Phase 2 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 treatment-resistant epilepsy, as confirmed by a specialist epilepsy review group called the Epilepsy Study Consortium.
• People aged 18 to 70 years old at the time of screening.
• People who are able to read, understand, and sign a consent form — or who have a legally authorised representative who can do this on their behalf.
• People who are able to keep a daily diary tracking their seizures, with the help of a caregiver if needed.
• People whose body weight falls within a Body Mass Index (BMI) range of 18.0 to 40 kg/m² (from normal weight to obese range).
• People who are able to swallow capsules whole, without crushing, chewing, or cutting them.
• People who are willing and able to follow all study procedures and attend appointments within required timeframes.
• People whose epilepsy has not been controlled despite trying at least two different seizure medications at appropriate doses.
• People who are currently taking at least one seizure medication at the time of screening and baseline. If also following a special diet (such as a ketogenic diet) as part of their epilepsy treatment, the diet must have been stable for at least one month before screening.
• People who had at least 4 countable seizures during the 42-day baseline diary period, with no more than a 21-day stretch without any seizures during that time.
• People with a clinical diagnosis of Focal Cortical Dysplasia (FCD) Type I or Type II — a specific structural brain condition — confirmed either by brain imaging done within the last 5 years or by laboratory analysis of tissue removed during previous brain surgery, in people who continue to have uncontrolled seizures.
• People who are in generally good health, as assessed by the treating doctor based on medical history, physical examination, heart tracing (ECG), and blood/lab tests done during screening.
• People who are able to complete the study procedures. In some cases, people with limited ability to complete questionnaires or thinking-related assessments may still be considered, with approval from the study sponsor on a case-by-case basis.
• Women of childbearing potential who are not pregnant and who agree to use an accepted form of contraception starting 30 days before the first dose and for 30 days after the last dose. Accepted methods include: a condom used together with an intrauterine device (IUD), a surgically sterile male partner, a male and female barrier method used together, or an established hormonal contraceptive. Women who are postmenopausal (no periods for at least 2 years with a confirming hormone blood test) or who have had a sterilisation procedure (such as tubal ligation or hysterectomy) for at least 6 months are not required to use contraception.
• Men who agree to use two forms of contraception together if their female partner could become pregnant, from screening until 90 days after the last dose. Men who have been surgically sterilised for at least 6 months are exempt. Men must also agree not to donate sperm from the first dose until 90 days after the last dose. Men in same-sex relationships or whose partners cannot become pregnant must use a condom from the first dose until 7 days after the last dose.

Who may not be able to join:

• People who have taken huperzine A (a supplement) at any point in the past year.
• People who are pregnant, breastfeeding, planning to become pregnant or to father a child, or who are not using an accepted method of contraception.
• People who have been diagnosed with Lennox-Gastaut syndrome.
• People who experience non-epileptic events (such as non-epileptic seizures) that could be mistaken for epileptic seizures by the person themselves or by study staff.
• People whose seizures are difficult or impossible to count, for example because they have no visible outward signs.
• People whose seizure history consists only of seizure clusters (multiple seizures occurring within 30 minutes of each other).
• People who have experienced a prolonged seizure episode (status epilepticus) in the 6 months before screening.
• People who have changed their seizure medication in the 28 days before screening. No changes to seizure medication are permitted during the screening, dose adjustment, or main study period.
• People who have had a brain stimulation device (such as a vagus nerve stimulator, deep brain stimulator, or responsive neurostimulation device) implanted or switched on less than one year before screening, or whose stimulation settings have not been stable for at least 3 months. People who have had epilepsy brain surgery less than one year before screening are also not eligible.
• People who have had certain types of serious suicidal thoughts or behaviour in the 2 years before screening, or who have had more than one lifetime suicide attempt.
• People who have any condition that could affect their safety or ability to follow study procedures, based on what is known about the trial medication.
• People who have a pre-existing medical condition — including a progressive neurological disorder, brain tumour, active brain infection, or inflammation — or who take medications that the treating doctor believes would make participation unsuitable.
• People who have a significant current psychiatric condition — such as schizophrenia, schizoaffective disorder, or bipolar disorder — that would prevent meaningful participation.
• People who have a current or recent (within the past 2 years) history of alcohol or substance use disorder as defined by standard diagnostic criteria.
• People who have had clinically significant abnormal laboratory test results within 2 months before screening, as determined by the treating doctor.
• People who test positive for HIV, Hepatitis B, or Hepatitis C. People who test positive on a urine drug screen may also be excluded, with some exceptions: those diagnosed with cannabis use disorder within the past 6 months who test positive for cannabis will be excluded; recreational cannabis use may be permitted at the sponsor's discretion if kept consistent throughout the study, and use must stop 48 hours before study visits; cannabis prescribed as a medical treatment is allowed if the dose has been stable for at least 28 days before screening; positive results for other drugs (such as benzodiazepines or amphetamines) due to a valid prescription are generally not grounds for exclusion.
• People currently taking non-seizure medications that stimulate the brain's cholinergic system (confirm with trial site).
• People who are currently taking, or have taken within 3 days before the first dose, over-the-counter supplements containing a compound called EGCG (found in concentrated green tea extracts) or foods containing more than 100 grams of carob powder. Drinking more than 3 cups per day of green, white, oolong, or black tea is also not permitted within the same timeframe.
• People who have participated in another clinical trial of an investigational drug or device within 4 weeks before joining this study, or within 5 half-lives of that drug — whichever is longer.
• People who have clinically significant heart abnormalities on their ECG at screening, including a very slow or irregular heart rate, abnormal electrical intervals in the heart, or certain types of heart conduction problems, as assessed by the treating doctor.
• People who have poor kidney function, specifically an estimated kidney filtration rate (eGFR) below 60 mL/min at screening.
• People with significantly abnormal blood pressure or heart rate readings at screening (blood pressure outside the range of 90–140 mmHg systolic or 50–90 mmHg diastolic, or heart rate outside the range of 50–100 beats per minute).
• People who have had more than 2 allergic reactions to a seizure medication, or 1 serious allergic reaction to a seizure medication.
• People who have donated 50–499 mL of blood within the past 30 days, or more than 499 mL within the past 56 days. People with low haemoglobin or haematocrit (red blood cell levels) below specified thresholds at screening are also not eligible.
• People who, in the treating doctor's opinion, should not participate for any other reason.

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