Trials / Unknown
UnknownNCT03024827
Cannabidiol in Children With Refractory Epileptic Encephalopathy
Cannabidiol in Children With Refractory Epileptic Encephalopathy: A Phase 1 Open Label Dose Escalation Study (CARE-E)
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- University of Saskatchewan · Academic / Other
- Sex
- All
- Age
- 1 Year – 10 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CanniMed® 1:20 | A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension. |
Timeline
- Start date
- 2017-04-26
- Primary completion
- 2020-02-01
- Completion
- 2023-12-31
- First posted
- 2017-01-19
- Last updated
- 2023-04-26
Locations
4 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03024827. Inclusion in this directory is not an endorsement.