NCT02318537

Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome

A Multicenter, Randomized, Double-blind, Placebo-controlled, Interventional Study to Assess the Safety and Efficacy of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Subjects With Inadequately Controlled Lennox-Gastaut Syndrome

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 2 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet inclusion/exclusion criteria. Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial. Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).

Conditions

• Lennox-Gastaut Syndrome

Interventions

Type	Name	Description
DRUG	Cannabidiol Oral Solution	An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
DRUG	Placebo Solution	A matching oral solution containing no cannabidiol.

Timeline

• Start date: 2017-12-30
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2014-12-17
• Last updated: 2018-01-04

Regulatory

• FDA-regulated drug study