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Trial record 28 of 56 for:    insys

Expanded Use of Cannabidiol Oral Solution

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ClinicalTrials.gov Identifier: NCT03196934
Expanded Access Status : Available
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Steven Phillips, MultiCare Health System Research Institute

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

Condition or disease Intervention/treatment
Refractory Epilepsy Drug: 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.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196934


Contacts
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Contact: Stacie Rebar 253-403-7251 stacie.rebar@multicare.org
Contact: Cassidy Canorro 253-403-9348 cassidy.canorro@multicare.org

Sponsors and Collaborators
Steven Phillips

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Responsible Party: Steven Phillips, Pediatric Neurologist, MultiCare Health System Research Institute
ClinicalTrials.gov Identifier: NCT03196934     History of Changes
Other Study ID Numbers: MulticareHSRI
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Drug Resistant Epilepsy
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pharmaceutical Solutions
Epidiolex
Anticonvulsants