This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3 antiepileptic drugs (AEDs) and who meet inclusion/exclusion criteria. Following a 28-day baseline period, participants will begin an 84-day treatment period. Participants will be assigned to receive twice daily doses of placebo or cannabidiol oral solution at the highest dose determined to be safe in a previous trial. Following study completion, all participants will be invited to receive Cannabidiol Oral Solution in an open label extension study (under a separate protocol).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
A matching oral solution containing no cannabidiol.
Percent change from baseline in the frequency of motor seizures involving the trunk or extremities [tonic, atonic, generalized tonic-clonic (GTC), focal seizures with motor components (FSMC)]
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Percent change from baseline in severity of motor seizures involving the trunk or extremities (tonic, clonic, GTC, FSMC)
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Percent change from baseline in frequency of all seizure activity independent of seizure type
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Percent change from baseline in the severity of all seizure activity independent of seizure type
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Percent change from baseline in the duration of all seizure activity independent of seizure type
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Improvement (CGI-I)
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Change from baseline in Investigator CGI-I
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Change from baseline in parent(s)/caregiver(s) Clinical Global Impressions of Severity (CGI-S)
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Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12
Change from baseline in Investigator CGI-S
Time frame: Data point for observation period to data point for treatment period Weeks 9 through 12