Ongoing Clinical Trials for Epilepsy
There are currently 12 clinical trials exploring new treatments for epilepsy, focusing primarily on drug-resistant forms of the condition and rare genetic disorders. These studies investigate various medications including cannabidiol, clioquinol, levetiracetam, perampanel, sirolimus, ganaxolone, and novel imaging techniques. Trials are taking place across multiple European countries including the Netherlands, Italy, Belgium, Poland, France, Spain, Germany, Greece, Czechia, Hungary, Romania, and Bulgaria.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- France
- Study on the Effectiveness and Safety of Perampanel for Children with Epilepsy
- Evaluation of 18F-DPA-714 PET-MRI imaging for locating epileptic focus in patients with drug-resistant partial epilepsy before surgery
- Study on Ganaxolone for Children and Adults with Epilepsy Related to Tuberous Sclerosis Complex
- Germany
- Greece
- Hungary
- Italy
- Study on Cannabidiol for Reducing Seizures in Children and Young Adults with Severe Epilepsy Associated with Rare Diseases
- Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy
- Study on Ganaxolone for Children and Adults with Epilepsy Related to Tuberous Sclerosis Complex
- Netherlands
- Poland
- Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy
- Study on the Effectiveness and Safety of Sirolimus for Patients with Drug-Resistant Epilepsy Linked to Tuberous Sclerosis Complex
- Study on the Safety and Effectiveness of Sirolimus and Vigabatrin for Preventing Symptoms in Infants with Tuberous Sclerosis Complex
- Study on the Safety and Effectiveness of Sirolimus for Treating Drug-Resistant Epilepsy in Children with Rare Brain Disorders Linked to mTOR Pathway Activation
- Romania
- Spain
Study on Cannabidiol and Dronabinol for Children with Refractory Epilepsy
This trial is investigating TA-CBD 10, an oral liquid containing two cannabis-derived substances: dronabinol and cannabidiol. The study focuses on children aged 1 to 18 years with refractory epilepsy, a type that does not respond well to standard treatments.
Main inclusion criteria: Children must have a confirmed diagnosis of refractory epilepsy and must have experienced at least four countable seizures during a four-week period before the study. All current anti-seizure medications must have been at stable doses for at least one month. A caregiver must be available to provide reports during the study.
Main exclusion criteria: Children who are not diagnosed with refractory epilepsy, are outside the specified age range, cannot follow study procedures, have other interfering medical conditions, are pregnant or breastfeeding, are participating in another clinical trial, or have a history of substance abuse or allergies to the study medication cannot participate.
Study focus: The main goal is to compare the effectiveness of TA-CBD 10 with a placebo in reducing seizure frequency. The study will also monitor various aspects of the children’s health and behavior, including sleep patterns and any side effects.
Investigational drug: Cannabidiol (CBD) is being studied as an additional treatment to see if it can help reduce the frequency or severity of seizures in children with treatment-resistant epilepsy.
Study on Cannabidiol for Reducing Seizures in Children and Young Adults with Severe Epilepsy Associated with Rare Diseases
This trial is testing Epidyolex 100 mg/ml, an oral solution containing cannabidiol (CBD), for severe epilepsy associated with rare diseases in children and young adults aged 2 to 25 years.
Main inclusion criteria: Participants must have rare disease-associated severe epilepsy recognized by the National Health System, experience at least 4 motor seizures per month, and have tried at least 2 anti-seizure medications with current treatment being stable for the last 4 weeks. Parents or caregivers must be willing to keep a diary and follow the study schedule.
Main exclusion criteria: Individuals without epilepsy, not currently taking anti-seizure medications, not in the specified age group, or not having severe epilepsy associated with a rare disease cannot participate.
Study focus: The study aims to determine if adding cannabidiol can help reduce the number and severity of seizures. It will also assess safety, tolerability, and interactions with other medications over a 24-week treatment period.
Investigational drug: Cannabidiol is used as an additional treatment to see if it can help reduce seizures when used alongside existing medications.
Study on Clioquinol for Reducing Seizures in Patients with Drug-Resistant Epilepsy
This Belgian trial is investigating Clioquinol, taken as an oral suspension, for patients aged 12 to 35 years with drug-resistant epilepsy.
Main inclusion criteria: Participants must have drug-resistant epilepsy with at least four seizures in a two-week period, be between 12 and 35 years old, have failed at least two anti-epileptic drugs, and currently be using a maximum of three anti-epileptic drugs.
Main exclusion criteria: Individuals without drug-resistant epilepsy, outside the specified age range, or belonging to vulnerable populations cannot participate.
Study focus: The primary goal is to determine the percentage of patients who experience a 50% reduction in seizure frequency after treatment. The study will also monitor safety through systematic recording of adverse events.
Investigational drug: Clioquinol is being studied as an add-on treatment to see if it can help reduce the frequency and severity of seizures.
