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

Epilepsy Clinical Trial

Official title:

A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170077
• Other study ID #: BIA-2093-201
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2014
• Last updated: July 18, 2014
• Start date: April 2002
• Est. completion date: November 2002

Study information

• Verified date: July 2014
• Source: Bial - Portela C S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

This clinical trial was performed as a multicentre, add-on, double-blind, randomised, placebo-controlled, phase II study. During the double-blind treatment phase (12 weeks) patients were assigned to three treatment groups receiving BIA 2 093 once daily (ODG - once-daily group), BIA 2 093 twice daily (TDG - twice-daily group) or placebo (PLG - placebo group), respectively. Daily doses of BIA 2 093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).

On completion of the 12-week double-blind treatment period, a 1-week tapering period was scheduled.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: November 2002
• Est. primary completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

• Pregnancy, nursing or inadequate contraception in women of childbearing age (oral contraception should be combined with a barrier method)

• Participation in other clinical trials within the last 2 months

• History of non-compliance.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Portugal	BIAL - Portela & Cª, S.A.	S. Mamede do Coronado

Sponsors (1)

Lead Sponsor	Collaborator
Bial - Portela C S.A.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Proportion of Patients 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	No