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Efficacy and Safety of Eslicarbazepine Acetate as Adjunctive Therapy for Refractory Partial Epilepsy

23. juni 2014 opdateret af: Bial - Portela C S.A.

Efficacy and Safety of BIA 2-093 as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Clinical Trial

The primary objective was to evaluate the efficacy of eslicarbazepine acetate (ESL) administered once daily at 1200 mg or 800 mg, compared with placebo as adjunctive therapy in patients with refractory partial epilepsy over a 12-week maintenance period.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a phase III, 2-part multicenter study. Part I was an 26-week parallel-group, randomized, placebo-controlled design consisting of an 8 week baseline period, a 2 week double-blinded titration period, 12 week maintenance period, and a 4 week tapering-off period. After completing the baseline period, patients were randomized in a 1:1:1 ratio to 1 of the 2 ESL daily dose levels (1200 or 800 mg) or placebo.

Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day. Patients who completed Part II could participate in a study extension and continue treatment with ESL until marketing authorization is obtained or clinical development is discontinued, with visits scheduled at the discretion of the investigator but at least every 6 months.

Results from Part I & II were presented in two separate reports.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

253

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Portugal
      • S. Mamede do Coronado, Portugal, 4745-457
        • Bial - Portela & Cª, S.A.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ESL 800 mg daily (Part I)
ESL 800mg daily
Medicin: eslicarbazepine acetate
oral tablet, 800 mg or 1200 mg once daily
Andre navne:
  • Zebinix
Eksperimentel: ESL 1200 mg daily (Part I)
ESL 1200mg daily
Medicin: eslicarbazepine acetate
oral tablet, 800 mg or 1200 mg once daily
Andre navne:
  • Zebinix
Placebo komparator: placebo (Part I)
placebo
Medicin: placebo (Part I)
once daily placebo comparator
Eksperimentel: ESL - Open-label Extension (Part II)
All patients were treated with only ESL during Part II.
Medicin: ESL - Open-label Extension (Part II)
Part II was a 1-year open-label extension for patients who had completed Part I. Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Seizure Frequency
Tidsramme: 12 weeks
The primary efficacy endpoint is the natural log transformation of the seizure frequency per 4 weeks. The primary efficacy analysis was based on results for the ITT population during the 12-week maintenance period. Seizure frequency was compared between each active treatment group and the placebo group using an ANCOVA model with treatment as a factor and seizure frequency as a covariate
12 weeks
PART II: Nº of Treatment-Emergent Adverse Events (TEAE)
Tidsramme: 1-year
The primary objective for Part II of the study was to evaluate the safety and tolerability of eslicarbazepine acetate (ESL, BIA 2-093) at doses titrated to an efficacy or safety endpoint over a 1-year open-label period. Safety assessments were based primarily on AEs (Number of participants with at least one treatment-emergent adverse events are reported); assessment of AEs was based on treatment relatedness, action taken on study drug, outcome, and causality.
1-year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bial - Portela C S.A.

Efterforskere

  • Ledende efterforsker: Antonio Gil-Nagel, MD, Hospital Ruber Internacional La Masó 38, Mirasierra 28034 Madrid, Spain
  • Ledende efterforsker: Jose Lopes-Lima, MD, Hospital Santo António Largo Prof. Abel Salazar, 4099-001 Porto, Portugal

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. december 2004

Primær færdiggørelse (Faktiske)

1. juni 2008

Studieafslutning (Faktiske)

1. juni 2008

Datoer for studieregistrering

Først indsendt

10. august 2009

Først indsendt, der opfyldte QC-kriterier

11. august 2009

Først opslået (Skøn)

12. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2014

Sidst verificeret

1. juni 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BIA-2093-303

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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