Phase 2
N=144
A Placebo-controlled Study to Investigate Safety and Efficacy of BIA 2-093
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT02170077 ↗Enrolled (actual)
144
Serious AEs
2.1%
Results posted
Aug 2014
Primary outcome: Primary: 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 — 54; 41; 28 percentage of responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BIA 2-093 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bial - Portela C S.A.
- Primary completion
- Nov 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
54; 41; 28 | — |
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.
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+ 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.
Data sourced from ClinicalTrials.gov (NCT02170077). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.