Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 14, 2006
May 13, 2013
March 2006
August 2009   (final data collection date for primary outcome measure)
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
The percentage change of monthly seizure frequency at the end of 16-week treatment from baseline.
Complete list of historical versions of study NCT00292461 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1. Response rate: defined as the percentage of subjects with >= 50% reduction of monthly seizure frequency at the end of 16-week treatment from baseline.
  • 2. Global assessment of efficacy by physician at the end of 16-week treatment.
  • 3. Global assessment of safety by subjects at the end of 16-week treatment.
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
  • Drug: Zonisamide
    Tablet once or twice daily orally for 16 weeks
  • Drug: Lamotrigine
    Tablet once daily orally for 16 weeks
  • Active Comparator: zonisamide
    tablet
    Intervention: Drug: Zonisamide
  • Active Comparator: lamotrigine
    tablet
    Intervention: Drug: Lamotrigine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
16 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00292461
E2090-AS886-202
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Ya-Hui Cheng Eisai Taiwan
Eisai Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP