201. アンジェルマン症候群 Angelman syndrome Clinical trials / Disease details
臨床試験数 : 25 / 薬物数 : 40 - (DrugBank : 11) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 20
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2019-004478-24-DE (EUCTR) | 05/06/2020 | 26/02/2020 | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA) | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA) - ELARA | Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gaboxadol monohydrate 0.5 mg (intended commercial formulation) Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE Product Name: Gaboxadol monohydrate 2 mg (intended commercial formulation) Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE Product Name: Gaboxadol monohydrate 5 mg (intended commercial formulation) Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE | Ovid Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 170 | Phase 3 | United States;Australia;Israel;Netherlands;Germany | ||
| 2 | EUCTR2019-002907-17-NL (EUCTR) | 19/02/2020 | 10/12/2019 | Clinical Trial to Evaluate the Efficacy and Safety of of OV101 in Pediatric Individuals With Angelman Syndrome | A MulticeNter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in PediaTric IndividUals With AngelmaN SyndromE (NEPTUNE) - NEPTUNE | Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gaboxadol monohydrate 0.5 mg capsule Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE Product Name: Gaboxadol monohydrate 2 mg capsule Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE | Ovid Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | United States;Australia;Israel;Germany;Netherlands;Italy | ||
| 3 | NCT04106557 (ClinicalTrials.gov) | September 9, 2019 | 25/9/2019 | A Study of OV101 in Individuals With Angelman Syndrome (AS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evaluate the Efficacy and Safety of OV101 in Pediatric Individuals With Angelman Syndrome | Primary Disease or Condition Being Studied: Angelman Syndrome (AS) | Drug: Gaboxadol;Drug: Placebo | Ovid Therapeutics Inc. | NULL | Completed | 2 Years | 12 Years | All | 104 | Phase 3 | United States;Australia;Germany;Israel;Netherlands |
| 4 | NCT03882918 (ClinicalTrials.gov) | February 25, 2019 | 18/3/2019 | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals With Angelman Syndrome | Angelman Syndrome | Drug: OV101 | Ovid Therapeutics Inc. | NULL | Recruiting | 13 Years | 49 Years | All | 82 | Phase 2 | United States;Israel |
| 5 | NCT03109756 (ClinicalTrials.gov) | April 3, 2017 | 6/4/2017 | Single Dose Pharmacokinetic (PK) Study | A Phase 1 Single Dose PK Study in Adolescent Subjects With Fragile X Syndrome or Angelman Syndrome | Angelman Syndrome;Fragile X Syndrome | Drug: OV101 | Ovid Therapeutics Inc. | NULL | Completed | 13 Years | 17 Years | All | 12 | Phase 1 | United States |
| 6 | NCT02996305 (ClinicalTrials.gov) | January 2016 | 2/12/2016 | A Study in Adults and Adolescents With Angelman Syndrome | A Phase 2 Adult and Adolescent Angelman Syndrome Clinical Trial: A Randomized, Double-Blind, Safety and Efficacy Study of Gaboxadol | Angelman Syndrome | Drug: OV101 Regimen 1;Drug: OV101 regimen 2;Other: Placebo | Ovid Therapeutics Inc. | NULL | Completed | 13 Years | 49 Years | All | 88 | Phase 2 | United States;Israel |
| 7 | EUCTR2019-004478-24-NL (EUCTR) | 18/03/2020 | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA) | An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals with Angelman Syndrome (ELARA) - ELARA | Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Gaboxadol monohydrate 0.5 mg Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE Product Name: Gaboxadol monohydrate 2 mg Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE Product Name: Gaboxadol monohydrate 5 mg Product Code: OV101 INN or Proposed INN: Gaboxadol Other descriptive name: GABOXADOL MONOHYDRATE | Ovid Therapeutics Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Australia;Israel;Germany;Netherlands |