Ongoing Clinical Trials for Petit Mal Epilepsy
Currently, there are 3 ongoing clinical trials investigating new treatment approaches for Petit Mal Epilepsy (also known as: Absence Epilepsy, Childhood Absence Epilepsy, Juvenile Absence Epilepsy). These studies are being conducted across several European countries and primarily focus on testing the medication brivaracetam for absence seizures, as well as exploring treatment strategies for severe, prolonged seizures in intensive care settings.
Clinical trial locations
- Denmark
- Italy
- Romania
- Slovakia
- Spain
Study of brivaracetam as a treatment for childhood and juvenile absence epilepsy in patients aged 2-25 years
This trial is testing brivaracetam, an anti-epileptic medication available as an oral solution, to see if it works and is safe when used as the only medication for treating absence seizures in young patients.
Who can participate:
- Patients between 2 and 25 years old with a confirmed diagnosis of Childhood Absence Epilepsy or Juvenile Absence Epilepsy
- Must have characteristic brain wave patterns on EEG showing typical absence seizure activity during a 1-hour recording
- Must experience visible absence seizures at least 3 days per week in the 2 weeks before joining
- Either never treated with anti-epileptic medications, or previously treated with no more than 2 different medications, with no treatment for at least 5 half-lives before study start
- Must weigh at least 9 kg and have normal neurological examination and development
- For younger participants or those with early seizure onset, must have a negative test for glucose transporter type 1 deficiency syndrome
- For sexually active participants, must agree to use contraception during treatment and for 2 days after the last dose
Who cannot participate:
- Anyone younger than 2 years or older than 25 years
- People diagnosed with any other type of epilepsy besides Childhood or Juvenile Absence Epilepsy
- Those currently taking multiple anti-epileptic medications at the same time
- People with serious allergic reactions to medications similar to brivaracetam
- Those with other significant medical conditions that could interfere with the study
- Anyone who participated in another clinical trial within the past 30 days
- Pregnant or breastfeeding women
- People with a history of drug or alcohol abuse within the past 2 years
What the study involves:
The trial uses a two-stage design where participants receive either brivaracetam oral solution or a placebo. The study monitors seizure control using 24-hour ambulatory EEG tests at specific timepoints (day 14 and week 12) and tracks seizure occurrence through patient diaries. Some participants who respond well to treatment may enter a withdrawal phase to further confirm the medication’s effectiveness. Throughout the entire study period, which continues until week 12, researchers carefully monitor for any side effects or adverse reactions.
Study medication: Brivaracetam is an anti-epileptic medication that works by reducing abnormal electrical activity in the brain that causes absence seizures. These seizures are brief periods where a person appears to blank out or stare into space. The medication binds to a protein called synaptic vesicle protein 2A in the brain, which helps regulate neurotransmitter release and reduces abnormal electrical activity between neurons.
Study on the Long-Term Safety of Brivaracetam for Children and Young Adults with Childhood or Juvenile Absence Epilepsy
This follow-up study focuses on evaluating the long-term safety and tolerability of brivaracetam over an extended period of up to 36 months. It is designed for patients who previously participated in specific earlier studies.
Who can participate:
- Patients who previously participated in specific studies (EP0132 and/or N01269) and qualified based on those protocols
- Must have a confirmed diagnosis of either Childhood Absence Epilepsy or Juvenile Absence Epilepsy
- The study doctor must believe the participant will benefit from long-term use of brivaracetam
- Male participants must agree to use birth control during the study and for at least 2 days after the last dose, and should not donate sperm during this time
- Female participants must not be pregnant or breastfeeding, and must either be unable to have children or agree to use birth control during the study and for at least 2 days after the last dose
- Must be able to give informed consent or assent (for minors, a parent or legal representative must also provide consent)
Who cannot participate:
- Patients without a diagnosis of Childhood Absence Epilepsy or Juvenile Absence Epilepsy
- Those not within the specified age range for the study
- People unable to follow study procedures or take the study medication as required
- Those with other medical conditions that might interfere with the study or patient safety
- People taking medications that might interfere with the study medication
- Anyone with a history of allergic reactions to brivaracetam or similar medications
- Pregnant or breastfeeding women
- Those currently participating in another clinical trial
What the study involves:
This is an open-label study, meaning both participants and researchers know which treatment is being administered. Participants receive brivaracetam (available as film-coated tablets or oral solution) for up to 36 months. Throughout the study, researchers regularly monitor for any side effects or adverse reactions, with particular attention to serious adverse events. The study aims to provide valuable information about the safety of using brivaracetam over an extended period for managing absence seizures.
