5 recruiting, 4 completed, 1 not yet recruiting, 1 terminated. 3 Not applicable, 3 Phase 2, 2 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 3 | Recruiting 2, Completed 1 |
| Phase 2 | 3 | Completed 1, Not yet recruiting 1, Recruiting 1 |
| Phase 1 | 2 | Terminated 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 1, Not yet recruiting 1 |
Follow Fragile X Syndrome (FXS): new trials by email Literature Review of Fragile X Syndrome (FXS) trials Research Report on Fragile X Syndrome (FXS)
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 to Investigate the Effects and Safety of Codabakalner for the Treatment of FXS in Male Participants and Adult Participants With ADS Codabakalner, Placebo - Fragile X Syndrome (FXS), Autism Spectrum Disorder (ASD) | Phase 2 / Phase 3 | Not yet recruiting | Spinogenix | 120 | 2026-12-01 | 2026-10-09 |
| The Neurocognitive Bases of Trust in Intellectual Disability Confidence adjustment assessment, clinical assessment, Cognitive assessment - Down Syndrome (Trisomy 21), Fragile X Syndrome (FXS) | Recruiting | Hospices Civils de Lyon | 112 | 2026-07-17 | 2026-08-05 | |
| Safety, Tolerability, and Preliminary Effectiveness of CTH120 in Fragile X Syndrome CTH120, CTH120 placebo hard capsules - Fragile X Syndrome (FXS), Fragile X Syndrome | Phase 2 | Recruiting | Connecta Therapeutics, S.L. | 30 | 2026-05-21 | 2026-07-17 |
| Optical Imaging in X-linked Disorders. Clinical assessment, Parental questionnaires, Cognitive assessment - Fragile X Syndrome (FXS), Creatine Transporter Deficiency | Not applicable | Recruiting | Hospices Civils de Lyon | 118 | 2026-03-30 | 2026-05-15 |
| Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD) | Recruiting | Healing Hope International | 100 | 2026-03-01 | 2026-03-25 | |
| Neural Biomarkers in Fragile X Syndrome Any - Fragile X Syndrome (FXS), Neurotypical Adults | Completed | Connecta Therapeutics, S.L. | 20 | 2024-12-16 | 2025-05-04 | |
| Group CBT in Adolescents With Fragile X Syndrome and in Adolescents With Autism Spectrum Disorder Cognitive behavioral therapy, Waiting List - Fragile X Syndrome (FXS), Autism Spectrum Disorder | Not applicable | Recruiting | Bambino Gesù Hospital and Research Institute | 20 | 2022-09-01 | 2024-11-08 |
| Clinical Study of Cannabidiol in Children, Adolescents, and Young Adults With Fragile X Syndrome ZYN002, Placebo - Fragile X Syndrome, Fragile X Syndrome (FXS) | Phase 3 | Completed | Harmony Biosciences Management, Inc. | 257 | 2021-09-13 | 2026-09-01 |
| Novel Clinical Target in Fragile X Syndrome 18F-FTC-146 - Fragile X Syndrome (FXS) | Phase 1 | Withdrawn | Guido A. Davidzon, MD, SM | 2021-01-12 | 2022-11-15 | |
| A Study of OV101 in Individuals With Fragile X Syndrome OV101 (gaboxadol) - Fragile X Syndrome (FXS) | Phase 2 | Completed | Ovid Therapeutics Inc. | 36 | 2018-09-17 | 2024-01-23 |
| Neuroimaging GABA Physiology in Fragile X Syndrome [18F]flumazenil - Fragile X Syndrome (FXS), Idiopathic Intellectual Developmental Disorder (IDD) | Phase 1 | Terminated | Stanford University | 17 | 2016-11-01 | 2021-01-28 |
| Decisional Capacity and Informed Consent in Fragile X Syndrome Paper and Pencil Informed Consent, Digital Informed Consent Tool - Fragile X Syndrome (FXS) | Not applicable | Completed | RTI International | 152 | 2016-03-14 | 2019-03-07 |
Fragile X Syndrome (12) · Intellectual Disability (5) · Autism Spectrum Disorder (3) · Neurodevelopmental Disorders (3) · Central Nervous System Diseases (2) · Congenital Abnormalities (2) · Down Syndrome (2) · Genetic Diseases, X-Linked (2) · Neurobehavioral Manifestations (2) · Rare Diseases (2) · Autistic Disorder (1) · Brain Injuries, Traumatic (1) · Cerebral Palsy (1) · Chromosome Aberrations (1) · Creatine deficiency, X-linked (1)
Chromosome Disorders (12) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (12) · Heredodegenerative Disorders, Nervous System (12) · Nervous System Diseases (12) · Neurologic Manifestations (12) · Sex Chromosome Disorders (12) · X-Linked Intellectual Disability (12) · Genetic Diseases, Inborn (11) · Congenital Abnormalities (10) · Genetic Diseases, X-Linked (10) · Neurobehavioral Manifestations (10) · Intellectual Disability (7) · Mental Disorders (7) · Pathological Conditions, Signs and Symptoms (6) · Signs and Symptoms (6)
Mental Status and Dementia Tests (2) · 5-(2'-fluoroethyl)flumazenil (1) · 6-(3-fluoropropyl)-3-(2-(azepan-1-yl)ethyl)benzo(d)thiazol-2(3H)-one (1) · Cognitive Behavioral Therapy (1) · Functional Status (1) · Neuropsychological Tests (1) · Paper (1) · Waiting Lists (1) · gaboxadol (1)
Connecta Therapeutics, S.L. (2) · Hospices Civils de Lyon (2) · Bambino Gesù Hospital and Research Institute (1) · Guido A. Davidzon, MD, SM (1) · Harmony Biosciences Management, Inc. (1) · Healing Hope International (1) · Ovid Therapeutics Inc. (1) · RTI International (1) · Spinogenix (1) · Stanford University (1)
United States (6) · France (2) · Spain (2) · Australia (1) · Ireland (1) · Italy (1) · New Zealand (1) · United Kingdom (1)
Amit Rakhit, MD (1) · Dr. Tina Casoglos-Adamopoulos, OT, OTD, BCP (1) · Frederick T Chin, PhD (1) · Guido Davidzon, MD SM (1) · Paolo Alfieri, MD, PhD (1) · Rafael De la Torre, Pharm, PhD (1) · Robert Furberg, PhD (1) · Stefano Vicari, MD, clinical professor (1)
PMID 29875084, PMID 30455171, PMID 31549310, PMID 34690787, PMID 35053752, PMID 39332280
2025 (1), R01HD071987 (1)