Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2017-02-02
2021-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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treatment
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Without clinically-apparent seizures
* Currently taking any Cannabinoid products.
1 Year
18 Years
ALL
No
Sponsors
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Tilray
INDUSTRY
The Hospital for Sick Children
OTHER
Responsible Party
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Carter Snead
Principal Investigator
Principal Investigators
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Blathnaid McCoy, MB BCh BAO
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1000047417
Identifier Type: -
Identifier Source: org_study_id