Clinical Trial: Cannabidiol in Children With Refractory Epileptic Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: University of Saskatchewan

Current Primary Outcome:

  • 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) [ Time Frame: Up to 6 months ]
    For participants taking clobazam who become excessively sedated
  • Urine Ketones [ Time Frame: Up to 6 months ]
    For participants on the ketogenic diet
  • Trough Level of Concomitant Anti-Convulsants [ Time Frame: Up to 6 months ]
    Same as current

    Current Secondary Outcome:

    • 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) [ Time Frame: Up to 6 months ]
      Levels in blood
    • Tetrahydrocannabinol (Δ9-THC) (ng/mL) [ Time Frame: Up to 6 months ]
      Levels in blood
    • 11-nor-9-carboxy-tetrahydrocannabinol (11-nor-9-Carboxy-THC) (ng/mL) [ Time Frame: Up to 6 months ]
      Levels in blood


    Original Secondary Outcome: Same as current

    Information By: University of Saskatchewan

    Dates:
    Date Received: December 16, 2016
    Date Started: April 26, 2017
    Date Completion: September 2018
    Last Updated: April 25, 2017
    Last Verified: April 2017