Expanded Use of Cannabidiol Oral Solution

MultiCare Health System Research Institute

Status

Conditions: Refractory Epilepsy

Treatments: Drug: Cannabidiol oral solution

Study type: Expanded Access

Funder types: Other

Identifiers

NCT03196934

MulticareHSRI

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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