Efficacy And Withdrawal Symptoms in Transition Between Cannabidivarin (CBDV) and Cannabidiol (CBD) in Children with Rett Syndrome and Refractory Epilepsy

Exclusion Criteria11

• Another significant neurological diagnosis (history of traumatic brain injury, metabolic disease, or infection).
• Significant non-neurological diagnosis (e.g., severe cardiac or respiratory disease).
• Pre-existing abnormalities of full blood count, electrolytes, coagulation, hepatic function or enzymes considered clinically significant as judged by the investigator (e.g., WCC < 4, platelets < 60 000, ANC < 1, ALT or AST > 2 times upper limit normal).
• Clinically significant ECG abnormality (e.g., QTc > 460 msec, PR > 0.2 sec).
• Patient currently using or has used other cannabinoid products other than CBDV and unwilling to abstain for duration of the trial.
• Female subjects who are pregnant will be excluded. A negative serum pregnancy test is required at screening. If female subjects become pregnant during the study, they must inform the investigator, and consult an obstetrician.
• Known allergy to or any component of either CBDV, CBD or any cannabinoid.
• Patient has any other significant disease or disorder which in the opinion of the investigator, may put the patient at risk or influence the result of the trial or the patient’s ability to participate in the trial.
• Any abnormalities identified following a physical examination of the patient that, in the opinion of the investigator, would jeopardize the safety of the patient if they took part in the trial.
• Patient is taking more than four other concurrent anti-epileptic drugs.
• Patient has taken felbamate in year prior to screening.