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	EUCTR2015-004167-37-IT (EUCTR)	17/05/2016	15/11/2018	Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome	A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome - Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and yo	Dravet syndrome MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato Product Name: Fenfluramina Cloridrato Product Code: ZX008 INN or Proposed INN: Fenfluramina Cloridrato	ZOGENIX INTERNATIONAL LTD	NULL	Not Recruiting			Female: yes Male: yes	260	Phase 3	France;Belgium;Spain;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Korea, Republic of;Sweden

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

EUCTR2015-004167-37-IT
(EUCTR)

17/05/2016

15/11/2018

Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and young adults with Dravet Syndrome

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of Two Fixed Doses of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children and Young Adults with Dravet Syndrome - Study to evaluate the safety and effectiveness of Fenfluramine as adjunct therapy in children and yo

Dravet syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10073682;Term: Dravet syndrome;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Product Name: Fenfluramina Cloridrato
Product Code: ZX008
INN or Proposed INN: Fenfluramina Cloridrato
Product Name: Fenfluramina Cloridrato
Product Code: ZX008
INN or Proposed INN: Fenfluramina Cloridrato
Product Name: Fenfluramina Cloridrato
Product Code: ZX008
INN or Proposed INN: Fenfluramina Cloridrato

ZOGENIX INTERNATIONAL LTD

NULL

Not Recruiting

Female: yes
Male: yes

260

Phase 3

France;Belgium;Spain;Denmark;Australia;Norway;Germany;United Kingdom;Switzerland;Italy;Korea, Republic of;Sweden