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
This clinical trial is designed to understand the long-term safety of a medicine called Fintepla oral solution. It's being studied as an additional treatment for seizures in adults who have rare types of epilepsy, specifically Dravet syndrome or Lennox-Gastaut syndrome. Participants in this study would have already used Fintepla in a previous trial. The main goal is to carefully check for any side effects and how the medicine affects the body over a longer period. This includes regular checks of blood tests, heart health, body weight, and general health examinations. The study also looks at how well the medicine might help to reduce seizures. This kind of research helps doctors understand how to best use new treatments safely and effectively for people living with these challenging conditions.
At a glance
What is this study about?
This study is a continuation for people who have previously taken Fintepla oral solution for their seizures. It's designed to gather more information about how safe Fintepla is when used over a long period. The study focuses on two specific types of epilepsy: Dravet syndrome and Lennox-Gastaut syndrome, which are rare and often severe forms of epilepsy.
Because these conditions are challenging to treat, new medicines are always being researched. This trial helps doctors understand if Fintepla remains safe and well-tolerated when taken for an extended time. This information is really important because it helps healthcare professionals make the best decisions about treating people with these conditions.
The study will involve careful monitoring of participants' health to ensure any potential issues are identified quickly. By continuing to gather data on long-term safety, researchers can build a more complete picture of Fintepla's overall profile, which is vital for its use in patient care.
Key takeaways
- This study investigates the long-term safety of Fintepla oral solution.
- It's for adults with Dravet syndrome or Lennox-Gastaut syndrome who previously used Fintepla.
- Participation involves regular checks of your general health and heart health.
- The study aims to understand how safe the medicine is over an extended period.
- It's an 'open-label' study, meaning everyone knows what medicine is being given.
Who may be eligible?
This study is looking for adults aged 18 years and older. Both men and women can take part.
To be eligible, you must have been diagnosed with either Dravet syndrome or Lennox-Gastaut syndrome. Importantly, you would have already taken part in a previous study using Fintepla (ZX008) oral solution.
The research team will have specific medical criteria to decide if this study is right for you, primarily focusing on your health history and past participation with the study medication.
- Are you 18 years old or older?
- Do you have a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome?
- Have you previously taken Fintepla (ZX008) oral solution in another study?
- Are you willing to attend regular appointments for health checks?
- Are you able to take an oral solution medication?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you take part in this study, you will continue to receive Fintepla 2.2 mg/ml oral solution. The study team will regularly check on your health to make sure the medicine is safe for you. This will involve several assessments over time. You can expect to have routine blood tests, and your heart health will be checked with an ECG (a heart tracing) and an ECHO (an ultrasound of your heart).
Your general health will also be monitored with checks like blood pressure, heart rate, temperature, and breathing. You'll also have physical examinations, including checks of your nervous system. Your weight and height will be recorded. Some participants, depending on where they live (France and Netherlands), might have a chest x-ray, and those in Italy might have an EEG (a brainwave test). The total duration of your participation will be clearly explained by the study team.
Potential risks and benefits
Locations (4)
- —Spain
- —Netherlands
- —Poland
- —Italy
Common questions
What is Fintepla?
Fintepla is an oral solution (a liquid medicine you swallow) that is being studied as an additional treatment for seizures in certain rare epilepsy conditions.
What are Dravet syndrome and Lennox-Gastaut syndrome?
These are two rare and severe types of epilepsy that start in childhood and can cause different types of seizures and developmental challenges.
Why is this study only for people who previously took Fintepla?
This is an 'extension' study, meaning it's designed to gather more long-term safety information from people who have already started treatment with Fintepla in an earlier study.
Will I get 'new' medicine in this study?
No, you will continue to receive the Fintepla 2.2 mg/ml oral solution, just as you did in the previous study. The aim is to see how safe it is over a longer period.
What kind of tests will I have?
You'll have regular health checks, including blood tests, heart checks (ECG and ECHO), physical exams, and monitoring of your vital signs like blood pressure and heart rate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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