Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:1 - 18
Updated:7/27/2018
Start Date:January 8, 2016
End Date:June 22, 2017

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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

This is a multicenter, open-label trial to assess the long-term safety and efficacy of
Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with
treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet
syndrome (DS). All participants have rolled over from previous trials: INS011-14-029
(NCT02324673) and INS011-15-054 (NCT02551731).


Inclusion Criteria:

- Completed activities through Day 11 in INS011-14-029 or Part A (Visit 6) INS011-15-054

- Informed consent/assent (as applicable) was voluntarily provided by the participant
and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and
local requirements

- Is medically stable with no anticipated changes in chronic medications in the opinion
of the Investigator

- Continues to meet protocol-specified criteria for qualification and contraception,
including treatment-resistant seizure disorder

- In the opinion of the Investigator, the subject and/or parent(s)/caregiver(s) are able
to continue keeping accurate seizure diaries

Exclusion Criteria:

- Inadequate supervision by parent(s)/caregiver(s)

- History or current use of dietary supplements, drugs or over-the counter medications
outside protocol-specified parameters

- Signs, symptoms or history of any condition that, per protocol or in the opinion of
the investigator, might compromise:

1. the safety or well-being of the participant or study staff

2. the safety or well-being of the participant's offspring (such as through
pregnancy or breast-feeding)

3. the analysis of results
We found this trial at
11
sites
Riverton, Utah 84096
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3100 SW 62nd Ave
Miami, Florida 33155
(305) 666-6511
Miami Children's Hospital Welcome to Miami Children
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Miami, FL
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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Dallas, TX
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Las Vegas, Nevada 89104
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Las Vegas, NV
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Memphis, Tennessee 38103
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Memphis, TN
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Pensacola, Florida 32504
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Pensacola, FL
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Portland, Oregon 97239
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Portland, OR
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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San Francisco, CA
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Tacoma, Washington 98405
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Tacoma, WA
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