Use of cannabidiol in the treatment of epilepsy

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC). In particular the TSC is treatment resistant and is characterised by generalised seizures or focal seizures with impairment. The disclosure further relates to the use of CBD in combination with one or more anti-epileptic drugs (AEDs).

1 . A method of treating seizures in a patient suffering from Tuberous Sclerosis Complex (TSC) comprising administering a cannabidiol (CBD) drug substance to the patient, wherein the CBD drug substance has a purity of at least 95% (w/w) CBD, and wherein the CBD is administered at a dose ranging from about 5 mg/kg/day to about 25 mg/kg/day. 
     
     
         2 . The method of  claim 1 , wherein the TSC is treatment resistant. 
     
     
         3 . The method of  claim 1 , wherein the administering treats TSC characterized by generalized seizures or focal seizures with impairment. 
     
     
         4 . The method of  claim 3 , wherein the generalized seizures include one or more seizure sub-types selected from the group consisting of tonic; atonic; tonic-clonic; and absence seizures. 
     
     
         5 . The method of  claim 3 , wherein CBD is administered at a does of about 25 mg/kg/day. 
     
     
         6 . The method of  claim 4 , wherein CBD is administered at a dose of about 25 mg/kg/day. 
     
     
         7 . The method of  claim 3 , wherein administering reduces the number of generalized seizures or focal seizures with impairment. 
     
     
         8 . The method of  claim 7 , wherein the number of generalized seizures or focal seizures with impairment is reduced by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered. 
     
     
         9 . The method according to  claim 1 , wherein CBD is present as a synthetic compound. The method according to  claim 1 , wherein the CBD is administered as a highly purified extract. 
     
     
         11 . The method according to  claim 1 , wherein the CBD has a purity of at least 98%. 
     
     
         12 . The method according to  claim 1 , wherein the dose of CBD is 20 mg/kg/day. 
     
     
         13 . The method according to  claim 1 , wherein the dose of CBD is 25 mg/kg/day. 
     
     
         14 . The method according to of  claim 1 , wherein the dose of CBD is 10 mg/kg/day. 
     
     
         15 . The method according to of  claim 1 , wherein the dose of CBD is 15 mg/kg/day. 
     
     
         16 . A method of treating seizures in a patient suffering from Tuberous Sclerosis Complex (TSC) comprises administering a cannabidiol (CBD) drug substance to the patient, wherein the CBD drug substance has a purity of at least 95% (w/w) CBD, and the CBD is administered at 25 mg/kg/day. 
     
     
         17 . The method according to  claim 16 , wherein the CBD has a purity of at least 98%. 
     
     
         18 . The method according to  claim 16 , wherein the CBD is present as a synthetic compound. 
     
     
         19 . The method of  claim 16 , wherein the CBD is administered as a highly purified extract. 
     
     
         20 . The method of  claim 16 , wherein the TSC is treatment resistant. 
     
     
         21 . The method of  claim 16 , wherein the administering treats TSC characterized by generalized seizures or focal seizures with impairment. 
     
     
         22 . The method of  claim 21 , wherein the generalized seizures include one or more seizure sub-types selected from the group consisting of tonic; actonic; tonic-clonic; and absence seizures. 
     
     
         23 . The method of  claim 21 , wherein administering reduces the number of generalized seizures or focal seizures with impairment. 
     
     
         24 . The method of  claim 23 , wherein the number of generalized seizures or the focal seizures with impairment is reduced by at least 50% compared to the number of seizures experienced during a baseline period before CBD was administered.