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

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ClinicalTrials.gov Identifier: NCT00848549
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : January 15, 2013
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE February 19, 2009
First Posted Date  ICMJE February 20, 2009
Results First Submitted Date  ICMJE November 12, 2012
Results First Posted Date  ICMJE January 15, 2013
Last Update Posted Date December 24, 2015
Study Start Date  ICMJE October 2008
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
Percentage of Participants Remaining in the Study at Each Visit [ Time Frame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months ]
The retention rate is defined as the percentage of subjects remaining on the study at each visit, starting from the first dose of study drug in the extension phase.
Original 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. ]
Change History Complete list of historical versions of study NCT00848549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2013)
  • Time to Drop-out Due to Lack of Efficacy [ Time Frame: Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study) ]
    Lack of efficacy was if the subject had poor seizure control (defined as experiencing a seizure despite being on the maximum dose for = 2 weeks). The subject could withdraw at any time due to lack of efficacy.
  • Time to Drop-out Due to Adverse Event (AE) [ Time Frame: Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study) ]
    Adverse events in study subjects included any change in the subject's condition. This includes symptoms, physical findings, or clinical syndromes. All AEs that occurred after signing of informed consent through the last visit and for 15 days following study drug discontinuation were captured on the AE Case Report Form (CRF).
  • Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase [ Time Frame: Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase) ]
    The number of participants that have remained seizure free for at least a 24 month consecutive period from the start of the Flexible Dosing Period (FDP: the period following the Titration Period and leading into the Maintenance Period) in the base study through the treatment period of this study. Seizure freedom was defined as the absence of all seizure regardless of seizure type.
  • Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit [ Time Frame: Weeks 0, 26, 52, 78 and 117 ]
    The QOLIE-31-P is a 31-item questionnaire evaluating a participant's QOL perception in 7 domains: seizure worry,emotional well being,energy/fatigue, cognitive functioning, medication effects, social functioning,overall QOL. The overall score is derived by weighing and then summing the 7 domain scores. Precoded numeric values for some domains are such that a higher number reflects a more favorable health state; others are such that a higher number reflects a less favorable state. Precoded values are converted to 0-100 point scores; higher converted scores always reflect better QOL.
Original 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. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Official Title  ICMJE A 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
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  ICMJE
  • Active Comparator: ZNS
    Intervention: Drug: Zonisamide
  • Active Comparator: CBZ
    Intervention: Drug: Carbamazepine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2013)
295
Original Estimated Enrollment  ICMJE
 (submitted: February 19, 2009)
580
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date June 2011   (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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Korea, Republic of,   Montenegro,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00848549
Other Study ID Numbers  ICMJE E2090-E044-314
2008-001159-23 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eisai Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michel Baulac Hopital de la Pitie-Saltpetriere
PRS Account Eisai Inc.
Verification Date November 2015

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