Severe myoclonic epilepsy of infancy – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 24 Jun 2026 04:14:47 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Severe myoclonic epilepsy of infancy – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A study using MPPF imaging to examine serotonin pathways in the brainstem of patients with Dravet Syndrome epilepsy https://clinicaltrials.eu/trial/a-study-using-mppf-imaging-to-examine-serotonin-pathways-in-the-brainstem-of-patients-with-dravet-syndrome-epilepsy/ Thu, 30 Apr 2026 13:08:43 +0000 https://clinicaltrials.eu/trial/a-study-using-mppf-imaging-to-examine-serotonin-pathways-in-the-brainstem-of-patients-with-dravet-syndrome-epilepsy/ 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.

]]> Study of zorevunersen to reduce seizures in patients with Dravet syndrome https://clinicaltrials.eu/trial/study-of-zorevunersen-to-reduce-seizures-in-patients-with-dravet-syndrome/ Wed, 29 Apr 2026 15:06:59 +0000 https://clinicaltrials.eu/trial/study-of-zorevunersen-to-reduce-seizures-in-patients-with-dravet-syndrome/ This clinical trial focuses on Dravet syndrome, a rare form of epilepsy that begins in early childhood and causes frequent, severe seizures. The study tests a new medication called zorevunersen (also known as STK-001), which is given as an injection into the spinal fluid. The purpose of the study is to determine if this medication can reduce the frequency of major seizures in people with Dravet syndrome.

The study examines how well zorevunersen works in controlling different types of seizures, including hemiclonic seizures, tonic seizures, tonic-clonic seizures, and other types of major motor seizures that can cause falling. The medication will be compared to a sham procedure to determine its effectiveness. During the study, participants will continue taking their regular anti-seizure medications while receiving either zorevunersen or the sham treatment.

The treatment period lasts for 52 weeks, during which participants will receive injections of either zorevunersen or sham treatment. The study will measure how much the frequency of seizures changes over time, particularly between weeks 16 and 28 of treatment. The researchers will also assess changes in the participants’ daily living skills and overall functioning throughout the study period.

]]> Study on the Effects of Bexicaserin for Treating Seizures in Children and Adults with Dravet Syndrome https://clinicaltrials.eu/trial/study-on-the-effects-of-bexicaserin-for-treating-seizures-in-children-and-adults-with-dravet-syndrome/ Wed, 29 Apr 2026 15:04:43 +0000 https://clinicaltrials.eu/trial/study-on-the-effects-of-bexicaserin-for-treating-seizures-in-children-and-adults-with-dravet-syndrome/ This clinical trial is focused on studying a condition known as Dravet Syndrome, which is a rare form of epilepsy that begins in infancy and is characterized by frequent and prolonged seizures. The study aims to evaluate a new treatment called Bexicaserin, also known by its code name LP352. This treatment is provided as an oral solution, which means it is taken by mouth. The trial will compare the effects of Bexicaserin to a placebo to determine its effectiveness in reducing seizures in both children and adults with Dravet Syndrome.

The purpose of the study is to assess how well Bexicaserin works in reducing the number of countable motor seizures, which are specific types of seizures that can be measured. Participants in the study will receive either Bexicaserin or a placebo, and their seizure activity will be monitored over time. The study will also look at the safety and tolerability of the treatment, which means checking for any side effects or adverse reactions that might occur.

Throughout the study, participants will undergo regular check-ups, including physical examinations and tests like Electrocardiograms (ECGs), which measure heart activity. Other assessments will include monitoring vital signs, growth parameters like height and weight, and responses to questionnaires about health and well-being. The study is designed to provide valuable information about the potential benefits and risks of using Bexicaserin for treating Dravet Syndrome.

]]> Study on Clemizole Hydrochloride for Children and Adults with Dravet Syndrome https://clinicaltrials.eu/trial/study-on-clemizole-hydrochloride-for-children-and-adults-with-dravet-syndrome/ Wed, 29 Apr 2026 15:02:30 +0000 https://clinicaltrials.eu/trial/study-on-clemizole-hydrochloride-for-children-and-adults-with-dravet-syndrome/ This clinical trial is focused on studying Dravet Syndrome, a rare and severe form of epilepsy that begins in infancy. The trial will test a treatment called EPX-100, which is the code name for a medication known as clemizole hydrochloride. This medication is being tested as an additional therapy to help manage seizures in both children and adults who have Dravet Syndrome. Participants in the study will receive either the EPX-100 treatment or a placebo, which looks like the treatment but does not contain the active medication.

