Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

NCT ID: NCT00327717

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2008-05-31

Brief Summary

The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).

Conditions

Partial Seizures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zonisamide 100 mg tablet

Group Type: EXPERIMENTAL

Zonisamide

Intervention Type: DRUG

Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in placebo group were titrated with placebo in the same way as in zonisamide group.

Interventions

Zonisamide

Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.

Intervention Type: DRUG

Placebo

Patients in placebo group were titrated with placebo in the same way as in zonisamide group.

Intervention Type: DRUG

Other Intervention Names

Zonegran

Eligibility Criteria

Inclusion Criteria

1. Adult male or female, 16 to 70 years old;

2. Classified according to the ILAE classification of seizure type (1981) and international classification of epilepsy and epileptic syndromes (ILAE, 1989) into partial seizures (with or without secondary generalized seizures);

3. Based on the retrospective subject diary, at least 4 partial seizures per month ( 4 weeks ) within 12 weeks prior to entry;

4. No more than 8 secondary generalized tonic, clonic, or tonic-clonic seizures per month within 12 weeks prior to entry;

5. Antiepileptic therapy including at least 1-2 concomitant AEDs and were on a stable dose(s) of the same AEDs for the 3 months prior to enrollment;

6. Had performed electro encephalogram (EEG) within 6 months prior to entry, and computer tomography (CT) or magnetic resonance imaging (MRI) examination to mainly exclude space-occupying disease;

7. Was able to count seizure frequencies;

8. Women with child bearing potential, were not to be pregnant or nursing, and must have agreed to practice during the study a reliable form of contraception (oral contraceptive, condom, intrauterine device or diaphragm).

9. Signed written informed consent and agreed to comply with the protocol.

Exclusion Criteria

1. History or evidence of a progressive central nervous system (CNS) disease;

2. Nonepileptic seizures and pseudoepileptic seizures;

3. Severe mental retardation or unstable psychical status;

4. Clinically significant cardiac, hepatic, renal, or hematological disease, uncontrolled hypertension (systolic blood pressure (SBP) ≥150 and/or diastolic blood pressure (DBP) ≥100mmHg), Symptomatic ischemic heart disease, cerebral infarction or atherosclerosis obliterans;

5. History of malignant neoplastic disease;

6. Any condition that might interfere the pharmacokinetics (absorption, distribution, and/or excretion) of drugs, such as liver or kidney dysfunction, hypoproteinemia;

7. Glucose-6-phosphate dehydrogenase (G-6-PD) deficiency or history of hemolytic anemia or acute intermittent porphyria.

8. History of kidney stone;

9. History of alcohol or drug abuse within 2 years;

10. Sensitivity to sulfonamide medications or history of severe drug allergy;

11. Administration of monoamine oxidase inhibitor (MAOI), antidepressants or antipsychotic a psycho-tropic within 14 days prior to entry;

12. History of status epileptics in the past years or seizure clusters where individual seizures cannot be counted ;

13. History of zonisamide administration;

14. History of acetazolamide administration to treat epilepsy within 2 months prior to entry;

15. Joined the clinical trial of other AEDs within 30 days prior to entry;

16. Pregnant women or women in lactation;

17. Abnormal clinical laboratory values with clinical significance judged by investigators (for example, if abnormal hepatic function is caused by concurrent other AEDs, the abnormal value within 2 times of normal could be acceptable);

18. Inability of subject to return for scheduled visits or to comply with any other aspect of the protocol.

19. Subjects who, in the opinion of the investigator, were poor medical candidates or pose any other risk for therapy with an investigational drug.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Di Hong

Role: STUDY_DIRECTOR

Eisai China Inc.

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking Union Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Shanghai Hua-shan Hospital

Shanghai, Shanghai Municipality, China

XiÆan Xijing Hospital

XiÆan, Shanxi, China

Chengdu Huaxi Hospital

Chengdu, Sichuan, China

Countries

China

Other Identifiers

E2090-AS086-311

Identifier Type: -

Identifier Source: org_study_id