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NCT03196934 Clinical Trial

Expanded Use of Cannabidiol Oral Solution

Refractory Epilepsy Clinical Trial

Official title:
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

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT03196934
Other study ID # MulticareHSRI
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date January 2024
Source MultiCare Health System Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cannabidiol oral solution
Cannabidiol; Pharmacological class of drug

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
MultiCare Health System Research Institute
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