ZX008-1900
ZX008-1900
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients with Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
Brief summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathyMedical Condition
Dravet Syndrome
Min. Age
2
Years
Max. Age
-
Who Can Join?
All
Status
Active, not recruiting
Inclusion criteria
- Male or nonpregnant, nonlactating female
- Satisfactory completion of a core study
- Has a rare seizure disorder, such as epileptic encephalopathy and has successfully completed another Zogenix-sponsored clinical trials with ZX008
- Subject’s caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability
Exclusion criteria
- Current cardiac valvulopathy or pulmonary hypertension that is clinically significant
- Moderate or severe hepatic impairment
- Receiving monoamine oxidase inhibitors, serotonin agonists, serotonin antagonists, and serotonin reuptake inhibitors within 14 days of receiving ZX008
-
Study Medication Description
Study Medication:
N/A
Other Descriptive Name:
N/A
Placebo
No
Comparator:
No
Refer to a friend
Study Dates
April 2019
Actual Start Date of Enrollment
July 2025
Planned Study Completion Date
General Information
Study ID:
ZX008-1900
EudraCT Number:
2019-001331-31
CT.gov Number:
NCT03936777
Phase:
Phase 3