LGS efficacy

Full study population

EPIDIOLEX® (cannabidiol) significantly reduced drop seizure frequency in patients living with LGS

Subgroup: Concomitant clobazam

A prespecified exploratory analysis evaluated the effect of EPIDIOLEX on drop seizure reduction in the subgroup of patients receiving clobazam3

Reduction in monthly frequency of drop seizures

Reduction in monthly frequency of drop seizures

Results from the 14-week treatment period. Drop seizures were defined as atonic, tonic, or tonic-clonic seizures that led to or could have led to a fall or injury.1,2

Among patients taking clobazam, those also taking EPIDIOLEX experienced a greater reduction in drop seizures than with placebo3

Among patients taking clobazam, those also taking EPIDIOLEX experienced a greater reduction in drop seizures than with placebo

Note: 49% of patients in LGS clinical trials were taking concomitant clobazam. Subgroup analysis is exploratory and descriptive in nature.

Recommended daily dosage of EPIDIOLEX is 10 mg/kg/day (5 mg/kg twice daily), with a maximum maintenance dosage of 20 mg/kg/day (10 mg/kg twice daily).

Administration of the 20 mg/kg/day dosage resulted in somewhat greater reductions in seizure rates than the recommended maintenance dosage of 10 mg/kg/day, but with an increase in adverse reactions. Patients with moderate to severe hepatic impairment require a dose adjustment.

Patients taking:

Placebo

EPIDIOLEX 10 mg/kg/day

EPIDIOLEX 20 mg/kg/day

Important considerations for your patients taking EPIDIOLEX and clobazam:

  • EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish with continued treatment. These effects were more common in patients on concomitant clobazam
  • Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam
  • Elevated ammonia levels have been reported in some EPIDIOLEX-treated patients who also had transaminase elevations. Most cases reported concomitant use of valproate, clobazam, or both
  • Consider a reduction of dosage or discontinuation of clobazam if known clobazam adverse reactions occur
  • Other CNS depressants, including alcohol, could potentiate the somnolence and sedation effect of EPIDIOLEX
  • Monitor for somnolence and sedation and advise patients not to drive or operate machinery until they have gained sufficient experience on EPIDIOLEX
  • Rapid withdrawal of ASMs can lead to increased seizure frequency and status epilepticus

Additional resources

LGS caregiver-reported outcomes

Clinical studies assessed impression of change in overall condition, and a real-world survey assessed change in seizure and non-seizure outcomes with EPIDIOLEX.4,5

See results

A Potential Treatment Partnership for LGS

Dr. Benbadis discusses how EPIDIOLEX and another established ASM work together to potentially reduce seizures in LGS.

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EPIDIOLEX Experience

Follow investigative journalist Ashley Benecchi as she interviews epilepsy experts and caregivers of those living with refractory epilepsy.

Explore now