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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bial - Portela C S.A.
ClinicalTrials.gov Identifier:
NCT00957047
First received: August 10, 2009
Last updated: August 1, 2013
Last verified: August 2013

August 10, 2009
August 1, 2013
July 2004
August 2006   (final data collection date for primary outcome measure)
  • PART I - Seizure Frequency [ Time Frame: 12-week maintenance period ] [ Designated as safety issue: No ]
    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.
  • PART II - Nº of Treatment-Emergent Adverse Events (TEAE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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.
seizure frequency standardized to 'frequency per 4 weeks' [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00957047 on ClinicalTrials.gov Archive Site
Not Provided
  • proportion of responders (i.e., patients with a ≥ 50% reduction in seizure frequency during the 12-week maintenance period compared with the 8-week baseline period) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • seizure frequency per week for each week of the baseline, titration, and maintenance periods [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • distribution of seizure reduction (< 50%, 50-75%, or > 75% seizure reduction) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • proportion of seizure-free patients (100% seizure reduction) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • proportion of patients with a ≥ 25% exacerbation in seizure frequency compared to baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • seizure frequency by seizure type [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Partial Epilepsy
  • Drug: eslicarbazepine acetate
    oral tablets
    Other Name: Zebinix
  • Drug: placebo
    once daily placebo comparator
    Other Name: Sugar pill
  • Drug: ESL - Part II
    Eslicarbazepine acetate was supplied as scored 800-mg tablets for daily oral administration.
    Other Name: Eslicarbazepine acetate (ESL), BIA 2-093
  • Experimental: ESL 400 mg once daily
    Eslicarbazepine acetate (ESL) was supplied in 400 mg tablets for Part I
    Intervention: Drug: eslicarbazepine acetate
  • Experimental: ESL 800 mg once daily
    Eslicarbazepine acetate (ESL) was supplied in 800-mg tablets for Part I
    Intervention: Drug: eslicarbazepine acetate
  • Experimental: ESL 1200 mg once daily
    Eslicarbazepine acetate (ESL) was supplied in 400-mg and 800-mg tablets for Part I
    Intervention: Drug: eslicarbazepine acetate
  • Placebo Comparator: placebo
    Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied
    Intervention: Drug: placebo
  • 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.
    Intervention: Drug: ESL - Part II
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
395
January 2008
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Sweden
 
NCT00957047
BIA-2093-302
No
Bial - Portela C S.A.
Bial - Portela C S.A.
Not Provided
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
Bial - Portela C S.A.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP