FindTrial
Sign In

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT03196934
Enrollment
Unknown
Registered
2017-06-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy

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.

Interventions

DRUGCannabidiol oral solution

Cannabidiol; Pharmacological class of drug

Sponsors

MultiCare Health System Research Institute
Lead SponsorOTHER

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026