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Cannabidiol in Children With Refractory Epileptic Encephalopathy (CARE-E)

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ClinicalTrials.gov Identifier: NCT03024827
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : February 5, 2018
University of Alberta
Information provided by (Responsible Party):
Richard Huntsman, University of Saskatchewan

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.

Condition or disease Intervention/treatment Phase
Epileptic Encephalopathy Drug: CanniMed® 1:20 Phase 1

Detailed Description:

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)
Actual Study Start Date : April 26, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Medical Cannabis Oil
CanniMed® 1:20
Drug: CanniMed® 1:20
A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension.
Other Name: Medical Cannabis Oil

Primary Outcome Measures :
  1. Heart Rate [ Time Frame: Up to 6 months ]
  2. Blood Pressure [ Time Frame: Up to 6 months ]
  3. Weight [ Time Frame: Up to 6 months ]
  4. Complete Blood Count (CBC) and Differential [ Time Frame: Up to 6 months ]
  5. Sodium, potassium, chloride, calcium, magnesium, phosphate and carbon dioxide (mmol/L) [ Time Frame: Up to 6 months ]
  6. Blood Urea Nitrogen (mmol/L) [ Time Frame: Up to 6 months ]
  7. Creatinine (umol/L) [ Time Frame: Up to 6 months ]
  8. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Gamma-glutamyl transferase (GGT) and Lipase (U/L) [ Time Frame: Up to 6 months ]
  9. Total and Direct Bilirubin (umol/L) [ Time Frame: Up to 6 months ]
  10. Albumin (g/L) [ Time Frame: Up to 6 months ]
  11. Total Cholesterol and Triglyceride (mmol/L) [ Time Frame: Up to 6 months ]
  12. Clobazam and Norclobazam Levels (umol/L) [ Time Frame: Up to 6 months ]
    For participants taking clobazam who become excessively sedated

  13. Clonazepam Level (umol/L) [ Time Frame: Up to 6 months ]
    For participants taking clonazepam who become excessively sedated

  14. Urine Ketones [ Time Frame: Up to 6 months ]
    For participants on the ketogenic diet

  15. Trough Level of Concomitant Anti-Convulsants [ Time Frame: Up to 6 months ]
    Measure interactions with any anti-convulsants participants may be already on

  16. Adverse Events [ Time Frame: Through study completion, up to 7 months ]
    Side effect rating scale, includes items related to sleepiness/lethargy, irritability, nausea/vomiting and diarrhea

  17. 2-hour Electroencephalogram (EEG) Recording [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Seizure Frequency Log Book [ Time Frame: Through study completion, up to 7 months ]
  2. Modified Quality of Life in Children with Epilepsy Questionnaire (QOLCE) [ Time Frame: Through study completion, up to 7 months ]
  3. Cannabidiol (CBD) (ng/mL) [ Time Frame: Up to 6 months ]
    Levels in blood

  4. Tetrahydrocannabinol (Δ9-THC) (ng/mL) [ Time Frame: Up to 6 months ]
    Levels in blood

  5. 11-nor-9-carboxy-tetrahydrocannabinol (11-nor-9-Carboxy-THC) (ng/mL) [ Time Frame: Up to 6 months ]
    Levels in blood

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 1-10 years
  • Epileptic Encephalopathy
  • A minimum of at least 1 major seizure per week or 4 major seizures per month. For the purposes of this research study, a major seizure would include atonic, tonic, clonic, tonic-clonic, major myoclonic, myoclonic astatic seizures and epileptic spasms (including infantile spasms)
  • Refractory to anticonvulsant medication as per the International League Against Epilepsy (ILAE) Definition of failing 2 appropriate anticonvulsants at therapeutic doses
  • The ability to attend appointments regularly
  • Negative pregnancy test at screening for females who have reached menarche

Exclusion Criteria:

  • Recent (<1 month) change in anticonvulsant therapies including anticonvulsant medications, ketogenic diet or settings on Vagal Nerve Stimulator
  • Recent (<6 months) change in intravenous immunoglobulin (IVIG) treatment
  • Initiation of ketogenic diet within 6 months (Patients must be on the ketogenic diet for at least 6 months to prevent any delayed response from the ketogenic diet affecting study results)
  • Implantation and activation of Vagal Nerve Stimulator within 12 months (Patients may have a vagal nerve stimulator for at least one year once again to prevent delayed response from the vagal nerve stimulator affecting study results)
  • Use of cannabis-based therapy within 2 months (Participants who have previously used a cannabis based therapy may be included if they have a 2 month period without use of cannabis based therapy prior to enrolment in the study)
  • Use of selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant or atypical neuroleptic medication in last month
  • Concomitant regular use of narcotics (Use of narcotics in emergency situations and supervised by a physician is allowed)
  • Initiation or dosage change of oral or injected steroids within 3 months
  • Allergy or known intolerance to any of the compounds within the study preparation
  • Inability of study participants to attend assessments on a monthly basis
  • Clinically significant cardiac, renal or hepatic disease (as assessed by the site investigator)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03024827

Contact: Doris Newmeyer 306-844-1208 doris.newmeyer@usask.ca
Contact: Simona Meier 306-978-8302 simona.meier@usask.ca

Canada, Alberta
University of Alberta Not yet recruiting
Edmonton, Alberta, Canada, T6G2R3
Contact: Dory Sample       dory.sample@albertahealthservices.ca   
Principal Investigator: Richard Tang-Wai         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T1Z4
Contact: Vesna Popovska       vpopovska@cw.bc.ca   
Principal Investigator: Linda Huh         
Canada, Manitoba
University of Manitoba Not yet recruiting
Winnipeg, Manitoba, Canada, R3T 2N2
Contact: Lise Bourrier       LBourrier@chrim.ca   
Principal Investigator: Edward Leung         
Canada, Quebec
Universite de Montreal Not yet recruiting
Montreal, Quebec, Canada, H3T1J4
Contact: Jonathan Bitton       jonathan.bitton@umontreal.ca   
Principal Investigator: Lionel Carmant         
Canada, Saskatchewan
University of Saskatchewan Recruiting
Saskatoon, Saskatchewan, Canada, S7N5C5
Contact: Doris Newmeyer    306-844-1208    doris.newmeyer@usask.ca   
Principal Investigator: Richard Huntsman         
Sub-Investigator: Blair Seifert         
Sub-Investigator: Jose Tellez-Zentino         
Sub-Investigator: Jane Alcorn         
Sub-Investigator: Bryan Acton         
Sub-Investigator: Andrew Lyon         
Sub-Investigator: June Lim         
Sub-Investigator: Simona Hasal         
Sponsors and Collaborators
University of Saskatchewan
University of Alberta
Principal Investigator: Richard Huntsman, MD University of Saskatchewan
Principal Investigator: Richard Tang-Wai, MD University of Alberta

Responsible Party: Richard Huntsman, MD, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT03024827     History of Changes
Other Study ID Numbers: CARE-E-01
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard Huntsman, University of Saskatchewan:
Infantile Spasms
Lennox Gastaut Syndrome
Doose Syndrome
Continuous Spike Wave in Sleep
Landau-Kleffner Syndrome
Dravet Syndrome
Malignant Migrating Partial Seizures of Infancy (MMPSI)

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases