New liquid seizure medicine for kids under study
NCT ID NCT06534502
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests a liquid form of the seizure drug zonisamide in children aged 1 month to 17 years who have partial-onset seizures. The goal is to find the right dose and check for side effects. About 40 children will take the medicine for up to 12 weeks, with a follow-up visit one week later.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zonisamide oral suspension
- What this could lead to
- If successful, this could provide a child-friendly liquid dose of zonisamide to better control partial-onset seizures in children.
- What could go wrong
- This is a small Phase 4 study with only 40 children, so results may not apply to all. Side effects are possible, and the drug may not work for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 month to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria: 1. Voluntarily obtained informed consent from parent/legal guardian of the participant and assent from the participant, when appropriate. 2. Willing and able to follow protocol specific requirements. 3. Participant of 1 month to 17 years of age, inclusive (at time of consent). 4. Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against Epilepsy (ILAE) classification of seizures. Participants with both focal-onset and generalized-onset seizures are eligible, but only focal-onset seizures count toward baseline seizure enrollment criteria. Tonic-clonic and tonic seizures with unknown onset are presumed to be focal-onset unless there are clear clinical and EEG data suggesting generalized-onset. 5. Participant with seizure occurrence more than once in the past three (3) months and more than two (2) times in the past six (6) months. a. Participant who is 6 months of age and younger will have seizure profiling patterns assessed by the Investigator for appropriate consideration and inclusion in the study. 6. Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening a. Participant who is 6 months of age and younger will have regimen assessed for inclusion in the study at Investigator's discretion. 7. Participant with acceptable laboratory investigations: 1. Hemoglobin within normal range 2. Alanine aminotransferase (ALT) within normal range 3. Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN) 4. Bilirubin within normal range 5. Creatinine clearance within normal range 8. If male participant is able to father children must be willing to use a highly effective method of contraception for at least one month after the last dose of investigational product if at risk of pregnancy with her/his partner. If female participant has reached menarche, the participant is authorized to participate in this clinical study if additional criteria are met. At screening: 1. (i) Participant reports sexual abstinence for the prior 3 months or reports use of at least 1 of the acceptable methods of contraception, including an intrauterine device, barrier methods (e.g., male or female condom), hormonal contraceptives (e.g., hormonal patches, vaginal devices, oral pills), levonorgestrel intrauterine system (e.g., Mirena®), or regular medroxyprogesterone injections (e.g., Depo-Provera®); or (ii) Participant agrees to initiate sexual abstinence from the time of screening until at least one month after end of treatment with study drug; and 2. Participant is advised to avoid conception from the time of screening until at least one month after last receipt of study drug and agrees not to attempt pregnancy from the time of screening until at least one month after end of treatment with study drug; and 3. Participant is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and 4. Participant has a negative serum β-human chorionic gonadotropin (β-hCG) test just prior to study entry. Since serum tests may miss an early pregnancy, relevant menstrual history and sexual history, including methods of contraception, should be considered. Note: if the result of the serum β-hCG test cannot be obtained prior to dosing of investigational product, a participant may be enrolled on the basis of a negative urine pregnancy test, though a serum β-hCG test result must still be obtained. Exclusion Criteria: * Pediatric participant will be excluded from the study based on the following criteria: 1. Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides. 2. Participant who is pregnant or nursing. 3. Participant with exclusively generalized-onset seizures. 4. Participant with predisposition to nephrolithiasis or prior history of kidney stone(s). 5. Participant who is underweight (weight-for-age \<2 standard deviation (SD) from the median of the World Health Organization (WHO) Child Growth Standards) or have a decreased appetite. 6. Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide. 7. Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction. 8. Participant who has previously received zonisamide. 9. Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV). 10. Participant who has degenerative or metabolic disease of the brain. 11. Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment). 12. Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study. 13. Participant who has participated in other clinical study 30 days prior to enrollment in this study or 4-5 half lives of investigational drug, whichever is longer. 14. Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants. 15. Participant has a positive COVID-19 polymerase chain reaction (PCR) test result; or has had exposure (within 2 weeks prior to screening) to someone who had a positive COVID-19 test result; or is suspected of having long COVID-19 by the Investigator or designee. 16. Participant who is missing more than 15% of daily diary entries during the screening period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
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Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101, United States
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