Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 0140BI17.MPB | Other Identifier | SCOPE | |
| 2009-012587-14 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
Multicenter study in approximately 100 elderly patients. The study will follow an open-label design and will consist of 8-week baseline period, followed by a 26-week treatment period and a 4-week follow-up period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eslicarbazepine Acetate tablets (800 mg) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eslicarbazepine Acetate | Drug | ESL tablets (800 mg) QD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Reported Adverse Events (AE) | An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP. TEAE assessment:
| throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Standardized Seizure Frequency | Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks. | 8-week Baseline Period and 26-week Treatment Period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie | Innsbruck | Austria | ||||
| Universitätsklinik für Neurologie; Christian-Doppler-Klinik |
In this trial all subjects received the same treatment.
44 clinical centres in Europe and Asia.
Studied period (years):
Date of first enrolment: 19-APR-2010 Date of last subject completed: 08-OCT-2013
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Esl 800 mg | Eslicarbazepine Acetate (Esl) tablets (800 mg) QD |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Salzburg |
| Austria |
| Medizinische Universitat Wien Klinik fur Neurologie | Vienna | Austria |
| 4 MHAT Sofia | Sofia | Bulgaria |
| Diagnostic & Consultative Center "Sveta Anna" EOOD | Sofia | Bulgaria |
| First MHAT-Sofia | Sofia | Bulgaria |
| UMHAT "Aleksandrovska" | Sofia | Bulgaria |
| UMHAT "Tsaritsa Yoanna -ISUL" | Sofia | Bulgaria |
| MHAT "Prof. Stoyan Kirkovich" | Stara Zagora | Bulgaria |
| General County Hospital Požega, Neurology department | Požega | Croatia |
| Polyclinic for neurology and psychiatry 'Interneuron | Rijeka | Croatia |
| Clinical Hospital Centre Split | Split | Croatia |
| Neurologická klinika, FN u Sv. Anny | Brno | Czechia |
| NZZ BORMED s.r.o. | Ostrava - Třebovice | Czechia |
| Neurologická ambulance | Pilsen | Czechia |
| Clintrial, s.r.o. | Prague | Czechia |
| Medical Services Prague s.r.o. | Prague | Czechia |
| Oddělení neurologie, FN Bulovka | Prague | Czechia |
| Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika | Praha 4 - Krč | Czechia |
| Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie | Montpellier | France |
| Hôpital Central - Service de Neurologie | Nancy | France |
| Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux | Paris | France |
| Klinik für Epileptologie Universität Bonn | Bonn | Germany |
| Zentrum Epilepsie Erlangen | Erlangen | Germany |
| Diakonie Kork, Epilepsiezentrum | Kehl-Kork | Germany |
| IZKS; Universitätsmedizin der Johannes-Gutenberg-Universität Mainz | Mainz | Germany |
| Studienzentrum Dr. Stephan Arnold | München | Germany |
| Neurologische Gemeinschaftspraxis am Seelberg | Stuttgart | Germany |
| Universitäts- und Rehabilitationskliniken Ulm (RKU), Klinik für Neurologie | Ulm | Germany |
| "Klinika Neurologii Rozwojowej | Gdansk | Poland |
| Centrum Leczenia Padaczki i Migreny | Krakow | Poland |
| Małopolskie Centrum Medyczne s.c. | Krakow | Poland |
| Centrum Terapii Współczesnej | Lodz | Poland |
| AIBILI - Centro de Estudos de Biodisponibildade | Coimbra | Portugal |
| Centro Hospitalar de Lisboa Norte, EPE - Hospital de Staª Maria - Centro de Estudos Egas Moniz | Lisbon | Portugal |
| Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz | Lisbon | Portugal |
| Unidade Local de Saúde de Alto Minho, EPE - Hospital de Santa Luzia - Serviço de Neurologi | Viana do Castelo | Portugal |
| Centro Hospitalar de Trás-os -Montes e Alto-Douro, EPE - Hospital de São Pedro - Serviço de Neurologia | Vila Real | Portugal |
| C.M.D.T.A. Neomed | Brasov | Romania |
| Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC) | Bucharest | Romania |
| Sc Clubul Sanatatii Srl | Campulung Muscel | Romania |
| Spitalul Clinic de Neuropsihiatrie Craiova | Craiova; Jud. Dolj | Romania |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain |
| IMAS Hospital del Mar | Barcelona | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Universitario Virgen Macarena | Seville | Spain |
| Safety Set |
|
| Full Analysis Set (FAS) |
|
| Per-Protocol Set (PPS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Esl 800 mg | Eslicarbazepine Acetate (Esl) tablets (800 mg) QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Number of Subjects With Reported Adverse Events (AE) | An AE was defined as Treatment-Emergent Adverse Event (TEAE), if first onset or worsening was after the first intake of investigational medicinal product (IMP) and not more than 14 days after the last administration of IMP. TEAE assessment:
| Posted | Number | participants | throughout the study |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Standardized Seizure Frequency | Absolute and relative changes from baseline of seizure frequency standardised to a frequency per 4 weeks. | Posted | Mean | Standard Deviation | seizures/4 weeks | 8-week Baseline Period and 26-week Treatment Period |
|
Throughout the study
Not provided
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 | Esl 800 mg | Eslicarbazepine Acetate (Esl) tablets (800 mg) QD | 11 | 72 | 43 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Altered state of consciousness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Glioblastoma multiforme | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Postictal psychosis | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director R&D | BIAL - Portela & Cª S.A. | +351-229866100 | clinical.trials@bial.com |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C416835 | eslicarbazepine acetate |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| 80-84 years |
|
| Title | Measurements |
|---|---|
|
| patients with at least one TESAE |
|
| patients prematurely terminated due to TEAE |
|
| patients with at least one TEAE |
|
| patients with at least one related TEAE |
|
| patients without any TEAE |
|
| patients with at least one severe TEAE |
|
The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
|
|