Significant seizure reductions in patients with TSC
EPIDIOLEX® (cannabidiol) significantly reduced the frequency of TSC-associated seizures by half
EPIDIOLEX® (cannabidiol) significantly reduced the frequency of TSC-associated seizures by half
*The median percent change from baseline for patients with TSC was 43% for patients receiving EPIDIOLEX 25 mg/kg/day, compared with 20% for patients receiving placebo (P<0.01).
Results from the 16-week treatment period. Primary endpoint seizures included all countable TSC-associated seizures, including partial-onset seizures and generalized seizures (tonic-clonic, tonic, clonic, or atonic).
Patients at baseline1:
- Had previously tried a median of 4 prior AEDs
- Were currently uncontrolled with a median of 3 current AEDs
89% of patients were taking ≥2 AEDs at baseline and still experiencing 57 TSC-associated seizures per 28 days2
The most commonly used concomitant AEDs were:
45% valproate
33% vigabatrin
29% levetiracetam
27% clobazam
Results from the 16-week treatment period. Primary endpoint seizures included all countable TSC-associated seizures, including partial-onset seizures and generalized seizures (tonic-clonic, tonic, clonic, or atonic).
*The median percent change from baseline for patients with TSC was 43% for patients receiving EPIDIOLEX 25 mg/kg/day, compared with 20% for patients receiving placebo (P<0.01).
Reductions in TSC-associated seizure frequency were reported as early as Day 6 in a post-hoc analysis of the TSC clinical trial3
The recommended maintenance daily dosage for EPIDIOLEX is 25 mg/kg/day for patients with TSC.
Patients with moderate to severe hepatic impairment require a dose adjustment.
See recommendeddosing information
EPIDIOLEX reduced TSC-associated partial-onset seizure score by 46% in a prespecified exploratory analysis2
Composite score is a weighted average of the 3 types of partial-onset seizures included in the primary endpoint1,2,4:
- Simple partial seizures
- Complex partial seizures
- Secondary generalized tonic-clonic seizures
Results from the 16-week treatment period. Results of the composite seizure score were not controlled for multiplicity; therefore, P-values are not reported.1,2
More patients with TSC achieved ≥50% and ≥75% reductions in TSC-associated seizures with EPIDIOLEX than with placebo
Results from the 16-week treatment period.
More patients achieved seizure freedom with EPIDIOLEX than with placebo
Freedom from TSC-associated seizures in the 12-week maintenance period
0%
Placebo
6%
EPIDIOLEX
25 mg/kg/day
PRESPECIFIED EXPLORATORY ENDPOINT: CHANGE IN MEAN NUMBER OF TSC-ASSOCIATED SEIZURE-FREE DAYS/28 DAYS2†
| Baseline (per 28 days) |
Maintenance period (per 28 days) |
||
| EPIDIOLEX 25 mg/kg/day, n=71 | 7.4 days | 14.7 days | 97% increase |
| Placebo, n=76 | 7 days | 10.9 days | 55% increase |
| Placebo, n=76 |
EPIDIOLEX 25 mg/kg/day, n=71 |
|
| Baseline (per 28 days) |
7 days |
7.4 days |
| Maintenance period (per 28 days) |
10.9 days 55% increase |
14.7 days 97% increase |
†Analysis was not controlled for multiplicity and is considered exploratory in nature.
EPIDIOLEX maintained reductions in TSC-associated seizures in an ongoing open-label extension trial5
Decreasing N-values reflect rolling entry into the open-label extension
- The retention rate at 48 weeks was 79%2
- 28% (n=11) of withdrawals were due to adverse reactions5
- LOCF sensitivity analyses showed no impact of withdrawn patients on change in seizure frequency5
Adverse events5
- The long-term safety profile of EPIDIOLEX in this open-label extension trial was generally similar to that observed in the 16-week trial for TSC
- There was 1 death reported during the study, which was deemed unrelated to treatment by the investigator
- In the open-label extension trial, titration to doses over 25 mg/kg/day was permitted. At higher doses, an increase in adverse reactions is possible
EPIDIOLEX is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product
