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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00848549




Registration number
NCT00848549
Ethics application status
Date submitted
19/02/2009
Date registered
20/02/2009
Date last updated
24/12/2015

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
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
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)
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
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
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
Sex
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
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2011
Sample size
Target
Accrual to date
Final
295
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
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Denmark
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Aalborg
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France
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Bethune cedex
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France
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Dijon cedex
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France
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Paris
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France
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St Etienne cedex 2
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Germany
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Berlin
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Germany
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Bochum
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Duesseldorf
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Munich
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Schwerin
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Westerstede
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Greece
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Athens
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Debrecen
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Gyula
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Hodmezovasarhely
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Zalaegerszeg-Poozva
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India
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Bangalore
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India
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Hyderabad
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India
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Koturpuram, Chennai
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India
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Madurai, Tamil Nadu
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Mumbai
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India
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New Delhi
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Pune
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Catanzaro
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Messina
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Milan
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Turin
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Udine
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Anyang
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Seoul
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Montenegro
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Yaroslavl
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Belgrade
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Kragujevac
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Serbia
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Krusevac
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Serbia
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Nis
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Serbia
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Tygerberg
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Alicante
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Barcelona
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Cruces (Vizcaya)
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Sevilla
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Goteborg
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Changhua
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Kaohsiung
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Yong Kang
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Tooting
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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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00848549