Use of cannabidiol in the treatment of seizures associated with rare epilepsy syndromes related to genetic abnormalities
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 those which are experienced inpatients diagnosed with autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE) with DEPDC5 gene mutation. In a further embodiment the types of seizures include tonic, tonic-clonic and focal seizures without impairment. Preferably the dose of CBD is between 5 mg/kg/day to 50 mg/kg/day.
1 . A method for treating seizures associated with autosomal dominant nocturnal frontal lobe epilepsy (ADNFLE) with DEPDC5 mutation, the method comprising administering a cannabidiol (CBD) drug substance to a patient in need thereof, wherein the CBD drug substance comprises greater than 95% (w/w) CBD, and 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 seizures associated with ADNFLE with DEPDC5 mutation are tonic, tonic-clonic and focal seizures without impairment.
3 . The method of claim 1 , wherein the CBD drug substance comprises not more than 0.15% (w/w) tetrahydrocannabinol (THC).
4 . 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.
5 . The method of claim 1 , wherein the CBD drug substance is used in combination with one or more concomitant anti-epileptic drugs (AED).
6 . The method of claim 5 , wherein the one or more AED is vigabatrin and/or carbamazepine.
7 . The method of claim 1 , wherein the CBD is isolated from cannabis plant material.
8 . The method of claim 1 , wherein the CBD drug substance comprises at least one cannabinoid in addition to CBD, and at least a portion of at least one of the non-CBD cannabinoids present in the CBD drug substance is isolated from cannabis plant material.
9 . The method of claim 1 , wherein the CBD is present as a synthetic preparation.
10 . The method of claim 9 , wherein the CBD drug substance comprises at least one cannabinoid in addition to CBD, and at least a portion of at least one of the non-CBD cannabinoids present in the drug substance is prepared synthetically.
11 . The method of claim 1 , wherein the dose of CBD is in the range of 5 mg/kg/day to 25 mg/kg/day.
12 . The method of claim 1 , wherein the dose of CBD is 20 mg/kg/day.
13 . The method of claim 1 , wherein the dose of CBD is 25 mg/kg/day.
14 . The method of claim 1 , wherein the dose of CBD is 50 mg/kg/day.
15 . The method of claim 1 , wherein the dose of CBD is in the range of 10 mg/kg/day to 25 mg/kg/day.