The purpose of the study is to evaluate how effective EPX-100 is in reducing the frequency of seizures in participants with Dravet Syndrome. The study will last for 20 weeks and will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, a method known as “double-blind.” This helps ensure that the results are not influenced by expectations about the treatment. Participants will take the medication orally, meaning it is taken by mouth in the form of a solution.

Throughout the study, participants will be monitored to see how their seizure frequency changes compared to before they started the treatment. The trial aims to provide valuable information on whether EPX-100 can be a helpful addition to the current treatment options for managing seizures in individuals with Dravet Syndrome.

]]> Long-Term Safety Study of Fenfluramine Hydrochloride for Seizures in Patients with Dravet or Lennox-Gastaut Syndrome https://clinicaltrials.eu/trial/long-term-safety-study-of-fenfluramine-hydrochloride-for-seizures-in-patients-with-dravet-or-lennox-gastaut-syndrome/ Wed, 29 Apr 2026 14:59:25 +0000 https://clinicaltrials.eu/trial/long-term-safety-study-of-fenfluramine-hydrochloride-for-seizures-in-patients-with-dravet-or-lennox-gastaut-syndrome/ This clinical trial is focused on studying the long-term safety of a medication called fenfluramine hydrochloride, also known by its code name ZX008. The study is designed for individuals with rare seizure disorders, specifically Dravet syndrome and Lennox-Gastaut syndrome. These are types of epileptic encephalopathies, which are severe forms of epilepsy that begin in childhood and are characterized by frequent seizures and developmental delays.

The purpose of the study is to assess how safe and tolerable fenfluramine hydrochloride is when used over a long period as an additional treatment for seizures. Participants in the study will take the medication in the form of an oral solution. The study will monitor the participants’ health and any side effects they may experience while taking the medication. This includes regular check-ups and various health assessments to ensure the safety of the participants.

Throughout the study, participants will continue to receive the medication and will be observed for any changes in their condition. The study aims to provide valuable information on the long-term use of fenfluramine hydrochloride in managing seizures associated with these rare disorders. This research is important for understanding how the medication can help improve the quality of life for those affected by these challenging conditions.

]]> Study on Long-Term Safety of Soticlestat for Patients with Dravet or Lennox-Gastaut Syndromes https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-patients-with-dravet-or-lennox-gastaut-syndromes/ Wed, 29 Apr 2026 14:57:00 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-patients-with-dravet-or-lennox-gastaut-syndromes/ This clinical trial is focused on studying the long-term safety and tolerability of a medication called soticlestat for individuals with Dravet Syndrome and Lennox-Gastaut Syndrome. These are both rare forms of epilepsy that begin in childhood and are characterized by frequent seizures. The medication, known by its code name TAK-935, is being tested as an additional treatment to standard care, which may include anti-seizure medications, vagus nerve stimulation, or specific diets like the ketogenic or modified Atkins diet.

The purpose of the study is to assess how well patients tolerate soticlestat over a long period. Participants in the study will take the medication in tablet form by mouth. The study will last up to 52 weeks, during which time participants will be monitored for any side effects and changes in their health. The study will also look at changes in seizure frequency and other health indicators, such as growth and development in children.

This trial is an extension of previous studies, meaning it includes participants who have already been involved in earlier research phases. The study aims to provide more information on the long-term use of soticlestat, helping to determine its safety and effectiveness as a treatment option for those living with Dravet Syndrome and Lennox-Gastaut Syndrome.

]]> Study on the Safety and Effects of Fenfluramine in Infants Aged 1 to Less Than 2 Years with Dravet Syndrome https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-fenfluramine-in-infants-aged-1-to-less-than-2-years-with-dravet-syndrome/ Wed, 29 Apr 2026 14:26:52 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-fenfluramine-in-infants-aged-1-to-less-than-2-years-with-dravet-syndrome/ This clinical trial is focused on studying the safety and effects of a medication called fenfluramine hydrochloride in infants aged 1 to less than 2 years who have Dravet syndrome. Dravet syndrome is a rare and severe form of epilepsy that begins in infancy and is characterized by frequent and prolonged seizures. The medication being tested, known by the code name ZX008, is given as an oral solution and is intended to help manage seizures associated with this condition.

The purpose of the study is to evaluate how safe and tolerable fenfluramine hydrochloride is for young children with Dravet syndrome. Participants in the study will receive the medication for up to 52 weeks. During this time, researchers will monitor the children to see how the medication moves through their bodies and how it affects their health, including any changes in seizure frequency and overall well-being. The study will also look at any potential side effects, such as changes in heart function or growth patterns.

Throughout the study, the children will have regular check-ups to assess their health and development. These visits will help researchers gather important information about the medication’s impact on the participants. The study aims to provide valuable insights into the use of fenfluramine hydrochloride for treating Dravet syndrome in very young children, potentially offering a new option for managing this challenging condition.

]]> Study on Soticlestat for Children and Adults with Dravet or Lennox-Gastaut Syndrome Previously Treated with Fenfluramine https://clinicaltrials.eu/trial/study-on-soticlestat-for-children-and-adults-with-dravet-or-lennox-gastaut-syndrome-previously-treated-with-fenfluramine/ Wed, 29 Apr 2026 14:26:09 +0000 https://clinicaltrials.eu/trial/study-on-soticlestat-for-children-and-adults-with-dravet-or-lennox-gastaut-syndrome-previously-treated-with-fenfluramine/ 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.

]]> Study on Cannabidiol Oral Solution for Infants with Tuberous Sclerosis, Dravet Syndrome, or Lennox-Gastaut Syndrome Experiencing Uncontrolled Seizures https://clinicaltrials.eu/trial/study-on-cannabidiol-oral-solution-for-infants-with-tuberous-sclerosis-dravet-syndrome-or-lennox-gastaut-syndrome-experiencing-uncontrolled-seizures/ Wed, 29 Apr 2026 14:25:55 +0000 https://clinicaltrials.eu/trial/study-on-cannabidiol-oral-solution-for-infants-with-tuberous-sclerosis-dravet-syndrome-or-lennox-gastaut-syndrome-experiencing-uncontrolled-seizures/ This clinical trial is focused on studying the effects of a treatment for children with certain types of epilepsy, specifically Tuberous Sclerosis Complex, Dravet Syndrome, and Lennox-Gastaut Syndrome. These conditions are known for causing seizures that are difficult to control with standard treatments. The study will use a medication called Cannabidiol, which is provided as an oral solution known by the code name GWP42003-P. Cannabidiol is a chemical compound that is being tested to see if it can help reduce the frequency of seizures in these young patients.

The purpose of the study is to evaluate the safety and effectiveness of this treatment over a period of 52 weeks. Participants will receive the Cannabidiol oral solution in addition to their current seizure medications. The study will monitor how the body processes the medication and its effects on seizure frequency. The trial is open-label, meaning all participants will receive the active treatment, and there is no placebo group. The study will involve regular check-ups to assess the health and development of the participants, as well as to monitor any side effects or changes in seizure patterns.

Throughout the study, caregivers will be asked to keep a diary of the participant’s seizures to help researchers understand how well the treatment is working. The study aims to provide valuable information on whether Cannabidiol can be a safe and effective addition to existing treatments for these challenging epilepsy conditions in young children.

]]> Study on Long-Term Safety of Soticlestat for Adults and Children with Developmental Epileptic Encephalopathies https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-adults-and-children-with-developmental-epileptic-encephalopathies/ Wed, 29 Apr 2026 14:23:27 +0000 https://clinicaltrials.eu/trial/study-on-long-term-safety-of-soticlestat-for-adults-and-children-with-developmental-epileptic-encephalopathies/ This clinical trial is focused on studying the long-term safety and tolerability of a medication called soticlestat (also known by its code name TAK-935). The study is designed for individuals with certain types of rare epilepsies, specifically Developmental Epileptic Encephalopathies. These include conditions such as Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome. The purpose of the study is to see how well soticlestat can be tolerated when used alongside other treatments for seizures, such as anti-seizure medications, a vagal nerve stimulator, or special diets like the ketogenic or modified Atkins diet.

Participants in this study will take soticlestat in the form of a tablet, which is taken orally. The study will follow participants over a period to monitor their health and any side effects they might experience. The maximum daily dose of soticlestat is 600 milligrams, and the treatment period can last up to 96 weeks. Throughout the study, researchers will keep track of any adverse events, changes in behavior, and other health indicators to ensure the safety of the participants.

This study is an extension of previous research, meaning that participants have already been involved in earlier studies of soticlestat. The goal is to gather more information about how the medication affects people over a longer period. By doing so, researchers hope to better understand the potential benefits and risks of using soticlestat as a treatment for these rare epileptic conditions.

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