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

Condition(s) targeted: Epilepsy

Intervention: Zonisamide (Drug); Carbamazepine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Eisai Inc.

Official(s) and/or principal investigator(s):
Rob van Maanen, M.D., Study Director, Affiliation: Eisai Limited

Overall contact:
Medical Information Department; Eisai Ltd., Phone: 02086001400, Email: med_info@eisai.net

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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.

Minimum age: 18 Years. Maximum age: 78 Years. Gender(s): Both.

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.

Medical Information Department; Eisai Ltd., Phone: 02086001400, Email: med_info@eisai.net

Dr. Graham Schapel, Queensland 4558, Australia; Not yet recruiting

Ladegaardsgade, Aalborg 9000, Denmark; Not yet recruiting

Centre Germon and Gauthier, Bethune cedex 62408, France; Not yet recruiting

Hopital Bellevue, St Etienne cedex 2 42055, France; Not yet recruiting

Hopital General, Dijon cedex 21033, France; Not yet recruiting

Hopital Pitie Salpetriee, Paris 75651, France; Not yet recruiting

Dr. Andreas Hufnagel, Duesseldorf 40212, Germany; Not yet recruiting

Dr. Heike Benes, Schwerin 19053, Germany; Not yet recruiting

Dr. Joachim Springub, Westerstede 26676, Germany; Not yet recruiting

Klinikum der Universitat, Munich 81377, Germany; Not yet recruiting

Castroper Hellweg 422, Bochum 44805, Germany; Not yet recruiting

Augustenburger Platz 1, Berlin 13353, Germany; Not yet recruiting

Exohi, Thessaloniki 57010, Greece; Not yet recruiting

Panorama, Thessaloniki 55236, Greece; Not yet recruiting

Central Ethics Committee (EED), Athens 15562, Greece; Not yet recruiting

Dr. Antonios Kodounis, Athens 11525, Greece; Not yet recruiting

Thessaloniki 54636, Greece; Not yet recruiting

Dr. Stilianos Gatzonis, Athens 10676, Greece; Not yet recruiting

Rio Patron, Patras 26500, Greece; Not yet recruiting

Kenezy Gyula Korhaz, Debrecen 4032, Hungary; Not yet recruiting

Zala Megyei Korhaz, Zalaegerszeg-Poozva 8908, Hungary; Not yet recruiting

Josa Andas Korhaz, Nyregyhaza 4400, Hungary; Recruiting

Uzsoki Utcai Korhaz, Budapest 1145, Hungary; Not yet recruiting

Erzsebet Korhaz, Hodmezovasarhely 6800, Hungary; Not yet recruiting

Szent Istvan Korhaz, Budapest 1096, Hungary; Not yet recruiting

Orszagos Idegsebeszeti Tudomanyos Inezet, Stroke es Epilepszia Osztaly, Budapest 1145, Hungary; Recruiting

Pandy Kalman Korhaz, Gyula 5700, Hungary; Recruiting

Peterfy Sandor utcai Korhaz, Budapest 1076, Hungary; Not yet recruiting

Poona hospital and Research center, Pune 411 030, India; Not yet recruiting

Apollo Speciality Hosp, Madurai, Tamil Nadu 625 020, India; Not yet recruiting

St John Hospitals, Bangalore 560034, India; Not yet recruiting

Indian Epilepsy Centre, New Delhi 110 016, India; Not yet recruiting

Apollo Center of Excellence, Koturpuram, Chennai 600 085, India; Not yet recruiting

VIMHANS, I Area, New Delhi 110 065, India; Not yet recruiting

M S Ramaiah Hospitals, Bangalore 560094, India; Not yet recruiting

Care Hospital, Hyderabad 500 001, India; Not yet recruiting

IHBAS, Post Box no - 9520, New - Delhi 110095, India; Not yet recruiting

KEM Hospital, Mumbai 400 012, India; Not yet recruiting

Policlinico Tor Vergata, Rome 00133, Italy; Not yet recruiting

Ospedale S Luigi, Orbassano 10043, Italy; Not yet recruiting

Ospedale San Raffaele, Milan 20132, Italy; Not yet recruiting

Dipartimento di Neurologia, Monza (MI) 20052, Italy; Not yet recruiting

Piazzale S Maria Misericordia 15, Udine 33100, Italy; Not yet recruiting

Policlinico G Martino, Messina 98122, Italy; Not yet recruiting

Istituto C Mondino, Pavia 27100, Italy; Not yet recruiting

Reparto Di Neurologia, Siena 53100, Italy; Not yet recruiting

Campus Universitario, Catanzaro 88100, Italy; Not yet recruiting

Ospedale Molinette, Turin 10126, Italy; Not yet recruiting

Konkuk University Hospital, Seoul 143-729, Korea, Republic of; Not yet recruiting

