Phase 3 Epilepsy Trial, Terminated

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:

• You are male or female and between 12 and 65 years old
• You have had at least 8 days with myoclonic seizures (sudden, brief muscle jerks) over a 2-month period, as part of a type of epilepsy called Idiopathic Generalised Epilepsy (IGE)
• You (or your parent/caregiver if you are under the age of consent) are willing to sign a consent form agreeing to take part
• You have been taking one or two epilepsy medications at a stable dose for at least two weeks before the first study visit
• A doctor has diagnosed you with a type of generalised epilepsy that includes myoclonic seizures, confirmed through medical history, a brainwave test (EEG), and a brain scan (CT or MRI)
• You have had a brain scan (CT or MRI) within the last five years, or one will be done during the study's baseline period
• You have had a brainwave test (EEG) within the last year, or one will be done during the study's baseline period
• If you are female, you are either before your first period, past menopause, or not currently pregnant or breastfeeding
• If you are female, aged 18 or over, and could become pregnant, you agree to use an approved form of contraception throughout the study; if you are under 18 and could become pregnant, you agree to abstain from sex or use an approved form of contraception

Who may not be able to join:

• You have a progressive or localised brain disease, or another significant physical illness
• You have a history of, or test results suggesting, a certain type of seizure called a partial (focal) seizure
• Your epilepsy is thought to have an unknown or identifiable physical cause (rather than being idiopathic/genetic)
• You have seizures that are psychological rather than neurological in origin
• You have had a serious prolonged seizure episode (convulsive status epilepticus) within the past year while taking epilepsy medication
• You have a history of kidney stones or poor kidney function
• You have been diagnosed with HIV, hepatitis B, or hepatitis C
• You have a condition that could affect how your body absorbs or processes medication (confirm with trial site)
• You have a known allergy or sensitivity to sulfonamide drugs, zonisamide, or any of its ingredients
• You have a recent history of excessive alcohol use or drug misuse
• You have made a suicide attempt in the past five years
• Your blood or other lab test results from screening are abnormal in a medically significant way
• You have a history of not following treatment plans, or it is expected you may not be able to complete the study
• You have taken part in another trial of an experimental drug or device within the last 30 days
• You have previously been treated with the study drug, zonisamide
• You are currently on a ketogenic diet or using a vagus nerve stimulator
• You regularly need emergency benzodiazepine medication for seizures and this is expected to continue during the study
• You are currently taking certain other medications, including acetazolamide, topiramate, or drugs with anticholinergic effects (confirm specific medications with trial site)
• You currently have psychosis or moderate-to-severe depression, or have taken certain psychiatric medications (such as antipsychotics, MAOIs, tricyclic antidepressants, stimulants, or barbiturates for non-epilepsy reasons) within the past 28 days
• You are currently taking, or have taken in the past two months, a drug called felbamate
• You are unable to swallow capsules
• You are not considered to be in generally good health based on your medical history, physical exam, and screening test results

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