9 completed, 1 active not recruiting, 1 unknown, 1 withdrawn. 12 Phase 1, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 12 | Completed 9, Active not recruiting 1, Unknown 1, Withdrawn 1 |
| Phase 2 | 7 | Completed 5, Active not recruiting 1, Withdrawn 1 |
Follow Prader-Willi Syndrome: new trials by email Literature Review of Prader-Willi Syndrome trials Research Report on Prader-Willi Syndrome
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment Part A: RM-718 or placebo (matched to specific RM-718 dose cohort), Part B: RM-718 or placebo (matched to specific RM-718 dose cohort), Part C: RM-718 - Hypothalamic Obesity, Prader-Willi Syndrome | Phase 1 / Phase 2 | Active not recruiting | Rhythm Pharmaceuticals, Inc. | 111 | 2024-03-05 | 2026-10-09 |
| A Pharmacokinetic and Safety Study of CSTI-500 in Subjects With Prader-Willi Syndrome CSTI-500 - Prader-Willi Syndrome | Phase 1 | Completed | ConSynance Therapeutics | 10 | 2022-11-14 | 2023-08-09 |
| tVNS in Children With Prader-Willi Syndrome tVNS - Prader-Willi Syndrome, Social Behavior | Phase 1 / Phase 2 | Withdrawn | Stanford University | 2020-07-01 | 2021-05-06 | |
| Intranasal Oxytocin for Infants With Prader-Willi Syndrome Oxytocin, Placebo - Prader-Willi Syndrome | Phase 1 / Phase 2 | Completed | University of Florida | 15 | 2017-08-01 | 2020-03-26 |
| Oxytocin Trial in Prader-Willi Syndrome Intranasal oxytocin, Placebo - Prader Willi Syndrome | Phase 1 | Completed | University of Florida | 24 | 2015-03-01 | 2018-04-05 |
| Parents Resources for Decreasing the Incidence of Change Triggered Temper Outbursts Visual Scheduling, signalling change - Child Behavior | Phase 1 | Completed | Queen's University, Belfast | 80 | 2015-01-01 | 2020-02-17 |
| Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome Deep Brain Stimulation - Prader-Willi Syndrome | Phase 1 | Unknown | University of Sao Paulo General Hospital | 6 | 2014-10-01 | 2015-12-16 |
| Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome DCCR, Placebo - Prader-Willi Syndrome | Phase 1 / Phase 2 | Completed | Essentialis, Inc. | 13 | 2014-04-01 | 2016-09-01 |
| Evaluation of Tolerance, Suckling and Food Intake After Repeated Nasals Administrations of Oxytocin in PWS Infants oxytocin - Prader Willi Syndrome | Phase 1 / Phase 2 | Completed | University Hospital, Toulouse | 18 | 2013-05-01 | 2024-02-21 |
| Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers somatropin - Genetic Disorder, Prader-Willi Syndrome | Phase 1 | Completed | Novo Nordisk A/S | 30 | 2011-07-14 | 2017-02-24 |
| Tolerance of Intranasal Administration of OT in Prader-Willi Newborn Babies Oxytocin - Prader-Willi Syndrome | Phase 1 / Phase 2 | Completed | University Hospital, Toulouse | 5 | 2011-07-01 | 2017-02-23 |
| Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project Cognitive-behavioral therapy, Wait-list control - Prader Willi Syndrome, Obsessive-compulsive Disorder | Phase 1 / Phase 2 | Completed | University of South Florida | 24 | 2008-09-01 | 2011-08-08 |
Obesity (2) · Autistic Disorder (1) · Child Behavior (1) · Compulsive Behavior (1) · Disease (1) · Down Syndrome (1) · Fragile X Syndrome (1) · Genetic Diseases, Inborn (1) · Growth Disorders (1) · Hoarding (1) · Intellectual Disability (1) · Obsessive-Compulsive Disorder (1) · Sexual Infantilism (1) · Social Behavior (1)
Abnormalities, Multiple (12) · Chromosome Disorders (12) · Congenital Abnormalities (12) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (12) · Imprinting Disorders (12) · Nervous System Diseases (12) · Neurobehavioral Manifestations (12) · Neurologic Manifestations (12) · Nutrition Disorders (12) · Nutritional and Metabolic Diseases (12) · Overnutrition (12) · Overweight (12) · Genetic Diseases, Inborn (11) · Intellectual Disability (11) · Obesity (10)
Oxytocin (4) · Cognitive Behavioral Therapy (1) · Deep Brain Stimulation (1) · Human Growth Hormone (1) · Sodium Chloride (1)
University Hospital, Toulouse (2) · University of Florida (2) · ConSynance Therapeutics (1) · Essentialis, Inc. (1) · Novo Nordisk A/S (1) · Queen's University, Belfast (1) · Rhythm Pharmaceuticals, Inc. (1) · Stanford University (1) · University of Sao Paulo General Hospital (1) · University of South Florida (1)
United States (7) · France (2) · Brazil (1) · United Kingdom (1)
David Meeker (1) · Durval Damiani (1) · Eric Storch, Ph.D. (1) · Italo Biaggioni, MD (1) · Jennifer L Miller, MD (1) · Jennifer Miller, MD (1) · Kate Woodcock, PhD (1) · Virginia Kimonis, MD (1)