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|NCT03083665 : A Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Asian Subjects (>=16 to 80 Years of Age) With Epilepsy|
|Ages||Min: 16 Years Max: 80 Years|
- Subjects (male or female) from 16 to 80 years of age at Visit 1, both inclusive.
Subjects who are not legal adults may only be included where legally permitted and
- Female subjects with childbearing potential are eligible if they use a medically
accepted contraceptive method.
- Well-characterized focal epilepsy/epileptic syndrome according to the 1989
International League Against Epilepsy (ILAE) classification.
- Presence of an electroencephalogram (EEG) reading compatible with the clinical
diagnosis of focal epilepsy within the last 5 years.
- Presence of a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan
performed within the last 2 years.
- Subjects having at least 8 partial seizures (according to the 1981 ILAE
classification) during the 8-Week Baseline Period with at least 2 partial seizures
during each 4-week interval of the Baseline Period.
- Subjects having at least 2 partial seizures whether or not secondary generalization
per month during the 3 months preceding Visit 1.
- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug
[AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a
- Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the
subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone)
before Visit 1 and expected to be kept stable during whole study period.
- Subject has history or presence of status epilepticus during the year preceding Visit
1 or during Baseline.
- Subject has history of cerebrovascular accident, including transient ischemic attack,
in the last 24 weeks.
- Subject has history or presence of known psychogenic nonepileptic seizures.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03083665
| Link to official Clinicaltrials.gov listing