Status:
COMPLETED
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
Lead Sponsor:
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Conditions:
Dravet Syndrome
Lennox Gastaut Syndrome
Eligibility:
All Genders
2-18 years
Phase:
PHASE1
Brief Summary
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).
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 24 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03467113
Start Date
January 19 2018
End Date
June 24 2020
Last Update
December 1 2023
Active Locations (2)
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1
PANDA Neurology/CIRCA
Atlanta, Georgia, United States, 30328
2
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States, 98405