US2021330636A1PendingUtilityA1

Use of cannabidiol in the treatment of epilepsy

Assignee: GW RES LTDPriority: Oct 14, 2014Filed: Jul 21, 2020Published: Oct 28, 2021
Est. expiryOct 14, 2034(~8.2 yrs left)· nominal 20-yr term from priority
A61K 36/3482A61K 31/658A61K 47/26A61P 25/10A61K 47/10A61K 9/08A61K 45/06A61P 25/12A61K 47/44A61P 25/08A61K 31/05A61K 31/352
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Claims

Abstract

The present disclosure relates to the use of cannabidiol (CBD) for the reduction of seizure frequency in the treatment of “treatment-resistant epilepsy” (TRE). In particular, the disclosure relates to the use of CBD of treating TRE when the TRE is Lennox-Gastaut syndrome; Dravet syndrome; or Acardi syndrome.

Claims

exact text as granted — not AI-modified
1 . A method of reducing convulsive seizure frequency in a patient with a treatment-resistant epilepsy, which is Lennox-Gastaut syndrome, comprising administering to the patient in need thereof cannabidiol (CBD), wherein the CBD has a purity of at least 98% (w/w) CBD and comprises not more than 0.15% (w/w) Δ9-tetrahydrocannabinol (THC), wherein the dose of the CBD ranges from 5-25 mg/kg/day. 
     
     
         2 . A method of treating seizures in a subject having Aicardi Syndrome, comprising administering to the subject in need thereof cannabidiol (CBD), wherein the CBD has a purity of at least 95 (w/w), and the dose of CBD ranges from about 5-25 mg/kg/day. 
     
     
         3 . The method of  claim 2 , wherein the seizures are convulsive seizures. 
     
     
         4 . The method of  claim 2 , wherein the seizures are focal seizures with impairment. 
     
     
         5 . The method of  claim 2 , wherein the seizures are infantile spasms. 
     
     
         6 . The method of  claim 2 , wherein the seizures are treatment resistant. 
     
     
         7 . The method of  claim 2 , wherein the CBD is a highly purified extract of  cannabis  which has a purity of at least 98% (w/w). 
     
     
         8 . The method of  claim 7 , wherein the extract comprises less than 0.15% tetrahydrocannabinol (THC). 
     
     
         9 . The method of  claim 7 , wherein the extract further comprises up to 1% cannabidivarin (CBDV). 
     
     
         10 . The method of  claim 2 , wherein the CBD is present as a synthetic compound. 
     
     
         11 . The method of  claim 2 , wherein the dose of the CBD is 10 mg/kg/day. 
     
     
         12 . The method of  claim 2 , wherein the dose of the CBD is 12 mg/kg/day. 
     
     
         13 . The method of  claim 2 , wherein the dose of the CBD is 14 mg/kg/day. 
     
     
         14 . The method of  claim 2 , wherein the dose of CBD is 15 mg/kg/day. 
     
     
         15 . The method of  claim 2 , wherein the dose of the CBD is 16 mg/kg/day. 
     
     
         16 . The method of  claim 2 , wherein the dose of the CBD is 18 mg/kg/day. 
     
     
         17 . The method of  claim 2 , wherein the dose of the CBD is 20 mg/kg/day. 
     
     
         18 . The method of  claim 24 , wherein the CBD is administered as a composition, comprising cannabidiol (CBD), a solvent, a co-solvent, a sweetener, and a flavoring. 
     
     
         19 . The method of  claim 18 , wherein the solvent is sesame oil. 
     
     
         20 . The method of  claim 18 , wherein the co-solvent is ethanol. 
     
     
         21 . The method of  claim 18 , wherein the sweetener is sucralose. 
     
     
         22 . The method of  claim 18 , wherein the CBD is present at a concentration of ranging from about 25 mg/ml and to about 100 mg/ml. 
     
     
         23 . The method of  claim 2 , wherein the patient is administered a starting dose of 5 mg/kg/day, and then the dose is increased by about 2-5 mg/kg up to a maximum of 25 mg/kg/day. 
     
     
         24 . The method of  claim 23 , wherein the dose of the CBD is increased up to 10 mg/kg/day. 
     
     
         25 . The method of  claim 23 , wherein the dose of the CBD is increased up to 12 mg/kg/day. 
     
     
         26 . The method of  claim 23 , wherein the dose of the CBD is increased up to 14 mg/kg/day. 
     
     
         27 . The method of  claim 23 , wherein the dose of CBD is increased up to 15 mg/kg/day. 
     
     
         28 . The method of  claim 23 , wherein the dose of the CBD is increased up to 16 mg/kg/day. 
     
     
         29 . The method of  claim 23 , wherein the dose of the CBD is increased up to 18 mg/kg/day. 
     
     
         30 . The method of  claim 23 , wherein the dose of the CBD is increased up to 20 mg/kg/day.

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