Study medication: Brivaracetam is an antiepileptic medication that helps control seizures. It works by binding to synaptic vesicle protein 2A in the brain, which helps stabilize electrical activity and prevent seizures. The medication is already approved for use in treating partial-onset seizures in adults and adolescents, and this study is evaluating its long-term safety for absence epilepsy.
Study on Fast Sedation with Propofol and Midazolam vs. Anti-Seizure Drug Combination for Treating Refractory Status Epilepticus in Intensive Care Patients
This trial compares two different treatment approaches for status epilepticus, a severe and prolonged seizure condition that can be life-threatening. The study focuses specifically on non-convulsive status epilepticus that hasn’t responded to initial treatments.
Who can participate:
- Adults older than 18 years
- Patients with EEG-verified non-convulsive status epilepticus according to the Salzburg criteria (EEG is a test that measures electrical activity in the brain)
- Patients with clear status epilepticus with minor motor symptoms after a generalized tonic-clonic seizure
- Those who have not responded to appropriate treatment with benzodiazepines and at least one second-line intravenous anti-epileptic medication, including levetiracetam, fosphenytoin, or valproate
Who cannot participate:
- Patients not experiencing status epilepticus
- Those not in the specific age range being studied
- People not part of the specific clinical trial group being studied
What the study involves:
Participants are randomly assigned to one of two treatment groups. One group receives fast sedation with propofol or midazolam in an intensive care setting, while the other receives high-dose intravenous anti-seizure medications (which may include levetiracetam, sodium valproate, fosphenytoin sodium, topiramate, lacosamide, or brivaracetam) in a hospital ward. The patient’s condition is monitored for 24 hours to assess treatment effectiveness. The study tracks various outcomes including whether seizures continue after 24 hours, any new neurological issues, length of hospital stay, and survival rates at 3, 6, 12, and 24 months after treatment begins.
Study medications: Propofol and midazolam are sedative medications that help calm the brain and reduce seizure activity by enhancing the activity of GABA, a neurotransmitter that inhibits nerve transmission in the brain. The anti-seizure medications work by stabilizing electrical activity in the brain to prevent seizures. This trial aims to determine which approach is more effective for managing this serious condition.
Summary
Three clinical trials are currently underway to advance treatment options for absence epilepsy. Two of these studies focus specifically on brivaracetam, a newer anti-epileptic medication, and are being conducted in multiple European countries including Slovakia, Romania, Spain, and Italy. The first brivaracetam study is evaluating its effectiveness as a standalone treatment for childhood and juvenile absence epilepsy in patients aged 2 to 25 years, while the second is examining its long-term safety over up to 36 months in patients who participated in earlier trials.
The third trial, conducted in Denmark, takes a different approach by studying treatment strategies for status epilepticus, a severe form of prolonged seizures. This study compares rapid sedation methods using propofol or midazolam against high-dose anti-seizure medication combinations in intensive care settings.
The concentration of research on brivaracetam suggests growing interest in this medication as a potential treatment option for absence seizures, particularly as a monotherapy. The variety of study designs—from initial effectiveness testing to long-term safety monitoring—indicates a comprehensive approach to understanding this treatment option. These studies are particularly important as they include younger patients, an age group that requires careful evaluation of both effectiveness and safety when introducing new medications.