Phase 4
N=121
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01140867 ↗Enrolled (actual)
121
Serious AEs
1.7%
Results posted
Sep 2011
Primary outcome: Primary: Seizure Reduction Rate — -16.35 Percentage of Seizure Reduction Rate
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- zonisamide (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- Eisai Korea Inc.
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seizure Reduction Rate |
-16.35 | — |
| SECONDARY Seizure Free Rate |
24.51 | — |
| SECONDARY Responder Rate |
61.76 | — |
| SECONDARY QoL-QOLIE31 (Quality of Life in Epilepsy) |
56.67; 57.70 | — |
Summary
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.
Eligibility Criteria
Inclusion criteria
- Epilepsy patient over 15 years old who agrees with Informed Consent Form
- Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
- Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
- Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
- Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.
Exclusion criteria
- Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
- Patient who experiences pseudoseizures and/or who has uncountable clusters.
- Patient who has serious systemic or drug metabolism affecting disorder .
- Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
- Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
- Patient who has medical history of renal stones.
- Patient who is allergic to sulfonamide.
- Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
- Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
- A terminal patient and/or a scheduled surgical patient.
- Patient who has medication history of zonisamide.
- Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
Data sourced from ClinicalTrials.gov (NCT01140867). 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.