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Sponsor elected not to continue with study.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabidiol Oral Solution | Experimental | Participants will receive cannabidiol oral solution at an appropriate dose (no higher than 40 mg/kg/day) determined by data from a previous trial. The total daily dose will be administered in twice daily doses, approximately 12 hours apart. |
|
| Placebo Solution | Placebo Comparator | Participants will receive matching placebo solution administered twice daily, approximately 12 hours apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oral Solution | Drug | An oral solution containing pharmaceutical grade cannabidiol (nonplant-based). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)] | Data point for observation period to data point for treatment period Weeks 9 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in severity of motor seizures involving the trunk or extremities (tonic, clonic, GTC, FSMC) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neha Parikh | INSYS Therapeutics Inc | Study Director |
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| ID | Term |
|---|---|
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D000073376 | Epileptic Syndromes |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Placebo Solution | Drug | A matching oral solution containing no cannabidiol. |
|
| 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 | 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 | 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) | Data point for observation period to data point for treatment period Weeks 9 through 12 |
| Change from baseline in Investigator CGI-I | 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) | Data point for observation period to data point for treatment period Weeks 9 through 12 |
| Change from baseline in Investigator CGI-S | Data point for observation period to data point for treatment period Weeks 9 through 12 |
| D009422 |
| Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |