Epidiolex and Drug Resistant Epilepsy in Children

NCT ID: NCT02397863

Last Updated: 2015-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2014-12-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This open-label, multi-center study is open to patients 1 to 18 years of age at time of enrollment with medication resistant epilepsy. The study consists of an 8 week baseline, titration, and treatment of Epidiolex in a daily dosage up to 25 mg/kg/day, with an optional secondary titration schedule after 26 weeks of treatment up to a maximal daily dosage up to 50 m/kg/day until End of Treatment, followed by a taper-down period, and a safety follow up. Treatment will be provided for a total of 52 weeks with an interim analysis conducted 12 weeks after achieving maximal dose (either 25 mg/kg/day or optimal dose with regards to safety and tolerability) and at the end of 1 year of treatment with treatment extensions conducted beyond 52 weeks until such time as there is market authorization for Epidiolex, if Epidiolex becomes unavailable, or the study is terminated. Cessation of Epidiolex administration will be concluded with a taper period and follow-up visit 4 weeks after the taper.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cannabidiol (Epidiolex)

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Epidiolex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

State of Georgia

UNKNOWN

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yong Park

Professor Child Neurology, Professor Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yong D Park, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgia Regents University

Augusta, Georgia, United States

Site Status AVAILABLE

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yong D Park, MD

Role: CONTACT

706-721-3371

GRU Clinical Trials Office

Role: CONTACT

706-721-9680

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yong D Park, MD

Role: primary

706-721-3371

GRU Clinical Trials Office

Role: backup

706-721-9680

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CBD02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Expanded Use of Cannabidiol Oral Solution
NCT03196934 NO_LONGER_AVAILABLE
Epidiolex in Typical Absence Seizures
NCT04899050 COMPLETED PHASE4