Efficacy and Safety of GWP42003-P for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

June 8, 2015

Primary Completion Date

May 19, 2016

Study Completion Date

May 19, 2016

Conditions
EpilepsyLennox Gastaut Syndrome
Interventions
DRUG

GWP42003-P

GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) 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). Participants were randomly assigned to receive either 10 or 20 mg/kg/day.

DRUG

Placebo control

Placebo was presented as an oral solution containing 0 mg/mL CBD 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).

Trial Locations (29)

10003

New York

10016

New York

14222

Buffalo

17403

York

22903

Charlottesville

27012

Clemmons

27157

Winston-Salem

28034

Madrid

29425

Charleston

30912

Augusta

31080

Pamplona

32819

Orlando

35294

Birmingham

41013

Seville

43205

Columbus

45267

Cincinnati

46026

Valencia

55905

Rochester

75015

Paris

76104

Fort Worth

78723

Austin

83702

Boise

85054

Phoenix

90027

Los Angeles

06106

Hartford

08022

Barcelona

EH9 1LF

Edinburgh

G51 4TF

Glasgow

WC1N 3JH

London

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY