Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures


Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 19, 2009)		Primary outcome measure will assess the occurrence of seizures which will be documented in a seizure diary to be maintained by the subjects. The diaries will contain information on the type and frequency of seizures. [ Time Frame: Subjects will attend the clinic at intervals of every 13 weeks until the end of the study. Subjects will attend the clinic for unscheduled visits if seizures occur. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00848549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 19, 2009)		Secondary outcome measures will include the occurrence of adverse events (AEs), the results of laboratory tests, physical examinations, vital signs, and the assessment of the Quality of Life in Epilepsy (QOLIE) Questionnaire. [ Time Frame: Subjects will attend the clinic at intervals of every 13 weeks until the end of the study. Subjects will attend the clinic for unscheduled visits if seizures occur. ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEAssessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Official Title  ICMJEA Randomized, Double-Blind Extension Study To Assess The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Brief Summary

The purpose of this study is to assess the long-term safety and tolerability and to explore the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly diagnosed partial seizures.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEEpilepsy
Intervention  ICMJE
  • Drug: Zonisamide
    Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.
    Other Name: Zonegran
  • Drug: Carbamazepine
    Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
Study Arms / Comparison Groups
  • 1: Active Comparator
    Intervention: Drug: Zonisamide
  • 2: Active Comparator
    Intervention: Drug: Carbamazepine

Recruitment Information

Estimated Enrollment  ICMJE580
Estimated Completion DateMay 2013
Estimated Primary Completion DateDecember 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject has completed study E2090-E044-310.
  2. Subject is able and willing to give written informed consent.
  3. Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects of childbearing potential must be non-pregnant, non-lactating and abide by one of the following medically acceptable contraceptive measures: oral contraceptive pill, contraceptive injections, implants or patches, intrauterine device in place for at least three months, vasectomised partner or abstinence throughout the study and for one month after discontinuation of study medication. When the contraceptive pill is used, this should contain no less than 50 μg oestrogen.
  4. The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.

Exclusion Criteria:

  1. Subject has a history of a significant or currently uncontrolled disease that will contraindicate the use of the study drugs or interfere with the conduct of this study and/or the assessment of safety and efficacy of the study drugs.
  2. Subject has a body weight <40 kg.
  3. Subject has a newly occurring progressive malignancy during study E2090-E044-310 (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
  4. Subject has developed a psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months and is considered uncontrolled; history of suicide attempt, alcohol or drug abuse, chronic treatment with benzodiazepines or barbiturates.
  5. Subject is currently taking carbonic anhydrase inhibitors.
  6. Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
  7. Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
  8. Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
  9. Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.
GenderBoth
Ages18 Years to 78 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Medical Information Department; Eisai Ltd.02086001400med_info@eisai.net
Location Countries  ICMJEAustralia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Korea, Republic of,   Montenegro,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00848549
Responsible PartyMedical Information Department; Eisai Ltd., Eisai Limited
Study ID Numbers  ICMJEE2090-E044-314
Study Sponsor  ICMJEEisai Inc.
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Rob van Maanen, M.D.Eisai Limited
Information Provided ByEisai Inc.