Studied in over 500 highly refractory patients1

The largest controlled, pivotal trial program in LGS and Dravet syndrome to date1-3

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER PHASE 3 TRIALS1,4-6

Epidiolex Clinical Phase 3 Trials for Dravet Syndrome and LGS Patients Epidiolex Clinical Phase 3 Trials for Dravet Syndrome and LGS Patients
*

PRIMARY ENDPOINT: Median % change from baseline in drop seizures (LGS) or convulsive seizures (Dravet syndrome) (per 28 days) in the 14-week treatment period for EPIDIOLEX vs placebo when added to current treatment1

Drop Seizures Icon

Drop seizures (LGS) were defined as tonic, atonic, or tonic-clonic seizures that led to or could have led to a fall or injury4

Convulsive Seizures Icon

Convulsive seizures (Dravet syndrome) were defined as countable tonic-clonic, tonic, clonic, or atonic seizures6

PATIENTS AT BASELINE1,4-6:

Epidiolex Clinical Trial - Patient Baseline Characteristics Table Epidiolex Clinical Trial - Patient Baseline Characteristics Table
>80% of patients in these studies had previously failed or were currently uncontrolled on clobazam or valproate2

Nearly half (49%) of the patients in the LGS clinical trials and 65% of the patients in the Dravet syndrome clinical trials were taking concomitant clobazam.1

The most commonly used concomitant AEDs across studies were clobazam, valproate, lamotrigine, levetiracetam, rufinamide, stiripentol, and topiramate.1

* 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.1,4,5

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.1

Explore the results from these clinical trials

SEE DATA

References: 1. EPIDIOLEX [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc.; 2018. 2. Data on file. Greenwich Biosciences, Inc., Carlsbad, CA. 3. Ostendorf AP, Ng YT. Neuropsychiatr Dis Treat. 2017;13:1131-1140. 4. Thiele EA, Marsh ED, French JA, et al. Lancet. 2018;391(10125):1085-1096. 5. Devinsky O, Patel AD, Cross JH, et al. N Engl J Med. 2018;378(20):1888-1897. 6. Devinsky O, Cross JH, Laux L, et al. N Engl J Med. 2017;376(21):2011-2020.