Phase 4 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 with epilepsy (who may receive the study drug):

• Adults aged 18 or older who have been diagnosed with focal-onset epilepsy (a type of epilepsy where seizures start in one area of the brain), confirmed by a specialist using medical history, brain imaging, and brainwave tests
• People who report having memory or thinking difficulties as a result of their epilepsy
• People whose seizure frequency has been stable enough that their doctor does not expect to need to change their epilepsy medications during the trial
• People who are able to live independently and carry out everyday tasks
• People who are able to read and speak English fluently
• People who are able to give informed consent to participate

People with epilepsy but no cognitive complaints (control group — no study drug):

• People who otherwise meet all the criteria listed above for people with epilepsy, but who do not report memory or thinking difficulties

Healthy volunteers (control group — no study drug):

• Adults aged 18 or older with no history of epilepsy or seizures
• People who are able to live independently and carry out everyday tasks
• People who are able to read and speak English fluently
• People who are able to give informed consent to participate

Who may not be able to join:

People with epilepsy (all groups):

• People who have seizures that are not truly epileptic (sometimes called psychogenic or non-epileptic spells)
• People who have experienced a state of sudden confusion or delirium in the past year
• People with a progressive brain condition, such as a malignant brain tumour (a stable, non-cancerous brain tumour that is not being treated with surgery would not automatically exclude someone — confirm with trial site)
• People with a history of alcohol or illicit drug misuse
• People who have had a generalised convulsive seizure within 48 hours, or a focal seizure with loss of awareness within 24 hours, of the cognitive testing session
• People who have had status epilepticus (a prolonged or repeated seizure emergency) within the past year
• People who have had brain surgery within the past 6 months
• People with an active suicide plan or intent in the past 6 months, a suicide attempt in the past 2 years, more than one lifetime suicide attempt, or a current high-risk suicide flag in their medical record
• People with a diagnosed psychotic disorder
• People with severe anxiety (as measured by a standard anxiety scale) or impulse control disorders
• People with an untreated sleep disorder
• People who have taken narcotic or sedating medications (such as diphenhydramine) within 6 hours of testing
• People with a serious ongoing medical illness, such as cancer requiring chemotherapy or surgery
• People who have had a prior stroke or mini-stroke (TIA)
• People diagnosed with dementia, such as Alzheimer's disease
• People with epilepsy and cognitive complaints whose score on a standard memory screening test (MoCA) is below 18
• People with epilepsy but no cognitive complaints whose MoCA score is below 26

Additional exclusions for people with epilepsy and cognitive complaints (who would receive the study drug):

• People who are currently pregnant or planning to become pregnant during the trial
• People who are breastfeeding
• People currently taking, or who have taken within the past 14 days, a type of medication called a monoamine oxidase inhibitor (MAOI)
• People with certain heart conditions, including structural heart abnormalities, cardiomyopathy, serious heart rhythm problems, coronary artery disease, or a history of heart attack, cardiac stent, bypass surgery, or angina
• People with a diagnosis of bipolar disorder
• People currently using medications for erectile dysfunction (such as tadalafil or sildenafil)
• People using medications that may lower the seizure threshold or trigger psychosis (such as tramadol, bupropion, or varenicline)
• People with a known allergy or intolerance to methylphenidate (the study drug)
• People with uncontrolled high blood pressure

Healthy volunteers:

• People with any history of seizures, epilepsy, or non-epileptic spells
• People diagnosed with dementia, or whose MoCA score is below 26
• People who have experienced delirium in the past year
• People with a progressive neurological condition, such as a malignant brain tumour
• People with a history of moderate or severe traumatic brain injury
• People with a mild traumatic brain injury within the past 6 months
• People with a history of alcohol or illicit drug misuse
• People with an active suicide plan or intent in the past 6 months, a suicide attempt in the past 2 years, more than one lifetime suicide attempt, or a current high-risk suicide flag in their medical record
• People with a psychotic disorder, severe anxiety, or impulse control disorder
• People with an untreated sleep disorder
• People who have taken narcotic or sedating medications within 6 hours of testing
• People with a serious ongoing neurological or medical illness, such as cancer requiring chemotherapy or surgery
• People who have had a prior stroke or mini-stroke (TIA)

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