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

NCT02286986 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2020-01-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cannabidiol

Sponsors & Collaborators

Principal Investigators

  • Francis Filloux, MD · University of Utah

  • Mathew Sweeney, MD · University of Utah

  • Colin VanOrman, MD · University of Utah

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-18
Primary Completion
2019-06-13
Completion
2019-06-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286986 on ClinicalTrials.gov