Phase 3
N=52
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Seizures
Bottom Line
View on ClinicalTrials.gov: NCT02318602 ↗Enrolled (actual)
52
Serious AEs
32.7%
Results posted
Jul 2018
Primary outcome: Primary: Percentage of Participants With Adverse Events — 88.9; 92.3; 88.2; 90.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cannabidiol Oral Solution (Drug)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- INSYS Therapeutics Inc
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events |
88.9; 92.3; 88.2; 90.4 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events |
77.8; 38.5; 0; 32.7 | — |
| PRIMARY Percentage of Participants With Clinically Significant Change From Baseline in Laboratory Values |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings |
0; 0; 0 | — |
| PRIMARY Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs |
0; 0; 0 | — |
| PRIMARY Change From Baseline in Trough Plasma Levels of Cannabidiol and Its 7-OH Metabolite |
— | — |
| SECONDARY Vineland Adaptive Behavior Scales (VABS) |
6.8; 40.4; 40.3; 8.3; 51.7; 36.0 | — |
| SECONDARY Number of Participants With a Positive Response on the Columbia-Suicide Severity Rating Scale (C-SSRS) |
0; 0; 0; 0; 0; 0 | — |
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).
Eligibility 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:
- the safety or well-being of the participant or study staff
- the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
- the analysis of results
Data sourced from ClinicalTrials.gov (NCT02318602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.