SeizuresPhase 4NCT06534502
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
A Phase 4 study testing Zonisamide Oral Product in people with Seizures and Seizures, Focal, run by Azurity Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Seizures, Seizures, Focal, Seizure, Partial Onset
- What is being tested?
- Zonisamide Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria:
- Voluntarily obtained informed consent from parent/legal guardian of the participant and assent from the participant, when appropriate.
- Willing and able to follow protocol specific requirements.
- Participant of 1 month to 17 years of age, inclusive (at time of consent).
- 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.
- 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.
Show all 21Show fewer
- 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.
- Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening
- Participant who is 6 months of age and younger will have regimen assessed for inclusion in the study at Investigator's discretion.
- Participant with acceptable laboratory investigations:
- Hemoglobin within normal range
- Alanine aminotransferase (ALT) within normal range
- Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN)
- Bilirubin within normal range
- Creatinine clearance within normal range
- 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:
- (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
- 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
- Participant is provided guidelines regarding continuation of abstinence, initiation of abstinence, or about allowed contraception; and
- 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.
Who cannot join
- Pediatric participant will be excluded from the study based on the following criteria:
- Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.
- Participant who is pregnant or nursing.
- Participant with exclusively generalized-onset seizures.
- Participant with predisposition to nephrolithiasis or prior history of kidney stone(s).
- 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.
Show all 17Show fewer
- Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide.
- Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction.
- Participant who has previously received zonisamide.
- Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- Participant who has degenerative or metabolic disease of the brain.
- Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment).
- Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study.
- 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.
- Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants.
- 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.
- Participant who is missing more than 15% of daily diary entries during the screening period.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
James Wheless, MD
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27101
Gautam Popli, MBBS
About this study
Official title: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg/5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures
The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).
- Conditions
- Seizures, Seizures, Focal, Seizure, Partial Onset, Seizure Disorder, Partial, Seizure, Partial, Epilepsies, Partial
- Being tested
- Zonisamide Oral Product
- Keywords
- Partial-onset (focal) seizures, Pediatrics, ZONISADE, Zonisamide
- Medical subject headings
- Seizures, Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide Oral ProductDrug
Also called ZONISADE, Zonisamide oral suspension
Zonisamide oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide Oral Suspension | Experimental | Zonisamide Oral Suspension, 100 mg/5 ml administered orally twice daily
* Titration Period: 1 mg/kg/day administered as a divided dose of 0.5 mg/kg twice daily for 2 weeks, then increased by 1 mg/kg/day (as divided doses) at weekly intervals in Weeks 3 to 8.
* Maintenance Period: Up to 8 mg/kg/day given as a divided dose twice a day for 4 weeks (i.e., Weeks 9 to 12). Receives: Drug: Zonisamide Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of serum zonisamide
The concentration in serum of zonisamide following administration of zonisamide oral suspension, 100 mg/5 ml
Measured: Up to 15 weeks
Secondary outcomes (3)
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs), serious and non-serious, reported throughout the study.
Measured: Up to 15 weeks
Number and/or percentage of participants who discontinued the study because of adverse events
Number and/or percentage of participants who discontinued the study because of adverse events
Measured: Up to 15 weeks
Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.
Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azurity Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534502
- Sponsor's protocol ID
- AZ04.001
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No