Back to resultsAssessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Zonisamide
Carbamazepine
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Monotherapy
Eligibility Criteria
Inclusion Criteria:
- Subject has completed study E2090-E044-310.
- Subject is able and willing to give written informed consent.
- 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.
- The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.
Exclusion Criteria:
- 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.
- Subject has a body weight <40 kg.
- 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).
- 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.
- Subject is currently taking carbonic anhydrase inhibitors.
- Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
- Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
- Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
- Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ZNS
CBZ
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00848549
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Monotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZNS
Arm Type
Active Comparator
Arm Title
CBZ
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Other Intervention Name(s)
Zonegran
Intervention Description
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
Intervention Name(s)
Carbamazepine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants Remaining in the Study at Each Visit
Description
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.
Time Frame
At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months
Secondary Outcome Measure Information:
Title
Time to Drop-out Due to Lack of Efficacy
Description
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.
Time Frame
Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study)
Title
Time to Drop-out Due to Adverse Event (AE)
Description
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).
Time Frame
Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study)
Title
Percentage of Participants That Are Seizure Free for at Least 24 Month Consecutive Period in the Base Study and Extension Phase
Description
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.
Time Frame
Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase)
Title
Change From Baseline in Quality of Life Assessed by Quality of Life in Epilepsy-Problems Questionnaire (QOLIE-31-P) Overall Score at Each Visit
Description
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.
Time Frame
Weeks 0, 26, 52, 78 and 117
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has completed study E2090-E044-310.
Subject is able and willing to give written informed consent.
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.
The subject is able and willing to follow the investigational study procedures, maintain a seizure diary and report adverse events.
Exclusion Criteria:
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.
Subject has a body weight <40 kg.
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).
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.
Subject is currently taking carbonic anhydrase inhibitors.
Subject developed pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory abnormalities, stroke or uncontrolled hypertension during study E2090-E044-310.
Subject is currently taking monoamine oxidase inhibitors (MAOIs) or any other excluded medications (see protocol section 9.9.3).
Subject has a history of allergy to carbamazepine or to zonisamide or to any of their ingredients or to sulphonamides.
Subject has developed a bone marrow depression, low platelet count or other blood dyscrasias.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Baulac
Organizational Affiliation
Hopital de la Pitie-Saltpetriere
Official's Role
Principal Investigator
Facility Information:
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Queensland
ZIP/Postal Code
4558
Country
Australia
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
Bethune cedex
ZIP/Postal Code
62408
Country
France
City
Dijon cedex
ZIP/Postal Code
21033
Country
France
City
Paris
ZIP/Postal Code
75651
Country
France
City
St Etienne cedex 2
ZIP/Postal Code
42055
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Bochum
ZIP/Postal Code
44805
Country
Germany
City
Duesseldorf
ZIP/Postal Code
40212
Country
Germany
City
Munich
ZIP/Postal Code
81377
Country
Germany
City
Schwerin
ZIP/Postal Code
19053
Country
Germany
City
Westerstede
ZIP/Postal Code
26676
Country
Germany
City
Athens
ZIP/Postal Code
10676
Country
Greece
City
Athens
ZIP/Postal Code
11525
Country
Greece
City
Athens
ZIP/Postal Code
