Epidiolex and Drug Resistant Epilepsy in Children

Epilepsy Clinical Trial

— CBD  

Official title:

An Open Label, Multi-Center Study to Investigate the Safety of Cannabinoid (GWP42003-P) in Children With Medication Resistant Epilepsy

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02397863
• Other study ID #: CBD02
• Status: Available
• Phase: N/A
• First received: March 19, 2015
• Last updated: April 23, 2015
• Start date: December 2014
• Est. completion date: January 2020

Study information

• Verified date: April 2015
• Source: Georgia Regents University
• Contact: Yong D Park, MD
• Phone: 706-721-3371
• Email: ypark[@]gru.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Georgia Regents University	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Regents University	State of Georgia

Country where clinical trial is conducted

United States,