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

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.

Acceptance and Commitment Training (ACT)

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. 

CBDV as a treatment for 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.  

PWS Anxiety and Distress Questionnaire

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.

DCCR for the Treatment of Hyperphagia in PWS

Study Purpose Soleno Therapeutics is conducting a Phase 3 study of DCCR to measure the efficacy of the DCCR for treating hyperphagia in PWS. The study seeks to enroll 105 patients with PWS ages 4 years and older. The study will be a 15 week, randomized, double-blind, placebo-controlled study of Diazoxide Choline Controlled-Release Tablet (DCCR) and will require a once-daily oral administration. The initial 15-week study will be followed by a 9-month extension during which time all patients will receive DCCR. Protocol Update: A recent amendment to the study protocol now allows patients between 20kg and 130kg to enroll in the study, provided they meet all eligibility criteria. Individual study sites will be able to enroll patients in the new weight band (20-30kg) once the appropriate tablet strengths come available, which will likely be in the September timeframe. Patients who are interested in enrolling should contact their nearest study coordinator.

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