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 |
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).
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
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Miami Children's Hospital Welcome to Miami Children
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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505 Parnassus Ave
San Francisco, California 94143
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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