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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.
Cannabidiol
PANDA Neurology/CIRCA
Atlanta, Georgia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Adverse Events
Number of adverse events including serious adverse events, number of adverse events leading to study withdrawal
Time frame: Baseline to Day 365
Change in Heart Rate
Change in resting heart rate using standard measures
Time frame: Baseline to Day 365
Change in blood pressure
Change in resting blood pressure using standard measures
Time frame: Baseline to Day 365
Change in temperature
Change in resting temperature using standard measures
Time frame: Baseline to Day 365
Change in respiratory rate
Change in resting respiratory rate using standard measures
Time frame: Baseline to Day 365
Changes in heart rhythm
Changes in heart beat as measured with 12-lead electrocardiogram
Time frame: Baseline to Day 365
Changes in heart valve function
Changes in heart valves as measured with standard echocardiogram
Time frame: 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
Time frame: Baseline to Day 365
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