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
NCT ID: NCT03467113
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
9 participants
INTERVENTIONAL
2018-01-19
2020-06-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ZX008 0.2 to 0.8 mg/kg/day
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)
ZX008 0.2 to 0.8 mg/kg/day
ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.
Cannabidiol
Cannabidiol
Interventions
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ZX008 0.2 to 0.8 mg/kg/day
ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.
Cannabidiol
Cannabidiol
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
2 Years
18 Years
ALL
No
Sponsors
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Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
INDUSTRY
Responsible Party
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Locations
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PANDA Neurology/CIRCA
Atlanta, Georgia, United States
MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
Countries
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Other Identifiers
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ZX008-1602
Identifier Type: -
Identifier Source: org_study_id