Back to resultsA Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
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
Eligibility Criteria
INCLUSION CRITERIA:
Subjects will be eligible for the study if they meet all of the following inclusion criteria:
- Male or female subjects, 18 to 75 years of age inclusive.
- Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) or generalized tonic-clonic seizures (without clear focal origin) within 12 months of the Screening Visit, of which at least one seizure occurred within three months of the Screening Visit (> one seizure within a 24 hour period will be counted as one seizure).
- Subjects will either have had no previous use of an AED, or treatment with one AED for a maximum duration of two weeks before the Randomization Visit (T1).
- Subjects have a documented electroencephalogram (EEG) within 12 months of the Screening Visit, compatible with localization-related epilepsy (to exclude primary generalized epilepsy).
- Subjects have a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the absence of a progressive neurological lesion within 12 months of the Screening Visit.
- Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and randomization, must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. Medically acceptable contraception is defined here as oral contraception pill with at least 50 micrograms ethinylestradiol per intake, contraceptive injections and implants, or intrauterine device in place for at least three months.
- Subjects who are able and willing to follow investigational study procedures, maintain a seizure diary, and report AEs.
- Subjects who are able and willing to give written informed consent.
EXCLUSION CRITERIA:
Subjects who meet any of the following exclusion criteria will not be eligible for the study:
- Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
- Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
- Subjects have a history of status epilepticus, and/or non-epileptic seizures (e.g., metabolic, pseudo-seizures).
- Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
- Subjects have progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination, or tumour).
- Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
- Subjects have been previously treated with carbamazepine or zonisamide.
- Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
- Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
- Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
- Subjects have a history of acute intermittent porphyria.
- Subjects have a history of renal disorder (serum creatinine level of > 135 ìmol / l (1.5 mg/dL at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper normal limit.
- Subjects have a body weight of less than 40 kg.
- Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
- Subjects have a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
- Subjects are currently taking carbonic anhydrase inhibitors.
- Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
- Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other excluded medications.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Zonisamide
Carbamazepine
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase
A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Secondary Outcome Measures
Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period
A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Analysis of Time to Drop Out Due to an Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.
Analysis of Time to Drop Out Due to Lack of Efficacy
Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.
Time to 6-months Seizure Freedom
A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Time to 12-months Seizure Freedom
A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1
The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.
Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1
The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.
Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1
The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall
Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:
10 (Best possible quality of life) - 0 (Worst possible quality of life);
Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales.
Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1
The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.
Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1
The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00477295
Brief Title
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
Official Title
A Randomized, Multi-centre, Double-blind Study, to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
Brief Summary
This is a two-arm, randomized, double-blind, non-inferiority study using a flexible dosing regime to allow optimal zonisamide or carbamazepine therapy for individual subjects. Assessment of eligibility will take place at the Screening Visit. The subjects will be randomized to either the carbamazepine or zonisamide arm at the Randomization Visit (T1). T1 must occur as soon as possible (and at least within 14 days) of the Screening Visit in order to optimize subject care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
583 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zonisamide
Arm Type
Active Comparator
Arm Title
Carbamazepine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Other Intervention Name(s)
Zonegran
Intervention Description
Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
Intervention Type
Drug
Intervention Name(s)
Carbamazepine
Intervention Description
Week 1 and 2 either 100mg zonisamide or 200 mg carbamazepine Week 3 and 4 either 200mg zonisamide or 4800 mg carbamazepine Week 5 and 6 either 300mg zonisamide or 600 mg carbamazepine; this dose then to be maintained unless a subject has a seizure more than two weeks post a dose increase.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Seizure Freedom for 26-weeks During the Maintenance Phase
Description
A subject achieved a 26-week seizure-free period if they were free of all seizures, regardless of seizure type, for 26 weeks while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Time Frame
Week 31 through Week 109
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Seizure Freedom for 12-months During the FDP and Maintenance Period
Description
A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12 months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Time Frame
Week 5 through Week 109
Title
Analysis of Time to Drop Out Due to an Adverse Event (AE)
Description
An AE is defined as any untoward medical occurrence in a subject and does not necessarily have a causal relationship with the medicinal product. Adverse events were identified by: any unfavorable or unintended sign, symptom or disease temporarily associated with the use of a medicinal product; any new disease or exacerbation of an existing disease; any deterioration in nonprotocol-required measurements of laboratory values or other clinical test; and recurrence of an intermittent medical condition not present at Baseline.
Time Frame
Week 1 through Week 109
Title
Analysis of Time to Drop Out Due to Lack of Efficacy
Description
Lack of efficacy was evaluated by the subject and on the basis of whether zonisamide and carbamazepine gave the subject at least a 26-week seizure free rate. The subject could withdraw at any time due to lack of efficacy.
