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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02170077
• Date of registration: 20/06/2014
• Prospective Registration: No
• Primary sponsor: Bial - Portela C S.A.
• Public title: A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
• Scientific title: A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093 in Controlling Refractory Partial Seizures When Added to Ongoing Therapy
• Date of first enrolment: April 2002
• Target sample size: 144
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02170077
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Portugal

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Epilepsy

Intervention(s)

Drug: Placebo

Drug: BIA 2-093

Primary Outcome(s)

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 [Time Frame: baseline, week 12]

Secondary ID(s)

BIA-2093-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/08/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02170077