Clinical trial NCT00848549: Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy
Monotherapy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants Remaining in the Study at Each Visit
timeFrame: At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Secondary outcomes:
measure: Time to Drop-out Due to Lack of Efficacy
timeFrame: Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)
measure: Time to Drop-out Due to Adverse Event (AE)
timeFrame: Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)
measure: Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase
timeFrame: Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)
measure: Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit
timeFrame: Weeks 0, 26, 52, 78 and 117
Other outcomes:
Locations:
city: Camperdown
country: Australia
state: New South Wales
city: Bedford Park
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Heidelberg West
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Queensland
country: Australia
city: Aalborg
country: Denmark
city: Bethune cedex
country: France
city: Dijon cedex
country: France
city: Paris
country: France
city: St Etienne cedex 2
country: France
city: Berlin
country: Germany
city: Bochum
country: Germany
city: Duesseldorf
country: Germany
city: Munich
country: Germany
city: Schwerin
country: Germany
city: Westerstede
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Patras
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyula
country: Hungary
city: Hodmezovasarhely
country: Hungary
city: Nyregyhaza
country: Hungary
city: Zalaegerszeg-Poozva
country: Hungary
city: Bangalore
country: India
city: Bangalore
country: India
city: Hyderabad
country: India
city: Koturpuram, Chennai
country: India
city: Madurai, Tamil Nadu
country: India
city: Mumbai
country: India
city: New - Delhi
country: India
city: New Delhi
country: India
city: New Delhi
country: India
city: Pune
country: India
city: Catanzaro
country: Italy
city: Messina
country: Italy
city: Milan
country: Italy
city: Monza (MI)
country: Italy
city: Orbassano
country: Italy
city: Pavia
country: Italy
city: Rome
country: Italy
city: Siena
country: Italy
city: Turin
country: Italy
city: Udine
country: Italy
city: Anyang
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
city: Podgorica
country: Montenegro
city: Gdansk
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Poznan
country: Poland
city: Sosnowiec
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Kaliningrad
country: Russian Federation
city: Kazan
country: Russian Federation
city: Madrid
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Krusevac
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Sombor
country: Serbia
city: Subotica
country: Serbia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Brezno
country: Slovakia
city: Kosice
country: Slovakia
city: NoveZamky
country: Slovakia
city: Spitalska 6
country: Slovakia
city: Vranov nad Toplou
country: Slovakia
city: Zilina
country: Slovakia
city: Bellair
country: South Africa
city: Berea
country: South Africa
city: Parktown
country: South Africa
city: Pretoria
country: South Africa
city: Richards Bay
country: South Africa
city: Sandton
country: South Africa
city: Tygerberg
country: South Africa
city: Umhlanga
country: South Africa
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Cruces (Vizcaya)
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Oviedo
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Zaragoza
country: Spain
city: Goteborg
country: Sweden
city: Linkoping
country: Sweden
city: Lund
country: Sweden
city: Basel
country: Switzerland
city: Berne
country: Switzerland
city: St Gallen
country: Switzerland
city: Changhua
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Tao-Yuan
country: Taiwan
city: Yong Kang
country: Taiwan
city: Bristol
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Tooting
country: United Kingdom
city: Treliske
country: United Kingdom
Study officials:
affiliation: Hopital de la Pitie-Saltpetriere
name: Michel Baulac
role: PRINCIPAL_INVESTIGATOR
References: