Ongoing Clinical Trials for Lennox-Gastaut Syndrome
This article provides information about 6 ongoing clinical trials focused on Lennox-Gastaut Syndrome, a severe form of childhood epilepsy. These studies are testing medications such as carisbamate, fenfluramine, cannabidiol, and soticlestat across multiple European countries, aiming to improve seizure control and safety for patients with this challenging condition.
Clinical trial locations
- Belgium
- Denmark
- France
- Germany
- Greece
- Hungary
- Italy
- Study on Carisbamate for Treating Seizures in Children and Adults with Lennox-Gastaut Syndrome
- Long-Term Safety Study of Fenfluramine Hydrochloride for Seizures in Patients with Dravet or Lennox-Gastaut Syndrome
- Study on Cannabidiol Oral Solution for Infants with Tuberous Sclerosis, Dravet Syndrome, or Lennox-Gastaut Syndrome Experiencing Uncontrolled Seizures
- Study on Long-Term Safety of Soticlestat for Patients with Dravet or Lennox-Gastaut Syndromes
- Latvia
- Netherlands
- Poland
- Study on Carisbamate for Treating Seizures in Children and Adults with Lennox-Gastaut Syndrome
- Long-Term Safety Study of Fenfluramine Hydrochloride for Seizures in Patients with Dravet or Lennox-Gastaut Syndrome
- Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies
- Study on Long-Term Safety of Soticlestat for Patients with Dravet or Lennox-Gastaut Syndromes
- Portugal
- Spain
- Study on Carisbamate for Treating Seizures in Children and Adults with Lennox-Gastaut Syndrome
- Long-Term Safety Study of Fenfluramine Hydrochloride for Seizures in Patients with Dravet or Lennox-Gastaut Syndrome
- Study on Cannabidiol Oral Solution for Infants with Tuberous Sclerosis, Dravet Syndrome, or Lennox-Gastaut Syndrome Experiencing Uncontrolled Seizures
- Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies
- Study on Long-Term Safety of Soticlestat for Patients with Dravet or Lennox-Gastaut Syndromes
Study on Carisbamate for Treating Seizures in Children and Adults with Lennox-Gastaut Syndrome
This trial is testing carisbamate (YKP509), an oral suspension, to see if it can reduce the number of drop seizures in people with Lennox-Gastaut Syndrome. Drop seizures include tonic, atonic, and tonic-clonic seizures that can cause sudden falls and injuries.
Main inclusion criteria: Participants must be between 4 and 55 years old and have a documented diagnosis of Lennox-Gastaut Syndrome with multiple seizure types, including at least one being atonic or tonic. They must experience at least 8 drop seizures during a 4-week baseline period. Participants should be taking 1 to 4 anti-seizure medications at stable doses and must have a history of developmental delay and specific brain activity patterns on an electroencephalogram.
Main exclusion criteria: The study excludes individuals who do not have a diagnosis of Lennox-Gastaut Syndrome, those younger than 4 or older than 55, patients not experiencing drop seizures, those unable to take the medication or with allergies to it, pregnant or breastfeeding women, and individuals with other serious health conditions that might interfere with the study.
Trial focus: This is a double-blind, placebo-controlled study where participants are randomly assigned to receive either carisbamate or a placebo alongside their current seizure medications. After a 4-week baseline period to record seizure frequency, participants enter the treatment phase where they take the assigned medication. The primary goal is to evaluate the change in drop seizure frequency. An optional open-label extension is available where all participants can receive carisbamate after the initial study period.
Investigational drug: Carisbamate (YKP509) is an oral anticonvulsant being studied as an additional treatment to help reduce drop seizures in both children and adults with Lennox-Gastaut Syndrome.
Long-Term Safety Study of Fenfluramine Hydrochloride for Seizures in Patients with Dravet or Lennox-Gastaut Syndrome
This trial focuses on evaluating the long-term safety of fenfluramine hydrochloride (ZX008) as an additional treatment for seizures in patients with rare epileptic conditions, including Lennox-Gastaut Syndrome.
Main inclusion criteria: Participants must be male or non-pregnant, non-breastfeeding females who have successfully completed a previous clinical trial with ZX008. They must have a rare seizure disorder such as epileptic encephalopathy, and their caregiver must be willing to follow study procedures and attend scheduled visits.
Main exclusion criteria: The study excludes patients without Dravet Syndrome or Lennox-Gastaut Syndrome, those outside the specified age range, individuals not part of the designated clinical trial groups, and those from non-vulnerable populations as defined by the study.
Trial focus: This is an extension study for patients who have completed earlier trials with fenfluramine. Participants take the medication as an oral solution while being regularly monitored for safety through laboratory tests, vital signs monitoring, physical examinations, and specialized heart function tests. The study also evaluates the effectiveness of treatment through caregiver and investigator assessments.
Investigational drug: Fenfluramine hydrochloride (ZX008) is an oral solution that works by influencing serotonin levels in the brain to reduce seizure frequency and severity. It is being tested as an add-on therapy for managing seizures in rare epileptic conditions.
Study on Cannabidiol Oral Solution for Infants with Tuberous Sclerosis, Dravet Syndrome, or Lennox-Gastaut Syndrome Experiencing Uncontrolled Seizures
This trial examines cannabidiol (GWP42003-P), also known as Epidyolex, as a potential treatment for young children with severe epilepsy conditions including Lennox-Gastaut Syndrome who have seizures not controlled by standard treatments.
Main inclusion criteria: Participants must be between 1 and 2 years old with a confirmed diagnosis of Lennox-Gastaut Syndrome according to international guidelines. They must have inadequately controlled seizures despite taking at least one anti-seizure medication at a stable dose. Caregivers must complete seizure diaries for at least 21 out of 28 days during the baseline period. A video electroencephalogram confirming the diagnosis and showing uncontrolled seizures is required.
