Study on Soticlestat for Children and Adults with Dravet or Lennox-Gastaut Syndrome Previously Treated with Fenfluramine

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What is this study about?

This clinical trial is focused on studying the effects of a medication called soticlestat in individuals with Dravet Syndrome or Lennox-Gastaut Syndrome. These are both rare forms of epilepsy that begin in childhood and are characterized by frequent seizures. The study is designed to evaluate whether soticlestat can help reduce seizures in patients who have previously been treated with another medication called fenfluramine.

The purpose of the study is to assess the effectiveness and safety of soticlestat. Participants in the study will take soticlestat in the form of a tablet, which is taken orally. The study will last for up to 52 weeks, during which time participants will be monitored to see how their seizure frequency changes. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substance.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The goal is to determine if soticlestat can provide a beneficial treatment option for those living with Dravet Syndrome or Lennox-Gastaut Syndrome, especially for those who have already tried fenfluramine. This study is an important step in finding new ways to manage these challenging conditions.

1 joining the study

Upon joining the study, eligibility is confirmed based on age (2 years or older) and a documented diagnosis of Dravet Syndrome or Lennox-Gastaut Syndrome. Previous exposure to the medication fenfluramine is also required.

2 initial assessment

An initial assessment is conducted to establish a baseline for seizure frequency. This involves monitoring the number of convulsive seizures for Dravet Syndrome or major motor drop seizures for Lennox-Gastaut Syndrome over a 28-day period.

3 medication administration

The medication soticlestat is administered orally in tablet form. The specific dosage and frequency are determined by the study protocol and the healthcare provider overseeing the trial.

4 maintenance period

During the maintenance period, which lasts for 12 weeks, the primary focus is on observing any changes in seizure frequency compared to the baseline established during the initial assessment.

5 evaluation of results

The primary endpoint of the study is to measure the percent change in seizure frequency over the 12-week maintenance period. This helps determine the efficacy of soticlestat in reducing seizures.

Who Can Join the Study?

The participant can be of any sex and must be at least 2 years old at the time of giving consent to join the study.
The participant must have a documented clinical diagnosis of Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). This means they have been diagnosed with one of these conditions based on typical symptoms and as determined by the doctor in charge.
The participant must have been exposed to fenfluramine, which means they are either currently taking it or have used it in the past.

Who Cannot Join the Study?

Patients who have not been diagnosed with Dravet Syndrome or Lennox-Gastaut Syndrome cannot participate. These are specific types of epilepsy.
Patients who have not been exposed to fenfluramine cannot participate. Fenfluramine is a medication that may have been used to treat seizures.
Patients who are not within the specified age range cannot participate. The age range includes children and young adults.
Patients who are not part of the specified clinical trial group cannot participate. This refers to a specific group of patients selected for the study.
Patients who are not male or female cannot participate. The study includes both genders.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children or those with certain health conditions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Filadelfia	Dianalund	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

Soticlestat

Soticlestat is a medication being studied for its effectiveness and safety in treating individuals with Dravet Syndrome or Lennox-Gastaut Syndrome. These are types of epilepsy that cause severe seizures. Soticlestat works by targeting specific pathways in the brain to help reduce the frequency and severity of seizures in patients with these conditions.

Fenfluramine is another medication that participants in the study have been exposed to. It is used to treat seizures associated with Dravet Syndrome. Fenfluramine helps to control seizures by affecting certain chemicals in the brain, which can help improve the quality of life for patients with this condition.

Investigated diseases:

Lennox-Gastaut syndrome

Dravet Syndrome – Dravet Syndrome is a rare, severe form of epilepsy that begins in infancy. It is characterized by prolonged seizures that are often triggered by fever or hot temperatures. As the child grows, other types of seizures may develop, including myoclonic and absence seizures. The condition can also lead to developmental delays and behavioral challenges. Over time, individuals may experience difficulties with balance and coordination. The frequency and severity of seizures can vary widely among those affected.

Lennox-Gastaut Syndrome – Lennox-Gastaut Syndrome is a complex, rare form of epilepsy that typically appears in early childhood. It is marked by multiple types of seizures, including tonic and atonic seizures, which can cause sudden falls. Children with this syndrome often experience developmental delays and learning difficulties. The condition is known for its resistance to many standard epilepsy treatments. Seizures can occur frequently and may be difficult to control. Over time, the syndrome can impact cognitive and motor skills.

Trial ID:

2023-504104-29-00

Protocol code:

TAK-935-3004

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Soticlestat for Children and Adults with Dravet or Lennox-Gastaut Syndrome Previously Treated with Fenfluramine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?