Expanded Use of Cannabidiol Oral Solution

N/ANo Longer AvailableNCT03196934

MultiCare Health System Research Institute

Overview

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

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.

Study Type

EXPANDED_ACCESS

Conditions

Refractory Epilepsy

Interventions

Cannabidiol oral solutionDRUG

Cannabidiol; Pharmacological class of drug

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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