Time Frame
Week 1 through Week 109
Title
Time to 6-months Seizure Freedom
Description
A subject achieved a 6-months seizure-free period if they were free of all seizures, regardless of seizure type, for 6-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Time Frame
Week 5 through Week 83
Title
Time to 12-months Seizure Freedom
Description
A subject achieved a 12-month seizure-free period if they were free of all seizures, regardless of seizure type, for 12-months while receiving the same dose. The occurrence of seizures was documented in the seizure diary, which was maintained by the subject and reviewed at each following visit.
Time Frame
Week 5 through Week 83
Title
Change From Baseline in Total ABNAS Score at Maintenance Period Visit 1
Description
The Aldenkamp-Baker Neuropsychological Assessment Scale(ABNAS) is a subject based questionnaire to measure subjective perceived drug-related cognitive impairments. The ABNAS measured seven critical domains of cognition(tiredness/fatigue,hyperexcitability, slowing(mental and motor),memory impairment,attention disorders,impairment of motor coordination, and language disorders). The total score ranged from 0 to 72, with a higher score reflecting a high level of problems.
Time Frame
Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)
Title
Change From Baseline in Bond and Lader VAS Mood Sub-Scores at Maintenance Period Visit 1
Description
The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line.
Subjects were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria.
Time Frame
Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)
Title
Change From Baseline in QOLIE-31-P Overall Score at Maintenance Period Visit 1
Description
The Quality of Life in Epilepsy - Problems(QOLIE-31-P) was completed by the patient and contained 30 items covering seven subscales(seizure worry, overall
Quality of Life (QOL),emotional well-being,energy-fatigue, cognition,medication effects and social function) and one item covering health status. It also included seven items addressing overall distress related to each subscale, an item addressing the relative importance of each subscale topic, and an item addressing perception of overall change in QOL at the end of the study. A high score reflects a good QOL. The following scale range is a sample of 1 of the 7 of the subscales:
10 (Best possible quality of life) - 0 (Worst possible quality of life);
Rand Corporation QOLIE-31 Scoring Manual was used. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing overall all scales.
Time Frame
Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)
Title
Change From Baseline in SF-36 Aggregate Mental and Physical Component Score at Maintenance Period Visit 1
Description
The Short Form 36 Health and Well-Being Questionnaire (SF-36) is a 36-item generic health related QOL instrument covering the following domains: physical functioning, role-physical,bodily pain, general health, social functioning,role-emotional, mental health, and vitality. It yields a profile of eight scores, one for each domain, and physical and mental health summary measures. Each domain is described by a score ranging from 0 to 100, for a range of total possible scoes of 0-400 for physical and 0-400 for mental. An increase represents an improvement, whereas a decrease reflects a worsening.
Time Frame
Baseline and Maintenance Period Visit 1 (Week 31 to Week 83)
Title
Percentage of Participants With EQ-5D Scores at Maintenance Period Visit 1
Description
The European Quality of Life Group 5-Dimension Self-Report Questionnaire (EQ-5D) is a preference based generic health related quality of life (HRQoL) instrument which classifies health states across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain has three levels, they are (1) no problems, (2) some problems, (3) extreme problems. The percentages shown are calculated from the number of subjects at that visit with non-missing data for that score.
Time Frame
Week 31 through Week 83
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA:
Subjects will be eligible for the study if they meet all of the following inclusion criteria:
Male or female subjects, 18 to 75 years of age inclusive.
Subjects with untreated, newly diagnosed epilepsy having at least two well documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) or generalized tonic-clonic seizures (without clear focal origin) within 12 months of the Screening Visit, of which at least one seizure occurred within three months of the Screening Visit (> one seizure within a 24 hour period will be counted as one seizure).
Subjects will either have had no previous use of an AED, or treatment with one AED for a maximum duration of two weeks before the Randomization Visit (T1).
Subjects have a documented electroencephalogram (EEG) within 12 months of the Screening Visit, compatible with localization-related epilepsy (to exclude primary generalized epilepsy).
Subjects have a documented computed axial tomography (CAT) scan or magnetic resonance imaging (MRI) scan confirming the absence of a progressive neurological lesion within 12 months of the Screening Visit.
Female subjects without childbearing potential (two years post-menopausal, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential must not be pregnant as confirmed by a negative pregnancy test at screening and randomization, must not be lactating and must be using a medically acceptable form of contraception, for the duration of the study and for one month following discontinuation of the study drug. Medically acceptable contraception is defined here as oral contraception pill with at least 50 micrograms ethinylestradiol per intake, contraceptive injections and implants, or intrauterine device in place for at least three months.
Subjects who are able and willing to follow investigational study procedures, maintain a seizure diary, and report AEs.
Subjects who are able and willing to give written informed consent.
EXCLUSION CRITERIA:
Subjects who meet any of the following exclusion criteria will not be eligible for the study:
Subjects have a history of clinical investigations, including EEG data, that are suggestive of idiopathic generalised epilepsy as defined by the International League Against Epilepsy (ILAE).
Subjects with a history of absence, myoclonic, clonic, tonic, or atonic seizures.