Study on the Effectiveness and Safety of Levetiracetam XR for Patients with Drug-Resistant Partial Onset Epilepsy
This multi-country trial (Italy, Poland, Bulgaria, Romania, Germany, Greece, Czechia, Spain, Hungary) is comparing Levetiracetam XR (extended-release) with the immediate-release form and a placebo for drug-resistant focal onset seizures.
Main inclusion criteria: Participants must be between 12 and 80 years old (with variations by country), have a diagnosis of epilepsy with focal-onset seizures, be on stable doses of anti-seizure medication for at least 4 weeks, and have drug-resistant seizures confirmed by at least 6 seizures during an 8-week observation period.
Main exclusion criteria: Individuals without refractory partial onset epilepsy or focal onset seizures, outside the specified age range, or part of vulnerable populations may be excluded.
Study focus: The study aims to assess if Levetiracetam XR can reduce weekly seizure frequency compared to baseline during a 12-week treatment period. The trial will also evaluate quality of life and patient satisfaction.
Investigational drugs: Both Levetiracetam Extended Release (taken once daily) and Levetiracetam Immediate Release are being compared.
Study on the Effectiveness and Safety of Perampanel for Children with Epilepsy
This trial across Belgium, Germany, Spain, and France is testing perampanel (available as 2 mg film-coated tablet and 0.5 mg/ml oral suspension) in children from 1 month to less than 18 years old.
Main inclusion criteria: Participants must have a diagnosis of childhood epilepsy, have experienced at least 4 seizures in the 4 weeks prior to the second visit, and be on stable doses of 1 to 4 approved antiepileptic drugs. For younger participants, babies must have been born at least 36 weeks after conception.
Main exclusion criteria: Children with a different type of epilepsy than being studied, outside the specified age range, unable to follow study procedures, with other serious health conditions, currently in another trial, with recent medication changes, pregnant or breastfeeding, or with allergies to the study medication cannot participate.
Study focus: The study aims to evaluate effectiveness and safety of perampanel when used alongside other antiepileptic medications, with a goal of achieving at least a 50% reduction in seizures over a 28-day period during the study, which lasts up to 52 weeks.
Investigational drug: Perampanel is given orally in addition to current medications to help control seizures.
Study on the Effectiveness and Safety of Sirolimus for Patients with Drug-Resistant Epilepsy Linked to Tuberous Sclerosis Complex
This Polish trial is investigating Rapamune 1 mg/mL oral solution (sirolimus/rapamycin) for drug-resistant epilepsy in individuals aged 3 months to 55 years with Tuberous Sclerosis Complex (TSC).
Main inclusion criteria: Participants must have a confirmed diagnosis of TSC, drug-resistant epilepsy related to TSC with at least 8 seizures in 4 weeks despite medication, be between 3 months and 55 years old, weigh at least 6 kilograms, and have proper nutritional status.
Main exclusion criteria: Individuals without tuberous sclerosis complex, without TSC-related epilepsy or organ tumors, outside the age range, unable to take the medication safely, pregnant or breastfeeding, with other serious health conditions, or currently in another trial cannot participate.
Study focus: The study aims to evaluate safety and effectiveness of rapamycin compared to placebo in reducing seizures, with assessment of at least a 50% reduction in seizures during the last month of treatment compared to the screening phase.
Investigational drug: Rapamycin is being tested for its potential to help manage drug-resistant epilepsy in patients with TSC.
Study on the Safety and Effectiveness of Sirolimus and Vigabatrin for Preventing Symptoms in Infants with Tuberous Sclerosis Complex
This Polish trial is comparing Rapamune (sirolimus) and Sabril (vigabatrin) for preventing symptoms in infants up to 16 weeks old with Tuberous Sclerosis Complex (TSC).
Main inclusion criteria: Infants must be between 41 to 56 weeks from expected birth, have a definite diagnosis of TSC using specific guidelines, have at least one area of cortical dysplasia found on a brain MRI, and parents or caregivers must be willing and able to consent and follow study requirements.
Main exclusion criteria: Patients without TSC, without TSC-associated epilepsy or tumors, who are not infants, or not part of the selected vulnerable population cannot participate.
Study focus: The study aims to determine safety and effectiveness of both medications in preventing seizures and other TSC symptoms, including assessment of seizure occurrence, tumor volume changes, developmental outcomes, and risk of autism over a period up to two years.
Investigational drugs: Vigabatrin (500 mg oral solution) and Rapamycin (1 mg/mL oral solution) are both being tested to see if they can prevent seizure onset in infants with TSC.
Study on the Safety and Effectiveness of Sirolimus for Treating Drug-Resistant Epilepsy in Children with Rare Brain Disorders Linked to mTOR Pathway Activation
This Polish trial is evaluating Rapamune 1 mg/mL oral solution (sirolimus) for children aged 4 months to 18 years with drug-resistant epilepsy linked to mTORopathies.
