NCT02286986

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4.7 years

First QC Date

May 14, 2014

Last Update Submit

January 24, 2020

Conditions

Epilepsy

Keywords

EpilepsyDravet syndromeSeizuresIntractable EpilepsyMedically Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Seizure Frequency

    Number of Seizures

    Baseline to 1 year

Secondary Outcomes (1)

  • Drug Plasma Levels of Cannabidiol

    Baseline, 8 weeks, 6 months

Study Arms (1)

Cannabidiol

OTHER

open label administration

Drug: Cannabidiol

Interventions

CannabidiolDRUG
Cannabidiol

Eligibility Criteria

Age2 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Documentation of a diagnosis of drug resistant epilepsy as evidenced by failure to control siezures despite appropriate trial of four or more Anti-Epileptic Drugs at therapeutic doses. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome (if possible), as well as the underlying case, when known.
  • Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator, ketogenic diet and modified Atkins diet do not count toward this limit.
  • Vagus nerve stimulator must be on stable settings for a minimum of 3 months.
  • Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.

You may not qualify if:

  • Treatment with any artisanal preparation containing or possible containing CBD during the month before initiation of the study drug.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah School of Medicine

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

EpilepsyEpilepsies, MyoclonicSeizuresDrug Resistant Epilepsy

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsy, GeneralizedEpileptic SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Francis Filloux, MD

    University of Utah

    PRINCIPAL INVESTIGATOR

  • Mathew Sweeney, MD

    University of Utah

    STUDY DIRECTOR

  • Colin VanOrman, MD

    University of Utah

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Masking Details
open label
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Francis M. Filloux, M.D. Division Chief, Pediatric Neurology University of Utah School of Medicine

Study Record Dates

First Submitted

May 14, 2014

First Posted

November 10, 2014

Study Start

September 18, 2014

Primary Completion

June 13, 2019

Study Completion

June 13, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)