DDrare: Database of Drug Development for Rare Diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
140	ドラベ症候群	1

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	NCT02091206 (ClinicalTrials.gov)	October 22, 2014	17/3/2014	A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)	A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome	Epilepsy;Dravet Syndrome	Drug: GWP42003-P 5 mg/kg/day Dose;Drug: Placebo control;Drug: GWP42003-P 10 mg/kg/day Dose;Drug: GWP42003-P 20 mg/kg/day Dose	GW Research Ltd	NULL	Completed	4 Years	10 Years	All	34	Phase 2	United States;United Kingdom

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

NCT02091206
(ClinicalTrials.gov)

October 22, 2014

17/3/2014

A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1)

A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

Epilepsy;Dravet Syndrome

Drug: GWP42003-P 5 mg/kg/day Dose;Drug: Placebo control;Drug: GWP42003-P 10 mg/kg/day Dose;Drug: GWP42003-P 20 mg/kg/day Dose

GW Research Ltd

NULL

Completed

4 Years

10 Years

All

Phase 2

United States;United Kingdom