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.
Epileptic Encephalopathies are a group of epilepsies that develop in children. These epilepsies can cause frequent and difficult to control seizures. Because of the ongoing seizures, these epilepsies can also cause cognitive impairment and neurological impairment. In many children with these Epileptic Encephalopathies, seizures are difficult to control with medical treatment, such as anti-convulsants or non-drug treatments like the ketogenic diet (a high fat, adequate-protein, low-carbohydrate diet). This has resulted in a need to find therapies that are effective and better tolerated for children with epileptic encephalopathies. There is very limited data regarding the use of cannabis products in children, in particular cannabidiol-enriched cannabis oil in children with epilepsy. However, hemp oil products with high cannabidiol and low tetrahydrocannabinol ratios have been reported to provide seizure relief and cognitive improvement in children who take them.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension.
University of British Columbia
Vancouver, British Columbia, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Universite de Montreal
Montreal, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Heart Rate
Time frame: Up to 6 months
Blood Pressure
Time frame: Up to 6 months
Weight
Time frame: Up to 6 months
Complete Blood Count (CBC) and Differential
Time frame: Up to 6 months
Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L)
Time frame: Up to 6 months
Blood Urea Nitrogen (mmol/L)
Time frame: Up to 6 months
Creatinine (umol/L)
Time frame: Up to 6 months
Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L)
Time frame: Up to 6 months
Total and Direct Bilirubin (umol/L)
Time frame: Up to 6 months
Albumin (g/L)
Time frame: Up to 6 months
Total Cholesterol and Triglyceride (mmol/L)
Time frame: Up to 6 months
Clobazam and Norclobazam Levels (umol/L)
For participants taking clobazam who become excessively sedated
Time frame: Up to 6 months
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Clonazepam Level (umol/L)
For participants taking clonazepam who become excessively sedated
Time frame: Up to 6 months
Urine Ketones
For participants on the ketogenic diet
Time frame: Up to 6 months
Trough Level of Concomitant Anti-Convulsants
Measure interactions with any anti-convulsants participants may be already on
Time frame: Up to 7 months
Adverse Events
Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea
Time frame: Through study completion, up to 7 months
2-hour Electroencephalogram (EEG) Recording
Time frame: Up to 6 months
Seizure Frequency Log Book
Time frame: Through study completion, up to 7 months
Modified Quality of Life in Children with Epilepsy Questionnaire (QOLCE)
Time frame: Through study completion, up to 7 months
Cannabidiol (CBD) (ng/mL)
Levels in blood
Time frame: Up to 7 months
Tetrahydrocannabinol (Δ9-THC) (ng/mL)
Levels in blood
Time frame: Up to 7 months
11-nor-9-carboxy-tetrahydrocannabinol (11-nor-9-Carboxy-THC) (ng/mL)
Levels in blood
Time frame: Up to 7 months