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

NCT00957047 | Completed Phase 3 Results

• 1 other identifier: BIA-2093-302
• Study Type: interventional
• Target: 395
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Epilepsy

Keywords

refractory; partial; epilepsy

Outcome Measures

Primary Outcomes (2)

• PART I - Seizure Frequency

  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.

  12-week maintenance period

• PART II - Nº of Treatment-Emergent Adverse Events (TEAE)

  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.

  1 year

Study Arms (5)

ESL 400 mg once daily

EXPERIMENTAL

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

Drug: eslicarbazepine acetate

ESL 800 mg once daily

EXPERIMENTAL

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

Drug: eslicarbazepine acetate

ESL 1200 mg once daily

EXPERIMENTAL

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

Drug: eslicarbazepine acetate

placebo

PLACEBO COMPARATOR

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

Drug: placebo

ESL - Part II

EXPERIMENTAL

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

Drug: ESL - Part II

Interventions

eslicarbazepine acetate DRUG

oral tablets

Also known as: Zebinix

ESL 1200 mg once daily; ESL 400 mg once daily; ESL 800 mg once daily

placebo DRUG

once daily placebo comparator

Also known as: Sugar pill

placebo

ESL - Part II DRUG

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

Also known as: Eslicarbazepine acetate (ESL), BIA 2-093

ESL - Part II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

Bial - Portela & Cª, S.A.

Trofa, Coronado (S.Romão E S. Mamede), 4745-457, Portugal

Location

Related Publications (1)

• 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.

  PMID: 33338829 DERIVED

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

eslicarbazepine acetate; Sugars

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbohydrates

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: Bial - Portela & Cª, S.A.

clinical.trials@bial.com

+ 351 22 986 61 00

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 12, 2009
• Study Start: July 1, 2004
• Primary Completion: August 1, 2006
• Study Completion: January 1, 2008
• Last Updated: March 25, 2025
• Results First Posted: August 5, 2013

Record last verified: 2025-03

Locations

PT (1)