Phase 3
Completed 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
Source: ClinicalTrials.gov NCT00292461 ↗Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Aug 2011
Primary outcomePrimary: 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
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.
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 |
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. Informational only — not medical advice.