EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) AS MONOTHERAPY FOR PATIENTS WITH NEWLY DIAGNOSED PARTIAL-ONSET SEIZURES:A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTER CLINICAL STUDY
- Conditions
- G40-G40
- Registration Number
- PER-108-10
- Lead Sponsor
- BIAL - Portela & Cª, S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 13
• Have signed an informed consent before submitting to activities related to the study. Subjects of Asian descent (subjects with a direct ancestor of Asian origin, regardless of generational difference) are required to grant written informed consent for genotype determination.
• Male or female> 18 years old.
• Recently diagnosed epilepsy with at least 2 well-documented, unprovoked, clinically evaluated and classified partial seizures (with or without secondary generalization) of clear focal origin, clinically documented OR by electroencephalogram (EEG) or imaging studies, within 12 months of Visit I. In this context, seizures that occur within a 48-hour period are counted as 1 seizure,
• At least I seizure during the previous 3 months.
• Demonstrated cooperation and willingness to complete all aspects of the study.
• Women without reproductive capacity (2 years postmenopause, oophorectomy or bilateral tubal ligation, or complete hysterectomy) meet the requirements. Women with reproductive capacity should not be pregnant, which must be confirmed by a negative analysis of serum human chorionic gonadotropin P (hCG), and sexually active women should use a non-hormonal, effective and medically acceptable method of contraception for the duration of study and until the post-study visit (VPE).
• Have successfully completed the subject´s electronic journal (electronic journal).
• Women with reproductive capacity should not be pregnant, which must be confirmed by a negative result of a urine pregnancy test, and sexually active women should use a non-hormonal and effective method of contraception that is medically acceptable, while it lasts the study and even the VPE
• History of pseudoconvulsions.
• Seizures that occur only in clusters.
• History of absence, myoclonic, clonic, tonic or atonic seizures.
• EEG documented within 12 months of Visit 1 that suggests primarily generalized epilepsy.
• History of epileptic status within 3 months prior to Visit 1.
• Known progressive neurological disorder (progressive brain disease, epilepsy secondary to progressive brain injury), as assessed by magnetic resonance imaging or computed tomography.
• Current or past use of any FAE, except for the use of a single FAE for a maximum of 2 weeks before Visit 1.
• Prior use of ESL or CBZ.
• Use of monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, nefazodone, isoniazid or protease inhibitors or any other antiretroviral agent (eg, efavirenz) that may increase CBZ-LC levels.
• Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
• History of uncontrolled psychiatric illness or mood disorder that requires electroconvulsive or pharmacological therapy within the previous 6 months, history of attempted suicide, schizophrenia, chronic treatment with benzodiazepines (except short-acting benzodiazepines) or barbiturates.
• Clinical evaluation that, in the opinion of the investigator, indicates suicide risk, based on a clinical interview and the Columbia scale for the classification of suicide-related severity (C-SSRS).
• History of alcoholism, drug addiction or drug abuse within the past 2 years.
• Cardiac disorder (including atrioventricular block and other clinically significant electrocardiographic abnormalities), renal, hepatic, endocrine, gastrointestinal, metabolic, hematological or oncological uncontrolled.
• 15- History of bone marrow depression.
• History of hepatic porphyrias (eg, acute intermittent porphyria, porphyria variegata, late cutaneous porphria).
• Relevant abnormalities in clinical laboratory tests (eg, sodium <130 mmoI / L, alanine or aspartate transaminase> 2 x the upper limit of normal, leukocyte count <3000 cells / mm ^) (measured in the Visit 1).
• Calculated glomerular filtration rate (TFGc) <60 ml / min / 1.73 m ^ 2 (measured in Visit 1).
• Subjects of Asian descent with a positive result in the analysis that determines the presence of the HLA-B * 1502 allele.
• Pregnancy or breastfeeding.
• Participation in another clinical trial of drugs within the last 2 months or having received a PEI within 5 half-lives of PEI, whichever is longer.
• Any other condition or circumstance that, in the opinion of the researcher, could compromise the subject´s ability to comply with the study protocol.
• Current or past use of any FAE, except for the use of a single FAE for a maximum of 2 weeks before Visit 1 and with a period of at least 5 days prior to Visit Al during which the drug was not administered . Benzodiazepines are allowed, no more than twice a week, for an epileptic indication and as rescue medication during the period without drugs of> 5 days.
• Use of prohibited medications.
• Pregnancy
• Any other condition or circumstance that, in the opinion of the researcher, could compromise the subject´s ability to comply with the study protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The amount of any seizure will be recorded by daily registration cards in electronic journals. Each subject will be instructed to keep a seizure record in their electronic journal and to record all seizures by date, time at which they occur and duration, throughout the entire study. The subject will be asked to indicate whether a seizure has occurred on each day.<br>Measure:Proportion of subjects in the PP set who do not have seizures during the entire evaluation period of 26 weeks at the last dose level received.<br>Timepoints:26 weeks<br>
- Secondary Outcome Measures
Name Time Method