NCT02397863

Epidiolex and Drug Resistant Epilepsy in Children

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

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2019-12-01
• Completion: 2020-01-01
• First posted: 2015-03-25
• Last updated: 2015-04-24

Locations

1 site across 1 country: United States