CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Cannabidiol Oral Solutiondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02318602
NCT02318602Phase 3Completed
CompareCT.gov

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

INSYS Therapeutics Inc·interventional·Posted Dec 17, 2014·Updated Jul 26, 2018

In Brief

A Phase 3 clinical trial evaluating Cannabidiol Oral Solution for Seizures. Completed, enrolled 52 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 17, 2014
Enrollment StartJan 8, 2016
Primary CompletionJun 22, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.5 years ago

Interventions

Cannabidiol Oral Solutiondrug

An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).