Gaboxadol ( DrugBank: Gaboxadol )
2 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 201 | Angelman syndrome | 5 |
| 206 | Fragile X syndrome | 2 |
201. Angelman syndrome
Clinical trials : 25 / Drugs : 40 - (DrugBank : 11) / Drug target genes : 22 - Drug target pathways : 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 | 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 |
| 5 | 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 |
206. Fragile X syndrome
Clinical trials : 108 / Drugs : 91 - (DrugBank : 36) / Drug target genes : 52 - Drug target pathways : 77
| 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 | NCT04823052 (ClinicalTrials.gov) | May 25, 2022 | 24/3/2021 | Investigation of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) in Male Fragile X Syndrome Patients Aged 13-40 | A Phase 2, Placebo-controlled, Adaptive Design Study to Explore the Safety and Efficacy of Sulindac (HLX-0201) and Gaboxadol (HLX-0206) and Possible Other Treatments in Adolescent and Adult Males With Fragile X Syndrome (FXS) | Fragile X Syndrome | Drug: Sulindac (HLX-0201), dose strength 1;Drug: Sulindac (HLX-0201), dose strength 2;Drug: Placebo;Drug: Gaboxadol (HLX-0206) | Healx Limited | NULL | Withdrawn | 13 Years | 40 Years | Male | 0 | Phase 2 | United States;Australia |
| 2 | NCT03697161 (ClinicalTrials.gov) | September 17, 2018 | 1/10/2018 | A Study of OV101 in Individuals With Fragile X Syndrome | A Phase 2, Randomized, Double-Blind, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of OV101 in Fragile X Syndrome | Fragile X Syndrome (FXS) | Drug: OV101 (gaboxadol) | Ovid Therapeutics Inc. | NULL | Completed | 13 Years | 22 Years | Male | 23 | Phase 2 | United States |