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
1 other identifier
expanded_access
N/A
0 countries
N/A
Brief Summary
To allow subjects who have completed Insys 030 extension study to continue to take Cannabidiol oral solution.
Trial Health
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedFebruary 2, 2024
January 1, 2024
March 21, 2017
January 31, 2024
Conditions
Interventions
Cannabidiol; Pharmacological class of drug
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Failure to follow study procedures in Insys 030
- Pregnant females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2017
First Posted
June 23, 2017
Last Updated
February 2, 2024
Record last verified: 2024-01