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Ongoing Clinical Trials for Partial Seizures

There are currently 14 ongoing clinical trials investigating new treatments for partial seizures (also known as focal seizures, focal onset seizures, partial-onset seizures). These studies are evaluating several investigational medications including vormatrigine (PRAX-628), BHV-7000, XEN1101 (azetukalner), cenobamate, and ENX-101 across multiple countries in Europe. Most trials focus on adults with difficult-to-control seizures who are already taking standard anti-seizure medications, though some studies include children and adolescents.

Clinical trial locations

Study of PRAX-628 to evaluate safety and effectiveness in adults with epilepsy who have focal seizures or generalized tonic-clonic seizures

This trial is investigating vormatrigine, also known as PRAX-628, in adults with epilepsy. The study focuses on two main types of seizures: those that start in one area of the brain and those that affect the entire brain from the start, causing muscle stiffness and jerking movements.

Who can participate: Adults aged 18 and older who have previously taken vormatrigine in other studies or through special access programs. Participants must have kept accurate seizure diaries and followed medication instructions in past trials. They should have either focal seizures or generalized tonic-clonic seizures and be willing to use appropriate birth control during the study.

Who cannot participate: People younger than 18 or older than 65, pregnant or breastfeeding women, and those with a history of allergic reactions to similar medications. Individuals with severe kidney or liver problems, uncontrolled high blood pressure, recent drug or alcohol abuse, major psychiatric disorders, or other serious medical conditions are also excluded.

What the trial involves: The study aims to determine how safe and well-tolerated vormatrigine is over a treatment period that may last up to 24 months. Participants will take the medication in capsule form by mouth. Throughout the study, doctors will monitor health through various tests including vital signs, blood tests, heart monitoring, and mental health assessments. Participants will need to maintain a seizure diary to track frequency. The study will also measure medication levels in the blood and evaluate how both doctors and patients perceive changes in condition severity.

Investigational drug: Vormatrigine is designed to help control both types of seizures by modulating sodium channels in the brain to reduce excessive electrical activity. It aims to decrease the frequency and severity of seizures in adult patients.

Study on PRAX-628 for Adults with Focal Epilepsy Taking 1 to 3 Anti-Seizure Medications

This trial examines PRAX-628 for adults with focal epilepsy who are already taking one to three anti-seizure medications. The medication is compared to a placebo to determine its effectiveness in reducing seizure frequency.

Who can participate: Adults between 18 and 75 years old with a diagnosis of focal epilepsy. Participants must be taking stable doses of 1 to 3 anti-seizure medications for at least 4 weeks. They need to have experienced at least 4 countable focal seizures in the 4 weeks before screening and record at least 8 such seizures during a 9-week observation period. Participants must complete a seizure diary on at least 80% of days and should not be seizure-free for more than 21 consecutive days during the observation period.

Who cannot participate: Those without focal epilepsy, people not taking 1 to 3 anti-seizure medications, anyone younger than 18 or older than 65, and vulnerable populations unable to give consent.

What the trial involves: During a 9-week screening period, participants keep a detailed seizure diary and must document at least 8 countable focal seizures. After screening, participants are randomly assigned to receive either PRAX-628 or placebo as capsules taken by mouth. The treatment continues while participants maintain their existing medications. Regular assessments monitor health, seizure frequency, and any side effects. The study compares seizure reduction between those taking the medication and those on placebo.

Investigational drug: PRAX-628 is believed to work by modulating brain receptors to stabilize nerve activity, potentially preventing seizures. It belongs to the antiepileptic drug category.

Study on PRAX-628 for Adults with Focal Onset or Generalized Tonic-Clonic Seizures

This trial evaluates PRAX-628 for adults experiencing either seizures that start in one part of the brain or those affecting the entire brain with muscle stiffness and convulsions. The study will last up to eight weeks as participants continue their usual anti-seizure medications while adding PRAX-628.

