NCT00957372

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

Completed Phase 3 Results posted Last updated 23 June 2014

What this trial tests

Phase 3 trial testing eslicarbazepine acetate in Partial Epilepsy in 253 participants. Completed in 1 June 2008.

Timeline

1 December 2004

Primary endpoint
1 June 2008

1 June 2008

Quick facts

Lead sponsor	Bial - Portela C S.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	253
Start date	1 December 2004
Primary completion	1 June 2008
Estimated completion	1 June 2008
Sites	1 location across Portugal

Drugs / interventions tested

• eslicarbazepine acetate (ESLICARBAZEPINE ACETATE) — full drug profile →
• placebo (Part I)
• ESL - Open-label Extension (Part II) — full drug profile →

Conditions studied

• Partial Epilepsy — all drugs for Partial Epilepsy →

Sponsor

Bial - Portela C S.A. — full company profile →

Who can join

18 and older, any sex, with Partial Epilepsy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Seizure Frequency
  Time frame: 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
• PART II: Nº of Treatment-Emergent Adverse Events (TEAE)
  Time frame: 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 r

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pooled efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: Data from four double-blind placebo-controlled pivotal phase III clinical studies.
   Elger C, Koepp M, Trinka E, Villanueva V, et al · · 2017 · cited 23× · PMID 29030894 · DOI 10.1111/cns.12765
2. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.
   Gama H, Vieira M, Costa R, Graça J, et al · · 2017 · cited 16× · PMID 28752473 · DOI 10.1007/s40264-017-0576-4
3. Eslicarbazepine acetate in the treatment of adults with partial-onset epilepsy: an evidence-based review of efficacy, safety and place in therapy.
   Lattanzi S, Brigo F, Cagnetti C, Verrotti A, et al · · 2018 · cited 13× · PMID 29563858 · DOI 10.2147/ce.s142858
4. Safety of Eslicarbazepine Acetate in Elderly Versus Non-Elderly Patients with Focal Seizures: From Pooled Data of Clinical Studies to 8 Years of Post-Marketing Experience.
   Magalhães LM, Costa R, Vieira M, Moreira J, et al · · 2021 · cited 5× · PMID 34536187 · DOI 10.1007/s40264-021-01097-5