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
Dravet syndrome
Convulsive seizures defined as countable3:
- Atonic
- Tonic
- Tonic-clonic
- Clonic
TSC
TSC-associated seizures defined as4:
- Partial-onset seizures§
- Atonic
- Tonic
- Tonic-clonic
- Clonic
§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‖
‖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