Clinical trial NCT02170077: A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy
BIA 2-093
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: baseline, week 12
Secondary outcomes:
Other outcomes:
Locations:
city: S. Mamede do Coronado
country: Portugal
facility: BIAL - Portela & Cª, S.A.
Study officials:
References: