Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001159-23 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZNS | Active Comparator |
| |
| CBZ | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zonisamide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michel Baulac | Hopital de la Pitie-Saltpetriere | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camperdown | New South Wales | 2050 | Australia | |||
Not provided
E2090-E044-314 is a double-blind extension of E2090-E044-310 (NCT00477295) "base study." Assessment of eligibility took place at the Study Entry Visit (SEV), which was the same day as their final visit of Study 310. Subjects remained on the same investigational product as they were randomized to in Study 310 until unblinding of that study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zonisamide | Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| E2090-E044-310 (Base Study) Disposition |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Carbamazepine | Drug | 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. |
|
| 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). |
| Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study) |
| 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. | Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase) |
| 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. | Weeks 0, 26, 52, 78 and 117 |
| Bedford Park |
| South Australia |
| 5042 |
| Australia |
| Clayton | Victoria | 3168 | Australia |
| Fitzroy | Victoria | 3065 | Australia |
| Heidelberg West | Victoria | 3084 | Australia |
| Parkville | Victoria | 3050 | Australia |
| Perth | Western Australia | 6000 | Australia |
| Queensland | 4558 | Australia |
| Aalborg | 9000 | Denmark |
| Béthune | 62408 | France |
| Dijon | 21033 | France |
| Paris | 75651 | France |
| Saint-Etienne | 42055 | France |
| Berlin | 13353 | Germany |
| Bochum | 44805 | Germany |
| Düsseldorf | 40212 | Germany |
| Munich | 81377 | Germany |
| Schwerin | 19053 | Germany |
| Westerstede | 26676 | Germany |
| Athens | 10676 | Greece |
| Athens | 11525 | Greece |
| Athens | 15562 | Greece |
| Pátrai | 26500 | Greece |
| Thessaloniki | 54636 | Greece |
| Thessaloniki | 55236 | Greece |
| Thessaloniki | 57010 | Greece |
| Budapest | 1076 | Hungary |
| Budapest | 1096 | Hungary |
| Budapest | 1145 | Hungary |
| Debrecen | 4032 | Hungary |
| Gyula | 5700 | Hungary |
| Hódmezővásárhely | 6800 | Hungary |
| Nyregyhaza | 4400 | Hungary |
| Zalaegerszeg-Poozva | 8908 | Hungary |
| Bangalore | 560034 | India |
| Bangalore | 560094 | India |
| Hyderabad | 500 001 | India |
| Koturpuram, Chennai | 600 085 | India |
| Madurai, Tamil Nadu | 625 020 | India |
| Mumbai | 400 012 | India |
| New Delhi | 110 016 | India |
| New Delhi | 110 065 | India |
| New Delhi | 110095 | India |
| Pune | 411 030 | India |
| Catanzaro | 88100 | Italy |
| Messina | 98122 | Italy |
| Milan | 20132 | Italy |
| Monza (MI) | 20052 | Italy |
| Orbassano | 10043 | Italy |
| Pavia | 27100 | Italy |
| Rome | 00133 | Italy |
| Siena | 53100 | Italy |
| Turin | 10126 | Italy |
| Udine | 33100 | Italy |
| Podgorica | 81000 | Montenegro |
| Gdansk | 80-803 | Poland |
| Gdansk | 80266 | Poland |
| Katowice | 40752 | Poland |
| Krakow | 31-530 | Poland |
| Lodz | 90-153 | Poland |
| Lodz | 93-513 | Poland |
| Lublin | 20-718 | Poland |
| Poznan | 60-355 | Poland |
| Sosnowiec | 41-200 | Poland |
| Szczecin | 71252 | Poland |
| Warsaw | 00-416 | Poland |
| Warsaw | 09-777 | Poland |
| Kaliningrad | 236000 | Russia |
| Kazan' | 420012 | Russia |
| Madrid | 28038 | Russia |
| Moscow | 117049 | Russia |
| Moscow | 117995 | Russia |
| Moscow | 198103 | Russia |
| Saint Petersburg | 194017 | Russia |
| Saint Petersburg | 194044 | Russia |
| Saint Petersburg | 197376 | Russia |
| Yaroslavl | 160000 | Russia |
| Belgrade | 11000 | Serbia |
| Kragujevac | 34000 | Serbia |
| Kruševac | 37000 | Serbia |
| Niš | 18000 | Serbia |
| Novi Sad | 21000 | Serbia |
| Sombor | 25000 | Serbia |
| Subotica | 24000 | Serbia |
| Bratislava | 80000 | Slovakia |
| Bratislava | 826 06 | Slovakia |
| Bratislava | 833 05 | Slovakia |
| Brezno | 97701 | Slovakia |
| Košice | 4190 | Slovakia |
| NoveZamky | 940 34 | Slovakia |
| Spitalska 6 | 94901 | Slovakia |
| Vranov nad Topľou | 093 27 | Slovakia |
| Žilina | 1207 | Slovakia |
| Bellair | 4001 | South Africa |
| Berea | 4001 | South Africa |
| Parktown | 2193 | South Africa |
| Pretoria | 0041 | South Africa |
| Richards Bay | 3900 | South Africa |
| Sandton | 2196 | South Africa |
| Tygerberg | 7505 | South Africa |
| Umhlanga | 4320 | South Africa |
| Anyang | 431-070 | South Korea |
| Seoul | 110-744 | South Korea |
| Seoul | 133-792 | South Korea |
| Seoul | 143-729 | South Korea |
| Wŏnju | 220-701 | South Korea |
| Alicante | 03010 | Spain |
| Barcelona | 08041 | Spain |
| Cruces (Vizcaya) | 48903 | Spain |
| Madrid | 28040 | Spain |
