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Cannabidiol Oral Solution in Pediatric Subjects With Treatment- Resistant Seizure Disorders

Seizures Clinical Trial

Official title:
A Phase 1/2 Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Pharmaceutical Cannabidiol Oral Solution in Pediatric Subjects With Treatment- Resistant Seizure Disorders

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02324673
Study type Interventional
Source INSYS Therapeutics Inc
Contact
Status Completed
Phase Phase 1/Phase 2
Start date April 2015
Completion date May 2016
View Details
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