Use of cannabidiol in the treatment of epilepsy
The present invention relates to the use of cannabidiol (CBD) in the treatment of patients with childhood-onset epilepsy who are concurrently taking caffeine. Where the CBD is used in combination with caffeine, caution should be taken. For example, the dose of either the CBD and/or caffeine may be required to be reduced. Moreover, the patient may need to be monitored for side effects of said drug-drug interaction. Preferably the CBD used is in the form of a highly purified extract of cannabis such that the CBD is present at greater than 95% of the total extract (w/w) and the other components of the extract are characterised. In particular the cannabinoid tetrahydrocannabinol (THC) has been substantially removed, to a level of not more than 0.15% (w/w) and the propyl analogue of CBD, cannabidivarin, (CBDV) is present in amounts of up to 1%. Alternatively, the CBD may be a synthetically produced CBD.
1 . A method of treating childhood-onset epilepsy in a patient in need thereof,
comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance comprising at least 98% w/w CBD, wherein the patient is taking caffeine concurrently;
wherein the dose of caffeine is reduced compared to a patient that is not taking CBD concurrently, wherein the dose of caffeine is reduced to lower than 200 mg/day.
2 . The method of claim 1 , wherein the dose of caffeine is reduced no more than 95 mg/day.
3 . The method of claim 1 , wherein the dose of CBD is about 5 mg/kg/day to about 20 mg/kg/day.
4 . The method of claim 1 , wherein the dose of caffeine is reduced to no more than 50 mg/day.
5 . The method of claim 1 , wherein the CBD drug substance comprises not more than 0.15% w/w CBDA.
6 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 1.0% w/w CBDV.
7 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 0.15% w/w Δ9THC.
8 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD and not more than 0.5% w/w CBD-C4.
9 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 1.0% w/w CBDV, and not more than 0.15% w/w Δ9THC.
10 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 1.0% w/w CBDV, not more than 0.15% w/w Δ9THC, and not more than 0.5% w/w CBD-C4.
11 . The method of claim 1 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 0.15% w/w CBDA, not more than 1.0% w/w CBDV, not more than 0.15% w/w Δ9THC, and not more than 0.5% w/w CBD-C4.
12 . The method of claim 1 , wherein the childhood-onset epilepsy is selected from the group consisting of Lennox-Gastaut Syndrome; Myoclonic Absence Epilepsy; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Jeavons Syndrome; CDKL5; Dup15q; Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities.
13 . The method of claim 1 , wherein the childhood-onset epilepsy is Lennox-Gastaut Syndrome.
14 . The method of claim 1 , wherein the childhood-onset epilepsy is Dravet Syndrome.
15 . The method of claim 1 , wherein the childhood-onset epilepsy is Tuberous Sclerosis Complex.
16 . A method of treating childhood-onset epilepsy in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance, wherein the patient is taking caffeine concurrently; and wherein the dose of CBD is in the range of about 5 mg/kg/day to about 20 mg/kg/day, and the dose of caffeine is lower than 200 mg/day.
17 . The method of claim 16 , wherein the CBD drug substance comprises at least 98% w/w CBD, not more than 0.15% w/w CBDA, not more than 1.0% w/w CBDV, not more than 0.15% w/w A9THC, and not more than 0.5% w/w CBD-C4.
18 . The method of claim 16 , wherein the childhood-onset epilepsy is selected from the group consisting of Lennox-Gastaut Syndrome; Myoclonic Absence Epilepsy; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Jeavons Syndrome; CDKL5; Dup15q; Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities.
19 . The method of claim 16 , wherein the childhood-onset epilepsy is Lennox-Gastaut Syndrome.
20 . The method of claim 16 , wherein the childhood-onset epilepsy is Dravet Syndrome.
21 . The method of claim 16 , wherein the childhood-onset epilepsy is Tuberous Sclerosis Complex.