A Multicenter Comparative Trial of Zonisamide and Topiramate as Monotherapy in Epilepsy Patients: Safety for cognitive function

Eisai Korea Inc.0 个研究点目标入组 133 人开始时间: 2017年4月21日最近更新: 2017年5月8日

适应症

试验速览

暂无简介。

•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

•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.

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