Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients

Epilepsy Clinical Trial

Official title:

Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422720
• Other study ID #: BIA-2093-401
• Secondary ID: 0140BI17.MPB2009
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2011
• Last updated: June 17, 2015
• Start date: April 2010
• Est. completion date: September 2013

Study information

• Verified date: June 2015
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesPortugal: National Pharmacy and Medicines InstituteFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Agencia Española de Medicamentos y Productos SanitariosRomania: National Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent form;

2. Of age 65 years or older;

3. A documented diagnosis of epilepsy for at least 12 months,

4. At least 2 partial-onset seizures (including subtypes of simple partial, complex partial and/or partial seizures evolving to secondarily generalised) in the 4 weeks prior to screening;

5. Currently treated with 1 or 2 AEDs (any except oxcarbazepine) in a stable dosage regimen for at least 4 weeks prior to screening. Vagus nerve stimulation (VNS) is to be considered as an AED (i.e., only one concomitant AED is allowed in patients with VNS);

6. Willing and able to comply with all trial requirements, in the judgment of the investigator;

7. At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;

8. Satisfactorily complied with the study requirements during the baseline period

Exclusion Criteria:

1. Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);

2. Primarily generalised seizures;

3. Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;

4. Occurrence of seizures too close to count accurately;

5. History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;

6. Seizures of non-epileptic origin;

7. Major psychiatric disorders;

8. History of suicide attempt;

9. Currently treated with oxcarbazepine;

10. Previous use of ESL or participation in a clinical study with ESL;

11. Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;

12. Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;

13. Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;

14. Relevant clinical laboratory abnormalities as determined by the investigator (e.g. plasma sodium <130 mmol/L, alanine or aspartate aminotransferases >2.0 times above the upper limit of the range, or white blood cell count <3,000 cells/mm3;

15. Calculated creatinine values < 30 mL/min at screening;

16. Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;

17. Received an investigational drug (or a medical device) within 3 months of screening or is currently participating in another trial of an investigational drug (or medical device) trial.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Eslicarbazepine Acetate
ESL tablets (800 mg) QD

Locations

Country	Name	City	State
Austria	Universitätsklinik für Neurologie; Arbeitsgruppe Epileptologie	Innsbruck
Austria	Universitätsklinik für Neurologie; Christian-Doppler-Klinik	Salzburg
Austria	Medizinische Universitat Wien Klinik fur Neurologie	Wien
Bulgaria	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
Croatia	General County Hospital Požega, Neurology department	Požega
Croatia	Polyclinic for neurology and psychiatry 'Interneuron	Rijeka
Croatia	Clinical Hospital Centre Split	Split
Czech Republic	Neurologická klinika, FN u Sv. Anny	Brno
Czech Republic	NZZ BORMED s.r.o.	Ostrava - Trebovice
Czech Republic	Neurologická ambulance	Plzen
Czech Republic	Clintrial, s.r.o.	Praha 10
Czech Republic	Fakultní Thomayerova nemocnice s poliklinikou, Neurologická klinika	Praha 4 - Krc
Czech Republic	Medical Services Prague s.r.o.	Praha 6
Czech Republic	Oddelení neurologie, FN Bulovka	Praha 8
France	Hôpital Gui de Chauliac, Explorations neurologiques et d'épileptologie	Montpellier Cedex 05
France	Hôpital Central - Service de Neurologie	Nancy
France	Groupement Hospitalier Universitaire Est, Pitié-Salpétrière; Clinique des Maladies du Système Nerveux	Paris Cedex 13
Germany	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
Poland	"Klinika Neurologii Rozwojowej	Gdansk
Poland	Centrum Leczenia Padaczki i Migreny	Kraków
Poland	Malopolskie Centrum Medyczne s.c.	Kraków
Poland	Centrum Terapii Wspólczesnej	Lodz
Portugal	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
Romania	C.M.D.T.A. Neomed	Brasov
Romania	Cabinet Medical Individual "Dr. Roceanu Adina Maria" -Neurologie, Neurofiziologie (EEG, EMG, PEC)	Bucuresti
Romania	Sc Clubul Sanatatii Srl	Campulung Muscel
Romania	Spitalul Clinic de Neuropsihiatrie Craiova	Craiova; Jud. Dolj
Spain	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	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Countries where clinical trial is conducted

Austria,  Bulgaria,  Croatia,  Czech Republic,  France,  Germany,  Poland,  Portugal,  Romania,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: patients who died; patients who died due to Treatment-emergent adverse event (TEAE); patients with at least one Serious Adverse Event (SAE); patients with at least one Treatment-emergent Serious Adverse Event (TESAE); patients prematurely terminated due to TEAE; patients with at least one TEAE; patients with at least one related TEAE; patients with at least one severe TEAE; patients with at least one severe TEAE	throughout the study	Yes
Secondary	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	No