201. アンジェルマン症候群 Angelman syndrome Clinical trials / Disease details


臨床試験数 : 24 薬物数 : 36 - (DrugBank : 9) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 20

  
5 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004478-24-DE
(EUCTR)
05/06/202026/02/2020An 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.NULLNot RecruitingFemale: yes
Male: yes
170Phase 3United States;Australia;Israel;Netherlands;Germany
2EUCTR2019-002907-17-NL
(EUCTR)
19/02/202010/12/2019Clinical 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.NULLNot RecruitingFemale: yes
Male: yes
95Phase 3United States;Australia;Israel;Germany;Netherlands;Italy
3NCT04106557
(ClinicalTrials.gov)
September 9, 201925/9/2019A 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 SyndromePrimary Disease or Condition Being Studied: Angelman Syndrome (AS)Drug: Gaboxadol;Drug: PlaceboOvid Therapeutics Inc.NULLCompleted2 Years12 YearsAll104Phase 3United States;Australia;Germany;Israel;Netherlands
4NCT02996305
(ClinicalTrials.gov)
January 20162/12/2016A Study in Adults and Adolescents With Angelman SyndromeA Phase 2 Adult and Adolescent Angelman Syndrome Clinical Trial: A Randomized, Double-Blind, Safety and Efficacy Study of GaboxadolAngelman SyndromeDrug: OV101 Regimen 1;Drug: OV101 regimen 2;Other: PlaceboOvid Therapeutics Inc.NULLCompleted13 Years49 YearsAll88Phase 2United States;Israel
5EUCTR2019-004478-24-NL
(EUCTR)
18/03/2020An 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.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Australia;Israel;Germany;Netherlands