Cannabidiol in Children With Refractory Epileptic Encephalopathy (CARE-E)
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ClinicalTrials.gov Identifier: NCT03024827 |
Recruitment Status :
Active, not recruiting
First Posted : January 19, 2017
Last Update Posted : October 17, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | December 16, 2016 | ||||||
First Posted Date ICMJE | January 19, 2017 | ||||||
Last Update Posted Date | October 17, 2019 | ||||||
Actual Study Start Date ICMJE | April 26, 2017 | ||||||
Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Cannabidiol in Children With Refractory Epileptic Encephalopathy | ||||||
Official Title ICMJE | 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 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Epileptic Encephalopathy | ||||||
Intervention ICMJE | 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
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Study Arms ICMJE | Experimental: Medical Cannabis Oil
CanniMed® 1:20
Intervention: Drug: CanniMed® 1:20
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE |
30 | ||||||
Estimated Study Completion Date ICMJE | September 1, 2020 | ||||||
Estimated Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year to 10 Years (Child) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03024827 | ||||||
Other Study ID Numbers ICMJE | CARE-E-01 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Richard Huntsman, University of Saskatchewan | ||||||
Study Sponsor ICMJE | University of Saskatchewan | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Saskatchewan | ||||||
Verification Date | October 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |