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

Childhood Absence Epilepsy Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03336242
Study type	Interventional
Source	Radius Pharmaceuticals, Inc.
Contact
Status	Terminated
Phase	Phase 2
Start date	December 29, 2017
Completion date	May 29, 2019

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See also
Status	Clinical Trial	Phase
Completed	`NCT00393666` - Why Are Patients With Absence Seizures Absent? A Brain Imaging Study	N/A
Terminated	`NCT06153186` - Flunarizine for Treatment Resistant Absence Epilepsy	Phase 2
Enrolling by invitation	`NCT05109234` - A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy	Phase 3
Not yet recruiting	`NCT06315322` - A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy	Phase 3
Recruiting	`NCT04666610` - A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy	Phase 3
Completed	`NCT00088452` - Childhood Absence Epilepsy Rx PK-PD-Pharmacogenetics Study	Phase 3
Terminated	`NCT03355300` - Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Pediatric Participants With Treatment-Resistant Childhood Absence Seizures	Phase 2
Completed	`NCT00361010` - A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy	N/A
Completed	`NCT00041951` - Search for Genes Influencing Childhood Absence Epilepsy (CAE) Study	N/A
Recruiting	`NCT06310772` - Assessing Comorbidities in Epilepsy Using Eye Movement Recordings