Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy

NCT ID: NCT00957047

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 395 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-01-31

Brief Summary

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.

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.

Conditions

Partial Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ESL 400 mg once daily

Eslicarbazepine acetate (ESL) was supplied in 400 mg tablets for Part I

Group Type: EXPERIMENTAL

eslicarbazepine acetate

Intervention Type: DRUG

oral tablets

ESL 800 mg once daily

Eslicarbazepine acetate (ESL) was supplied in 800-mg tablets for Part I

Group Type: EXPERIMENTAL

eslicarbazepine acetate

Intervention Type: DRUG

oral tablets

ESL 1200 mg once daily

Eslicarbazepine acetate (ESL) was supplied in 400-mg and 800-mg tablets for Part I

Group Type: EXPERIMENTAL

eslicarbazepine acetate

Intervention Type: DRUG

oral tablets

placebo

Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

once daily placebo comparator

ESL - Part II

All patients in Part II (Open-label Extension ) received ESL on an open-label basis, starting at 800 mg once daily.

Group Type: EXPERIMENTAL

ESL - Part II

Intervention Type: DRUG

Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.

Interventions

eslicarbazepine acetate

oral tablets

Intervention Type: DRUG

placebo

once daily placebo comparator

Intervention Type: DRUG

ESL - Part II

Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.

Intervention Type: DRUG

Other Intervention Names

Zebinix; Sugar pill; Eslicarbazepine acetate (ESL), BIA 2-093

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bial - Portela C S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elinor Ben-Menachem, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgren University Hospital, Göteborg, Sweden

Alberto Alain Gabbai, MD

Role: PRINCIPAL_INVESTIGATOR

Rua Pedro de Toledo 655, Vila Clemento, Sao Paulo, Brazil

Locations

Bial - Portela & Cª, S.A.

Trofa, Coronado (S.Romão E S. Mamede), Portugal

Countries

Portugal

References

Andermann E, Rosenfeld W, Penovich P, Rogin J, Cendes F, Carreno M, Ramsay RE, Ben-Menachem E, Gama H, Rocha F, Soares-da-Silva P, Tosiello R, Blum D, Grinnell T. Comparative analysis of the safety and tolerability of eslicarbazepine acetate in older (>/=60 years) and younger (18-59 years) adults. Epilepsy Res. 2021 Jan;169:106478. doi: 10.1016/j.eplepsyres.2020.106478. Epub 2020 Oct 10.

Reference Type: DERIVED

PMID: 33338829 (View on PubMed)

Other Identifiers

BIA-2093-302

Identifier Type: -

Identifier Source: org_study_id