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	EUCTR2007-003702-95-IT (EUCTR)	03/07/2007	07/09/2007	A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND	A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND	Dravet Syndrome Level: PTClassification code 10054859	Trade Name: stiripentolo Trade Name: TOPAMAX INN or Proposed INN: Topiramate Trade Name: FRISIUM *30CPS 10MG INN or Proposed INN: Clobazam	ISTITUTO C. MONDINO	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	90		Italy
2	EUCTR2007-002198-30-IT (EUCTR)	03/07/2007	17/01/2012	A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY	A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY	Dravet Syndrome MedDRA version: 14.1;Level: PT;Classification code 10054859;Term: Myoclonic epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Trade Name: stiripentolo INN or Proposed INN: Other antiepileptics Trade Name: TOPAMAX INN or Proposed INN: Topiramate Trade Name: FRISIUM *30CPS 10MG INN or Proposed INN: Clobazam	Inserm-ISP Pole Recherches cliniques et thérapeutiques	NULL	Not Recruiting			Female: yes Male: yes	90		Italy

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

EUCTR2007-003702-95-IT
(EUCTR)

03/07/2007

07/09/2007

A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET'S SYNDROME (SMEI) NOT ADEQUATELY CONTROLLED WITH CLOBAZAM AND VALPROATE, AND AUXILIARY PHARMACOGENETIC STUDY - ND

Dravet Syndrome
Level: PTClassification code 10054859

Trade Name: stiripentolo
Trade Name: TOPAMAX
INN or Proposed INN: Topiramate
Trade Name: FRISIUM *30CPS 10MG
INN or Proposed INN: Clobazam

ISTITUTO C. MONDINO

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

Italy

EUCTR2007-002198-30-IT
(EUCTR)

03/07/2007

17/01/2012

A MULTICENTRE RANDOMIZED CONTROLLED TRIAL COMPARING TOPIRAMATE, STIRIPENTOL AND CLOBAZAM AT THE MAXIMAL TOLERATED DOSAGE, AS ADJUNCTIVE THERAPY TO VALPROATE AND CLOBAZAM IN PAEDIATRIC PATIENTS WITH DRAVET`S SYNDROME (SMEI), AND AUXILIARY PHARMACOGENETIC STUDY

Dravet Syndrome
MedDRA version: 14.1;Level: PT;Classification code 10054859;Term: Myoclonic epilepsy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Trade Name: stiripentolo
INN or Proposed INN: Other antiepileptics
Trade Name: TOPAMAX
INN or Proposed INN: Topiramate
Trade Name: FRISIUM *30CPS 10MG
INN or Proposed INN: Clobazam

Inserm-ISP Pole Recherches cliniques et thérapeutiques

NULL

Not Recruiting

Female: yes
Male: yes

Italy