Study register · detailKohortenstudie · Epilepsy · 2019
Prospective evaluation of oral cannabis extracts in children with epilepsy.
Knupp et al.·SeizureImpact 2.2
No benefit demonstratedGRADEVery low40 citations
Samplen = 21 Pat.
Duration12-week treatment period
EndpointSeizure frequency
Blindingn.a.
DesignKohortenstudie
Cannabinoidvollspektrum
Routeoral
”Key finding
Response rate of 24% similar to placebo rates in randomised trials; 14% discontinuation due to perceived seizure increase.
Summary
Prospective observational study of oral cannabis extracts (OCE) in children with refractory epilepsy; n=21, median 10,3 years, baseline 2,7 seizures/day. Median CBD dose 0,9 mg/kg/day (IQR 0,6-2,2). Responder rate (≥50% seizure reduction over 8 weeks) 24% (5/21), similar to placebo rates in RCTs. Discontinuation rate 14% (3/21) due to perceived seizure increase. No significant association between CBD/THC-COOH blood levels and response (p=0,95 and p=0,53 respectively).
P
PopulationChildren with refractory epilepsy, n=21 (evaluable)
I
InterventionOral cannabis extract (OCE), median maximum CBD dose 0,9 mg/kg/day, oral, 12 weeks
O
OutcomeResponder rate (≥50% seizure reduction): 5/21 (24%); no significant association between CBD/THC-COOH blood levels and responder status (p=0,95 and p=0,53 respectively)
Confidence in the evidence
Very lowLowModerateHigh
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Purpose: Interest in the use of artisanal cannabinoids in pediatric epilepsy has increased but safety and utility data are lacking. Our aim was to prospectively characterize the use of oral cannabis extracts (OCE) in a refractory pediatric epilepsy population.
Methods: Families considering the use of an OCE were enrolled in a prospective observational study. Baseline seizure frequency was assessed over a period of 4 weeks. Seizure frequency, CBD and THC-COOH levels were assessed every 4 weeks during a 12-week treatment period. Response was defined as at least a 50% reduction in seizure frequency over the final 8 weeks of the study relative to baseline.
Results: Consent was obtained in 32 children; 11 were excluded from analysis (3 failed to complete baseline data, 3 started OCE before completing baseline period and 5 did not start OCE) leaving 21 to be included in subsequent analyses. Median age was 10.3 years (IQR 6.8-12.6), 13 (62%) were male and median seizure frequency was 2.7 seizures/day during the baseline period. The median of the high dose of CBD that was administered during the observation period was of 0.9 (0.6-2.2) mg/kg/day. Of the 21 subjects who were included in the analysis, 5 (24%) were responders. OCE was stopped early in 3 subjects (14%) due to a perceived increase in seizures. THC-COOH and CBD blood levels did not have a significant association with response status (p = 0.95 CBD, p = 0.53 THC-COOH, N = 14).
Conclusion: The observed response rate in this study is similar to placebo rates in prospective randomized trials of pharmaceutical grade products and the withdrawal rate is greater than rates obtained with retrospective methods. Doses of OCE administered were lower than doses used in randomized trials.