Skip to main content
MedPathMedPath Home
Clinical Trials/CTRI/2011/04/001686
CTRI/2011/04/001686
Completed
Phase 3

Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Trial

Bial Portela C SA0 sites615 target enrollmentTBD
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsHealth Condition 1: null- Partial Epilepsy

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Health Condition 1: null- Partial Epilepsy
Sponsor
Bial Portela C SA
Enrollment
615
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Bial Portela C SA

Eligibility Criteria

Inclusion Criteria

  • •1\.Diagnosis of epilepsy for at least 12 months prior
  • •to screening
  • •2\.At least 4 partial\-onset seizures in the 4 weeks
  • •prior to screening
  • •3\.Currently taking 1 or 2 AEDs
  • •4\.Aged 18\+ years

Exclusion Criteria

  • •1Only simple partial seizures with no motor
  • •symptomatology
  • •2Primarily generalised seizures
  • •3Known progressive neurological disorders
  • •4Currently taking oxcarbazepine

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 3
Efficacy and safety of Eslicarbazepine Acetate (BIA 2-093) as single therapy for patients with newly diagnosed partial-onset seizures - ESL extension studyEpilepsyG40.0G40.1G40.2
RBR-93gkd4Instituto de Neurologia de Curitiba
Active, not recruiting
Phase 1
Eslicarbazepine Acetate (BIA 2-093) as Therapy for Refractory Partial Seizures in Childrechildren and adolescents with refractory partial epileptic seizuresMedDRA version: 14.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2007-001887-55-ATBIAL - Portela & Ca, S.A.315
Active, not recruiting
Phase 1
Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as monotherapy for patients with newly diagnosed partial-onset seizures - open label extension study with eslicarbazepine acetateAdult patients with recently diagnosed partial-onset seizuresMedDRA version: 21.1Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2015-001243-36-ITBIAL-PORTELA & Cª, S.A.207
Active, not recruiting
Phase 1
Efficacy and safety of eslicarbazepine acetate (BIA 2-093) as adjunctive therapy for refractory partial seizures in children: a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial
EUCTR2007-001887-55-GBBIAL - Portela & Ca, S.A.304
Active, not recruiting
Phase 1
Eslicarbazepine Acetate (BIA 2-093) as Therapy for Refractory Partial Seizures in Childrechildren and adolescents with refractory partial epileptic seizuresMedDRA version: 16.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2007-001887-55-CZBIAL - Portela & Ca, S.A.315