Subjects have a history of status epilepticus, and/or non-epileptic seizures (e.g., metabolic, pseudo-seizures).
Subjects have experienced seizures relating to drugs, alcohol, acute medical illness, mental retardation, or subjects with situation-related seizures.
Subjects have progressive encephalopathy or findings consistent with progressive CNS disease or lesion (e.g. infection, demyelination, or tumour).
Subjects have a history of a significant or currently uncontrolled disease that will interfere with the conduct of this study or the assessment of safety and efficacy of the study drug.
Subjects have been previously treated with carbamazepine or zonisamide.
Subjects have received an investigational drug or device in the three months prior to the Screening Visit.
Subjects have a known hypersensitivity to sulfonamides, dibenzazepine derivatives, or tricyclic antidepressants.
Subjects have a history of bone marrow depression, low platelet count or other blood dyscrasia.
Subjects have a history of acute intermittent porphyria.
Subjects have a history of renal disorder (serum creatinine level of > 135 ìmol / l (1.5 mg/dL at the Screening Visit), hepatic disorder or clinically significant abnormal liver function tests; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2 times the upper normal limit.
Subjects have a body weight of less than 40 kg.
Subjects have a history of progressive malignancy within the previous 5 years (excluding a history of non-metastasized and adequately treated cutaneous squamous cell carcinoma).
Subjects have a history of psychiatric illness or mood disorder requiring electro-convulsive or drug therapy within the previous 6 months which is considered uncontrolled; a history of suicide attempt; alcohol or drug abuse; chronic treatment with benzodiazepines or barbiturates.
Subjects are currently taking carbonic anhydrase inhibitors.
Subjects have a history of pancreatitis, nephrolithiasis or hypercalcuria, clinically significant laboratory or electro-cardiographic abnormalities, or uncontrolled hypertension.
Subjects are currently taking mono-amine oxidase inhibitors (MAOIs) or any other excluded medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Segieth
Organizational Affiliation
Eisai Limited
Official's Role
Study Director
Facility Information:
City
Camperdown
Country
Australia
City
Clayton
Country
Australia
City
Fitzroy
Country
Australia
City
Flinders
Country
Australia
City
Heidelberg West
Country
Australia
City
Parkville
Country
Australia
City
Queensland
Country
Australia
City
Wellington
Country
Australia
City
Aalborg
Country
Denmark
City
Bethune cedex
Country
France
City
Dijon
Country
France
City
Paris
Country
France
City
St. Etienne
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
Thessaloniki
Country
Greece
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Gyula
Country
Hungary
City
Hodmezovasarhely
Country
Hungary
City
Nyregyhaza
Country
Hungary
City
Zalaegerszeg-Pozva
Country
Hungary
City
Bangalore
Country
India
City
Hyderabad
Country
India
City
Koturpuram
Country
India
City
Madurai
Country
India
City
New Delhi
Country
India
City
Pune
Country
India
City
Milan
Country
Italy
City
Monza
Country
Italy
City
Orbassano
Country
Italy
City
Rome
Country
Italy
City
Anyang
Country
Korea, Republic of
City
Seol
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Wonju
Country
Korea, Republic of
City
Gdansk
Country
Poland
City
Katowice
Country
Poland
City
Krakow
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Poznan
Country
Poland
City
Sosnowiec
Country
Poland
City
Szcecin
Country
Poland
City
Warszawa
Country
Poland
City
Kaliningrad
Country
Russian Federation
City
Kazan
Country
Russian Federation
City
Moscow
Country
Russian Federation
City
Saint Petersburg
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Belgrade
Country
Serbia
City
Nis
Country
Serbia
City
Novi Sad
Country
Serbia
City
Subotica
Country
Serbia
City
Bratislava
Country
Slovakia
City
Bratslava
Country
Slovakia
City
Brezno
Country
Slovakia
City
Nove Zamky
Country
Slovakia
City
Vranov nad Toplou
Country
Slovakia
City
Zilina
Country
Slovakia
City
Sandton
Country
South Africa
City
Alicante
Country
Spain
City
Bacelona
Country
Spain
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Malaga
Country
Spain
City
Oviedo
Country
Spain
City
Sevilla
Country
Spain
City
Goteborg
Country
Sweden
City
Lund
Country
Sweden
City
Changhua
Country
Taiwan
City
Yong Kang
Country
Taiwan
City
Bristol
Country
United Kingdom
City
Liverpool
Country
United Kingdom
City
Treliske
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22683226
Citation
Baulac M, Brodie MJ, Patten A, Segieth J, Giorgi L. Efficacy and tolerability of zonisamide versus controlled-release carbamazepine for newly diagnosed partial epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2012 Jul;11(7):579-88. doi: 10.1016/S1474-4422(12)70105-9. Epub 2012 Jun 8.
Results Reference
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Learn more about this trial
A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy
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