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

NCT ID: NCT00848549

Last Updated: 2015-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2011-11-30

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.

Conditions

Epilepsy

Keywords

Epilepsy; Monotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ZNS

Group Type: ACTIVE_COMPARATOR

Zonisamide

Intervention Type: DRUG

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.

CBZ

Group Type: ACTIVE_COMPARATOR

Carbamazepine

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Zonegran

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Baulac

Role: PRINCIPAL_INVESTIGATOR

Hopital de la Pitie-Saltpetriere

Locations

Orbassano, , Italy

Pavia, , Italy

Rome, , Italy

Siena, , Italy

Turin, , Italy

Udine, , Italy

Podgorica, , Montenegro

Gdansk, , Poland

Gdansk, , Poland

Katowice, , Poland

Krakow, , Poland

Lodz, , Poland

Lodz, , Poland

Lublin, , Poland

Poznan, , Poland

Sosnowiec, , Poland

Szczecin, , Poland

Warsaw, , Poland

Warsaw, , Poland

Kaliningrad, , Russia

Kazan', , Russia

Madrid, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Yaroslavl, , Russia

Belgrade, , Serbia

Camperdown, New South Wales, Australia

Bedford Park, South Australia, Australia

Clayton, Victoria, Australia

Fitzroy, Victoria, Australia

Heidelberg West, Victoria, Australia

Parkville, Victoria, Australia

Perth, Western Australia, Australia

Queensland, , Australia

Aalborg, , Denmark

Béthune, , France

Dijon, , France

Paris, , France

Saint-Etienne, , France

Berlin, , Germany

Bochum, , Germany

Düsseldorf, , Germany

Munich, , Germany

Schwerin, , Germany

Westerstede, , Germany

Athens, , Greece

Athens, , Greece

Athens, , Greece

Pátrai, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Gyula, , Hungary

Hódmezővásárhely, , Hungary

Nyregyhaza, , Hungary

Zalaegerszeg-Poozva, , Hungary

Bangalore, , India

Bangalore, , India

Hyderabad, , India

Koturpuram, Chennai, , India

Madurai, Tamil Nadu, , India

Mumbai, , India

New Delhi, , India

New Delhi, , India

New Delhi, , India

Pune, , India

Catanzaro, , Italy

Messina, , Italy

Milan, , Italy

Monza (MI), , Italy

Kragujevac, , Serbia

Kruševac, , Serbia

Niš, , Serbia

Novi Sad, , Serbia

Sombor, , Serbia

Subotica, , Serbia

Bratislava, , Slovakia

Bratislava, , Slovakia

Bratislava, , Slovakia

Brezno, , Slovakia

Košice, , Slovakia

NoveZamky, , Slovakia

Spitalska 6, , Slovakia

Vranov nad Topľou, , Slovakia

Žilina, , Slovakia

Bellair, , South Africa

Berea, , South Africa

Parktown, , South Africa

Pretoria, , South Africa

Richards Bay, , South Africa

Sandton, , South Africa

Tygerberg, , South Africa

Umhlanga, , South Africa

Anyang, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Seoul, , South Korea

Wŏnju, , South Korea

Alicante, , Spain

Barcelona, , Spain

Cruces (Vizcaya), , Spain

Madrid, , Spain

Madrid, , Spain

Málaga, , Spain

Oviedo, , Spain

Seville, , Spain

Seville, , Spain

Seville, , Spain

Zaragoza, , Spain

Gothenburg, , Sweden

Linköping, , Sweden

Lund, , Sweden

Basel, , Switzerland

Bern, , Switzerland

Sankt Gallen, , Switzerland

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Taoyuan District, , Taiwan

Yongkang District, , Taiwan

Bristol, , United Kingdom

Cardiff, , United Kingdom

Glasgow, , United Kingdom

Liverpool, , United Kingdom

Tooting, , United Kingdom

Treliske, , United Kingdom

Countries

Australia; Denmark; France; Germany; Greece; Hungary; India; Italy; Montenegro; Poland; Russia; Serbia; Slovakia; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; United Kingdom

Other Identifiers

2008-001159-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E2090-E044-314

Identifier Type: -

Identifier Source: org_study_id