15562
Country
Greece
City
Patras
ZIP/Postal Code
26500
Country
Greece
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
City
Thessaloniki
ZIP/Postal Code
55236
Country
Greece
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
City
Hodmezovasarhely
ZIP/Postal Code
6800
Country
Hungary
City
Nyregyhaza
ZIP/Postal Code
4400
Country
Hungary
City
Zalaegerszeg-Poozva
ZIP/Postal Code
8908
Country
Hungary
City
Bangalore
ZIP/Postal Code
560034
Country
India
City
Bangalore
ZIP/Postal Code
560094
Country
India
City
Hyderabad
ZIP/Postal Code
500 001
Country
India
City
Koturpuram, Chennai
ZIP/Postal Code
600 085
Country
India
City
Madurai, Tamil Nadu
ZIP/Postal Code
625 020
Country
India
City
Mumbai
ZIP/Postal Code
400 012
Country
India
City
New - Delhi
ZIP/Postal Code
110095
Country
India
City
New Delhi
ZIP/Postal Code
110 016
Country
India
City
New Delhi
ZIP/Postal Code
110 065
Country
India
City
Pune
ZIP/Postal Code
411 030
Country
India
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
City
Messina
ZIP/Postal Code
98122
Country
Italy
City
Milan
ZIP/Postal Code
20132
Country
Italy
City
Monza (MI)
ZIP/Postal Code
20052
Country
Italy
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Rome
ZIP/Postal Code
00133
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Turin
ZIP/Postal Code
10126
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Anyang
ZIP/Postal Code
431-070
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
133-792
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
City
Podgorica
ZIP/Postal Code
81000
Country
Montenegro
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
City
Gdansk
ZIP/Postal Code
80266
Country
Poland
City
Katowice
ZIP/Postal Code
40752
Country
Poland
City
Krakow
ZIP/Postal Code
31-530
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
City
Szczecin
ZIP/Postal Code
71252
Country
Poland
City
Warszawa
ZIP/Postal Code
00-416
Country
Poland
City
Warszawa
ZIP/Postal Code
09-777
Country
Poland
City
Kaliningrad
ZIP/Postal Code
236000
Country
Russian Federation
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
City
Madrid
ZIP/Postal Code
28038
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117995
Country
Russian Federation
City
Moscow
ZIP/Postal Code
198103
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
194017
Country
Russian Federation
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
City
Yaroslavl
ZIP/Postal Code
160000
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Krusevac
ZIP/Postal Code
37000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Sombor
ZIP/Postal Code
25000
Country
Serbia
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
City
Bratislava
ZIP/Postal Code
80000
Country
Slovakia
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
City
Brezno
ZIP/Postal Code
97701
Country
Slovakia
City
Kosice
ZIP/Postal Code
4190
Country
Slovakia
City
NoveZamky
ZIP/Postal Code
940 34
Country
Slovakia
City
Spitalska 6
ZIP/Postal Code
94901
Country
Slovakia
City
Vranov nad Toplou
ZIP/Postal Code
093 27
Country
Slovakia
City
Zilina
ZIP/Postal Code
1207
Country
Slovakia
City
Bellair
ZIP/Postal Code
4001
Country
South Africa
City
Berea
ZIP/Postal Code
4001
Country
South Africa
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
City
Pretoria
ZIP/Postal Code
0041
Country
South Africa
City
Richards Bay
ZIP/Postal Code
3900
Country
South Africa
City
Sandton
ZIP/Postal Code
2196
Country
South Africa
City
Tygerberg
ZIP/Postal Code
7505
Country
South Africa
City
Umhlanga
ZIP/Postal Code
4320
Country
South Africa
City
Alicante
ZIP/Postal Code
03010
Country
Spain
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
City
Cruces (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28047
Country
Spain
City
Malaga
ZIP/Postal Code
29010
Country
Spain
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
City
Goteborg
ZIP/Postal Code
41345
Country
Sweden
City
Linkoping
ZIP/Postal Code
SE-58185
Country
Sweden
City
Lund
ZIP/Postal Code
22185
Country
Sweden
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Berne
ZIP/Postal Code
3010
Country
Switzerland
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
80099
Country
Taiwan
City
Tao-Yuan
ZIP/Postal Code
33305
Country
Taiwan
City
Yong Kang
ZIP/Postal Code
71004
Country
Taiwan
City
Bristol
ZIP/Postal Code
BS16 1LE
Country
United Kingdom
City
Cardiff
ZIP/Postal Code
CF144XN
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AJ
Country
United Kingdom
City
Tooting
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
City
Treliske
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
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