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This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX008 0.2 to 0.8 mg/kg/day | Experimental | ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will receive open-label ZX008 (flexible dosing 0.2 mg/kg/day to 0.8 mg/kg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX008 0.2 to 0.8 mg/kg/day | Drug | ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Number of adverse events including serious adverse events, number of adverse events leading to study withdrawal | Baseline to Day 365 |
| Change in Heart Rate | Change in resting heart rate using standard measures | Baseline to Day 365 |
| Change in blood pressure | Change in resting blood pressure using standard measures | Baseline to Day 365 |
| Change in temperature | Change in resting temperature using standard measures | Baseline to Day 365 |
| Change in respiratory rate | Change in resting respiratory rate using standard measures | Baseline to Day 365 |
| Changes in heart rhythm | Changes in heart beat as measured with 12-lead electrocardiogram | Baseline to Day 365 |
| Changes in heart valve function | Changes in heart valves as measured with standard echocardiogram | Baseline to Day 365 |
| Changes in treatment-emergent body weight and height | Changes in body weight and height by report of BMI in kg/m^2 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PANDA Neurology/CIRCA | Atlanta | Georgia | 30328 | United States | ||
| MultiCare Institute for Research & Innovation |
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| Cannabidiol | Drug | Cannabidiol |
|
| Baseline to Day 365 |
| Tacoma |
| Washington |
| 98405 |
| United States |
| ID | Term |
|---|---|
| D004831 | Epilepsies, Myoclonic |
| D065768 | Lennox Gastaut Syndrome |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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