Main inclusion criteria: Participants must be between 4 months and 18 years old, have drug-resistant epilepsy with focal onset and confirmed or suspected mTORopathy (such as focal cortical dysplasia or hemimegalencephaly) on MRI, and have had at least 8 seizures in the 4 weeks before joining. Legal caregivers must provide informed consent, and sexually active participants of reproductive age must agree to use effective contraception.
Main exclusion criteria: Individuals without epilepsy or related conditions like mTORopathies, focal cortical dysplasia, or LEATS, outside the age range of 2 to 18 years, or not part of a vulnerable population are excluded.
Study focus: The study aims to assess safety and tolerability of rapamycin, with a goal of achieving at least a 50% reduction in seizures. Secondary assessments include severity of adverse reactions and impact on quality of life.
Investigational drug: Rapamycin is being studied for managing drug-resistant epilepsy in children with rare central nervous system disorders linked to the mTOR pathway.
Evaluation of 18F-DPA-714 PET-MRI imaging for locating epileptic focus in patients with drug-resistant partial epilepsy before surgery
This French trial is using 18F-DPA-714, a radioactive imaging substance given through intravenous injection, for patients aged 12 and older with drug-resistant epilepsy being considered for surgery.
Main inclusion criteria: Participants must have drug-resistant epilepsy (continuing after trying two different properly administered treatments), be 12 years of age or older, have undergone pre-surgical assessment showing need for SEEG (stereoelectroencephalography), and have partial epilepsy (seizures starting in one specific brain area).
Main exclusion criteria: Patients under 12 years old, without drug-resistant epilepsy, not candidates for SEEG, pregnant or breastfeeding, with previous brain surgery, unable to undergo PET imaging, unable to provide informed consent, with known allergies to the study medication, participating in other trials, or with severe interfering medical conditions cannot participate.
Study focus: The study aims to determine how helpful this advanced imaging method is in identifying the precise location of seizure-causing brain tissue before surgery. The imaging combines PET scanning (using 18F-DPA-714 to show areas of inflammation) with MRI (providing detailed brain structure pictures) to help surgeons better plan SEEG electrode placement.
Investigational substance: 18F-DPA714 is a radioactive tracer that helps visualize brain inflammation by binding to activated immune cells often present in seizure-starting areas.
Long-Term Safety Study of Lacosamide for Children with Epilepsy
This trial in Hungary and Romania is studying long-term use of lacosamide syrup in children under 6 years old who have completed previous lacosamide studies.
Main inclusion criteria: Participants must be younger than 6 years old at the time of consent, have completed participation in one of the previous studies (NCT01964560 or NCT00938912), and be expected to benefit from participation according to the study doctor.
Main exclusion criteria: Children who have not completed the specified previous studies, are outside the age range, are not diagnosed with epilepsy, cannot take the oral solution form, have interfering medical conditions, or cannot follow study procedures are excluded.
Study focus: The study aims to evaluate the long-term safety and tolerability of lacosamide, monitoring for any side effects or adverse events while determining the most suitable daily dose (ranging from 2 to 12 mg/kg/day) for long-term use.
Investigational drug: Lacosamide helps control seizures by affecting electrical signal transmission in the brain, potentially reducing seizure frequency and severity.
Summary
The current landscape of clinical trials for epilepsy shows a strong focus on drug-resistant forms of the condition, with 12 ongoing studies across Europe. A notable concentration of trials is taking place in Poland, which hosts four studies, particularly focusing on sirolimus for various forms of treatment-resistant epilepsy associated with genetic conditions.
Several medications are receiving significant attention in these trials. Cannabidiol appears in two studies, exploring its potential for refractory epilepsy in children. Sirolimus (rapamycin) is being investigated in four separate trials, primarily for epilepsy linked to Tuberous Sclerosis Complex and mTOR pathway disorders. This suggests growing interest in targeting specific molecular pathways underlying certain types of epilepsy.
The trials demonstrate diversity in approaches, ranging from traditional pharmaceutical interventions to innovative imaging techniques. One French study is exploring advanced PET-MRI imaging using 18F-DPA-714 to better locate seizure-causing areas before surgery, representing a diagnostic rather than therapeutic approach.
Age ranges vary widely across studies, with some focusing specifically on infants and young children, while others include adolescents and adults up to 80 years old. Several trials are investigating treatments for rare genetic conditions such as Tuberous Sclerosis Complex and mTORopathies, addressing significant unmet medical needs in these populations.
Most studies are designed to assess both effectiveness and safety, with primary outcomes typically measuring seizure reduction of at least 50% compared to baseline. The international scope of these trials, spanning multiple European countries, reflects collaborative efforts to advance treatment options for patients with challenging forms of epilepsy.
