Expanded Use of Cannabidiol Oral Solution

A Multicenter, Open-label, Flexible Dose Study to Assess the Long-term Safety of Pharmaceutical Cannabidiol Oral Solution as an Adjunctive Treatment for Pediatric Subjects With a Treatment-resistant Seizure Disorder Who Complete INS011-14-029 or Part A of INS011-15-054

NCT03196934•MultiCare Health System Research Institute

View on ClinicalTrials.gov

Summary

To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.

Detailed Description

To allow subjects who have completed Insys 030 extension study (A multicenter, open-label, flexible dose study to assess the long-term safety of pharmaceutical Cannabidiol Oral Solution as an adjunctive treatment for pediatric subjects with a treatment-resistant seizure disorder who complete INS011-14-029 or Part A of INS011-15-054) to continue to take Cannabidiol oral solution.

Eligibility

Age

1 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Completed the Insys 030 protocol
•2. Compliant in drug study procedures
•3. Non-pregnant females of child bearing age, willing to utilize a double-barrier method of birth control during treatment and for 30 days after treatment has ended

Exclusion Criteria

•1. Failure to follow study procedures in Insys 030
•2. Pregnant females

Key Dates

Last Updated

February 2, 2024

Conditions

Refractory Epilepsy

Interventions

Cannabidiol oral solution

DRUG

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

NCT06425029

EpilepsyRefractory Epilepsy+1 more

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RECRUITINGNA

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

NCT06304389

Refractory Epilepsy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Expanded Use of Cannabidiol Oral Solution

Inclusion Criteria

Exclusion Criteria

Self-administered ONe-of-a Kind Approach to Epilepsy Therapy Through a Web-based Music Application

Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy

The Efficacy of a Subanesthetic Doses of IV Ketamine in the Treatment Drug Resistant Epilepsy

Optimal Stimulation Parameters to Disrupt Epileptiform Activity

Localization of the Reward Positivity to ACC

The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy