Trials / Completed
CompletedNCT02983695
Cannabinoid Therapy for Pediatric Epilepsy
Cannabinoid Therapy in Medically Refractory Pediatric Epilepsy - Phase 1: Dosing and Tolerability Study of a Cannabidiol-Rich Whole Plant Extract of Cannabis.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- The Hospital for Sick Children · Academic / Other
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 trial to determine the tolerability and optimal dose of CBD rich cannabis extract as an adjunct treatment in children with severe drug resistant epilepsy due to Dravet Syndrome. This is an open label intervention. Study duration is 20 weeks to primary analysis with continued follow-up until 64 weeks completed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TIL-TC150 | The active ingredients in TIL-TC150 are tetrahydrocannabinol (THC) and Cannabidiol (CBD), isolated from the Cannabis sativa L. strains produced by Tilray, and formulated into an oral liquid drug product. |
Timeline
- Start date
- 2017-02-02
- Primary completion
- 2018-08-24
- Completion
- 2021-07-20
- First posted
- 2016-12-06
- Last updated
- 2021-11-16
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02983695. Inclusion in this directory is not an endorsement.