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Abstract Details

Long-term Effectiveness of Cannabidiol (CBD) Against Focal-onset Seizures in Treatment-resistant Epilepsies (TRE): Experience from the Expanded Access Program (EAP)
Epilepsy/Clinical Neurophysiology (EEG)
S29 - Epilepsy Diagnostics and Therapeutics (1:48 PM-2:00 PM)
005

Four-year EAP results demonstrated that CBD was associated with sustained seizure improvement in TRE.

To report the effect of CBD in EAP patients with focal-onset seizures, including focal aware seizures (FAS), focal impaired awareness seizures (FIAS), and focal to bilateral tonic-clonic seizures (FBTCS).

Patients received plant-derived highly purified CBD (Epidiolex®; 100 mg/mL oral solution) starting at 2–10 mg/kg/d and further titrated to a maximum of 25–50 mg/kg/d. Percentage change from baseline in median monthly frequency of focal seizures and responder rates (RRs) across 12-week intervals through 144 treatment weeks were evaluated.

Of 892 EAP patients, 351 (39%) experienced focal seizures. Mean (range) age: 15.8 (<1–73.2) years. Median (range) ASMs at baseline: 3 (0–10). Most common ASMs: clobazam (43%), levetiracetam (35%). Patients withdrew mainly because of lack of efficacy (18%) or AEs (5%). Median CBD exposure: 684 days (range, 10–1793). Median top CBD dose: 25 mg/kg/d (IQR, 24–31). Baseline median (IQR) monthly seizure frequency: 28 (4–87) for FAS, 22 (7–76) for FIAS, and 12 (4–41) for FBTCS. CBD treatment was associated with median reduction of 67%–99% (FAS), 61%–78% (FIAS), and 50%–81% (FBTCS). The FAS RRs were 61%–88% (≥50% reduction), 45%–72% (≥75% reduction), and 20%–46% (100% reduction). The FIAS RRs were 55%–69%, 41%–56%, and 18%–29%, respectively. The FBTCS RRs were 52%–69%, 41%–54%, and 23%–36%, respectively. Among patients with any focal seizure, 90% reported AEs and 38% serious AEs; 7% withdrew due to AEs. Five deaths, not considered treatment-related, occurred in the cohort. Most common AEs: diarrhea (40%), convulsion (24%), somnolence (21%). Liver-related AEs (>1%) were increased ALT and AST (4% each) and abnormal liver function test (3%).

CBD treatment was associated with reduction in focal seizures with an acceptable safety profile. 
Authors/Disclosures
Karthik Rajasekaran (Jazz Pharmaceuticals)
PRESENTER
Dr. Rajasekaran has received personal compensation for serving as an employee of Jazz Pharmaceuticals.
Yong Park (Augusta University) Dr. Park has nothing to disclose.
No disclosure on file
Farhad Sahebkar-Moghaddam (Amgen) Dr. Sahebkar-Moghaddam has received personal compensation for serving as an employee of Jazz pharmaceuticals. Dr. Sahebkar-Moghaddam has stock in Jazz pharmaceuticals.
Robert Flamini Dr. Flamini has received personal compensation in the range of $0-$499 for serving as a Consultant for Biocodex. Dr. Flamini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Dr. Flamini has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Jazz Pharmaceuticals.