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Tests treatment safety and results for Epilepsies, Partial
Official title A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
ClinicalTrials.gov ID: NCT06967012
What this study is testing
What is Oral Zonisamide Therapy?
Oral Zonisamide Therapy is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for epilepsies, partial.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study primarily aims to assess the efficacy and safety of zonisamide when used as an adjunctive therapy for focal epilepsy. The main questions it aims to answer are: 1.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 14. Healthy volunteers may be eligible.
You may be able to join if
- Consent to participate in the clinical trial, and the trial subject and/or legal guardian has signed the informed consent form.
- Age 1-14 years, no gender restrictions.
- Compliant with the diagnostic criteria for focal seizures and focal-to-bilateral tonic-clonic seizures as outlined by the International League...
- Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.
- ≥ 2 episodes of generalized tonic-clonic seizures （secondary to focal epileptic seizures) per 28-day interval during the 8-week retrospective...
You likely can't join if
- History of zonisamide treatment.
- History of allergy to sulfonamide drugs, zonisamide or any excipients.
- History of drug/alcohol abuse.
- History of suicide attempt or suicidal ideation within the past 6 months.
- Current use of antidepressants, anxiolytics, or antipsychotics.
- Diagnosed with progressive diseases affecting the brain and its functions.
See the full eligibility criteria
- Consent to participate in the clinical trial, and the trial subject and/or legal guardian has signed the informed consent form.
- Age 1-14 years, no gender restrictions.
- Compliant with the diagnostic criteria for focal seizures and focal-to-bilateral tonic-clonic seizures as outlined by the International League Against Epilepsy (ILAE) in 2017.
- Stable on one antiepileptic drug for ≥4 weeks, and deemed to be appropriate for the addition of zonisamide therapy by the investigator.
- ≥ 2 episodes of generalized tonic-clonic seizures （secondary to focal epileptic seizures) per 28-day interval during the 8-week retrospective baseline period.
- History of zonisamide treatment.
- History of allergy to sulfonamide drugs, zonisamide or any excipients.
- History of drug/alcohol abuse.
- History of suicide attempt or suicidal ideation within the past 6 months.
- Current use of antidepressants, anxiolytics, or antipsychotics.
- Diagnosed with progressive diseases affecting the brain and its functions.
- Psychogenic non-epileptic seizures.
- Diagnosed with severe pulmonary/hematologic diseases, malignant tumors, immunodeficiency, or psychiatric illnesses.
- Have undergone epilepsy brain surgery or plan to undergo epilepsy surgery within the next 4 months.
- Deemed to be unsuitable for participation in the trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nantong, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 14 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantong, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.