Who can participate: Adults aged 18 to 75 with a diagnosis of focal onset seizures or primary generalized tonic-clonic seizures. Participants must have had a brain scan showing epilepsy is not caused by a progressive condition. They should be taking stable doses of 1 to 3 anti-seizure medications for at least four weeks. During the initial study period, participants must record at least 2 countable seizures if they have focal onset seizures, or 1 countable seizure if they have generalized tonic-clonic seizures. The seizure diary must be completed on at least 80% of days over a 4-week period.

Who cannot participate: Those not currently taking anti-seizure medications, individuals without the specified seizure types, people outside the 18-75 age range, and vulnerable populations.

What the trial involves: After a screening period to establish baseline seizure frequency, participants receive PRAX-628 in oral capsule form. The main goal is evaluating changes in seizure frequency from the screening period to the treatment period. Throughout the study, participants are monitored through regular health assessments including vital signs, laboratory tests, and ECG parameters. The impact on condition is evaluated using specific scales, and any side effects are carefully recorded. At the end of treatment, seizure frequency is compared to the baseline established during screening.

Investigational drug: PRAX-628 works by modulating specific ion channels in the brain to stabilize neuronal activity and prevent seizures. It is classified as an anti-seizure medication.

Study on the Effectiveness and Safety of BHV-7000 for Adults with Refractory Focal Onset Epilepsy

This study investigates BHV-7000 for adults whose focal seizures are difficult to control with standard treatments. The medication is designed to release slowly into the body over time and is taken as a prolonged-release tablet.

Who can participate: Males and females aged 18 to 75 years with a diagnosis of focal onset epilepsy for at least 1 year before screening. Participants must meet the definition of drug-resistant epilepsy, meaning they have tried at least two different anti-seizure medications that did not stop seizures. They must be able to keep accurate seizure diaries and currently be taking at least 1 and up to 3 anti-seizure medications, with a total of up to 4 epilepsy treatments including medications, diet changes, or devices.

Who cannot participate: Patients with seizure types other than refractory focal onset epilepsy, those outside the specified age range, individuals unable to follow study procedures, those with other interfering medical conditions, pregnant or breastfeeding women, current participants in other trials, those with recent drug or alcohol abuse history, and individuals with allergies to the study medication.

What the trial involves: The study begins with confirming eligibility and establishing baseline seizure frequency. Participants are randomly assigned to receive either BHV-7000 or placebo during an 8-week double-blind period where neither participants nor researchers know who receives which treatment. Seizure frequency is monitored and recorded throughout. The primary goal is determining if there is at least a 50% reduction in seizures over 28 days compared to the observation period. Safety is evaluated by monitoring adverse events and laboratory abnormalities.

Investigational drug: BHV-7000 is being studied as an additional treatment for refractory focal onset epilepsy. It works by modulating specific neurotransmitter pathways in the brain to stabilize neuronal activity and prevent seizures. The trial aims to see if this medication can decrease seizures by at least 50% in a month for those who have not responded well to other treatments.

Study on the Effectiveness and Safety of BHV-7000 for Adults with Refractory Focal Onset Epilepsy

This trial also examines BHV-7000 for adults with treatment-resistant focal seizures. It compares two different doses of BHV-7000 to placebo to determine effectiveness and safety in reducing seizure frequency.

Who can participate: Adults between 18 and 75 years old with focal onset epilepsy diagnosed at least 1 year before screening. Participants must have drug-resistant focal onset seizures according to specific criteria, meaning previous treatments did not stop seizures. They should be using no more than 4 epilepsy treatments, with no more than 3 being anti-seizure medications. Other treatments can include special diets or devices. Participants must be able to keep accurate seizure records with at least 85% compliance in an electronic diary.

Who cannot participate: Patients without refractory focal onset epilepsy, those outside the specified age range, individuals not part of the specified trial group, and vulnerable populations.