Hallym Univ. Hosp., Anyang 431-070, Korea, Republic of; Not yet recruiting

Wonju Christian Hospital, Wonju 220-701, Korea, Republic of; Not yet recruiting

Hanyang Univ. Hospital, Seoul 133-792, Korea, Republic of; Not yet recruiting

Seoul National Univ.Hosp, Seoul 110-744, Korea, Republic of; Not yet recruiting

Dr. Slavica Vujisic, Podgorica 81000, Montenegro; Not yet recruiting

ul Kopcinskiego 22, Lodz 90-153, Poland; Not yet recruiting

Klinika Neurologii, Szczecin 71252, Poland; Not yet recruiting

ul Medykow, AC 106, Katowice 40752, Poland; Not yet recruiting

Pl Medykow 1, Sosnowiec 41-200, Poland; Not yet recruiting

Al Komisji Edukacji, Warszawa 09-777, Poland; Not yet recruiting

Indyw Spec Praktyka Lek, Gdansk 80266, Poland; Not yet recruiting

Ul Czemiakowska 231, Warszawa 00-416, Poland; Not yet recruiting

Medical University of Lodz, Lodz 93-513, Poland; Not yet recruiting

Centrum Neurologii Klin, Krakow 31-530, Poland; Not yet recruiting

Univ. Med.Sci.,Poznan, Poznan 60-355, Poland; Not yet recruiting

Oddzial Neurologiczny, Gdansk 80-803, Poland; Not yet recruiting

Oddzial Neurologii, Lublin 20-718, Poland; Not yet recruiting

Kazan Medical University, Kazan 420012, Russian Federation; Not yet recruiting

Clinic of Neurosurgery, Moscow 198103, Russian Federation; Not yet recruiting

City center of Paroxysms, Kaliningrad 236000, Russian Federation; Not yet recruiting

Yaroslavl Medical Academy, Yaroslavl 160000, Russian Federation; Not yet recruiting

Clinic of Neurology, Moscow 117049, Russian Federation; Not yet recruiting

Ambul Hermanos Sangro, Madrid 28038, Russian Federation; Not yet recruiting

Medical Military Academy, Saint Petersburg 194044, Russian Federation; Not yet recruiting

Center of Psychiatry, Moscow 117995, Russian Federation; Not yet recruiting

Clinical Hospital, Saint-Petersburg 194017, Russian Federation; Not yet recruiting

Institute of Human Brain, Saint-Petersburg 197376, Russian Federation; Not yet recruiting

University Clinic of Neurology, Nis 18000, Serbia; Not yet recruiting

Doktora Subotica 6, Belgrade 11000, Serbia; Not yet recruiting

Clinic of Neurology and Psychiatry for Children and Youth, Belgrade 11000, Serbia; Not yet recruiting

Institute of Mental Health, Belgrade 11000, Serbia; Not yet recruiting

Hajduk Veljkova 1-9, Novi Sad 21000, Serbia; Not yet recruiting

Dr. Dragan Nikodijevic, Subotica 24000, Serbia; Not yet recruiting

Luke Ivanovica bb, Krusevac 37000, Serbia; Not yet recruiting

Zmaj Jovina 30, Kragujevac 34000, Serbia; Not yet recruiting

Vojvodjanska 75, Sombor 25000, Serbia; Not yet recruiting

Neurologicka Klinika FN L. Derera, Bratislava 833 05, Slovakia; Not yet recruiting

Neurologicka Klinika FN Ruznov, Bratislava 826 06, Slovakia; Not yet recruiting

Neurolog oddelenie NsPZilina, Zilina 1207, Slovakia; Not yet recruiting

Brezno, Vranov nad Toplou 093 27, Slovakia; Not yet recruiting

Neurologicka klinika FN NoveZamky, NoveZamky 940 34, Slovakia; Not yet recruiting

