EPIDIOLEX® (cannabidiol) is proven across a broad range of seizure types, patient types, and concomitant therapies

EPIDIOLEX was studied in highly refractory patient populations1-5

PATIENTS AT BASELINE

Median number of seizures at baseline/28 days Median number of previous AEDs Median number of current AEDs Patients taking ≥ 2 AEDs (%)
LGS Study 1
(ages 2-55 years)*		 74
(drop seizures)		 6 3 94%
LGS Study 2
(ages 2-55 years)*		 85
(drop seizures)		 6 3 94%
Dravet syndrome Study 3
(ages 2-18 years)†		 13
(convulsive seizures)		 4 3 93%
TSC Study 4
(ages 1-65 years)‡		 57
(TSC-associated
seizures)		 4 3 89%
LGS Study 1 (ages 2-55 years)*
Median number of seizures at baseline/28 days 74
(drop seizures)
Median number of previous AEDs 6
Median number of current AEDs 3
Patients taking ≥2 AEDs (%) 94%
LGS Study 2 (ages 2-55 years)*
Median number of seizures at baseline/28 days 85
(drop seizures)
Median number of previous AEDs 6
Median number of current AEDs 3
Patients taking ≥2 AEDs (%) 94%
Dravet syndrome Study 3 (ages 2-18 years)†
Median number of seizures at baseline/28 days 13
(convulsive seizures)
Median number of previous AEDs 4
Median number of current AEDs 3
Patients taking ≥2 AEDs (%) 93%
TSC Study 4 (ages 1-65 years)‡
Median number of seizures at baseline/28 days 57
(TSC-associated seizures)
Median number of previous AEDs 4
Median number of current AEDs 3
Patients taking ≥2 AEDs (%) 89%

* Eligibility criteria for age was 2-55 years. 32% of patients in LGS studies were ages 18-55. Both trials had a 4-week baseline period, during which patients were required to have a minimum of 8 drop seizures while on stable AED therapy.1,2

†Eligibility criteria for age was 2-18 years. During the 4-week baseline period, patients were required to have at least 4 convulsive seizures while on stable AED therapy.

‡Eligibility criteria for age was 1-65 years. During the 4-week baseline period, patients were required to have a minimum of 8 TSC-associated seizures, with at least 1 seizure per week in ≥3 of the 4 weeks while on stable AED therapy.

EPIDIOLEX significantly reduced multiple seizure types across 3 different epilepsies

PRIMARY ENDPOINT: Change (per 28 days) from baseline vs placebo when added to current treatment in

LGS

Drop seizures defined as seizures that led to or could have led to a fall or injury1,2:

  • Atonic
  • Tonic
  • Tonic-clonic
SEE RESULTS

Dravet syndrome

Convulsive seizures defined as countable3:

  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic
SEE RESULTS

TSC

TSC-associated seizures defined as4:

  • Partial-onset seizures§
  • Atonic
  • Tonic
  • Tonic-clonic
  • Clonic
SEE RESULTS

§Partial-onset seizures (focal) included simple partial seizures (focal motor seizure), complex partial seizures (focal impaired), and secondary generalized tonic-clonic seizures (focal to bilateral tonic-clonic).6

EPIDIOLEX was studied in over 900 patients with LGS, Dravet syndrome, and TSC7‖

4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trials Chart 4 Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trials Chart

‖There was a second randomized controlled trial in 199 patients with Dravet syndrome that has been completed since its original approval.7

Explore clinical trial results

SEE DATA