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ClinicalTrials.gov Identifier: NCT03196934
Expanded Access Status :
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Information provided by (Responsible Party):
Steven Phillips, MultiCare Health System Research Institute
To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.
Condition or disease
Drug: 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.
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
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Layout table for eligibility information
Ages Eligible for Study:
1 Year to 18 Years (Child, Adult)
Sexes Eligible for Study:
Completed the Insys 030 protocol
Compliant in drug study procedures
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