OV101

( DrugBank: - / KEGG DRUG: - )

2 diseases

ID	Disease name (Link within this page)	Number of trials
201	Angelman syndrome	7

ID	Disease name (Link within this page)	Number of trials
206	Fragile X syndrome	2

201. Angelman syndrome

Clinical trials : 25 / Drugs : 40 - (DrugBank : 11) / Drug target genes : 22 - Drug target pathways : 20

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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 OV101in Individu ...	An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101in Individu ...	Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndr ...	Product Name: Gaboxadol monohydrate 0.5 mg (intended commercial formulation) Product Code: OV101 INN o ...	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 OV101in Pediatric Individuals With Angelman ...	A MulticeNter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Evalua ...	Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndr ...	Product Name: Gaboxadol monohydrate 0.5 mg capsule Product Code: OV101 INN or Proposed INN: Gaboxadol O ...	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 Evalua ...	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 OV101in Individu ...	An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101in Individu ...	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 ...	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 OV101in Individu ...	An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101in Individu ...	Angelman Syndrome MedDRA version: 20.0;Level: PT;Classification code 10049004;Term: Angelman's syndr ...	Product Name: Gaboxadol monohydrate 0.5 mg Product Code: OV101 INN or Proposed INN: Gaboxadol Other des ...	Ovid Therapeutics Inc.	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Australia;Israel;Germany;Netherlands

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206. Fragile X syndrome

Clinical trials : 108 / Drugs : 91 - (DrugBank : 36) / Drug target genes : 52 - Drug target pathways : 77

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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	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 E ...	Fragile X Syndrome (FXS)	Drug: OV101 (gaboxadol)	Ovid Therapeutics Inc.	NULL	Completed	13 Years	22 Years	Male	23	Phase 2	United States
2	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

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