Cannabinoid Therapy for Pediatric Epilepsy

The Hospital for Sick Children

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: TIL-TC150

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02983695

1000047417

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment

Experimental group

Description:

all participants will be in this arm and will receive study drug 'Cannabidiol-Rich whole Plant Extract (TIL-TC150) to assess dosing and tolerability according to study protocol.TIL-TC150 Oil is the study product The active ingredients in TIL-TC150 Oil are THC and CBD, present in a 1:50 ratio. These active ingredients are derived from Cannabis sativa L. strains produced by Tilray, and suspended in a grape seed oil. This suspension is administered at a dose of 2mg/kg/day CBD divided BID and titrated up to a maximal dose of 16mg/kg/day CBD (or maximal tolerated).

Treatment:

Drug: TIL-TC150