A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093

NCT02170077 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-201
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of BIA 2 093 in the treatment of epileptic patients with refractory simple or complex partial seizures with or without secondary generalization.

Conditions

Epilepsy

Keywords

Epilepsy; BIA 2-093

Outcome Measures

Primary Outcomes (1)

• The Percentage of Participants With a 50% or Greater Reduction in Seizure Frequency (Further Referred to as "Responders") in a Treatment Period Compared to the Baseline Period

  baseline, week 12

Study Arms (3)

ODG - once-daily group

EXPERIMENTAL

BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

Drug: BIA 2-093

TDG - twice-daily group

EXPERIMENTAL

BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

Drug: BIA 2-093

PLG - placebo group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

BIA 2-093 DRUG

BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route

ODG - once-daily group; TDG - twice-daily group

Placebo DRUG

Placebo tablets administered orally

PLG - placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aged 18-65 years
• Patients with simple or complex partial seizures with or without secondary generalization since at least one year prior to randomisation visit
• At least 4 seizures per month within the last 2 months prior to randomisation
• Stable dose regimen of a maximum of two of the following AEDs: phenytoin, valproate, primidone, phenobarbital, lamotrigine, gabapentin, topiramate, clonazepam, during 2 months prior to randomisation
• Electroencephalogram (EEG) findings not contradicting the epilepsy diagnosis (e.g., primarily generalized epilepsy)
• Written informed consent.

You may not qualify if:

• Patient with nervus vagus stimulation
• Patient with primarily generalized seizures
• Known progressive neurological disturbance
• A history of status epilepticus within the past 3 months
• Seizure of non-epileptic origin
• Restricted legal competence and incapability to follow trial instructions
• Major psychiatric disorders
• Concurrent drug therapy with monoamine oxidase inhibitors or calcium channel blockers
• Need of excluded concomitant medication (see section 9.4.6.2)
• Use of oxcarbazepine or carbamazepine during the last 6 months before the randomisation visit
• Known hypersensitivity to oxcarbazepine or carbamazepine, or its metabolites
• Abuse of alcohol, drugs or medications
• History of relevant cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, hematologic or oncology disorders
• Second- or third-degree atrioventricular block not corrected with a pacemaker
• Relevant laboratory abnormalities (e.g., Na+\< 130 mmol/L, alanine (ALT) or aspartate (AST) transaminase \>2.0 times the upper limit of normal, white blood cell (WBC) count \<3000 cells/mm3)

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

Study Sites (1)

BIAL - Portela & Cª, S.A.

S. Mamede Do Coronado, S. Mamede Do Coronado, 4045-457, Portugal

Location

MeSH Terms

Conditions

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
• Organization: BIAL - Portela & Cª, SA

clinical.trials@bial.com

+351 22 9866100

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: June 23, 2014
• Study Start: April 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: August 18, 2017
• Results First Posted: August 12, 2014

Record last verified: 2017-07

Locations

PT (1)