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US 11,406,623 B2Granted
Methods of treating tuberous sclerosis complex with cannabidiol and everolimus
AssigneeGW Research Limited
InventorsGeoffrey Guy, Volker Knappertz, Eduardo Dunayevich, David Critchley
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Abstract
The present disclosure provides methods of treating tuberous sclerosis complex comprising administering cannabidiol and everolimus.
Claims25
A method of initiating everolimus treatment in a human who is suffering from tuberous sclerosis complex and has partial onset seizures who is currently being treated with a therapeutically effective amount of cannabidiol, the method comprising:
- (a) co-administering a reduced starting dose of everolimus and the therapeutically effective amount of cannabidiol to the human;
- (b) monitoring the human's blood plasma concentration of everolimus;
- (c) increasing the reduced starting dose of everolimus administered in step (a) by at least 10% to a dose that achieves a blood plasma trough concentration of everolimus ranging from 5-15 ng/mL, Cmax of everolimus that is less than or equal to 50 ng/mL, or AUC0-24 of everolimus that is less than or equal to 500 h*ng/mL;
- wherein said monitoring in step (b) occurs one to two weeks after the human begins receiving everolimus;
- wherein cannabidiol is synthetic or purified;
- and
- wherein the starting dose of everolimus for treating tuberous sclerosis complex in the human is 5 mg/m2 once daily.
4 more elements
Dependencies are inferred from the claim text.