NCT02397863

Brief Summary

This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 24, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

March 19, 2015

Last Update Submit

April 23, 2015

Conditions

Epilepsy

Interventions

Cannabidiol (Epidiolex)DRUG

Daily dosage up to 25 mg/kg/day with an optional up titration to a maximal daily dosage up to 50 m/kg/day until End of Treatment.

Also known as: Epidiolex

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient should have history of trying at least four antiepileptic drugs (AEDs), including one trial of a combination of two concomitant drugs, without successful seizure control. Vagal nerve stimulation, RNS deep brain stimulation, or the ketogenic diet can be considered equivalent to a drug trial.
  • Patient must be taking two or more AEDs at a dose which has been stable for at least four weeks.
  • A State of Georgia resident.

You may not qualify if:

  • Patient is diagnosed as having Dravet Syndrome or Lennox-Gastaut Syndrome and eligible for a GW Pharmaceutical-Sponsored Clinical Trial.
  • Patients who have been part of a clinical trial involving another investigational product in the previous six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Regents University

Augusta, Georgia, 30912, United States

AVAILABLE

MeSH Terms

Conditions

Epilepsy

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Yong D Park, MD

    Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong D Park, MD

CONTACT

706-721-3371ypark@gru.edu

GRU Clinical Trials Office

CONTACT

706-721-9680ctscto@gru.edu

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Child Neurology, Professor Pediatrics

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 25, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

April 24, 2015

Record last verified: 2015-04

Locations

US(1)