Zonisamide for Partial Seizures
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and optimal dose of zonisamide, a liquid medicine, for children with partial-onset seizures. These seizures begin in one part of the brain and can sometimes spread. The trial seeks children who have experienced seizures more than once in the last three months and are already on stable epilepsy medication. Participants will undergo various treatment periods, including dose adjustments, to evaluate effectiveness and potential side effects. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial requires participants to be on a stable regimen of anti-epilepsy drugs for at least 30 days before screening, so you should not stop taking your current medications if they are part of this regimen.
What is the safety track record for zonisamide?
Earlier studies have shown that zonisamide is well-tolerated by adults with partial seizures. Some research indicates its effectiveness and safety in treating seizures. The FDA has approved zonisamide for adults, confirming it meets certain safety standards.
Zonisamide is often used alongside other seizure treatments, but limited safety information exists specifically for children. Since it is being tested in a Phase 4 trial, it has already passed earlier safety tests. This phase typically focuses on adjusting doses and confirming safety in larger groups.
Common side effects in adults include dizziness, sleepiness, or loss of appetite. Discuss any concerns with a healthcare provider before deciding to join the trial.12345Why are researchers enthusiastic about this study treatment?
Unlike the standard treatments for partial seizures, such as carbamazepine or valproate, Zonisamide offers a unique approach with its oral suspension form, which allows for flexible dosing. This can be especially beneficial for patients who struggle with swallowing pills, ensuring better adherence to the treatment. Additionally, Zonisamide has a distinct mechanism of action, as it works by blocking sodium channels and reducing abnormal electrical activity in the brain. Researchers are excited about its potential to provide a more tailored and potentially more effective treatment option for those with partial seizures.
What is the effectiveness track record for zonisamide in treating partial seizures?
Research has shown that zonisamide effectively treats partial seizures. In various studies, about 70% of patients experienced improvements, with many reducing their seizures by more than half. One study found that zonisamide significantly decreased seizure frequency and improved overall conditions in most cases. It is a well-tolerated treatment for managing partial seizures in both children and adults. This trial will evaluate zonisamide oral suspension, focusing on determining the optimal dose for young patients.36789
Who Is on the Research Team?
Evan Scullin, MD
Principal Investigator
Azurity Pharmaceuticals, Inc.
Are You a Good Fit for This Trial?
This trial is for children aged 1 month to 17 years with partial-onset seizures. They must be on a stable anti-epilepsy drug regimen for at least 30 days and have had more than one seizure in the past three months. Infants under six months are assessed individually. Participants need normal hemoglobin and liver enzyme levels, consent from guardians, and willingness to follow the study's protocol.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Titration
Participants receive zonisamide starting at 1 mg/kg/day, increasing weekly over 8 weeks
Maintenance
Participants receive up to 8 mg/kg/day of zonisamide for 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Zonisamide
Trial Overview
The study tests Zonisamide oral suspension's optimal dose, safety, and tolerability in young patients with epilepsy. It includes a two-week screening, eight weeks of dosage adjustments (titration), four weeks where the dose remains the same (maintenance), followed by one week of follow-up.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Azurity Pharmaceuticals
Lead Sponsor
Citations
Zonisamide – a review of experience and use in partial ...
In addition, zonisamide as monotherapy was effective in these trials, with 72% of patients experiencing greater than 50% seizure reduction compared with ...
Efficacy of zonisamide: our experience
Zonisamide was highly effective for treating partial seizures, with 70% of patients reporting improvement. More than half of patients with generalized seizures ...
The SANAD II study of the effectiveness and cost ...
For people with focal epilepsy, there is evidence that both levetiracetam and zonisamide have efficacy when used as monotherapy. However, the ...
Zonisamide | Neurology Clinical Practice
ZNS was associated with significant reductions in seizure frequency and overall improvements in 15 of 16 evaluated studies. In the existing ...
Evaluation of safety and efficacy of zonisamide in adult ...
This open label real-world study suggests that zonisamide is an effective and well-tolerated antiepileptic drug in Indian adults for treatment of partial, ...
SAFETY DATA SHEET ZONISAMIDE CAPSULES USP Pack ...
Zonisamide capsules are recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below ...
ZONEGRAN® (zonisamide) capsules, for oral administration
ZONEGRAN is indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. CONTRAINDICATIONS. ZONEGRAN is contraindicated in ...
Zonisamide | Anti-Seizure Medication
Zonisamide helps prevent brain cells from working as fast as a seizure requires them to. In this way, seizures can be stopped when they are just beginning.
9.
ema.europa.eu
ema.europa.eu/en/documents/product-information/zonegran-epar-product-information_en.pdfZonegran, INN-zonisamide - European Medicines Agency
Zonisamide prevents maximal electroshock seizures and restricts seizure spread, including the propagation of seizures from cortex to sub-cortical structures and ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.