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Clinical Trials for Partial Seizures: Current Treatment Studies

There are currently 14 ongoing clinical trials investigating new treatments for partial seizures, testing medications such as vormatrigine (PRAX-628), BHV-7000, XEN1101, cenobamate, and ENX-101 across multiple countries in Europe. These trials focus on evaluating the safety and effectiveness of investigational drugs for adults and children with focal onset seizures that have not been adequately controlled by existing medications. (Also known as: Focal Seizures, Focal Onset Seizures, Partial Onset Seizures)

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 testing vormatrigine, also known as PRAX-628, in adults who have either focal onset seizures or primary generalized tonic-clonic seizures. The study is conducted in Italy, Poland, Spain, and Germany, and aims to evaluate the long-term safety and tolerability of the medication over a treatment period of up to 24 months.

Inclusion criteria: Adults aged 18 years or older with a diagnosis of focal onset seizures or primary generalized tonic-clonic seizures can join. Participants must have previously received vormatrigine in earlier clinical trials or through special access programs and shown good compliance with medication and seizure diary keeping. They must be willing to follow all study procedures and use appropriate contraception during the study.

Exclusion criteria: Individuals younger than 18 or older than 65 years cannot participate. Pregnant or breastfeeding women are excluded, as are people with severe kidney or liver problems, uncontrolled high blood pressure, or a history of drug or alcohol abuse within the past two years. Those with major psychiatric disorders, other serious medical conditions, or seizure types different from focal onset or primary generalized tonic-clonic seizures are also excluded.

Main focus: The study monitors participants’ health through regular checks of vital signs, laboratory tests, heart monitoring, and mental health assessments. Participants maintain a seizure diary to track seizure frequency. The trial evaluates both the safety profile of vormatrigine and changes in seizure severity as assessed by doctors and patients.

Investigational drug: Vormatrigine is an oral medication designed to reduce the frequency and severity of seizures. It works by modulating sodium channels in the brain to reduce excessive electrical activity. The drug is being developed as a potential new option for controlling seizures in adults.

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

This randomized, placebo-controlled trial evaluates PRAX-628 in adults with focal onset seizures who are taking one to three anti-seizure medications. The study is conducted in Italy, Poland, and Spain. Participants take either PRAX-628 or a placebo while continuing their current medications.

Inclusion criteria: Adults aged 18 to 75 years with focal onset seizures can participate. They must have experienced at least four countable seizures in the four weeks before the study and record at least eight countable seizures during a nine-week observation period. Participants must be on stable doses of one to three anti-seizure medications for at least four weeks before starting the study and maintain accurate seizure diaries.

Exclusion criteria: People with seizure types other than focal onset seizures, those not taking one to three anti-seizure medications, and individuals younger than 18 or older than 65 years are excluded.

Main focus: The trial assesses the effectiveness of PRAX-628 in reducing seizure frequency compared to placebo. Participants maintain a seizure diary for nine weeks during the observation period and continue recording throughout the treatment period. Regular health assessments are conducted.

Investigational drug: PRAX-628 is an oral capsule being tested for its ability to reduce the number of seizures experienced by adults with focal onset seizures. The medication is designed to be taken alongside existing anti-seizure treatments.

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

This study evaluates PRAX-628 in adults with either focal onset seizures or primary generalized tonic-clonic seizures. Conducted in Germany and Spain, the trial compares PRAX-628 to placebo over an eight-week treatment period.

Inclusion criteria: Adults aged 18 to 75 years with focal onset seizures or primary generalized tonic-clonic seizures can join. They must have had at least four seizures per month in the three months before the study and must be taking stable doses of one to three anti-seizure medications for at least four weeks prior to starting. Participants must complete a seizure diary on at least 80% of days during a four-week initial period.

Exclusion criteria: People not taking anti-seizure medications, those with seizure types other than focal onset or primary generalized tonic-clonic seizures, and individuals outside the specified age range are excluded.

Main focus: The trial assesses whether PRAX-628 reduces seizure frequency and monitors safety through regular health checks, including vital signs and laboratory tests. The impact of the medication is evaluated using specific assessment scales.

Investigational drug: PRAX-628 is an oral capsule being studied for its ability to reduce seizures in adults already taking other anti-seizure medications. It works by modulating ion channels in the brain to stabilize neuronal activity.

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

This randomized, double-blind study tests BHV-7000 in adults with refractory focal onset seizures. Participants are randomly assigned to receive either BHV-7000 or placebo. The trial is conducted across nine European countries: Germany, Romania, Slovakia, Italy, Spain, Portugal, Finland, Greece, and Denmark.

Inclusion criteria: Adults aged 18 to 75 years with focal onset seizures diagnosed at least one year before screening can participate. Participants must meet the definition of drug-resistant epilepsy, meaning they have tried at least two different suitable anti-seizure medications without achieving seizure control. They must be taking one to three anti-seizure medications and up to four total treatments including diet or devices, and be able to maintain accurate seizure diaries.

Exclusion criteria: People with epilepsy types other than refractory focal onset, those outside the age range, and individuals unable to follow study procedures or take the medication are excluded.

