Use of cannabinoids in the treatment of epilepsy
The present disclosure relates to the use of cannabidiol (CBD) for the reduction of total convulsive 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 Dravet syndrome; myoclonic absence seizures or febrile infection related epilepsy syndrome (FIRES). 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 associated with a type of treatment-resistant epilepsy, which is Lennox-Gastaut syndrome or Dravet syndrome, in a patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance and testing liver function,
wherein the CBD drug substance comprises at least 98% w/w CBD, and
wherein the CBD is administered at a starting dose of about 5 mg/kg/day, and then the dose is increased by increments of about 5 mg/kg.
2. The method of claim 1 , wherein the dose of CBD is increased up to a maximum of about 25 mg/kg/day.
3. The method of claim 1 , wherein the dose of CBD is increased to about 10 mg/kg/day.
4. The method of claim 1 , wherein the dose of CBD is increased to about 20 mg/kg/day.
5. The method of claim 1 , wherein the dose of CBD is increased to a dose ranging from about 10 mg/kg/day to about 20 mg/kg/day.
6. The method of claim 1 , wherein the CBD is synthetic.
7. The method of claim 1 , wherein the CBD drug substance comprises not more than 0.15% w/w Δ 9 THC.
8. The method of claim 1 , wherein the CBD drug substance comprises 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.
9. The method of claim 1 , wherein the administering treats convulsive seizures.
10. The method of claim 1 , wherein the administering reduces seizure frequency.
11. The method of claim 1 , wherein the administering reduces total convulsive seizure frequency by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.
12. The method of claim 3 , wherein the administering treats convulsive seizures.
13. The method of claim 3 , wherein the administering reduces seizure frequency.
14. The method of claim 3 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.
15. The method of claim 4 , wherein the administering treats convulsive seizures.
16. The method of claim 4 , wherein the administering reduces seizure frequency.
17. The method of claim 4 , wherein the administering reduces convulsive seizure frequency by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.
18. The method of claim 1 , wherein the type of treatment-resistant epilepsy is Lennox-Gastaut syndrome, and the dose of the CBD is increased to about 10 mg/kg/day or about 20 mg/kg/day.
19. The method of claim 18 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.
20. The method of claim 18 , wherein the dose of the CBD is increased to about 10 mg/kg/day.
21. The method of claim 18 , wherein the dose of the CBD is increased to about 20 mg/kg/day.
22. The method of claim 1 , wherein the type of treatment-resistant epilepsy is Dravet syndrome, and the dose of the CBD is increased to about 10 mg/kg/day or about 20 mg/kg/day.
23. The method of claim 22 , wherein the patient's convulsive seizure frequency is reduced by at least 50% compared to the number of convulsive seizures experienced during a baseline period before CBD was administered.
24. The method of claim 22 , wherein the dose of the CBD is increased to about 10 mg/kg/day.
25. The method of claim 22 , wherein the dose of the CBD is increased to about 20 mg/kg/day.
26. The method of claim 1 , wherein the testing is performed at baseline.
27. The method of claim 1 , wherein the testing is performed after administering the CBD drug substance.
28. The method of claim 27 , wherein the testing is performed 4 weeks or 12 weeks after initiating treatment.
29. The method of claim 1 , wherein the testing is performed at baseline and after administering the CBD drug substance.
30. The method of claim 29 , wherein the testing is performed after 4 weeks or 12 weeks of treatment.