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 who have been diagnosed with focal onset epilepsy (a type of epilepsy where seizures start in one specific area of the brain), according to a recognised international classification system.
• People who have had a brain scan (CT or MRI) in the past that ruled out a progressive or worsening underlying cause of their epilepsy, in the opinion of the investigating doctor.
• People who have been taking a stable dose of 1 to 3 approved anti-seizure medicines for at least 4 weeks before the screening stage of the trial begins.
• People who have had at least 4 countable focal onset seizures in the 4 weeks before joining the trial, with no more than 21 consecutive seizure-free days during that period.
• People who have kept a seizure diary on at least 80% of days during the observation period before joining the trial.

Who may not be able to join:

• People who, in the 12 months before joining, have had non-epileptic (psychogenic) seizures, seizures that occur in clusters too close together to count individually, a severe prolonged seizure requiring hospitalisation and breathing support (intubation), or seizures caused by illicit drug or alcohol use.
• People whose seizures are caused by an ongoing condition such as an active infection, a tumour, a disease affecting the nervous system's protective covering, a progressive degenerative disease, a worsening metabolic illness, a growing structural brain lesion, or a brain disorder affecting overall function.
• People whose previous brain wave test (EEG) showed a pattern that is not consistent with seizures starting from a single focal area of the brain.
• People who are planning to have epilepsy surgery during the trial period.
• People who have had brain surgery for seizures within the past year, a type of radiation treatment for the brain within the past 2 years, a nerve stimulation device implanted within the past year, or a nerve stimulation device implanted more than a year ago whose settings have not been stable for at least 2 months before the screening stage.
• People who have had active thoughts of suicide or a plan to end their life in the past 6 months, a suicide attempt in the past 2 years, or more than one suicide attempt at any point in their life, as assessed using a standardised questionnaire.
• People who have any significant ongoing illness, disorder, abnormal laboratory results, alcohol or drug dependence, or a recent or ongoing psychiatric, medical, or surgical condition.
• People who have had a cancer, blood cell disorder, or lymph system disorder within the past 3 years.
• People who have a history of or currently have uncontrolled heart conditions, including problems with heart rhythm or heart structure.
• People whose blood test results show certain liver-related values above acceptable levels (specifically, total bilirubin more than 1.5 times the upper limit of normal, or liver enzyme levels ALT or AST more than 3 times the upper limit of normal).
• People who have or have had an HIV infection, or who test positive for HIV antibodies at screening, or who show signs of active hepatitis B or hepatitis C infection based on screening tests.
• People who have taken part in another clinical trial or used an experimental drug, device, or treatment within 30 days or 5 half-lives (whichever is longer) before screening, or who have ever had gene or cell therapy.
• People who have taken the anti-seizure medicine vigabatrin in the past 5 years, unless their visual fields have been tested and shown to be stable on two occasions in the 12 months following their last dose.
• People currently taking felbamate (another anti-seizure medicine) who have not been on it for at least 2 years with a stable dose for at least 2 months before screening; or people who previously took felbamate but stopped less than 2 months before screening.
• People who have had a serious allergic reaction to an anti-seizure medicine, including severe skin reactions (such as Stevens-Johnson syndrome), blood-related reactions, or reactions affecting internal organs.
• People who are pregnant, breastfeeding, have a positive pregnancy test at screening, or are planning to become pregnant during the trial or before the end-of-study visit.
• People who have previously been exposed to the study drug vormatrigine, or who are known to be allergic to any ingredient in the vormatrigine formulation.

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