What the trial involves: The study lasts approximately 12 weeks. After enrollment, participants are randomly assigned to receive either one of two doses of BHV-7000 or placebo. They take the assigned medication daily in prolonged-release tablet form while continuing to record seizures in an electronic diary. Regular check-ups monitor health and medication effects. The final 12 weeks are the maintenance phase, focusing on observing long-term effects. At the end, participants undergo final evaluation to assess overall health and changes in seizure activity.

Investigational drug: BHV-7000 is in Phase 2/3 clinical trials. It works by modulating specific neurotransmitter pathways in the brain to stabilize neuronal activity and prevent seizures, classified as an antiepileptic drug.

Study on the Effects of Azetukalner in Patients with Focal-Onset Seizures

This clinical trial studies XEN1101 (azetukalner) for individuals with seizures that start in one area of the brain. The medication is compared to placebo to assess its ability to reduce seizure frequency.

Who can participate: Adults aged 18 or older with a body mass index of 40 or less. Participants must have been diagnosed with focal epilepsy for at least two years and tried at least two anti-seizure medications without achieving sustained seizure freedom. They must be on stable doses of one to three allowed anti-seizure medications for at least one month before and during the study. Participants need to keep accurate seizure records and have had a brain scan within the last 10 years. Those with devices like vagal nerve stimulators must have had them in place for over one year with stable settings for more than three months. Participants must agree to follow birth control rules and not donate sperm or eggs during specified periods.

Who cannot participate: Those without focal onset seizures, people outside the specified age range or not meeting clinical trial group criteria, and vulnerable populations.

What the trial involves: After providing written consent and confirming eligibility, participants maintain stable doses of current medications during a baseline period of at least one month. During the double-blind phase, participants receive either XEN1101 or placebo in capsule form. Seizure frequency is monitored throughout, with the primary goal of assessing reduction. Participants report changes in condition and any side effects. At study end, overall response to treatment is evaluated.

Investigational drug: XEN1101 is in Phase 3 trials. It targets specific potassium channels in brain cells to stabilize electrical activity and prevent seizures. It is classified as an anticonvulsant used to prevent or reduce severity of epileptic seizures.

Study on the Long-term Safety and Tolerability of Azetukalner for Patients with Epilepsy, Including Focal-onset and Primary Generalized Tonic-Clonic Seizures

This long-term study examines XEN1101 safety and tolerability in people with either focal-onset seizures or primary generalized tonic-clonic seizures. It monitors participants over an extended period to understand long-term effects.

Who can participate: Patients who completed previous study periods without leaving early and met all necessary requirements without major issues preventing joining this long-term study. They should keep accurate seizure records and be fully informed about study nature and risks before signing consent. Participants must follow birth control rules and agree not to donate sperm for 3 months or eggs for 6 months after last medication dose. They should understand instructions and be willing to follow all schedules and requirements.

Who cannot participate: Those who have not completed specific previous studies, people outside the specified age range, those without the specific seizure types being studied, and vulnerable populations needing special protection.

What the trial involves: This open-label study means both participants and researchers know the treatment being given. Participants take XEN1101 in capsule form orally, with dosage and frequency determined by study protocol. Throughout the study, regular assessments monitor safety and tolerability, tracking side effects and health changes. Participants maintain accurate seizure diaries recording frequency and severity. The study evaluates changes in seizure frequency over time and includes quality of life assessments. Expected to continue until September 2028, with final assessments evaluating long-term effects.

Investigational drug: XEN1101 modulates potassium channels in the brain to stabilize neuronal activity and reduce seizure frequency. It is classified as an anticonvulsant for preventing or reducing severity of epileptic seizures.

Study on the Safety of BHV-7000 for Adults with Hard-to-Treat Focal Onset Epilepsy

This long-term trial evaluates BHV-7000 safety and tolerability in adults with refractory focal onset epilepsy. The study lasts up to 52 weeks with close monitoring by healthcare professionals.

Who can participate: Participants must have completed the double-blind phase of a previous BHV7000 study. Females of childbearing potential must have a negative pregnancy test at baseline (Day 0).

