Overview
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Status:
Completed
Completed
Trial end date:
2017-06-22
2017-06-22
Target enrollment:
0
0
Participant gender:
All
All
Summary
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
INSYS Therapeutics IncTreatments:
Cannabidiol
Pharmaceutical Solutions
Criteria
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