Clareo Health | A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With Dravet Syndrome or Lennox Gastaut Syndrome Currently Taking Cannabidiol
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Age
2–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has a clinical diagnosis of DS or LGS, where convulsive seizures (generalized tonic clonic seizures, tonic seizures, atonic seizures, tonic/atonic seizures, focal seizures with clear observable motor signs) are not completely controlled by current AEDs.
All medications or interventions for epilepsy (including ketogenic diet \[KD\] and vagal nerve stimulation \[VNS\]) must be stable for at least 4 weeks prior to first ZX008 dose and are expected to remain stable throughout the study.
Subjects must be taking a stable dose of CBD for at least 4 weeks prior to first ZX008 dose.
Subject's source of CBD is expected to be consistent for at least 3 months during study participation.
You may not be if
Subject has current or past history of cardiovascular or cerebrovascular disease, myocardial infarction or stroke.
Subject with current cardiac valvulopathy or pulmonary hypertension that the Investigator, parent/caregiver, Independent Cardiac Advisory Board, Independent Data and Safety Monitoring Committee, or sponsor deems clinically significant.
Subject has a current or past history of glaucoma.
