seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Dravet syndrome and Lennox-Gastaut syndrome seizures
Conditions
Interventions
Participation for subjects will be up to 36 months or until ZX008 is approved
in a subject*s country of residence and listed on a patient*s health plan
formulary, whichever occurs first.
Sponsors
Zogenix International Limited
Eligibility
Age
2 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject is currently enrolled in core Study ZX008-1503 ORSubject has successfully completed core Study ZX008-1601-Part 2 OR Subject with a rare seizure disorder, such as epileptic encephalopathy, that has successfully completed another Zogenix-sponsored clinical trial with ZX008, and has been invited to participate in this study by the Sponsor. 2. Subjects must, in the medical opinion of the Investigator, be candidates for continued treatment for an extended period of time with ZX008 (ie, subject has demonstrated a clinically meaningful benefit with ZX008 in the prior trial, and benefits of continued treatment outweigh potential risks). 3. Subject is male or a nonpregnant, nonlactating female. Female subjects of childbearing potential must not be pregnant or breast-feeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study entry. Subjects of childbearing or child-fathering potential must be willing to use medically acceptable forms of birth control, which includes abstinence, while being treated on this study and for 90 days after the last dose of study drug. 4. Subject has been informed of the nature of the study and informed consent has been obtained from the legally responsible parent/guardian. 5. Subject has provided assent in accordance with Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements, if capable. 6. Subject*s caregiver is willing and able to be compliant with study procedures, visit schedule and study drug accountability.
Exclusion criteria
Exclusion criteria: 1. Subject has a known hypersensitivity to fenfluramine or any of the excipients in the study medication. 2. Subject has current cardiac valvulopathy or pulmonary hypertension that the investigator, ICAB, IDSMC, or Sponsor deems reason for exclusion. 3. Subject is at imminent risk of self-harm or harm to others, in the investigator*s opinion, based on clinical interview and responses provided on the Columbia-Suicide Severity Rating Scale (C-SSRS). Subjects must be excluded if they report suicidal behavior as measured by the C SSRS Since Last Visit, which includes suicidal ideation with intent and plan (Item #5). If a subject reports suicidal ideation on Item 4 without specific plan, and the investigator feels that the subject is appropriate for the study considering the potential risks, the investigator must document appropriateness for inclusion, and discuss with the parent/caregiver to be alert to mood or behavioral changes, especially around times of dose adjustment. 4. Subject has moderate or severe hepatic impairment. Asymptomatic subjects with mild hepatic impairment (elevated liver enzymes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is: • To assess the long-term safety and tolerability of ZX008 | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of the study are: • To assess the effect of ZX008 on the following effectiveness measures: - Investigator assessment of convulsive seizure response (=25%, >=50%, >=75%, or 100% [ie, seizure-free] improvement) - Clinical Global Impression - Improvement (CGI-I) rating, as assessed by the investigator - CGI-I rating, as assessed by the parent/caregiver - Symptomatic CGI-I for cognition, behavior, motor abilities, as assessed by the investigator - Symptomatic CGI-I for cognition, behavior, motor abilities, as assessed by the parent/caregiver | — |
Countries
Netherlands
Outcome results
None listed