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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00292461
First received: February 14, 2006
Last updated: May 13, 2013
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Zonisamide
Drug: Lamotrigine
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
  • Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline. [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2006
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: zonisamide
tablet
Drug: Zonisamide
Tablet once or twice daily orally for 16 weeks
Active Comparator: lamotrigine
tablet
Drug: Lamotrigine
Tablet once daily orally for 16 weeks

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292461

Locations
China, Taiwan
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, China
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Ya-Hui Cheng Eisai Taiwan
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00292461     History of Changes
Other Study ID Numbers: E2090-AS886-202
Study First Received: February 14, 2006
Results First Received: September 27, 2010
Last Updated: May 13, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Eisai Inc.:
Epilepsy
seizures

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Anticonvulsants
Lamotrigine
Zonisamide
Antioxidants
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014