Phase 3
N=64
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
Bottom Line
View on ClinicalTrials.gov: NCT00292461 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Aug 2011
Primary outcome: Primary: The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline — -32.7; -35.6 percent change — p=0.240
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zonisamide (Drug); Lamotrigine (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline |
-32.7; -35.6 | 0.240 |
| SECONDARY Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period |
5; 4; 9; 15; 10; 5 | 0.460 |
| SECONDARY Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period |
3; 8; 14; 12; 4; 4 | 0.079 |
| 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. |
45.8; 45.8 | 0.860 |
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
Data sourced from ClinicalTrials.gov (NCT00292461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.