Who cannot participate: Patients with different epilepsy types than refractory focal onset epilepsy, those outside specified age range, individuals not part of specified trial groups, and vulnerable populations.

What the trial involves: Participation begins after completing a previous study’s double-blind phase. Participants receive BHV-7000 as prolonged-release tablets taken orally. The main objective is evaluating safety and tolerability by monitoring deaths, serious adverse events, events leading to discontinuation, moderate and severe events, and laboratory abnormalities. The study is estimated to end December 30, 2026, with recruitment expected to start December 1, 2024.

Investigational drug: BHV-7000 is in Phase 2 trials, being studied for safety and tolerability in refractory focal onset epilepsy patients. It modulates specific brain pathways to reduce seizure activity and is classified under antiepileptic drugs.

Study on ENX-101 for Treating Focal Epilepsy in Patients Using 1 to 4 Antiseizure Medications

The ENACT Trial studies ENX-101 effects for people with focal epilepsy already using anti-seizure medications. It compares ENX-101 to placebo to determine effectiveness in reducing seizure frequency.

Who can participate: Males and females aged 18 to 75 diagnosed with focal epilepsy according to specific classification. Participants must experience poorly controlled focal onset seizures with at least 3 observable seizures every 28 days in the 3 months before study start, but less than 10 seizures per day. They must have at least 6 observable seizures during the 8-week period before study start. Participants should have been treated with approved medications for at least 2 years and currently take 1 to 4 medications at stable doses for at least 28 days. Body mass index must be between 18 and 40. Participants need an imaging study from the last 10 years and must keep an accurate seizure diary.

Who cannot participate: Those without focal epilepsy, people not taking 1 to 4 antiseizure medications, those younger than 3 years old, and vulnerable populations.

What the trial involves: The treatment period lasts from Day 1 to Day 56. Participants take ENX-101 or placebo as capsule or tablet orally, continuing existing medications at stable doses. Throughout, participants keep a seizure diary recording frequency and type. The study aims to determine if ENX-101 significantly reduces seizure frequency compared to placebo. At the end of 56 days, participation is evaluated based on diary data and other assessments.

Investigational drug: ENX-101 is being studied for effectiveness in treating focal epilepsy. It modulates specific brain pathways to stabilize nerve activity and prevent seizures, classified as an antiseizure medication with safety and efficacy being evaluated in clinical trials.

Study of Cenobamate for Children with Partial-Onset Seizures

This trial focuses on cenobamate (YKP3089) for children and teenagers aged 2 to less than 18 years with partial-onset seizures. The medication is given as oral suspension to understand how young patients’ bodies process it.

Who can participate: Boys and girls aged 2 to less than 18 years diagnosed with epilepsy with partial-onset seizures, confirmed by doctor and electroencephalogram. The diagnosis should have been made at least 6 months before study start. Participants must meet specific weight criteria based on age cohort. They should currently take 1 to 3 approved antiepileptic drugs with stable doses for at least 4 weeks. Written informed consent must be signed by participant, legal guardian, or legally authorized representative, with age-appropriate assent for cognitively able children. Doctors must believe parents or caregivers can accurately report seizures. If participants have vagal nerve stimulators, they must have been in place for at least 5 months with stable settings for 30 days. Those on ketogenic diet must have been stable for at least 30 days.

Who cannot participate: Children younger than 2 or older than 18, those without partial onset seizures, participants unable to follow procedures or take medication as required, those with other interfering medical conditions, pregnant or breastfeeding females, current participants in other trials, those with recent drug or alcohol abuse, and individuals with allergies to study medication.

What the trial involves: The study begins with initial assessment confirming eligibility, reviewing diagnosis and ensuring weight requirements are met. Current medications are reviewed to ensure stable doses. Blood samples are collected to measure medication levels and understand how the body processes cenobamate. Safety and tolerability are closely monitored, with regular checks for side effects. The medication’s acceptability and palatability are assessed. Seizure frequency is recorded using a diary. The study is estimated to end March 31, 2026, with final evaluation assessing overall outcomes and long-term effects.

