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Completed Phase 1 Interventional

Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy

ClinicalTrials.gov ID: NCT02286986

Public ClinicalTrials.gov record NCT02286986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 9:49 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 2-part Study to Investigate the Dose-ranging Pharmacokinetics and Tolerability, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P compared with placebo with respect to: * Incidence, type and severity of adverse events (AEs) * Effect on vital signs, including weight * Effect on 12-lead electrocardiogram (ECG) findings * Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive seizures * To determine the plasma concentration time curves for GWP42003-P and its major human metabolite, following escalating multiple doses of GWP42003-P. * To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant anti-epileptic drugs (AEDs). * To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking GWP42003-P in combination with AEDs.

Study identification

NCT ID
NCT02286986
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
University of Utah
Other
Enrollment
26 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
2 Years to 25 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 17, 2014
Primary completion
Jun 12, 2019
Completion
Jun 12, 2019
Last update posted
Jan 26, 2020

2014 – 2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Utah School of Medicine Salt Lake City Utah 84113

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02286986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 26, 2020 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02286986 live on ClinicalTrials.gov.

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