A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures

NCT06967012 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2024-K171-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does the frequency of epileptic seizures decrease after oral zonisamide， and does it improve cognitive function?
2. 2.Are there any treatment-emergent adverse events associated with oral administration of zonisamide?

Conditions

Epilepsies, Partial; Epilepsy, Tonic-Clonic

Keywords

Zonisamide; Epilepsies, Partial; Epilepsy, Tonic-Clonic

Outcome Measures

Primary Outcomes (2)

• Primary Observational Indicators

  Change in seizure frequency: The reduction in seizure frequency over an average of four weeks during the maintenance period, compared with the retrospective baseline period, in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures.

  Week 0±7day, Week 8±7day, Week 20±7day

• Primary Observational Indicators

  ≥50% response rate: The proportion of subjects achieving a ≥50% reduction in the average four-week seizure frequency during the maintenance period compared to the retrospective baseline period in patients with focal epilepsy with or without secondary generalized tonic-clonic seizures.

  Week 0±7day, Week 8±7day, Week 20±7day

Secondary Outcomes (10)

• Secondary Observational Indicators

  Week 0±7day, Week 8±7day, Week 20±7day

• Safety Evaluation

  Week 0±7day, Week 8±7day, Week 20±7day

• Safety Evaluation

  Week 0±7day, Week 8±7day, Week 20±7day

• Safety Evaluation

  Week 0±7day, Week 8±7day, Week 20±7day

• Safety Evaluation

  Week 0±7day, Week 8±7day, Week 20±7day

Study Arms (1)

Monotherapy and add-on therapy

EXPERIMENTAL

Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. Participants weighing ≥50 kg receive adult-equivalent dosing.

Drug: Oral Zonisamide Therapy

Interventions

Oral Zonisamide Therapy DRUG

Zonisamide tablets are administered orally with the following dosage schedule: Weeks 1-2: 2 mg/kg/day, Weeks 3-4: 4 mg/kg/day, Weeks 5-6: 6 mg/kg/day. After the initial six weeks, the dosage is adjusted based on the patient's condition, with weekly increments of 1 mg/kg/day. The maintenance dose ranges from 4 to 6 mg/kg/day, administered in 1-2 divided doses daily. For children weighing ≥50 kg, the adult dosage should be used.

Monotherapy and add-on therapy

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify 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 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.

You may not qualify 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.
• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

RECRUITING

Related Publications (1)

• Cho D, Yu MS, Shin J, Lee J, Kim Y, Kang HC, Kim SH, Na D. A computational clinical decision-supporting system to suggest effective anti-epileptic drugs for pediatric epilepsy patients based on deep learning models using patient's medical history. BMC Med Inform Decis Mak. 2024 May 31;24(1):149. doi: 10.1186/s12911-024-02552-w.

  PMID: 38822293 BACKGROUND

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy, Tonic-Clonic

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized

Central Study Contacts

youjia Y Wu, Doctorate

CONTACT

13962969655; francis_nt@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: May 13, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: May 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)