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

NCT00957372 | Completed Phase 3 Results

• 1 other identifier: BIA-2093-303
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Partial Epilepsy

Keywords

epilepsy

Outcome Measures

Primary Outcomes (2)

• 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 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)

  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

Study Arms (4)

ESL 800 mg daily (Part I)

EXPERIMENTAL

ESL 800mg daily

Drug: eslicarbazepine acetate

ESL 1200 mg daily (Part I)

EXPERIMENTAL

ESL 1200mg daily

Drug: eslicarbazepine acetate

placebo (Part I)

PLACEBO COMPARATOR

placebo

Drug: placebo (Part I)

ESL - Open-label Extension (Part II)

EXPERIMENTAL

All patients were treated with only ESL during Part II.

Drug: ESL - Open-label Extension (Part II)

Interventions

eslicarbazepine acetate DRUG

oral tablet, 800 mg or 1200 mg once daily

Also known as: Zebinix

ESL 1200 mg daily (Part I); ESL 800 mg daily (Part I)

placebo (Part I) DRUG

once daily placebo comparator

placebo (Part I)

ESL - Open-label Extension (Part II) DRUG

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

ESL - Open-label Extension (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.

S. Mamede Do Coronado, 4745-457, Portugal

Location

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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

• Antonio Gil-Nagel, MD

  Hospital Ruber Internacional La Masó 38, Mirasierra 28034 Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Jose Lopes-Lima, MD

  Hospital Santo António Largo Prof. Abel Salazar, 4099-001 Porto, Portugal

  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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: December 1, 2004
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 2, 2014
• Results First Posted: August 5, 2013

Record last verified: 2014-06

Locations

PT (1)