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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT01140867
First received: May 19, 2010
Last updated: September 8, 2011
Last verified: May 2011

May 19, 2010
September 8, 2011
February 2008
August 2010   (final data collection date for primary outcome measure)
Seizure Reduction Rate [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.
Seizure Reduction Rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01140867 on ClinicalTrials.gov Archive Site
  • Seizure Free Rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    The percentage of the participants who experienced no seizure during the trial.
  • Responder Rate [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.
  • QoL-QOLIE31 (Quality of Life in Epilepsy) [ Time Frame: Baseline and 16 weeks ] [ Designated as safety issue: No ]
    Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.
QOLIE-31 - Investigator's Global Evaluation Scale [ Time Frame: Baseline, 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
Drug: zonisamide
zonisamide 100 mg tablet
Experimental: 1
Intervention: Drug: zonisamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
March 2011
August 2010   (final data collection date for primary outcome measure)

Inclusion criteria:

  1. Epilepsy patient over 15 years old who agrees with Informed Consent Form
  2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
  3. 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).
  4. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
  5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.

Exclusion criteria:

  1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
  2. Patient who experiences pseudoseizures and/or who has uncountable clusters.
  3. Patient who has serious systemic or drug metabolism affecting disorder .
  4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
  5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
  6. Patient who has medical history of renal stones.
  7. Patient who is allergic to sulfonamide.
  8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
  9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
  10. A terminal patient and/or a scheduled surgical patient.
  11. Patient who has medication history of zonisamide.
  12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01140867
E2090-S082-409
Not Provided
Eisai Inc. ( Eisai Korea Inc. )
Eisai Korea Inc.
Not Provided
Study Director: Jihee Mun Medical Department, Eisai Korea Inc.
Eisai Inc.
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP