Phase 3 Epilepsy Trial, Recruiting

Written by an AI model from 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 12 or older with a body mass index (BMI) of 40 or below at the first visit
• People who have tried at least 2 anti-seizure medicines at proper doses without becoming seizure-free
• People who have had a specific type of seizure called primary generalised tonic-clonic seizures (with or without other generalised seizure types) for at least 1 year, as part of a diagnosed generalised epilepsy — and whose case has been reviewed and approved by the Epilepsy Study Consortium
• People who have been on a steady dose of 1 to 3 approved anti-seizure medicines for at least 3 months before the study starts, and who are able to continue that stable dose throughout the trial
• People who are able to keep an accurate daily diary recording their seizures
• People who have experienced a sufficient number of qualifying seizures in the 56 days leading up to the randomisation visit, including at least one in each of the two 4-week periods before that visit
• People who have completed the electronic seizure diary on at least 80% of the required days during the baseline period before randomisation
• People who have not changed, stopped, or started any anti-seizure medicines in the 3 months before randomisation and who plan to keep their dose stable during the study
• People who give written consent before entering the study (for those under 18, a parent or legal guardian must also provide written consent or assent)

Who may not be able to join:

• People who have had a prolonged seizure episode (status epilepticus) in the 12 months before the first visit
• People who have had clusters of seizures in the past 12 months where individual seizures could not be counted separately
• People who have had seizures caused by psychological rather than neurological reasons (non-epileptic psychogenic seizures) within the past 10 years
• People who have also been diagnosed with focal-onset seizures (seizures that start in one specific part of the brain)
• People who have, or have had, a condition involving both a developmental disorder and epilepsy together, including Lennox-Gastaut syndrome
• People whose seizures are caused by drug or alcohol use, infection, tumours, nerve damage, degenerative brain conditions, metabolic conditions, or other progressive brain diseases
• People who have had brain surgery for seizures within 1 year before the first visit, or a type of radiation-based brain treatment within 2 years before the first visit
• People with schizophrenia, psychotic disorders, bipolar disorder, or other serious mental health conditions — or people with uncontrolled major depression where changes to medication are expected during the study
• People with significant abnormalities in lab results, physical examination, vital signs, or heart tests (ECG) that the doctor believes would make participation unsafe — including a history or presence of a heart rhythm condition called long QT syndrome, a specific ECG measurement above a certain threshold, or a family history of sudden unexplained death
• People whose personal circumstances, in the opinion of the investigator, would prevent them from following the study requirements

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