Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
March 11, 2025 updated by: Bial - Portela C S.A.
Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Trial
The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.
Patients who complete Part I may enter a 1-year open-label extension.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Part I was a 22-week parallel-group, randomized, placebo-controlled period (8 weeks baseline, 2 weeks double-blind titration, and 12 weeks maintenance). After completing the baseline period, patients were randomized in a 1:1:1:1 ratio to 1 of the 3 ESL dose levels or to placebo.
Part II was a 1-year open-label extension for patients who had completed Part I. The starting dose was 800 mg once daily and could be titrated up or down at 400-mg intervals between 400 and 1200 mg.
Study Type
Interventional
Enrollment (Actual)
395
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Coronado (S.Romão E S. Mamede)
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Trofa, Coronado (S.Romão E S. Mamede), Portugal, 4745-457
- Bial - Portela & Cª, S.A.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- written informed consent signed by patient
- aged 18 years or more
- documented diagnosis of simple or complex partial seizures with or without secondary generalisation since at least 12 months prior to screening
- at least 4 partial seizures in each 4 week period during the last 8 weeks prior to screening, currently treated with 1 or 2 AEDs (any except oxcarbazepine and felbamate), in a stable dose regimen during at least 2 months prior to screening (patients using vigabatrin should have been on this medication for at least 1 year with no deficit in visual field identified)
- excepting epilepsy, patient is judged to be in general good health based on medical history, physical examination and laboratory tests
- post-menopausal or otherwise incapable of becoming pregnant by reason of surgery or tubal ligation; in case of woman of childbearing potential, patient must present a serum beta-hCG test consistent with a non-gravid state and agree to remain abstinent or use reliable contraception (oral contraception should be combined with a barrier method
Exclusion Criteria:
- only simple partial seizures with no motor symptomatology (classified as A2-4 according to the International Classification of Epileptic Seizures) that are not video-EEG documented
- primarily generalised epilepsy
- known rapid progressive neurological disorder; history of status epilepticus or cluster seizures (i.e., 3 or more seizures within 30 minutes) within the 3 months prior to screening
- seizures of psychogenic origin within the last 2 years
- history of schizophrenia or suicide attempt
- currently on or with exposure to felbamate or oxcarbazepine more within one month of screening
- using benzodiazepines on more than on an occasional basis (except when used chronically as AED)
- previous use of ESL or participation in a clinical study with ESL
- known hypersensitivity to carbamazepine, oxcarbazepine or chemically related substances
- history of abuse of alcohol, drugs or medications within the last 2 years
- uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological or oncology disorder
- second or third-degree atrioventricular blockade not corrected with a pacemaker
- relevant clinical laboratory abnormalities
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ESL 400 mg once daily
Eslicarbazepine acetate (ESL) was supplied in 400 mg tablets for Part I
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oral tablets
Other Names:
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Experimental: ESL 800 mg once daily
Eslicarbazepine acetate (ESL) was supplied in 800-mg tablets for Part I
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oral tablets
Other Names:
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Experimental: ESL 1200 mg once daily
Eslicarbazepine acetate (ESL) was supplied in 400-mg and 800-mg tablets for Part I
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oral tablets
Other Names:
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Placebo Comparator: placebo
Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied
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once daily placebo comparator
Other Names:
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Experimental: ESL - Part II
All patients in Part II (Open-label Extension ) received ESL on an open-label basis, starting at 800 mg once daily.
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Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PART I - Seizure Frequency
Time Frame: 12-week maintenance period
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The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks.
The primary efficacy analysis was based on the ITT population.
Efficacy analyses were performed chiefly using data from the 12-week maintenance period in Part I of the study.
The primary efficacy variable is the ln transformation of the seizure frequency per 4 weeks.
Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA that models seizure frequency as a function of baseline seizure frequency and treatment.
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12-week maintenance period
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PART II - Nº of Treatment-Emergent Adverse Events (TEAE)
Time Frame: 1 year
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Safety assessments were based primarily on AEs (Number of patients who experienced at least one AEs), and on whether these were related to the study medication, were serious, led to permanent discontinuation of study participation, or led to death.
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elinor Ben-Menachem, MD, Sahlgren University Hospital, Göteborg, Sweden
- Principal Investigator: Alberto Alain Gabbai, MD, Rua Pedro de Toledo 655, Vila Clemento, Sao Paulo, Brazil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 11, 2009
First Posted (Estimated)
August 12, 2009
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 11, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIA-2093-302
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