Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)

PHASE3CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

March 30, 2015

Primary Completion Date

November 26, 2015

Study Completion Date

November 26, 2015

Conditions
EpilepsyDravet Syndrome
Interventions
DRUG

GWP42003-P 20 mg/kg/day Dose

GWP42003-P was an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) dissolved in the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

DRUG

Placebo control

Placebo oral solution contained the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).

Trial Locations (22)

10016

New York

13385

Marseille

19104

Philadelphia

27408

Winston-Salem

30328

Atlanta

32819

Orlando

33155

Miami

43205

Columbus

52242

Iowa City

55905

Rochester

60611

Chicago

67098

Strasbourg

70034

Toulouse

75015

Paris

77030

Houston

84113

Salt Lake City

02114

Boston

80-952

Gdansk

30-349

Krakow

G51 4TF

Glasgow

L12 2AP

Liverpool

WC1N 3JH

London

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY