Please note that the ANZCTR website will be unavailable from 1pm until 2pm (AEST) on Wednesday 29th May for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00848549




Registration number
NCT00848549
Ethics application status
Date submitted
19/02/2009
Date registered
19/02/2009
Date last updated
21/12/2015

Titles & IDs
Public title
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Scientific 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
Secondary ID [1] 0 0
2008-001159-23
Secondary ID [2] 0 0
E2090-E044-314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Zonisamide
Treatment: Drugs - Carbamazepine

Active Comparator: ZNS -

Active Comparator: CBZ -


Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Remaining in the Study at Each Visit - 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.
Timepoint [1] 0 0
At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Secondary outcome [1] 0 0
Time to Drop-out Due to Lack of Efficacy - 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.
Timepoint [1] 0 0
Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)
Secondary outcome [2] 0 0
Time to Drop-out Due to Adverse Event (AE) - 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).
Timepoint [2] 0 0
Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)
Secondary outcome [3] 0 0
Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and 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.
Timepoint [3] 0 0
Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)
Secondary outcome [4] 0 0
Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit - 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.
Timepoint [4] 0 0
Weeks 0, 26, 52, 78 and 117

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
78 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Clayton
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Heidelberg West
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Queensland
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg West
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
4558 - Queensland
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
France
State/province [2] 0 0
Bethune cedex
Country [3] 0 0
France
State/province [3] 0 0
Dijon cedex
Country [4] 0 0
France
State/province [4] 0 0
Paris
Country [5] 0 0
France
State/province [5] 0 0
St Etienne cedex 2
Country [6] 0 0
Germany
State/province [6] 0 0
Berlin
Country [7] 0 0
Germany
State/province [7] 0 0
Bochum
Country [8] 0 0
Germany
State/province [8] 0 0
Duesseldorf
Country [9] 0 0
Germany
State/province [9] 0 0
Munich
Country [10] 0 0
Germany
State/province [10] 0 0
Schwerin
Country [11] 0 0
Germany
State/province [11] 0 0
Westerstede
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Greece
State/province [13] 0 0
Patras
Country [14] 0 0
Greece
State/province [14] 0 0
Thessaloniki
Country [15] 0 0
Hungary
State/province [15] 0 0
Budapest
Country [16] 0 0
Hungary
State/province [16] 0 0
Debrecen
Country [17] 0 0
Hungary
State/province [17] 0 0
Gyula
Country [18] 0 0
Hungary
State/province [18] 0 0
Hodmezovasarhely
Country [19] 0 0
Hungary
State/province [19] 0 0
Nyregyhaza
Country [20] 0 0
Hungary
State/province [20] 0 0
Zalaegerszeg-Poozva
Country [21] 0 0
India
State/province [21] 0 0
Bangalore
Country [22] 0 0
India
State/province [22] 0 0
Hyderabad
Country [23] 0 0
India
State/province [23] 0 0
Koturpuram, Chennai
Country [24] 0 0
India
State/province [24] 0 0
Madurai, Tamil Nadu
Country [25] 0 0
India
State/province [25] 0 0
Mumbai
Country [26] 0 0
India
State/province [26] 0 0
New - Delhi
Country [27] 0 0
India
State/province [27] 0 0
New Delhi
Country [28] 0 0
India
State/province [28] 0 0
Pune
Country [29] 0 0
Italy
State/province [29] 0 0
Catanzaro
Country [30] 0 0
Italy
State/province [30] 0 0
Messina
Country [31] 0 0
Italy
State/province [31] 0 0
Milan
Country [32] 0 0
Italy
State/province [32] 0 0
Monza (MI)
Country [33] 0 0
Italy
State/province [33] 0 0
Orbassano
Country [34] 0 0
Italy
State/province [34] 0 0
Pavia
Country [35] 0 0
Italy
State/province [35] 0 0
Rome
Country [36] 0 0
Italy
State/province [36] 0 0
Siena
Country [37] 0 0
Italy
State/province [37] 0 0
Turin
Country [38] 0 0
Italy
State/province [38] 0 0
Udine
Country [39] 0 0
Korea, Republic of
State/province [39] 0 0
Anyang
Country [40] 0 0
Korea, Republic of
State/province [40] 0 0
Seoul
Country [41] 0 0
Korea, Republic of
State/province [41] 0 0
Wonju
Country [42] 0 0
Montenegro
State/province [42] 0 0
Podgorica
Country [43] 0 0
Poland
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Katowice
Country [45] 0 0
Poland
State/province [45] 0 0
Krakow
Country [46] 0 0
Poland
State/province [46] 0 0
Lodz
Country [47] 0 0
Poland
State/province [47] 0 0
Lublin
Country [48] 0 0
Poland
State/province [48] 0 0
Poznan
Country [49] 0 0
Poland
State/province [49] 0 0
Sosnowiec
Country [50] 0 0
Poland
State/province [50] 0 0
Szczecin
Country [51] 0 0
Poland
State/province [51] 0 0
Warszawa
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Kaliningrad
Country [53] 0 0
Russian Federation
State/province [53] 0 0
Kazan
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Madrid
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Moscow
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Saint Petersburg
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Saint-Petersburg
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Yaroslavl
Country [59] 0 0
Serbia
State/province [59] 0 0
Belgrade
Country [60] 0 0
Serbia
State/province [60] 0 0
Kragujevac
Country [61] 0 0
Serbia
State/province [61] 0 0
Krusevac
Country [62] 0 0
Serbia
State/province [62] 0 0
Nis
Country [63] 0 0
Serbia
State/province [63] 0 0
Novi Sad
Country [64] 0 0
Serbia
State/province [64] 0 0
Sombor
Country [65] 0 0
Serbia
State/province [65] 0 0
Subotica
Country [66] 0 0
Slovakia
State/province [66] 0 0
Bratislava
Country [67] 0 0
Slovakia
State/province [67] 0 0
Brezno
Country [68] 0 0
Slovakia
State/province [68] 0 0
Kosice
Country [69] 0 0
Slovakia
State/province [69] 0 0
NoveZamky
Country [70] 0 0
Slovakia
State/province [70] 0 0
Spitalska 6
Country [71] 0 0
Slovakia
State/province [71] 0 0
Vranov nad Toplou
Country [72] 0 0
Slovakia
State/province [72] 0 0
Zilina
Country [73] 0 0
South Africa
State/province [73] 0 0
Bellair
Country [74] 0 0
South Africa
State/province [74] 0 0
Berea
Country [75] 0 0
South Africa
State/province [75] 0 0
Parktown
Country [76] 0 0
South Africa
State/province [76] 0 0
Pretoria
Country [77] 0 0
South Africa
State/province [77] 0 0
Richards Bay
Country [78] 0 0
South Africa
State/province [78] 0 0
Sandton
Country [79] 0 0
South Africa
State/province [79] 0 0
Tygerberg
Country [80] 0 0
South Africa
State/province [80] 0 0
Umhlanga
Country [81] 0 0
Spain
State/province [81] 0 0
Alicante
Country [82] 0 0
Spain
State/province [82] 0 0
Barcelona
Country [83] 0 0
Spain
State/province [83] 0 0
Cruces (Vizcaya)
Country [84] 0 0
Spain
State/province [84] 0 0
Madrid
Country [85] 0 0
Spain
State/province [85] 0 0
Malaga
Country [86] 0 0
Spain
State/province [86] 0 0
Oviedo
Country [87] 0 0
Spain
State/province [87] 0 0
Sevilla
Country [88] 0 0
Spain
State/province [88] 0 0
Zaragoza
Country [89] 0 0
Sweden
State/province [89] 0 0
Goteborg
Country [90] 0 0
Sweden
State/province [90] 0 0
Linkoping
Country [91] 0 0
Sweden
State/province [91] 0 0
Lund
Country [92] 0 0
Switzerland
State/province [92] 0 0
Basel
Country [93] 0 0
Switzerland
State/province [93] 0 0
Berne
Country [94] 0 0
Switzerland
State/province [94] 0 0
St Gallen
Country [95] 0 0
Taiwan
State/province [95] 0 0
Changhua
Country [96] 0 0
Taiwan
State/province [96] 0 0
Kaohsiung
Country [97] 0 0
Taiwan
State/province [97] 0 0
Tao-Yuan
Country [98] 0 0
Taiwan
State/province [98] 0 0
Yong Kang
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Bristol
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Cardiff
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Glasgow
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Liverpool
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Tooting
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Treliske

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00848549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michel Baulac
Address 0 0
Hopital de la Pitie-Saltpetriere
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications