NCT03336242

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

A Phase 2, Open-label, Dose-finding Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Patients With Treatment-Resistant Childhood Absence Seizures

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Radius Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Childhood Absence Epilepsy

Interventions

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

Timeline

• Start date: 2017-12-29
• Primary completion: 2019-05-15
• Completion: 2019-05-29
• First posted: 2017-11-08
• Last updated: 2023-07-21
• Results posted: 2023-07-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study