This study will assess the safety and tolerability of a cannabidiol-enriched Cannabis Herbal Extract in a small group of children with refractory epileptic encephalopathy. The dosage of Cannabis Herbal Extract will be gradually increased over a four month time period.
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Heart Rate
Timeframe: Up to 6 months
Blood Pressure
Timeframe: Up to 6 months
Weight
Timeframe: Up to 6 months
Complete Blood Count (CBC) and Differential
Timeframe: Up to 6 months
Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L)
Timeframe: Up to 6 months
Blood Urea Nitrogen (mmol/L)
Timeframe: Up to 6 months
Creatinine (umol/L)
Timeframe: Up to 6 months
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L)
Timeframe: Up to 6 months
Total and Direct Bilirubin (umol/L)
Timeframe: Up to 6 months
Albumin (g/L)
Timeframe: Up to 6 months
Total Cholesterol and Triglyceride (mmol/L)
Timeframe: Up to 6 months
Clobazam and Norclobazam Levels (umol/L)
Timeframe: Up to 6 months
Clonazepam Level (umol/L)
Timeframe: Up to 6 months
Urine Ketones
Timeframe: Up to 6 months
Trough Level of Concomitant Anti-Convulsants
Timeframe: Up to 7 months
Adverse Events
Timeframe: Through study completion, up to 7 months
2-hour Electroencephalogram (EEG) Recording
Timeframe: Up to 6 months