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Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders

NCT02324673 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2017-06-23

Study results available
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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.

Conditions

Interventions

DRUG

Cannabidiol Oral Solution

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

Sponsors & Collaborators

  • INSYS Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Neha Parikh · INSYS Therapeutics Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-13
Primary Completion
2016-05-09
Completion
2016-05-09

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02324673 on ClinicalTrials.gov