10 completed, 8 terminated, 2 unknown, 2 withdrawn. 25 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 25 | Completed 10, Terminated 8, Unknown 2, Withdrawn 2, Active not recruiting 1, Enrolling by invitation 1, Recruiting 1 |
| Phase 2 | 4 | Completed 2, Terminated 2 |
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 Pitolisant in Participants With Prader-Willi Syndrome Pitolisant - Prader-Willi Syndrome | Phase 3 | Enrolling by invitation | Harmony Biosciences Management, Inc. | 150 | 2025-08-20 | 2026-03-17 |
| ARD-101 for Treatment of PWS: The Hunger Elimination or Reduction Objective Trial Placebo, ARD-101 - Hyperphagia, Prader-Willi Syndrome | Phase 3 | Terminated | Aardvark Therapeutics, Inc. | 68 | 2024-12-20 | 2026-06-30 |
| The Hunger Elimination or Reduction Objective (HERO ) Open -Label Extension (OLE) Trial ARD-101 - Hyperphagia, Prader-Willi Syndrome | Phase 3 | Terminated | Aardvark Therapeutics, Inc. | 19 | 2024-07-23 | 2026-06-30 |
| A Study of Pitolisant in Patients With Prader-Willi Syndrome Pitolisant tablet, Placebo tablet - Prader-Willi Syndrome | Phase 3 | Recruiting | Harmony Biosciences Management, Inc. | 134 | 2024-05-28 | 2026-08-25 |
| A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS tVNS, intermittent stimulation, tVNS, continuous stimulation - Prader-Willi Syndrome | Phase 3 | Active not recruiting | Foundation for Prader-Willi Research | 102 | 2024-01-08 | 2026-04-06 |
| Open-Label Extension Study of DCCR in Patients With Prader-Willi Syndrome DCCR - Prader-Willi Syndrome | Phase 3 | Completed | Soleno Therapeutics, Inc. | 77 | 2023-01-31 | 2026-10-13 |
| A Phase 3 Extension Study of RAD011 (Cannabidiol Oral Solution) in Patients With Prader-Willi Syndrome RAD011 - Prader-Willi Syndrome | Phase 3 | Withdrawn | Radius Pharmaceuticals, Inc. | 2023-01-01 | 2022-10-06 | |
| A Study to Assess RAD011 (Cannabidiol Oral Solution) for the Treatment of Participants With Prader-Willi Syndrome RAD011, Placebo - Prader-Willi Syndrome | Phase 2 / Phase 3 | Terminated | Radius Pharmaceuticals, Inc. | 4 | 2022-04-13 | 2023-10-19 |
| Effect of Intranasal Oxytocin on Dysphagia in Children and Adolescents With Prader-Willi Syndrome Oxytocin nasal spray, Placebo - Prader-Willi Syndrome | Phase 2 / Phase 3 | Completed | University Hospital, Toulouse | 25 | 2022-04-05 | 2023-06-01 |
| Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial Follow-up study of the treated cohort, Follow-up study of the untreated cohort - Prader-Willi Syndrome | Phase 3 | Unknown | University Hospital, Toulouse | 80 | 2021-09-07 | 2024-04-30 |
| Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS somatropin - GH naïve pediatric cohort, somatropin - GH treated cohort, somatropin - adult cohort - Prader-Willi Syndrome | Phase 3 | Completed | Pfizer | 33 | 2021-02-09 | 2026-01-14 |
| Oxytocin Treatment in Neonates and Infants With Prader-Willi Syndrome OT, Placebo comparator - Prader-Willi Syndrome | Phase 3 | Completed | University Hospital, Toulouse | 52 | 2020-03-10 | 2023-06-01 |
| An Open-Label Study of DCCR Tablet in Patients With PWS DCCR - Prader-Willi Syndrome | Phase 3 | Withdrawn | Soleno Therapeutics, Inc. | 2019-10-01 | 2021-08-03 | |
| Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome Livoletide, Placebo - Prader-Willi Syndrome, Hyperphagia | Phase 2 / Phase 3 | Terminated | Millendo Therapeutics SAS | 158 | 2019-03-25 | 2021-02-17 |
