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An extension study to learn about the long-term safety of fenfluramine hydrochloride for seizures in children and adults with rare seizure disorders such as epileptic encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
EU CTIS ID: 2024-515680-61-00
What this study is testing
To assess the long-term safety and tolerability of ZX008
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • 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
You likely can't join if
- • Current cardiac valvulopathy or pulmonary hypertension that is clinically significant • Moderate or severe hepatic impairment • Receiving prohibited medication (please see protocol section 5.6.2) within 14 days of receiving ZX008
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Canada
- Australia
- United States
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Canada; Australia; United States; Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.