Phase 3 Epilepsy Trial, Terminated

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:

• You are male or female and between 6 and 65 years old.
• You have had at least 3 major generalized seizures (where the whole body is involved) in the two months before the study starts, with at least one seizure in each of those months.
• Your seizures are caused by a type of epilepsy called idiopathic generalized epilepsy (a form of epilepsy not caused by brain damage or another known condition).
• You (or your parent/caregiver if you are a child) are willing to sign a consent form agreeing to take part.
• You have been taking one or two epilepsy medications at a steady, unchanged dose for at least two weeks before the study begins.
• Your epilepsy diagnosis has been confirmed using brain scans (CT or MRI) and brainwave tests (EEG), with the brain scan done within the last five years.
• You have had a brainwave test (EEG) within the last year, or are able to have one done at the start of the study.
• If you are a female who could become pregnant, you are not currently pregnant or breastfeeding.
• If you are a female who could become pregnant, you agree to use an approved method of contraception throughout the study (such as the pill, injection, implant, patch, coil, vasectomised partner, or abstinence).
• You weigh at least 20 kg (approximately 44 lbs).

Who may not be able to join:

• You have a progressive brain disease or a condition affecting only one part of the brain, as shown on a brain scan done in the last five years.
• You have a history of, or test results suggesting, a certain type of seizure that starts in one part of the brain (called partial or focal seizures), including seizures that may have started locally before spreading.
• Your epilepsy is thought to have an unknown or identifiable underlying cause (called cryptogenic or symptomatic epilepsy).
• You have seizures that are caused by psychological rather than neurological reasons (psychogenic seizures).
• You have had a prolonged, dangerous seizure (status epilepticus) within the past year while taking your epilepsy medications as prescribed.
• Your seizures only happen in groups or clusters rather than as individual episodes.
• You have a history of kidney stones or kidney problems.
• 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 medicines or to zonisamide (the study drug).
• You have a recent history of heavy alcohol use or misuse of drugs.
• You have attempted suicide at any point in the five years before the study screening.
• Your blood test results at screening show values that are medically concerning.
• You have a history of not following treatment plans, or it is expected that you (or your caregiver) would not be able to follow the study requirements.
• You have taken part in another clinical trial involving an experimental drug or device within the last 30 days.
• You have previously been treated with zonisamide (the study drug).
• You are currently on a ketogenic diet or have a vagus nerve stimulator (a device implanted to help control seizures).
• You regularly need emergency benzodiazepine medicines (fast-acting sedatives used to stop severe seizures) and expect to continue needing them during the study.
• You currently have psychosis or moderate to severe depression, or have taken certain psychiatric medications (such as antipsychotics, MAOIs, tricyclic antidepressants, stimulants, or certain sedatives for non-epilepsy conditions) within the last 28 days.
• You are currently taking certain other medications that could interact with the study drug, including acetazolamide, topiramate, drugs with anticholinergic effects, or felbamate (confirm specific medications with trial site).
• You have used felbamate within the two months before the study starts.
• You are unable to swallow capsules.
• You are not in generally good health based on your medical history, physical examination, and blood test results.

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