Investigational drug: Cenobamate is administered orally and currently studied for effectiveness in treating partial onset seizures, particularly in pediatric patients. It modulates certain neurotransmitters in the brain to stabilize neuronal activity and prevent seizures, classified as an anticonvulsant gaining attention for potential benefits in managing epilepsy.

Study of EQU-001 and Placebo for Patients with Uncontrolled Focal Seizures in Epilepsy

This trial tests EQU-001 as additional treatment for people with focal onset seizures continuing to experience seizures despite medication. It evaluates effectiveness compared to placebo in reducing seizure frequency.

Who can participate: Adults aged 18 to 65 with focal epilepsy whose seizures are not controlled even after trying at least one anti-seizure medication in the last 2 years. Participants must currently take 1 to 3 anti-seizure medications with stable doses for at least 4 weeks before and during the study. If using devices like vagal nerve stimulators, they must have been working for more than a year with stable settings for over 3 months. Females who can have children must agree to effective birth control during study and for 30 days after last dose. Participants must keep accurate study diaries and follow study rules. They need a brain scan from the last 10 years showing no other interfering conditions and must have had at least 8 observable seizures during the 8-week period before starting with at least 3 seizures in each 4-week period and no 21-day seizure-free period.

Who cannot participate: Those without epilepsy diagnosis, individuals not experiencing focal onset seizures, people younger than 4 or older than 18, those unable to follow procedures, pregnant or breastfeeding patients, those with drug or alcohol abuse history, recent participants in other trials, individuals with known allergies to study medication, and those with serious interfering medical conditions.

What the trial involves: After enrollment, participants undergo an 8-week baseline period continuing current medications without changes while keeping detailed seizure diaries. Following baseline, participants are randomly assigned to receive either EQU-001 or placebo. The treatment period lasts 16 weeks with daily medication and regular check-ups monitoring health and effects. The last 12 weeks are the maintenance phase observing long-term effects. At trial end, participants have final evaluation assessing overall health and changes in seizure activity, returning unused medication and completing final questionnaires.

Investigational drug: EQU-001 is administered orally and currently studied for effectiveness in treating uncontrolled focal onset seizures. It modulates certain brain pathways to reduce seizure frequency and severity, classified as an antiepileptic drug designed to help control seizures.

Summary

The 14 ongoing clinical trials for partial seizures represent a significant research effort across Europe, with studies concentrated primarily in Germany, Italy, Spain, and Poland. These countries appear most frequently as trial locations, suggesting strong clinical research infrastructure for epilepsy treatments in these regions.

Several investigational medications are being evaluated across multiple trials. XEN1101 (azetukalner) appears in four separate studies, examining both short-term effectiveness and long-term safety. BHV-7000 is featured in four trials focusing on adults with difficult-to-treat seizures. PRAX-628 (vormatrigine) is being tested in three studies for both focal and generalized seizures. Cenobamate is being evaluated in two pediatric trials, while ENX-101 and EQU-001 each appear in single trials.

Most trials target adults with treatment-resistant seizures who are already taking one to three anti-seizure medications, reflecting the clinical reality that many patients need additional treatment options. Two notable trials focus specifically on children and adolescents, addressing an important need for pediatric epilepsy treatments.

The studies employ rigorous methodology, typically including placebo-controlled phases and requiring participants to maintain detailed seizure diaries. Many trials evaluate not only seizure frequency reduction but also safety, tolerability, and quality of life impacts. Several medications work through similar mechanisms, modulating ion channels or neurotransmitter pathways in the brain to stabilize neuronal activity and prevent seizures.

These trials collectively offer hope for improved treatment options for people living with partial seizures, particularly those whose condition has not responded adequately to currently available medications.

Ongoing Clinical Trials on Seizure

  • Study of Pyridoxal Phosphate for Treatment of Seizures in Patients with PNPO Deficiency

    Recruiting

    3 1 1
    Investigated diseases:
    Poland

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