Poliklinika, Neurologicka, Bratislava 80000, Slovakia; Not yet recruiting

Neurologicke oddelenie NsP, Brezno 97701, Slovakia; Not yet recruiting

NeurologickaKlinika LF UPJS, Kosice 4190, Slovakia; Not yet recruiting

Neurologicka Klinika FN Nitra, Spitalska 6 94901, Slovakia; Not yet recruiting

St Augustine's Medic Mews, Berea 4001, South Africa; Not yet recruiting

Umhlanga Hospital, Umhlanga 4320, South Africa; Not yet recruiting

Bellair Medical Centre, Bellair 4001, South Africa; Not yet recruiting

Tygerberg Hospital, Tygerberg 7505, South Africa; Not yet recruiting

Morningside Medi-Clinic, Sandton 2196, South Africa; Not yet recruiting

Richards Bay Trial Centre, Richards Bay 3900, South Africa; Not yet recruiting

Milpark Hospital, Parktown 2193, South Africa; Not yet recruiting

Willows MedCentre Suite 7, Pretoria 0041, South Africa; Not yet recruiting

Hosp Reg Univ Carlos Haya, Malaga 29010, Spain; Not yet recruiting

Instituto Universitario Dexeus, Servicio de Neurologia, Barcelona 08041, Spain; Not yet recruiting

Hospital General Univ Alicante, Alicante 03010, Spain; Not yet recruiting

Hosp Clinico S. Carlos, Madrid 28040, Spain; Not yet recruiting

Hosp General Univ Alicante, Alicante 03010, Spain; Not yet recruiting

Hosp Defensa Gomez Ulla, Madrid 28047, Spain; Not yet recruiting

Hospital Nuestra Senora, Sevilla 41014, Spain; Not yet recruiting

Hosp S Creu i Sant Pau, Barcelona 08041, Spain; Recruiting

Hospital Universitario Virgen del Rocio, Sevilla 41013, Spain; Not yet recruiting

Hospital Asturias, Oviedo 33006, Spain; Not yet recruiting

Hosp Clinico Lozano Blesa, Zaragoza 50009, Spain; Not yet recruiting

Hosp Virgen Macarena, Sevilla 41009, Spain; Not yet recruiting

Hosp de Cruces, Cruces (Vizcaya) 48903, Spain; Not yet recruiting

Hospital Virgen del Rocio, Sevilla 41013, Spain; Not yet recruiting

Neurologen NL 40 E, Lund 22185, Sweden; Not yet recruiting

Sahlgrenska Univ Hosp, Goteborg 41345, Sweden; Not yet recruiting

Center for Image Science and Visualization, Linkoping SE-58185, Sweden; Not yet recruiting

Rohrschacherstr 95, St Gallen 9007, Switzerland; Not yet recruiting

Am Petersgraben 4, Basel 4031, Switzerland; Not yet recruiting

Neurologische Klinik, Berne 3010, Switzerland; Not yet recruiting

Dr. Der-Shin Ke, Yong Kang 71004, Taiwan; Not yet recruiting

Professor Ta-Chen, Changhua 50006, Taiwan; Not yet recruiting

Kuei-Shan Chiang, Tao-Yuan 33305, Taiwan; Not yet recruiting

Dr. Chung-Yao Hsu, Kaohsiung 80099, Taiwan; Not yet recruiting

Lower Lane, Liverpool L9 7AJ, United Kingdom; Not yet recruiting

Royal Cornwall Hospital, Treliske TR1 3LJ, United Kingdom; Not yet recruiting

Frenchay Park Road, Bristol BS16 1LE, United Kingdom; Not yet recruiting

Heath Park, Cardiff CF144XN, United Kingdom; Not yet recruiting

Atkinson Morley Wing, Tooting SW17 0QT, United Kingdom; Not yet recruiting

Dumbarton Road, Glasgow G11 6NT, United Kingdom; Not yet recruiting

Royal Prince Alfred Hos, Camperdown, New South Wales 2050, Australia; Not yet recruiting

Flinders Medical Centre, Bedford Park, South Australia 5042, Australia; Not yet recruiting

Monash medical Centre, Clayton, Victoria 3168, Australia; Not yet recruiting

Royal Melbourne Hospital, Parkville, Victoria 3050, Australia; Recruiting

Austin Health Epi Res Cen, Heidelberg West, Victoria 3084, Australia; Not yet recruiting

St Vincent's Hospital, Fitzroy, Victoria 3065, Australia; Not yet recruiting

Royal Perth Hospital, Perth, Western Australia 6000, Australia; Not yet recruiting

Starting date: September 2008
Ending date: May 2013
Last updated: September 1, 2009