Use of cannabidiol in the treatment of seizures associated with rare epilepsy syndromes related to structural abnormalities of the brain
The present invention relates to the use of cannabidiol (CBD) for the treatment of seizures associated with rare epilepsy syndromes. In particular the seizures associated with rare epilepsy syndromes that are treated are experienced in patients diagnosed with Cortical Dysplasia and Cortical Brain Malformation. In a further embodiment the types of seizures include atonic, tonic, and focal without impairment seizures. Preferably the dose of CBD is between 5 mg/kg/day to 50 mg/kg/day.
1 . A method of treating seizures associated with Cortical Brain Malformation, wherein the seizures associated with Cortical Brain Malformation are atonic, tonic, and focal without impairment seizures comprising administering a cannabidiol (CBD) drug substance, wherein the CBD drug substance comprises greater than 95% (w/w) CBD and not more than 0.15% (w/w) tetrahydrocannabinol (THC), wherein the CBD drug substance provides a dose of CBD in the range of 5 mg/kg/day to 50 mg/kg/day.
2 . The method of claim 1 , wherein the CBD drug substance comprises greater than or equal to 98% (w/w) CBD and less than or equal to 2% (w/w) other cannabinoids, wherein the less than or equal to 2% (w/w) other cannabinoids comprise the cannabinoids tetrahydrocannabinol (THC); cannabidiol-C1 (CBD-C1); cannabidivarin (CBDV); and cannabidiol-C4 (CBD-C4), and wherein the THC is present as a mixture of trans-THC and cis-THC.
3 . The method of claim 1 , wherein the CBD preparation is used in combination with one or more concomitant anti-epileptic drugs (AED).
4 . The method of claim 3 , wherein the one or more AED is selected from the group consisting of: valproic acid, levetiracetam, clobazam, vigabatrin, zonisamide, rufinamide, lacosamide, topiramate and lamotrigine.
5 . The method of claim 1 , wherein the CBD is present is isolated from cannabis plant material.
6 . The method of claim 1 , wherein at least a portion of at least one of the cannabinoids present in the CBD preparation is isolated from cannabis plant material.
7 . The method of claim 1 , wherein the CBD is present as a synthetic drug substance.
8 . The method of claim 7 , wherein at least a portion of at least one of the cannabinoids present in the CBD drug substance preparation is prepared synthetically.
9 . The method of claim 1 , wherein the dose of CBD is greater than 5 mg/kg/day.
10 . The method of claim 1 wherein the dose of CBD is 20 mg/kg/day.
11 . The method of claim 1 , wherein the dose of CBD is 25 mg/kg/day.
12 . The method of claim 1 , wherein the dose of CBD is 50 mg/kg/day.
13 . The method of claim 1 , wherein the cortical brain malformation is cortical dysplasia.