Phase 2 Epilepsy Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 16 to 75 years at the time of giving consent
• People who have been diagnosed with genetic generalised epilepsy that includes absence seizures, based on established international classification guidelines
• People whose brain activity scan (EEG) shows a specific pattern of electrical bursts, lasting 3 seconds or more, at least 4 times during a 72-hour recording taken before the trial
• People who have been taking at least one seizure medication at a stable dose for at least 30 days (or who have had a vagal nerve stimulator at stable settings for at least 30 days, without using the handheld magnet)
• People who have normal thinking and memory abilities, with no significant findings on a neurological examination, in the opinion of the trial doctor
• People who are otherwise in good general health, apart from their epilepsy, based on their medical history, physical examination, and lab tests
• People with a body mass index (BMI) between 18 and 40 kg/m²
• Women who could become pregnant, and all men, who agree to use highly effective contraception during the trial and for 28 days after the last dose of the study medication
• People who are able to communicate clearly with the trial team and follow all study requirements, including attending scheduled visits (and their parent or caregiver, where applicable)
• For participants under 18, a parent or legal guardian must be willing and able to provide signed consent on their behalf

Who may not be able to join:

• People whose seizures are caused by a metabolic condition, a mitochondrial disorder, a structural brain abnormality, or an infection
• People who have a developmental epileptic encephalopathy, such as Lennox-Gastaut syndrome
• People who have had a prolonged convulsive seizure episode (convulsive status epilepticus) within the past year
• People who have had brain surgery to treat epilepsy
• People who have a history of seizures that are not caused by epilepsy (for example, seizures related to metabolic or structural causes, or non-epileptic episodes)
• People with a severe intellectual disability, severe autism, or a severe developmental condition that would prevent them from consenting or cooperating with the study
• Women who are pregnant or breastfeeding
• People with significant abnormal results on laboratory tests that, in the trial doctor's opinion, would make participation unsuitable
• People with an active brain or nervous system condition, such as an infection of the central nervous system, a disease affecting the nerve coverings, or a progressive neurological disease
• People with significant psychiatric illness or behavioural problems that, in the trial doctor's opinion, would interfere with participation — including anyone who has expressed active thoughts of suicide (as measured by a specific rating scale), or who has a lifetime history of a suicide attempt
• People with significant active liver disease, a condition called porphyria, or abnormal liver function test results more than three times the upper limit of normal — or a family history of severe liver problems
• People who have been diagnosed with alcohol or drug abuse or addiction in the past 12 months
• People who have taken part in another clinical trial involving an investigational treatment or device within 30 days before screening (or longer, depending on local requirements)
• People who are currently taking medications that are not permitted in this trial
• People who are unable to swallow four placebo capsules with at least 240 mL (eight ounces) of water during the screening visit
• People whose regular daily commitments would prevent them from attending all required study visits (including their parent or caregiver, where applicable)
• People who test positive for non-prescribed or illegal substances on a urine drug test at screening

Important: Always verify eligibility with the trial site directly before applying.