A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

171

Participants

Timeline

Start Date

April 28, 2015

Primary Completion Date

March 18, 2016

Study Completion Date

March 18, 2016

Conditions
EpilepsyLennox-Gastaut Syndrome
Interventions
DRUG

GWP42003-P 20 mg/kg/day Dose

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).

DRUG

Placebo

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 (24)

8025

Denekamp

10467

The Bronx

14642

Rochester

22601

Winchester

30328

Atlanta

33606

Tampa

40536

Lexington

50010

Ames

52242

Iowa City

55102

Saint Paul

60611

Chicago

63131

St Louis

75251

Dallas

77030

Houston

81143

Salt Lake City

02114

Boston

03756

Lebanon

19104-4399

Philadelphia

85-080

Bydgoszcz

80-952

Gdansk

30-349

Krakow

20-093

Lublin

20-718

Lublin

60-355

Poznan

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY