Cannabis for epilepsy

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Epilepsy trials

Tuberous Sclerosis GWEP1521 (2019) – unpublished

•   CBD 25mg/kg vs 50mg/kg vs placebo

•   ~75pts/group

•   Median sz reduction

o   27% vs 49% vs 48% (i.e. ~22% reduction relative to placebo)

•   Adverse effects (25mg/kg group)

o   Leading to withdrawal ~8% (relative to placebo)

o   Diarrhoea 6%

o   Somnolence 4%

o   Increased liver enzymes ~11%

o   Vomiting 7%

o   All higher in the 50mg/kg group

 

RCTs as per 2020:

Table Description automatically generated

 

•   Pooled median seizure reduction ~19%

•   50% reduction – RR 1.8

•   No dosing efficacy difference

•   GI Side effects – OR 1.5

Thiele 2018 – GWPCARE4

•   2-55yrs old

o   ~1/3 adults

•   LGS

•   85 placebo vs 86 cannabidiol

•   2.5mg/kg increasing every 2 weeks up to 20mg/kg

•   Mean seizure reduction - 22%

•   Seizure free 3 (3.5%) vs 0

 

 

 

BELIEVE 1 (2019)

·         Zygel in developmental and epileptic encephalopathies

·         Phase 2 trial

·         44% reduction in seizures ?but open label

 

Negative trials

CBD-V GW 2017-2019 – unpublished

•   No difference between placebo and Rx

 

ZYNERBA – STAR trial - unpublished

•   Australian trial 2018

•   Negative result