Main focus: The eight-week double-blind period evaluates whether BHV-7000 reduces seizure frequency by at least 50% compared to the observation period. Safety is monitored through adverse event tracking and laboratory tests.

Investigational drug: BHV-7000 is a prolonged-release tablet taken orally. It is being studied as an additional treatment for people whose seizures have not responded well to other medications. The drug works by modulating neurotransmitter pathways to stabilize neuronal activity and prevent seizures.

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

This Phase 2/3 trial evaluates BHV-7000 in adults with refractory focal onset seizures. The study is conducted in Croatia, Poland, Hungary, Netherlands, Belgium, Austria, France, Slovenia, and Czechia. Participants receive either BHV-7000 or placebo in a double-blind design.

Inclusion criteria: Adults aged 18 to 75 years with focal onset epilepsy diagnosed at least one year before screening can join. Participants must have drug-resistant seizures, meaning they have tried at least two anti-seizure medications without success. They must be taking one to three anti-seizure medications and no more than four total treatments, with stable doses for at least four weeks. Accurate seizure diary keeping is required.

Exclusion criteria: People with epilepsy types other than refractory focal onset, those outside the age range, and individuals unable to comply with study requirements are excluded.

Main focus: The 12-week study evaluates whether BHV-7000 reduces seizure frequency by at least 50% over a 28-day period. Participants maintain electronic seizure diaries with at least 85% compliance. Regular check-ups assess health and side effects.

Investigational drug: BHV-7000 is a prolonged-release tablet designed to reduce seizure frequency when added to existing treatments. It modulates specific neurotransmitter pathways to help stabilize brain activity and prevent seizures.

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

This Phase 3 trial studies XEN1101 in adults with focal onset seizures. The medication is compared to placebo over a 12-week period. The study is conducted across 14 European countries.

Inclusion criteria: Adults aged 18 years or older with a body mass index of 40 or less can participate. 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 throughout the study. Brain scans from the last 10 years must be available, and participants must agree to birth control requirements.

Exclusion criteria: People without focal onset seizures, those outside the age range, and individuals not meeting the clinical trial criteria are excluded.

Main focus: The study evaluates the safety, tolerability, and effectiveness of XEN1101 in reducing seizure frequency. Participants maintain seizure diaries and attend regular check-ups.

Investigational drug: XEN1101 is an oral capsule that targets specific potassium channels in brain cells to stabilize electrical activity and prevent seizures. It is classified as an anticonvulsant.

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

This open-label extension study evaluates the long-term safety and tolerability of XEN1101 in people with either focal onset seizures or primary generalized tonic-clonic seizures. All participants receive XEN1101. The study is conducted across 16 European countries and is expected to continue until September 2028.

Inclusion criteria: Participants must have completed earlier XEN1101 studies without leaving early and met all requirements. They should not have had major issues or side effects preventing participation in the long-term study. Participants must be able to keep accurate seizure records, be fully informed about the study, and agree to follow birth control requirements.

Exclusion criteria: People who have not completed earlier XEN1101 studies, those outside the specified age range, individuals with seizure types different from focal onset or primary generalized tonic-clonic seizures, and those in vulnerable populations are excluded.

Main focus: The study monitors long-term safety through regular assessments and tracks seizure frequency changes over time. Quality of life assessments are also conducted.

Investigational drug: XEN1101 is an oral capsule that modulates potassium channels to stabilize neuronal activity and reduce seizure frequency. It is classified as an anticonvulsant and is being evaluated for long-term use.

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

This open-label extension study evaluates the long-term safety of BHV-7000 in adults with refractory focal onset seizures. All participants receive BHV-7000 after completing an earlier double-blind phase. The study is conducted across 18 European countries and is expected to end in December 2026.

Inclusion criteria: Participants must have completed the double-blind phase of earlier BHV-7000 studies. Females of childbearing potential must have a negative pregnancy test at the start of the study.

Exclusion criteria: People with epilepsy types other than refractory focal onset, those outside the age range, and individuals in vulnerable populations are excluded.

Main focus: The study evaluates long-term safety by monitoring deaths, serious adverse events, adverse events leading to discontinuation, moderate and severe adverse events, and laboratory abnormalities.

Investigational drug: BHV-7000 is a prolonged-release oral tablet being studied for its long-term safety in patients whose seizures do not respond well to existing treatments. It modulates specific brain pathways to reduce seizure activity.

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

The ENACT Trial studies ENX-101 in adults with focal onset seizures who are taking one to four anti-seizure medications. Participants receive either ENX-101 or placebo over an eight-week treatment period. The study is conducted in Belgium, Spain, Germany, and Netherlands.

Inclusion criteria: Adults aged 18 to 75 years with focal epilepsy diagnosed according to international guidelines can participate. They must have poorly controlled seizures with at least three observable seizures every 28 days in the three months before the study, but fewer than 10 seizures per day. Participants must be taking one to four approved anti-seizure medications at stable doses for at least 28 days. Body mass index must be between 18 and 40.

