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

Sponsor:	Eisai Inc.
Information provided by (Responsible Party):	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00848549

Purpose

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.

Condition	Intervention	Phase
Epilepsy	Drug: Zonisamide Drug: Carbamazepine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Seizures

Drug Information available for: Zonisamide Carbamazepine

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

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: retention rate at 12, 15, 18..months ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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: 24 month seizure free period ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	580
Study Start Date:	October 2008
Estimated Study Completion Date:	November 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	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
Active Comparator: 2	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.

Arms

Assigned Interventions

Active Comparator: 1

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

Active Comparator: 2

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.

Eligibility

Ages Eligible for Study:	18 Years to 78 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has completed study E2090-E044-310.
Subject is able and willing to give written informed consent.
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.
The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.

Exclusion Criteria:

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.
Subject has a body weight <40 kg.
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).
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.
Subject is currently taking carbonic anhydrase inhibitors.
Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848549

Show 133 Study Locations

Sponsors and Collaborators

Eisai Inc.

Investigators

Principal Investigator:

Michel Baulac

Hopital de la Pitie-Saltpetriere

More Information

No publications provided

Responsible Party:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00848549 History of Changes
Other Study ID Numbers:	E2090-E044-314
Study First Received:	February 19, 2009
Last Updated:	October 11, 2011
Health Authority:	European Union: European Medicines Agency

Keywords provided by Eisai Inc.:

Epilepsy
Monotherapy

Additional relevant MeSH terms:

Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Carbamazepine
Zonisamide
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012