Expanded Use of Cannabidiol Oral Solution

NCT ID: NCT03196934

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: NO_LONGER_AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Refractory Epilepsy

Interventions

Cannabidiol oral solution

Cannabidiol; Pharmacological class of drug

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MultiCare Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MulticareHSRI

Identifier Type: -

Identifier Source: org_study_id