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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292461
• Other study ID #: E2090-AS886-202
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2006
• Last updated: May 13, 2013
• Start date: March 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

Inclusion criteria:

• Subjects must sign and date the informed consent form

• Clinical diagnosis as refractory epilepsy

Exclusion criteria:

• Progressive neurologic disease

• Serious psychiatric disease

• Hemolytic anemia

• G6PD (glucose-6-phosphate dehydrogenase) deficiency

• Acute intermittent porphyrias

• Subjects 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 (ALT or AST > 2x 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

• Taking valproic acid within 7 days prior to screening

• Subjects with simple partial seizures without motor component

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Zonisamide
Tablet once or twice daily orally for 16 weeks
• Lamotrigine
Tablet once daily orally for 16 weeks

Locations

Country	Name	City	State
China	Changhua Christian Hospital	Changhua	Taiwan
China	Chang-Gung Memorial Hospital (CGMH)	Kaohsiung	Taiwan
China	Chang-Gung Memorial Hospital (CGMH)	Linkou	Taiwan
China	China Medical University Hospital (CMUH)	Taichun	Taiwan
China	National Cheng Kung University Hospital	Tainan	Taiwan
China	Chang-Gung Memorial Hospital (CGMH)	Taipei	Taiwan
China	Taipei Tzu Chi General Hospital	Taipei	Taiwan
China	Taipei Veterans General Hospital	Taipei	Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Percentage Change of Frequency = (T-B)/B*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)* 4 B= The monthly seizure frequence with one month prior to enrollment	Baseline and 16 weeks	No
Secondary	Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period		Baseline and 16 weeks	No
Secondary	Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period		Baseline and 16 weeks	No
Secondary	Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.		Baseline and 16 weeks	No