Main exclusion criteria: The study excludes patients with severe allergic reactions to the medication, pregnant or breastfeeding individuals, those with significant liver or kidney disease, anyone who participated in another trial within 30 days, patients with substance abuse history, and those unable to follow study procedures.
Trial focus: This is a 52-week open-label study where all participants receive cannabidiol oral solution in addition to their current seizure medications. The study monitors safety, how the body processes the medication, and changes in seizure frequency. Regular assessments include blood tests, developmental evaluations, and seizure diary reviews.
Investigational drug: Cannabidiol (GWP42003-P/Epidyolex) is an oral solution containing a cannabis-derived compound that interacts with the endocannabinoid system in the brain to help reduce seizure frequency in young children with difficult-to-treat epilepsy.
Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies
This extension trial studies the long-term safety and tolerability of soticlestat (TAK-935) in patients with developmental epileptic encephalopathies, including Lennox-Gastaut Syndrome, who participated in previous soticlestat studies.
Main inclusion criteria: Participants must have completed a previous soticlestat study or received at least 10 weeks of treatment with the medication. They should not have experienced serious side effects that would make continued use unsafe. The study doctor must believe the participant could benefit from taking soticlestat. Participants can be of any gender and include individuals from vulnerable populations.
Main exclusion criteria: The study excludes patients with medical conditions other than the specific epileptic encephalopathies being studied, those not using at least one anti-seizure therapy (including medications, vagal nerve stimulator, or special diets), individuals outside the specified age range, and those unwilling or unable to follow study procedures.
Trial focus: Participants take soticlestat tablets orally alongside their existing anti-seizure treatments for up to 96 weeks. The study monitors safety through regular health assessments, laboratory tests, vital signs, and behavioral evaluations using specialized scales. Seizure frequency is tracked to evaluate treatment effectiveness.
Investigational drug: Soticlestat (TAK-935) is an oral tablet that works by inhibiting an enzyme involved in producing certain brain chemicals related to seizure activity. It is being tested as an add-on treatment for rare forms of epilepsy.
Study on Long-Term Safety of Soticlestat for Patients with Dravet or Lennox-Gastaut Syndromes
This extension trial evaluates the long-term safety of soticlestat for patients with Dravet Syndrome and Lennox-Gastaut Syndrome over a period of up to 52 weeks.
Main inclusion criteria: Participants must have completed a previous phase 3 study of soticlestat with at least 12 weeks of treatment and without serious drug-related side effects. The study doctor must believe the patient could benefit from continued treatment. Patients or their caregivers must be able to maintain daily seizure diaries and follow study requirements. Female participants of childbearing potential must use effective birth control and have negative pregnancy tests.
Main exclusion criteria: The study excludes patients without Dravet Syndrome or Lennox-Gastaut Syndrome, those outside the specified age range, individuals unable to follow the treatment plan including additional therapies like vagus nerve stimulation or special diets, and those who cannot safely take soticlestat.
Trial focus: This extension study continues monitoring participants who completed earlier soticlestat trials. Patients take soticlestat tablets alongside standard treatments while undergoing regular safety assessments, laboratory tests, and heart evaluations. Height, weight, and other health indicators are tracked, and participants maintain daily seizure diaries to assess medication effectiveness.
Investigational drugs: Soticlestat is the primary medication being tested. The trial also includes combination use with other anti-seizure medications, vagus nerve stimulation therapy, ketogenic diet, and modified Atkins diet as part of standard care for managing seizures.
Study on Soticlestat for Children and Adults with Dravet or Lennox-Gastaut Syndrome Previously Treated with Fenfluramine
This trial investigates whether soticlestat can effectively reduce seizures in patients with Dravet Syndrome or Lennox-Gastaut Syndrome who have previously been treated with fenfluramine.
Main inclusion criteria: Participants must be at least 2 years old with a documented clinical diagnosis of Dravet Syndrome or Lennox-Gastaut Syndrome. They must have previous exposure to fenfluramine, either currently taking it or having used it in the past. Participants can be of any gender.
Main exclusion criteria: The study excludes patients without a diagnosis of Dravet Syndrome or Lennox-Gastaut Syndrome, those not exposed to fenfluramine, individuals outside the specified age range, and patients not part of the designated clinical trial group.
Trial focus: This study establishes a 28-day baseline seizure frequency before beginning soticlestat treatment. During a 12-week maintenance period, researchers monitor changes in seizure frequency compared to baseline. The primary goal is to measure the percent change in convulsive seizures (for Dravet Syndrome) or major motor drop seizures (for Lennox-Gastaut Syndrome).
Investigational drugs: Soticlestat is administered as oral tablets to help reduce seizure frequency and severity by targeting specific brain pathways. Fenfluramine is referenced as a previous treatment that participants have been exposed to, which also works by affecting brain chemicals to control seizures.
Summary
These six clinical trials represent important research efforts to find better treatments for Lennox-Gastaut Syndrome, a severe form of childhood epilepsy characterized by multiple seizure types and developmental challenges. The trials are testing four different medications: carisbamate, fenfluramine hydrochloride, cannabidiol, and soticlestat.
There is notable concentration of research activity in Spain, Poland, and Italy, which appear in multiple trials. Several studies focus specifically on long-term safety evaluation, reflecting the importance of understanding how these medications perform over extended periods. Soticlestat appears in three separate trials, indicating significant research interest in this particular compound.
The trials include both children and adults, with some studies specifically focusing on very young children. Most studies are extension trials, meaning they follow patients who have already participated in earlier research, which helps researchers understand the long-term effects of these treatments. All medications are being tested as add-on therapies, meaning they would be used alongside existing seizure treatments rather than replacing them.
