# US 2021/0330636 A1 · Use of cannabidiol in the treatment of epilepsy > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2021/0330636 A1 - Document ID: US20210330636A1 - Status: Published application - Kind: A1 - Application number: 16/935,005 - Filed: 2020-07-21 - Published: 2021-10-28 - Earliest claimed: 2014-10-14 - Applicants: GW Research Limited - Inventors: Geoffrey GUY; Stephen WRIGHT; Orrin DEVINSKY - Web page: https://patentgrep.com/patent/US20210330636A1 ## CPC - A61K 31/658: {o-phenolic cannabinoids, e.g. cannabidiol, cannabigerolic acid, cannabichromene or tetrahydrocannabinol} - A61K 9/08: Solutions {(composition of solutions A61K47/00)} - A61K 36/3482: {Cannabis} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers - A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin - A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14) - A61P 25/08: Antiepileptics; Anticonvulsants - A61P 25/10: for petit-mal - A61P 25/12: for grand-mal - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS ## 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 ### Claim 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. ### Claim 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. ### Claim 3 (depends on 2) The method of claim 2, wherein the seizures are convulsive seizures. ### Claim 4 (depends on 2) The method of claim 2, wherein the seizures are focal seizures with impairment. ### Claim 5 (depends on 2) The method of claim 2, wherein the seizures are infantile spasms. ### Claim 6 (depends on 2) The method of claim 2, wherein the seizures are treatment resistant. ### Claim 7 (depends on 2) 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). ### Claim 8 (depends on 7) The method of claim 7, wherein the extract comprises less than 0.15% tetrahydrocannabinol (THC). ### Claim 9 (depends on 7) The method of claim 7, wherein the extract further comprises up to 1% cannabidivarin (CBDV). ### Claim 10 (depends on 2) The method of claim 2, wherein the CBD is present as a synthetic compound. ### Claim 11 (depends on 2) The method of claim 2, wherein the dose of the CBD is 10 mg/kg/day. ### Claim 12 (depends on 2) The method of claim 2, wherein the dose of the CBD is 12 mg/kg/day. ### Claim 13 (depends on 2) The method of claim 2, wherein the dose of the CBD is 14 mg/kg/day. ### Claim 14 (depends on 2) The method of claim 2, wherein the dose of CBD is 15 mg/kg/day. ### Claim 15 (depends on 2) The method of claim 2, wherein the dose of the CBD is 16 mg/kg/day. ### Claim 16 (depends on 2) The method of claim 2, wherein the dose of the CBD is 18 mg/kg/day. ### Claim 17 (depends on 2) The method of claim 2, wherein the dose of the CBD is 20 mg/kg/day. ### Claim 18 (depends on 24) 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. ### Claim 19 (depends on 18) The method of claim 18, wherein the solvent is sesame oil. ### Claim 20 (depends on 18) The method of claim 18, wherein the co-solvent is ethanol. ### Claim 21 (depends on 18) The method of claim 18, wherein the sweetener is sucralose. ### Claim 22 (depends on 18) 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. ### Claim 23 (depends on 2) 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. ### Claim 24 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 10 mg/kg/day. ### Claim 25 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 12 mg/kg/day. ### Claim 26 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 14 mg/kg/day. ### Claim 27 (depends on 23) The method of claim 23, wherein the dose of CBD is increased up to 15 mg/kg/day. ### Claim 28 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 16 mg/kg/day. ### Claim 29 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 18 mg/kg/day. ### Claim 30 (depends on 23) The method of claim 23, wherein the dose of the CBD is increased up to 20 mg/kg/day.