A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Phase 1

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

• Registration Number: EUCTR2016-004954-13-Outside-EU/EEA
• Lead Sponsor: Eisai Taiwan Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-24
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

•Participants must sign and date the informed consent form
•Clinical diagnosis as refractory epilepsy
•Male or female participants =16 and =70 years old
Are the trial subjects under 18? yes
Number of subjects for this age range: 60
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

•Progressive neurologic disease
•Serious psychiatric disease
•Hemolytic anemia
•Glucose-6-phosphate dehydrogenase (G6PD) deficiency
•Acute intermittent porphyrias
•Participants who have received study drugs (Zonisamide, Lamotrigine) in the past
•Drug or alcohol addiction
•Renal impairment (serum creatinine = 1.5 mg/dL), or hepatic abnormality (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x upper limit normal (ULN))
•Stevens-Johnson syndrome
•Progressive exfoliative dermatitis
•Pregnant, lactating or of childbearing potential female
•Regularly taking oral contraceptives
•Hypersensitivity to study drugs
•Severe cardiac disease (New York Heart Association Functional Class III and IV)
•History of malignancy within 5 years
•Participants who had received any investigational drugs (including any investigational
AEDs) within 1 month prior to screening
•Participants with simple partial seizures without motor component

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated participants with refractory simple partial, complex partial or partial with secondary generalized seizures.;Secondary Objective: Not applicable;Primary end point(s): Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline ;Timepoint(s) of evaluation of this end point: Baseline and 16 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period<br><br>Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period<br><br>Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline;Timepoint(s) of evaluation of this end point: Baseline and 16 weeks