A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Phase 1

• Conditions: Epilepsy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2016-004955-64-Outside-EU/EEA
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-21
• Last Update Posted: 8 May 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

1. Participants over 13 years old (complete the elementary school course).
2. Participants had at least two seizures in the past and at least one seizure for the last 3 months before screening.
3. Participants had no antiepileptic drugs for the last 4 months.
4. Women of childbearing age who agree to contraception for the duration of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 133
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 133
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 133

Exclusion Criteria

1. Pregnancy
2. Participants who have progressive neurologic disease
3. Allergy to sulfonamides
4. Use of acetazolamide within a year
5. Hemolytic anemia
6. Participants who have abnormal liver function (GOT or GPT) values more than twice the normal values.
7. Participants who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
8. Participants who have history of drug or alcohol abuse.
9. Participants with Glucose-6-phosphate dehydrogenase deficiency.
10. Participants who were detected with renal stones on Kidney-Ureter-Bladder (KUB) test.
11. Participants who have progressive internal or surgical disease.
12. Participants who have progressive psychiatric disease.
13. Participants who have mental retardation (IQ 70 and less).
14. Participants taking Vitamin C.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess seizure rates in the Zonisamide and Topiramate group ;Secondary Objective: Neuropsychological assessments and safety assessments;Primary end point(s): Percentage of Participants Who Were Seizure Free or Experienced Seizure Reduction at 24 Weeks;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Change From Baseline in the List Learning Subtest Scores<br>2. Change From Baseline in the List Recall and Delayed List Recall Subtest Scores<br>3. Change From Baseline in the Prose Memory Subtest Scores<br>4. Change From Baseline in List Recognition Subtest Score<br>5. Chang From Baseline in the Visual Reproduction Subtest Scores<br>6. Change From Baseline in the Immediate Visual Recognition Subtest Scores<br>7. Change From Baseline in the Delayed Visual Recognition Subtest Scores<br>8. Change From Baseline in the Verbal Span Subtest Scores<br>9. Change From Baseline in Visual Span Subtest Scores<br>10. Total Memory Quotient (MQ) Score<br>11. Change From Baseline in the Trail Making Test (TMT) Scores<br>12. Change From Baseline in Controlled Oral Word Association Test (COWAT) Scores<br>13. Change From Baseline in Finger Dominant and Finger Non-dominant Scores<br>;Timepoint(s) of evaluation of this end point: Baseline and Week 24