Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

April 16, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Patients were first observed for a 4-week baseline period, which required no medication adjustments and a seizure frequency of greater than or equal to 2 times per 4-week . After the baseline observation period, if the patients met the criteria for enrolment and there were no contraindications, zonisamide was added as an additional therapeutic drug.Clinical data were collected before the initiation of treatment, at 1 month, 3 months and 6 months after taking zonisamide respectively, with regular review of blood tests and urinary ultrasound, and imaging and electrophysiological examinations according to the clinical needs of the patient's actual condition.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Before starting zonisamide treatment, a 4-week baseline observation period is required, which needs to meet the following criteria: no medication adjustment and at least 2 times of seizure per 4 weeks.
  2. If patients meet the criteria for the baseline period, after the baseline observation period, they are required to complete the blood routine, urine routine, renal function, liver function, ultrasound of the urinary tract, and scale completion (including the QOLIE-31 quality of life scale, GAD-7, C-NDDI-E, Pittsburgh sleep quality, and the Epworth Sleepiness Scale (ESS)) prior to initiating treatment. If the patient still meets the inclusion criteria, zonisamide may be added to the treatment, and the patient's seizures and medications prior to zonisamide treatment will be recorded.
  3. Outpatient follow-up and scale filling were carried out in the 1st, 3rd and 6th month of zonisamide treatment, and blood tests were reviewed in the first/third (according to the clinical situation) and sixth month, and urological ultrasound was reviewed in the sixth month, and imaging and electrophysiological examinations were carried out according to the clinical need in the light of the actual situation of the patients, and the changes of seizures and side effects during the medication period were recorded in detail.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Hangzhou, Zhejiang, China, 310005
        • Hangzhou Children's Hospital
        • Contact:
      • Huzhou, Zhejiang, China, 313002
        • Huzhou third people's Hospital
        • Contact:
      • Jiaxing, Zhejiang, China, 314099
        • Jiaxing Second Hospital
        • Contact:
      • Jinhua, Zhejiang, China, 321016
        • Jinhua Second Hospital
        • Contact:
      • Jinhua, Zhejiang, China, 322099
        • The Fourth Affilicated Hospital of Zhejiang University School of Medicine
        • Contact:
      • Lishui, Zhejiang, China, 323050
        • Lishui People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315048
        • Ningbo Medical Center Lihuili Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315012
        • Ningbo Women and Children's Hospital
        • Contact:
      • Yuyao, Zhejiang, China, 315499
        • Yuyao People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

As this is a real-world study,we prospectively enrolled patients with focal epilepsy who are suitable for taking zonisamide as an add-on medication

Description

Inclusion Criteria:

  1. Meet the International League Against Epilepsy 2017 diagnostic criteria for epilepsy; and the patient's seizures can be clearly classified as partial seizures according to the seizure classification proposed by the International League Against Epilepsy, including simple partial seizures, complex partial seizures, and secondary generalised seizures;
  2. Be greater than or equal to 2 years of age;
  3. Have been on antiepileptic medication, and during the 4-week period of the retrospective baseline period, the patient did not medication adjustments and had at least 2 seizures greater than or equal to 2 seizures per 4-week period;
  4. The patient demonstrated good compliance and was able to complete the scale assessment and record the epilepsy diary on his/her own or with the assistance of a parent;
  5. The informed consent form was signed and dated by the patient or a parent or legal guardian.

Exclusion Criteria:

  1. Patients who are allergic to zonisamide ;
  2. CT or MRI suggestive of progressive intracranial tumours;
  3. Severe mental retardation or severe psychiatric disorders;
  4. Patients suffering from serious underlying diseases that can affect brain function, such as heart disease, liver disease, renal disease, haematological disorders, malignant tumours, and patients who are immunocompromised;
  5. Ultrasound suggestive of renal stones 6) Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with focal epilepsy
who using zonisamide as an add-on anti-seizure drug
Drug: Zonisamide
This is a real-world study，so we prospectively enrolled patients with focal epilepsy suitable for taking zonisamide as an add-on medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective rate at 6 months of treatment
Time Frame: 6 months
Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effective rate at 3 months of treatment
Time Frame: 3 months
Effective definition: achievement of clinical seizure freedom or >50% reduction in seizure frequency
3 months
Total time to treatment failure
Time Frame: 6 months
Total time to treatment failure: number of days from initiation of zonisamide to decision to withdraw zonisamide/add new antiepileptic medication
6 months
Incidence of side effects
Time Frame: 6 months
Record the occurrence of side effects in patients and calculate the probability of each side effect occurring
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Ningbo Medical Center Lihuili Hospital
The Second Affiliated Hospital of Jiaxing University
Lishui Country People's Hospital
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Ningbo Women & Children's Hospital
Hangzhou Children's Hospital
Huzhou Third People's Hospital
Jinhua Second Hospital
Yuyao People's Hospital

Investigators

  • Principal Investigator: Shuang Wang, doctorate, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0246

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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