4 completed, 1 terminated. 4 Phase 2, 1 Phase 1, 1 Phase 3.
By phase and status
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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 |
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome OV101 - Angelman Syndrome | Phase 3 | Terminated | 141 | 2019-01-31 | 2025-07-18 |
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY) Soticlestat - 15q Duplication Syndrome, CDKL5 Deficiency Disease | Phase 2 | Completed | 20 | 2018-09-10 | 2026-09-10 |
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies TAK-935, Placebo - Epilepsy, Dravet Syndrome | Phase 2 | Completed | 141 | 2018-08-08 | 2026-09-14 |
Study of TAK-935 as an Adjunctive Therapy in Participants With Developmental and/or Epileptic Encephalopathies TAK-935, Placebo - Developmental and/or Epileptic Encephalopathies | Phase 1 / Phase 2 | Completed | 18 | 2017-08-17 | 2026-09-14 |
A Study in Adults and Adolescents With Angelman Syndrome (STARS) OV101 Regimen 1, OV101 regimen 2, Placebo - Angelman Syndrome | Phase 2 | Completed | 88 | 2016-01-01 | 2025-08-03 |
Conditions studied
Angelman Syndrome (2) · Brain Diseases (2) · CDKL5 deficiency disorder (2) · Central Nervous System Diseases (2) · Epilepsy (2) · Autistic Disorder (1) · Epilepsies, Myoclonic (1) · Hypoxia-Ischemia, Brain (1) · Lennox Gastaut Syndrome (1) · Malformations of Cortical Development (1) · Nervous System Diseases (1) · Polyposis Syndrome, Hereditary Mixed, 1 (1) · Seizures (1) · Spasms, Infantile (1) · Tuberous Sclerosis (1)
Interventions
gaboxadol (2) · soticlestat (1)
Countries
United States (5) · Israel (3) · Australia (1) · Canada (1) · China (1) · Poland (1) · Portugal (1) · Spain (1)
Top investigators
Amit Rakhit, MD, MBA (1)
Results publications
PMID 33395098, PMID 33443117, PMID 33940389, PMID 35841234, PMID 37011526
NIH funding
2018 (1)