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A study using MPPF imaging to examine serotonin pathways in the brainstem of patients with Dravet Syndrome epilepsy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Dravet Syndrome, a type of severe epilepsy that usually begins in infancy, and comparing it with another condition called drug-resistant focal epilepsy, which is a form of epilepsy where seizures start in one specific area of the brain and do not respond well to medications. The study will also include healthy people without any neurological problems for comparison. The treatment being used in this research is [18F]-MPPF, which is a special substance given as an injection that helps doctors see certain parts of the brain during imaging scans.

The purpose of this study is to compare how a specific type of brain receptor, called 5HT1A receptors, is distributed in the brainstem of people with Dravet Syndrome compared to people with drug-resistant focal epilepsy. These receptors are part of the brain's chemical messaging system involving serotonin, which is a substance that helps control many body functions. The brainstem is the lower part of the brain that connects to the spinal cord and controls important automatic functions like breathing and heart rate.

During the study, participants will receive an injection of [18F]-MPPF and then undergo imaging scans using PET-MRI, which is a combination of two types of brain scanning technologies that work together to create detailed pictures of the brain. The scans will help researchers measure the distribution of the 5HT1A receptors in different areas of the brainstem and outer layer of the brain. The study will also look at the size of different brainstem regions and examine whether there is any connection between these brain measurements and breathing function in people with Dravet Syndrome. The researchers will compare the findings between people with Dravet Syndrome, those with drug-resistant focal epilepsy, and healthy individuals.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Consent and enrollment
Your participation in this study will begin after you have provided written informed consent. If you are a woman of childbearing potential, you will need to use highly effective contraception during your participation in the study.
The study involves patients with Dravet Syndrome, patients with drug-resistant focal epilepsy, and healthy control subjects.
Step 2
PET-MRI scan procedure
You will undergo a combined PET-MRI scan. PET stands for Positron Emission Tomography, which is an imaging technique that shows how tissues and organs are functioning. MRI stands for Magnetic Resonance Imaging, which creates detailed pictures of the inside of your body.
During the scan, you will receive an injection of a substance called [18F]-MPPF. This is a solution for injection that contains the active substance 4-fluoro-n-[2-[4-(2-methoxyphenyl)piperazin-1-yl]ethyl]-n-pyridin-2-ylbenzamide.
The [18F]-MPPF is a tracer that allows doctors to see the distribution of specific receptors in your brainstem called 5HT1A receptors. These receptors are part of the brain's serotonin system.
The scan will focus on examining the brainstem and cortical regions of your brain.
Step 3
Respiratory function assessment
If you are a patient with Dravet Syndrome, your respiratory function will be evaluated between seizures. This assessment will help determine if there is a relationship between the receptor distribution in your brainstem and your breathing function.
Step 4
MRI volume analysis
The MRI images obtained during your scan will be analyzed to measure the volumes of specific regions in your brainstem.
These measurements will be compared across different patient groups and healthy subjects to identify any differences in brain structure.

Who can join the trial?

9 criteria

You must be an adult, which means you are 18 years of age or older
If you have Dravet Syndrome, which is a specific type of severe epilepsy that usually starts in childhood, you must be younger than 60 years old
If you have Dravet Syndrome, your diagnosis must be confirmed by your medical history, the types of seizures you experience (which are sudden bursts of electrical activity in the brain that can cause various symptoms), your EEG data (a test that records electrical activity in your brain), and results of genetic testing (tests that look at your genes to find changes that might cause disease)
If you have drug-resistant focal epilepsy, which means you have seizures that start in one area of the brain and do not respond well to medications, your doctors must be considering surgery as a treatment option
If you are a healthy volunteer without Dravet Syndrome or epilepsy, you must be younger than 50 years old
If you are a healthy volunteer, you must not have any history of brain or nervous system disorders or other serious medical conditions
You or your legal representative (a person legally authorized to make decisions on your behalf) must be willing to sign a written consent form agreeing to participate in the study
If you are a woman who is able to become pregnant, you must agree to use a very reliable method of birth control during your time in the study
There are no restrictions on how often you have seizures to participate in this study

Who cannot join the trial?

7 criteria

The study information does not list specific reasons why patients cannot participate in this clinical trial
If you are interested in this study, the research team will need to review your individual medical situation to determine if you can safely take part
General safety concerns that typically prevent participation in brain imaging studies may include pregnancy, which means carrying an unborn baby, or breastfeeding, which means nursing a baby with breast milk
Some studies may exclude patients who have metal implants, which are medical devices made of metal placed inside the body, or certain electronic devices like pacemakers, which are devices that help control heart rhythm
People who have had severe allergic reactions, which means the body's harmful response to certain substances, to imaging materials in the past may not be able to participate
Patients with other serious medical conditions affecting the brain or nervous system beyond those being studied may not qualify
Women who might be pregnant will likely need to take a pregnancy test before participating due to the use of radioactive imaging materials, which are special substances that help create pictures of the inside of the body but involve small amounts of radiation

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Centre Hospitalier Lyon Sud
Pierre Benite, France

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Investigated drugs

[18F]-MPPF is a radioactive tracer used during PET imaging scans to help doctors see and measure specific receptors in the brain called 5HT1A receptors. This tracer is injected into the body and shows up on special imaging equipment, allowing researchers to study how these receptors are distributed in the brainstem of patients with Dravet Syndrome compared to patients with other types of epilepsy.

4-Fluoro-N-[2-[4-(2-Methoxyphenyl)Piperazin-1-Yl]Ethyl]-N-Pyridin-2-Ylbenzamide

What is already known about the treatment

[18F]-MPPF – This is a radioactive tracer substance administered intravenously that is used specifically for PET (Positron Emission Tomography) imaging procedures. In this clinical trial, [18F]-MPPF is being used as an investigational tool to visualize and measure serotonin receptors (specifically 5HT1A receptors) in the brainstem of patients with Dravet Syndrome and drug-resistant epilepsy. The substance works by binding to serotonin 5HT1A receptors in the brain, allowing doctors to see their distribution and density using special scanning equipment. This medication belongs to the class of radioactive diagnostic agents and is used exclusively for research and diagnostic imaging purposes rather than for treating diseases directly.

Investigated diseases

Dravet Syndrome
Dravet Syndrome is a severe form of epilepsy that typically begins in the first year of life. The condition is characterized by prolonged seizures that are often triggered by fever or elevated body temperature. As the disease progresses, children develop multiple types of seizures and experience developmental delays. The seizures in this condition are typically resistant to standard epilepsy medications. Children with this syndrome often have difficulties with movement, balance, and speech as they grow older. The condition significantly impacts cognitive development and daily functioning.
Drug-Resistant Focal Epilepsy
Drug-resistant focal epilepsy is a form of epilepsy where seizures originate from a specific area of the brain and do not respond adequately to anti-seizure medications. The seizures begin in one part of the brain and may remain localized or spread to other areas. Patients continue to experience seizures despite trying at least two appropriate medications at adequate doses. The frequency and severity of seizures can vary widely among individuals. The condition may be associated with underlying structural brain abnormalities or previous brain injuries. Over time, repeated seizures can affect memory, mood, and quality of life.