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

NCT03336242 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-07-21

Study results available
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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

DRUG

Cannabidiol Oral Solution

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

Sponsors & Collaborators

  • Radius Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Ahmed Elkashef, MD · INSYS Therapeutics Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-29
Primary Completion
2019-05-15
Completion
2019-05-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336242 on ClinicalTrials.gov