At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 61 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.
A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Seizure Disorders
In Brief
A Phase 2 clinical trial evaluating Cannabidiol Oral Solution for Seizures. Completed, enrolled 61 participants across 10 sites.
Detailed Summary
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion. Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeizures
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 2014
Enrollment StartApr 2015
Primary CompletionMay 2016
TodayJul 2026
First PostedDec 24, 2014
Enrollment StartApr 13, 2015
Primary CompletionMay 9, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 11.5 years ago
Interventions
Cannabidiol Oral Solutiondrug
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).