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Clinical Trials/NCT03196934
NCT03196934No Longer AvailableNot Applicable

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

MultiCare Health System Research Institute0 sitesStarted: June 23, 2017Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
No Longer Available
Sponsor
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
1 Year to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Failure to follow study procedures in Insys 030
  • •Pregnant females

Investigators

Sponsor
MultiCare Health System Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

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