Safety and Efficacy of Eslicarbazepine Acetate as Adjunctive Therapy for Partial Seizures in Elderly Patients
This study has been completed.
Information provided by (Responsible Party):
Bial - Portela C S.A.
First received: July 29, 2011
Last updated: March 1, 2017
Last verified: March 2017
This is an open Label study to investigate the safety and efficacy of eslicarbazepine acetate as adjunctive therapy for partial seizures in elderly patients.
Drug: Eslicarbazepine Acetate
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||Safety and Efficacy of Eslicarbazepine Acetate (ESL) as Adjunctive Therapy for Partial Seizures in Elderly Patients
Primary Outcome Measures:
- Number of Subjects With Reported Adverse Events (AE) [ Time Frame: throughout the study ]
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.
- 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 without any TEAE
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2013 (Final data collection date for primary outcome measure)
Experimental: Eslicarbazepine Acetate tablets (800 mg)
Drug: Eslicarbazepine Acetate
ESL tablets (800 mg) QD
Other Name: Zebinix
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.
|Ages Eligible for Study:
||65 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Written informed consent form;
- Of age 65 years or older;
- A documented diagnosis of epilepsy for at least 12 months,
- 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;
- 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);
- Willing and able to comply with all trial requirements, in the judgment of the investigator;
- At least 2 partial-onset seizures (documented in the diary) per 4 weeks during the 8-week baseline period;
- Satisfactorily complied with the study requirements during the baseline period
- Only simple partial seizures with no motor symptomatology (classified as A2-4) according to the International Classification of Epileptic Seizures);
- Primarily generalised seizures;
- Known progressive neurological disorders (progressive brain disease, epilepsy secondary to progressive central nervous system lesion) and progressive dementia;
- Occurrence of seizures too close to count accurately;
- History of status epileptic or cluster seizures 8i.e. 3 or more seizures within 30 minutes) within the 3 months prior to screening;
- Seizures of non-epileptic origin;
- Major psychiatric disorders;
- History of suicide attempt;
- Currently treated with oxcarbazepine;
- Previous use of ESL or participation in a clinical study with ESL;
- Known hypersensitivity to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients;
- Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder, hypo - or hyper thyroidism of any type;
- Second or third-degree atrioventricular blockade or any clinically significant abnormality in the 12-lead electrocardiogram (ECG) as determined by the investigator;
- 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;
- Calculated creatinine values < 30 mL/min at screening;
- Any other condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol;
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01422720
Bial - Portela C S.A.
||Bial - Portela C S.A.
History of Changes
|Other Study ID Numbers:
0140BI17.MPB ( Other Identifier: SCOPE )
2009-012587-14 ( EudraCT Number )
|Study First Received:
||July 29, 2011
|Results First Received:
||May 9, 2014
||March 1, 2017
Keywords provided by Bial - Portela C S.A.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 28, 2017
Central Nervous System Diseases
Nervous System Diseases
Signs and Symptoms
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action