| Phase 3 Study of Intranasal Carbetocin (LV-101) in Patients With Prader-Willi Syndrome 3.2 mg intranasal carbetocin, 9.6 mg intranasal carbetocin, placebo - Prader-Willi Syndrome | Phase 3 | Completed | Levo Therapeutics, Inc. | 130 | 2018-11-20 | 2022-07-26 |
| Open-Label Extension Study of DCCR in PWS Followed by Double-Blind, Placebo-Controlled, Randomized Withdrawal Period DCCR, Placebo for DCCR - Prader-Willi Syndrome | Phase 3 | Completed | Soleno Therapeutics, Inc. | 115 | 2018-10-01 | 2024-04-19 |
| A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome DCCR, Placebo for DCCR - Prader-Willi Syndrome | Phase 3 | Completed | Soleno Therapeutics, Inc. | 127 | 2018-05-09 | 2023-09-21 |
| A Study to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome Recombinant Human Growth Hormone (rhGH) Injection - Prader-Willi Syndrome | Phase 3 | Unknown | Changchun GeneScience Pharmaceutical Co., Ltd. | 30 | 2018-04-14 | 2018-06-12 |
| Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome ZGN-440 for Injectable Suspension, ZGN-440 Placebo for Injectable Suspension - Prader-Willi Syndrome, Obesity | Phase 3 | Terminated | Zafgen, Inc. | 108 | 2014-09-01 | 2017-01-26 |
| Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome Oxytocin (OXT) continuous, Placebo, Placebo continuous - Prader-Willi Syndrome | Phase 2 / Phase 3 | Completed | University Hospital, Toulouse | 50 | 2014-06-01 | 2025-12-05 |
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Hyperphagia (5) · Obesity (2) · Body Weight (1) · Disorders of Excessive Somnolence (1) · Feeding and Eating Disorders (1) · Impulsive Behavior (1) · Problem Behavior (1)
Abnormalities, Multiple (25) · Chromosome Disorders (25) · Congenital Abnormalities (25) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (25) · Genetic Diseases, Inborn (25) · Imprinting Disorders (25) · Intellectual Disability (25) · Nervous System Diseases (25) · Neurobehavioral Manifestations (25) · Neurologic Manifestations (25) · Nutrition Disorders (25) · Nutritional and Metabolic Diseases (25) · Overnutrition (25) · Overweight (25) · Obesity (23)
Oxytocin (3) · Growth Hormone (2) · pitolisant (2) · CKD732 (1) · Human Growth Hormone (1) · Rimonabant (1) · Topiramate (1) · cyclic des-acyl ghrelin (6-13) (1)
Soleno Therapeutics, Inc. (4) · University Hospital, Toulouse (4) · Aardvark Therapeutics, Inc. (2) · Harmony Biosciences Management, Inc. (2) · Radius Pharmaceuticals, Inc. (2) · Assistance Publique - Hôpitaux de Paris (1) · Changchun GeneScience Pharmaceutical Co., Ltd. (1) · Children's Mercy Hospital Kansas City (1) · Foundation for Prader-Willi Research (1) · LG Life Sciences (1) · Levo Therapeutics, Inc. (1) · Millendo Therapeutics SAS (1) · Pfizer (1) · University of British Columbia (1) · Weill Medical College of Cornell University (1)
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David Seiden, MD (1) · Deepan Singh, MD (1) · Dennis Kim, MD (1) · Evelien Gevers, MD, PhD (1) · Feihong Luo, Doctor (1) · Jean-Pierre Chanoine, MD (1) · Jennifer L. Miller, MD (1) · Merlin G Butler, MD (1) · Moris Angulo, MD (1) · Roja Motaghedi, MD (1)
PMID 37919617, PMID 38671361, PMID 20965292, PMID 26994593, PMID 28556449, PMID 31511031, PMID 33232306, PMID 36633570, PMID 36639249, PMID 40436776, PMID 42486751
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