Exclusion criteria: People without focal onset seizures, those not taking one to four anti-seizure medications, and individuals younger than three years are excluded.

Main focus: The study evaluates whether ENX-101 reduces seizure frequency compared to placebo. Participants maintain electronic seizure diaries throughout the treatment period.

Investigational drug: ENX-101 is administered as an oral capsule or tablet alongside existing medications. It modulates specific brain pathways to stabilize nerve activity and prevent seizures.

Study of Cenobamate for Children with Partial-Onset Seizures

This study evaluates cenobamate (YKP3089) in children and teenagers aged 2 to less than 18 years with partial onset seizures. The medication is given as an oral suspension in increasing doses. The study is conducted in Hungary and Spain.

Inclusion criteria: Children and adolescents aged 2 to less than 18 years with a diagnosis of epilepsy with partial onset seizures for at least six months can participate. They must be taking one to three stable doses of approved antiepileptic drugs for at least four weeks. Specific weight criteria apply based on age groups. Participants or their caregivers must be able to accurately report seizures.

Exclusion criteria: Children without partial onset seizures, those younger than two years or 18 years and older, and individuals unable to follow study procedures are excluded.

Main focus: The study evaluates how children’s bodies process cenobamate through blood sample analysis. Safety and tolerability are monitored, and seizure frequency is recorded throughout the study.

Investigational drug: Cenobamate is an oral suspension being studied for its effects on partial onset seizures in children. It works by modulating ion channels in the brain to stabilize neuronal activity and reduce seizures.

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

This trial evaluates EQU-001 in adults with focal onset seizures that continue despite taking current medications. Participants receive either EQU-001 at doses of 20 mg or 60 mg daily, or placebo. The study is conducted in Lithuania, Czechia, Italy, France, Spain, Poland, Sweden, and Netherlands.

Inclusion criteria: Adults aged 18 to 65 years with focal onset seizures not controlled by at least one anti-seizure medication in the past two years can participate. Participants must be taking one to three anti-seizure medications at stable doses for at least four weeks. They must have at least eight observable seizures during an eight-week baseline period with at least three seizures in each four-week period and no 21-day seizure-free period. Brain scans from the last 10 years must show no other conditions.

Exclusion criteria: People without focal onset seizures, those younger than four years or older than 18 years, pregnant or breastfeeding individuals, and those with drug or alcohol abuse history are excluded.

Main focus: The 16-week treatment period evaluates whether EQU-001 reduces seizure frequency compared to placebo. The last 12 weeks are a maintenance phase observing long-term effects. Participants maintain seizure diaries and attend regular check-ups.

Investigational drug: EQU-001 is an oral soft capsule being studied as an additional treatment to help control seizures better than current treatments alone. It works by modulating certain brain pathways to reduce seizure frequency and severity.

Note: Four additional trials are available beyond these ten detailed descriptions. These include studies on XEN1101 for reducing focal onset seizures, XEN1101 for adults with focal epilepsy taking one to three anti-seizure medications, and cenobamate studies for children with focal seizures.

Summary

The 14 ongoing clinical trials for partial seizures represent significant research efforts across Europe. Several notable patterns emerge from this collection of studies.

Geographically, trials are concentrated in Western and Central European countries. Germany, Spain, and Italy appear most frequently as trial locations, hosting 10, 11, and 9 trials respectively. Poland and Netherlands also feature prominently. This concentration reflects both the research infrastructure and the patient populations available in these countries.

Several investigational drugs are being tested across multiple trials. XEN1101 (azetukalner) appears in four separate studies, including both efficacy trials and long-term safety extensions. BHV-7000 is evaluated in three trials focusing on refractory focal onset seizures. PRAX-628 (vormatrigine) is being tested in three studies across different European locations. This pattern of multiple trials for the same medications reflects the comprehensive evaluation process required for new treatments, examining both short-term effectiveness and long-term safety.

Most trials focus exclusively on adults, typically those aged 18 to 75 years. However, two studies specifically evaluate treatments in children and adolescents aged 2 to less than 18 years, testing cenobamate in this younger population. This pediatric research addresses an important gap in treatment options for children with partial onset seizures.

The trials predominantly target patients with drug-resistant or refractory seizures who have not achieved adequate control despite taking one to four anti-seizure medications. This focus reflects the significant unmet medical need in this patient population. All investigational drugs are being tested as add-on therapies rather than replacements for existing medications.

Study designs vary but commonly include randomized, double-blind, placebo-controlled phases lasting 8 to 12 weeks, followed by open-label extension periods to evaluate long-term safety and tolerability. These extended phases can last up to 24 months, providing important information about sustained treatment effects and safety profiles over time.

Ongoing Clinical Trials on Partial seizures

  • Study of SPN-817 (Huperzine A) in Adults with Focal Onset Seizures: Testing Safety and Effectiveness of Treatment

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Hungary Poland

  • Study of Cenobamate for Children with Partial-Onset Seizures

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary Spain

  • Study on the Safety and Effectiveness of Cenobamate for Children with Focal Seizures

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary Poland Spain

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