11 completed, 2 recruiting, 2 unknown, 1 enrolling by invitation. 6 Not applicable, 3 Phase 1, 2 Phase 2, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 6 | Completed 3, Enrolling by invitation 1, Recruiting 1, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 2 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
Follow Smith-Magenis Syndrome: new trials by email Literature Review of Smith-Magenis Syndrome trials Research Report on Smith-Magenis 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 |
|---|---|---|---|---|---|---|
| Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders Electroencephalography/Polysomnography (EEG/PSG), Skin Biopsy, Blood draw - RAI1 Gene 17P11.2 Deletion+Duplication | Recruiting | Baylor College of Medicine | 90 | 2024-03-13 | 2026-06-03 | |
| Smith Magenis Syndrome and Autism Spectrum Disorders Assessment - Smith-Magenis Syndrome, Autism Spectrum Disorder | Not applicable | Recruiting | Hospices Civils de Lyon | 40 | 2022-03-30 | 2026-10-26 |
| Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity acylated and unacylated ghrelin dosages - Angelman Syndrome, Smith-Magenis Syndrome | Unknown | University Hospital, Toulouse | 300 | 2021-06-10 | 2023-08-24 | |
| Parent and Infant Inter(X)Action Intervention (PIXI) Parent-Infant Inter(X)action Intervention (PIXI) - Fragile X Syndrome, Angelman Syndrome | Not applicable | Enrolling by invitation | RTI International | 120 | 2018-11-30 | 2026-07-13 |
| Home Blood Pressure SMS Telemonitoring in the Primary Care Setting Home blood pressure monitoring - Hypertension | Not applicable | Completed | Universidad Peruana Cayetano Heredia | 40 | 2018-04-09 | 2019-05-07 |
| Melatonin in Adults With SMS Hourly dosing of the nychtemeral secretion of melatonin - Smith Magenis Syndrome | Not applicable | Completed | Hôpital le Vinatier | 10 | 2018-03-07 | 2019-04-22 |
| Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity Setmelanotide - Genetic Obesity, Obesity | Phase 2 | Completed | Rhythm Pharmaceuticals, Inc. | 213 | 2017-02-10 | 2023-08-18 |
| Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents tasimelteon - Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder | Phase 1 | Completed | Vanda Pharmaceuticals | 24 | 2016-10-04 | 2024-03-21 |
| Evaluating the Effects of Tasimelteon vs Placebo on Sleep Disturbances in SMS tasimelteon, placebo - Smith-Magenis Syndrome, Circadian | Phase 2 / Phase 3 | Completed | Vanda Pharmaceuticals | 49 | 2015-09-01 | 2022-11-18 |
| Observational Study to Investigate the Melatonin and Cortisol Circadian Rhythms of Individuals With Smith-Magenis Syndrome (SMS) Smith Magenis Syndrome | Unknown | Vanda Pharmaceuticals | 8 | 2014-06-01 | 2016-03-25 | |
| Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities Circadin 2/5/10 mg, Placebo - Sleep Disorders | Phase 3 | Completed | Neurim Pharmaceuticals Ltd. | 125 | 2013-10-01 | 2024-04-23 |
| Assessment of the Pharmacokinetics of Circadin® in Children With Neurodevelopmental Disorders and Sleep Disturbances Circadin 2 mg, Circadin 10 mg - Sleep Problems | Phase 1 | Completed | Neurim Pharmaceuticals Ltd. | 16 | 2013-03-01 | 2014-04-04 |
| Effectiveness of Messages to Mobile Phone in Smoke Cessation Quit smoking combined cessation programme, health advice - Smoking | Not applicable | Completed | Basque Health Service | 320 | 2013-03-01 | 2015-10-21 |
| Treatment Strategies for Children With Smith-Magenis Syndrome dTR Melatonin (NIH CC PDS), Phototherapy (Bright Light), Melatonin CR - Developmental Delay Disorders, Chromosome Deletion | Phase 1 | Completed | National Human Genome Research Institute (NHGRI) | 23 | 2007-07-17 | 2019-12-12 |
| Natural History Study of Smith-Magenis Syndrome Smith-Magenis Syndrome (SMS) | Completed | National Human Genome Research Institute (NHGRI) | 593 | 2001-03-19 | 2026-09-09 | |
| Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes Williams Syndrome, Angelman Syndrome | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | 20 | 1999-09-01 | 2005-06-24 | |
| Melatonin Levels in Smith Magenis Syndrome (SMS) Melatonin, Enviro-light artificial light box - Chromosome Disorders | Not applicable | Terminated | Oregon Health and Science University | 5 | 1998-09-01 | 2019-11-27 |
Angelman Syndrome (5) · Autism Spectrum Disorder (4) · Parasomnias (4) · Prader-Willi Syndrome (3) · Sleep Wake Disorders (3) · Tuberous Sclerosis (3) · Chromosome Aberrations (2) · Developmental Disabilities (2) · DiGeorge Syndrome (2) · Fragile X Syndrome (2) · Intellectual Disability (2) · Sleep Disorders, Circadian Rhythm (2) · Williams Syndrome (2) · Chromosome Deletion (1)
Abnormalities, Multiple (17) · Chronobiology Disorders (17) · Congenital Abnormalities (17) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (17) · Nervous System Diseases (17) · Chromosome Disorders (16) · Genetic Diseases, Inborn (16) · Mental Disorders (7) · Neurodevelopmental Disorders (7) · Neurologic Manifestations (6) · Pathological Conditions, Signs and Symptoms (6) · Signs and Symptoms (6) · Central Nervous System Diseases (5) · Imprinting Disorders (5) · Movement Disorders (5)
Melatonin (3) · tasimelteon (2) · Blood Specimen Collection (1) · Electroencephalography (1) · Phototherapy (1) · Polysomnography (1) · Restraint, Physical (1) · setmelanotide (1)
Vanda Pharmaceuticals (3) · National Human Genome Research Institute (NHGRI) (2) · Neurim Pharmaceuticals Ltd. (2) · Basque Health Service (1) · Baylor College of Medicine (1) · Hospices Civils de Lyon (1) · Hôpital le Vinatier (1) · National Institute of Neurological Disorders and Stroke (NINDS) (1) · Oregon Health and Science University (1) · RTI International (1) · Rhythm Pharmaceuticals, Inc. (1) · Universidad Peruana Cayetano Heredia (1) · University Hospital, Toulouse (1)
United States (11) · France (5) · Netherlands (3) · Spain (2) · United Kingdom (2) · Canada (1) · Finland (1) · Germany (1) · Greece (1) · Israel (1) · Peru (1)
William A Gahl, M.D. (2) · Anne Wheeler, PhD (1) · David Meeker, MD (1) · Davut Pehlivan, MD (1) · Eilis Boudreau, MD (1) · James R. Lupski (1) · Paul Gringras, PhD (1) · Robert Findling, MD (1)
PMID 29096777, PMID 31982581, PMID 35112343, PMID 35393403, PMID 36961653
2017 (1)