NCT02318602

Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder

A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: INSYS Therapeutics Inc · Industry
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label trial to assess the long-term safety and efficacy of Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS). All participants have rolled over from previous trials: INS011-14-029 (NCT02324673) and INS011-15-054 (NCT02551731).

Conditions

• Seizures

Interventions

Type	Name	Description
DRUG	Cannabidiol Oral Solution	An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Timeline

• Start date: 2016-01-08
• Primary completion: 2017-06-22
• Completion: 2017-06-22
• First posted: 2014-12-17
• Last updated: 2018-07-26
• Results posted: 2018-07-26

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study