satisfaction, reducing stress and improving family functioning. This remote study will use Zoom video conferencing to provide 4 sessions of ACT training. The study is seeking fathers who have an adolescent with PWS age 13-18 to participate in a 4-session, on-line, small group training exercise to reduce father’s perception of stress, improve parenting satisfaction and increase family involvement. Participants must reside at home with their adolescent and the adolescent’s mother, have a personal computer with a camera, microphone and internet access, and agree to privacy and confidentiality of shared information. They must be able to read and speak English. Sessions will be scheduled to accommodate 8 fathers per group. After an initial 90 minute session, three additional 60 minute training sessions will occur at a frequency of every other week. Additional “on-your-own” time will be needed to practice newly acquired skills. Both fathers and mothers will be required to participate in a brief screening interview by phone and then complete several on line questionnaires at the outset, during the study, and at the conclusion of the study. These questionnaires will assess stress, family function and behaviors unique to the adolescent with PWS.
Study Purpose This phase 2, randomized, double blind 12-week treatment trial of Cannabidivarin (CBDV) will assess the affect of CBDV on behavior in people with PWS.
Got Anxiety? Want to help pave the way for new medicines to treat anxiety in PWS? Levo Therapeutics and the Foundation for Prader-Willi Research are working to develop a new questionnaire for use in clinical studies of novel treatments for PWS. We want to know more about how anxiety is expressed in people with PWS.
This study has completed enrollment. Study Purpose This phase 2 randomized double blind 8-week treatment trial of intranasal oxytocin (IN-OXT) will assess IN-OXT's affect on: eating behaviors, repetitive behaviors, weight and body composition, quality of life, and salivary OXT and hormone levels. Data from the study will add to the current knowledge that OXT is an effective treatment for hyperphagia as well as other symptoms of PWS.
