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

NCT00292461 | Completed Phase 3 Results

• 1 other identifier: E2090-AS886-202
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Epilepsy

Keywords

Epilepsy; seizures

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period

  Baseline and 16 weeks

• Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period

  Baseline and 16 weeks

• 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

Study Arms (2)

zonisamide

ACTIVE COMPARATOR

tablet

Drug: Zonisamide

lamotrigine

ACTIVE COMPARATOR

tablet

Drug: Lamotrigine

Interventions

Zonisamide DRUG

Tablet once or twice daily orally for 16 weeks

zonisamide

Lamotrigine DRUG

Tablet once daily orally for 16 weeks

lamotrigine

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must sign and date the informed consent form
• Clinical diagnosis as refractory epilepsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (8)

Changhua Christian Hospital

Changhua, Taiwan, China

Location

Chang-Gung Memorial Hospital (CGMH)

Kaohsiung, Taiwan, China

Location

Chang-Gung Memorial Hospital (CGMH)

Linkou, Taiwan, China

Location

China Medical University Hospital (CMUH)

Taichun, Taiwan, China

Location

National Cheng Kung University Hospital

Tainan, Taiwan, China

Location

Chang-Gung Memorial Hospital (CGMH)

Taipei, Taiwan, China

Location

Taipei Tzu Chi General Hospital

Taipei, Taiwan, China

Location

Taipei Veterans General Hospital

Taipei, Taiwan, China

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Zonisamide; Lamotrigine

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazines

Results Point of Contact

• Title: Takao Ishii, Asia regulatory affaires
• Organization: Eisai Co., Ltd.

81-3-3817-3914

Study Officials

• Ya-Hui Cheng

  Eisai Taiwan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 16, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: May 20, 2013
• Results First Posted: August 15, 2011

Record last verified: 2009-08

Locations

CN (8)