Cannabinoid Therapy for Pediatric Epilepsy

Epilepsy Clinical Trial

Official title:

Cannabinoid Therapy in Medically Refractory Pediatric Epilepsy - Phase 1: Dosing and Tolerability Study of a Cannabidiol-Rich Whole Plant Extract of Cannabis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983695
• Other study ID #: 1000047417
• Status: Completed
• Phase: Phase 1
• Start date: February 2, 2017
• Est. completion date: July 20, 2021

Study information

• Verified date: November 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 20, 2021
• Est. primary completion date: August 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Drug resistant epilepsy due to Dravet syndrome

• Must have clinically apparent seizures

• Must be able to tolerate administration of medication orally or enterally via gastrostomy tube

• Was never on Cannabinoid therapy or have not been treated with Cannabinoid products for at least last 60 days (confirmed by negative urine test for Tetrahydrocannabidiol (THC), only for those who had been treated with CBD).

Exclusion Criteria:

• Co-morbid liver or renal disease

• Without clinically-apparent seizures

• Currently taking any Cannabinoid products.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Tilray

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establishment of tolerability of TIL-TC150 by measuring the number of participants with adverse events and / or abnormal laboratory values that are related to treatment	During this study, the dose of TIL-TC150 will be titrated according to study protocol and participant tolerance. Tolerance will be assessed as documented in title, by evaluating for adverse events clinically and by parent report of adverse event every week during the first 20 weeks of the study, also by blood work at weeks 0, 4, and between 8-16 weeks.; For those choose to continue the study drug after 20 week period of assessment, tolerance will be evaluated by assessing for adverse events at weeks 28, 40,52 and 64.	20-64 weeks
Primary	Establishment of tolerability of TIL-TC150 by standardised side effects questionnaire -pediatric epilepsy side effects questionnaire (PESQ)	During this study, tolerance will also be assessed by the standardised side effects questionnaire- PESQ in clinic at weeks 2,4,8,12 and 16. For those choosing to continue therapy will be reassessed by PESQ in clinic at week 28,40,52 and 64.	16-64 weeks
Secondary	The impact of therapy on quality of life using the Quality of Life in Childhood Epilepsy (QOLCE) questionnaire	The QOLCE will be completed by parents at clinic at first visit or baseline(week 0), at maximal dose (8 weeks) and at 16 weeks for primary analysis. For those choosing to continue therapy will be reassessed at 28 weeks and 52 weeks. Parents will be provided with a research report detailing the assessment findings at study completion.	16-52 weeks
Secondary	The impact of therapy on everyday behaviours using the Vineland Adaptive Behavior Scales, Second Edition.	Vineland Adaptive Behaviour Scale, Second Edition: is a standardized parent interview to complete either in person at the clinic or by telephone on week 0, prior to starting the TIL-TC150. The interview will also be completed again at the primary evaluation period anytime between weeks 16 and 20 and again for those choosing to continue the therapy will be reassessed during the longitudinal follow-up anytime between 52 and 64 weeks. This will be done by study team. Parents will be provided with a research report detailing the assessment findings at study completion.	20-64 weeks
Secondary	change in seizure frequency from baseline		20 weeks

External Links

•   Research Article: A prospective open-label trial of a CBD/THC cannabis oil in dravet syndrome