search
Back to results

Expanded Use of Cannabidiol Oral Solution

Primary Purpose

Refractory Epilepsy

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Cannabidiol oral solution
Sponsored by
Steven Phillips
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Refractory Epilepsy

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All Sexes

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2017
    Last Updated
    December 11, 2019
    Sponsor
    Steven Phillips
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03196934
    Brief Title
    Expanded Use of Cannabidiol Oral Solution
    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
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Steven Phillips

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Refractory Epilepsy

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Cannabidiol oral solution
    Intervention Description
    Cannabidiol; Pharmacological class of drug

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Failure to follow study procedures in Insys 030 Pregnant females
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stacie Rebar
    Phone
    253-403-7251
    Email
    stacie.rebar@multicare.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cassidy Canorro
    Phone
    253-403-9348
    Email
    cassidy.canorro@multicare.org

    12. IPD Sharing Statement

    Learn more about this trial

    Expanded Use of Cannabidiol Oral Solution

    We'll reach out to this number within 24 hrs