Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures

Summary

The primary purpose of this study is to assess the efficacy of Cannabidiol Oral Solution in the treatment of pediatric participants with treatment-resistant childhood absence seizures. This study will also assess safety, tolerability and pharmacokinetics of Cannabidiol Oral Solution, and any improvement in qualitative assessments of participant status over the duration of the study in pediatric participants with treatment-resistant childhood absence seizures. The study will include a 4-week Screening Period, a 5 or 10 day Titration Period (depending study Cohort), a 4-week Treatment Period followed by 5-day Tapering for doses \>20 mg/kg/day and a 4-week Follow-up Period.

Timeline

Start

2017-12-29

Primary completion

2019-05-15

Completion

2019-05-29

Outcome

Outcome not reported

Stopped (Enrollment): “More patients in Cohort 1 than Cohort 2 demonstrated a clinically meaningful reduction of seizure count. Given this, enrollment of Cohort 3 was discontinued.”

Drugs

Indications