DDrare: Database of Drug Development for Rare Diseases

Searched query = "Dorabe syndrome", "Dravet syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = Ataluren; CANNABIDIOL; CBD; CBD - Oral Solution, is known as Epidiolex, and is the approved name in the USA.; Cannabidiol; Cannabidiol (CBD); Cannabidiol Oral Solution; Carbidopa; Clemizole; Clobazam; DIACOMIT; DIACOMIT (Stiripentol); Diacomit; EPX-100 (Clemizole HCl); EPX-100 (Clemizole Hydrochloride); FENFLURAMINE HYDROCHLORIDE; FENFLURAMINE HYDROCHLORIDE (colorless); FENFLURAMINE HYDROCHLORIDE (red); FRISIUM*30CPS 10MG; Fenfluramina; Fenfluramina Cloridrato; Fenfluramine; Fenfluramine Hydrochloride; Fenfluramine hydrochloride; Fenfluramine hydrochloride (colorless); Fenfluramine hydrochloride (red); Frisium; GWP42003-P; GWP42003-P 10 mg/kg/day Dose; GWP42003-P 20 mg/kg/day Dose; GWP42003-P 5 mg/kg/day Dose; Levodopa; Lorcaserin; ME2080 (stiripentol); None; None at this time; Other antiepileptics; Placebo; Procedure: 12-Lead ECG; STK-001; Stiripentol; Stiripentolo; TAK-935; TOPAMAX; Topiramate; Turmeric; Verapamil; ZX008; ZX008 (Fenfluramine Hydrochloride); ZX008 - 0.2 mg/kg/day; ZX008 - 0.4 mg/kg/day; ZX008 - 0.8 mg/kg/day; ZX008 - 20 mg/day maximum dose; ZX008 0.2 and 0.8 mg/kg/day

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	EUCTR2018-002484-25-PT (EUCTR)	29/04/2019	19/11/2018	A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)	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 PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES (ELEKTRA)	Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Code: TAK-935 INN or Proposed INN: None at this time Product Code: TAK-935 INN or Proposed INN: None at this time	Ovid Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	126	Phase 2	United States;Portugal;Canada;Poland;Spain;Australia;Israel;China
2	EUCTR2018-002484-25-PL (EUCTR)	14/03/2019	11/12/2018	A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)	A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES	Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]		Ovid Therapeutics, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	126	Phase 2	Portugal;United States;Canada;Spain;Poland;Australia;Israel;China
3	NCT03650452 (ClinicalTrials.gov)	August 8, 2018	27/8/2018	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 Patients With Developmental and/or Epileptic Encephalopathies	A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies	Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome	Drug: TAK-935;Drug: Placebo	Takeda	Ovid Therapeutics Inc.	Completed	2 Years	17 Years	All	141	Phase 2	United States;Australia;Canada;China;Israel;Poland;Portugal;Spain
4	NCT03635073 (ClinicalTrials.gov)	July 19, 2018	6/8/2018	A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy	A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy	Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder	Drug: TAK-935	Takeda	Ovid Therapeutics Inc.	Recruiting	2 Years	65 Years	All	176	Phase 2	United States;Australia;Canada;China;Israel;Poland;Portugal;Spain

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

EUCTR2018-002484-25-PT
(EUCTR)

29/04/2019

19/11/2018

A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)

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 PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES (ELEKTRA)

Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Code: TAK-935
INN or Proposed INN: None at this time
Product Code: TAK-935
INN or Proposed INN: None at this time

Ovid Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

126

Phase 2

United States;Portugal;Canada;Poland;Spain;Australia;Israel;China

EUCTR2018-002484-25-PL
(EUCTR)

14/03/2019

11/12/2018

A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES

Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Ovid Therapeutics, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

126

Phase 2

Portugal;United States;Canada;Spain;Poland;Australia;Israel;China

NCT03650452
(ClinicalTrials.gov)

August 8, 2018

27/8/2018

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 Patients With Developmental and/or Epileptic Encephalopathies

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 as an Adjunctive Therapy in Pediatric Patients With Developmental and/or Epileptic Encephalopathies

Epilepsy;Dravet Syndrome;Lennox-Gastaut Syndrome

Drug: TAK-935;Drug: Placebo

Takeda

Ovid Therapeutics Inc.

Completed

2 Years

17 Years

All

141

Phase 2

United States;Australia;Canada;China;Israel;Poland;Portugal;Spain

NCT03635073
(ClinicalTrials.gov)

July 19, 2018

6/8/2018

A Phase 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of TAK-935 (OV935) as Adjunctive Therapy in Patients With Rare Epilepsy

Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder

Drug: TAK-935

Takeda

Ovid Therapeutics Inc.

Recruiting

2 Years

65 Years

All

176

Phase 2

United States;Australia;Canada;China;Israel;Poland;Portugal;Spain