Mode
Text Size
Log in / Sign up
Phase 4 N=121 Treatment

Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Epilepsy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search