| Madrid | 28047 | Spain |
| Málaga | 29010 | Spain |
| Oviedo | 33006 | Spain |
| Seville | 41009 | Spain |
| Seville | 41013 | Spain |
| Seville | 41014 | Spain |
| Zaragoza | 50009 | Spain |
| Gothenburg | 41345 | Sweden |
| Linköping | SE-58185 | Sweden |
| Lund | 22185 | Sweden |
| Basel | 4031 | Switzerland |
| Bern | 3010 | Switzerland |
| Sankt Gallen | 9007 | Switzerland |
| Changhua | 50006 | Taiwan |
| Kaohsiung City | 80099 | Taiwan |
| Taoyuan | 33305 | Taiwan |
| Yongkang District | 71004 | Taiwan |
| Bristol | BS16 1LE | United Kingdom |
| Cardiff | CF144XN | United Kingdom |
| Glasgow | G11 6NT | United Kingdom |
| Liverpool | L9 7AJ | United Kingdom |
| Tooting | SW17 0QT | United Kingdom |
| Treliske | TR1 3LJ | United Kingdom |
| Carbamazepine |
Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| E2090-E044-310 (Base Study) Transition |
|
|
| E2090-E044-314 (Extension Study) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zonisamide | Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. |
| BG001 | Carbamazepine | Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||
| Sex/Gender, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Intent-to-Treat (ITT) Population is defined as all subjects who received at least one dose of investigational product(IP) | Posted | Number | 95% Confidence Interval | Percentage of Participants | At 3, 6, 9, 12, 15, 18, 21, 24, and 27 months |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | 310 ITT Population (combined ITT Population from basecore study and extension phase). 24 participants were discontinued in each arm due to lack of efficacy; these were the participants that were evaluated in this outcome. | Posted | Mean | Standard Deviation | Days | Week 1 to Week 109 (in core study) and Month 1 to Month 27 (in extension study) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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). | 310 ITT Population (33 participants were discontinued in the Zonisamide arm and 35 were discontinued in the Carbamazepine arm; these were the participants evaluated for this outcome) | Posted | Mean | Standard Deviation | Days | Week 1 to Week 109 (in base study) and Month 1 to Month 27 (in extension study) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 310 ITT Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 5 to Week 109 (in base study) and Month 1 to Month 27 (in extension phase) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population | Posted | Mean | Standard Deviation | Score on a scale | Weeks 0, 26, 52, 78 and 117 |
|
From the time the subject signed the informed consent form through the Final Visit/Early Termination Visit and for 15 days following study drug discontinuation.
Adverse events were assessed at clinical visits based on the subject's diary, vitals, weight, physical examination, neurological exam, and laboratory evaluations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zonisamide (Extension Study 314, NCT00848549) | Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. | 7 | 137 | 12 | 137 | ||
| EG001 | Carbamazepine (Extension Study 314, NCT00848549) | Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range. | 7 | 158 | 10 | 158 | ||
| EG002 | Zonisamide (Base Study 310, NCT00477295) | The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP. | 15 | 281 | 72 | 281 | ||
| EG003 | Carbamazepine (Base Study 310, NCT00477295) | The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP. | 17 | 300 | 69 | 300 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Peptic ulcer haemorrhage | Gastrointestinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Electrocardiogram abnormal | Investigations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Prostatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Unwanted pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Partial seizures with secondary generalization | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Complex partial seizures | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Acute psychosis | Psychiatric disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA V. 13.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight Decreased | Investigations | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA V. 13.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA V. 13.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc. | Eisai Call Center | 888-422-4743 |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078305 | Zonisamide |
| D002220 | Carbamazepine |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Other |
|
|
| Male (Base Study 310, NCT00477295) |
|
| Female (Extension Study 314, NCT00848549) |
|
| Male (Extension Study 314, NCT00848549) |
|
| 9 months |
|
| 12 months |
|
| 15 months |
|
| 18 months |
|
| 21 months |
|
| 24 months |
|
| 27 months |
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|