Clinical trial NCT00292461: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
seizures
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-02-16
Enrollment: 64
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline
timeFrame: Baseline and 16 weeks
Secondary outcomes:
measure: Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period
timeFrame: Baseline and 16 weeks
measure: Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period
timeFrame: Baseline and 16 weeks
measure: Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.
timeFrame: Baseline and 16 weeks
Other outcomes:
Locations:
city: Changhua
country: China
facility: Changhua Christian Hospital
state: Taiwan
city: Kaohsiung
country: China
facility: Chang-Gung Memorial Hospital (CGMH)
state: Taiwan
city: Linkou
country: China
facility: Chang-Gung Memorial Hospital (CGMH)
state: Taiwan
city: Taichun
country: China
facility: China Medical University Hospital (CMUH)
state: Taiwan
city: Tainan
country: China
facility: National Cheng Kung University Hospital
state: Taiwan
city: Taipei
country: China
facility: Chang-Gung Memorial Hospital (CGMH)
state: Taiwan
city: Taipei
country: China
facility: Taipei Tzu Chi General Hospital
state: Taiwan
city: Taipei
country: China
facility: Taipei Veterans General Hospital
state: Taiwan
Study officials:
affiliation: Eisai Taiwan
name: Ya-Hui Cheng
role: STUDY_DIRECTOR
References: