Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03083665 : A Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Asian Subjects (>=16 to 80 Years of Age) With Epilepsy
PhasePhase 3
AgesMin: 16 Years Max: 80 Years
Eligibility
Inclusion Criteria:

- 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
ethically accepted.

- 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
concomitant AED.

- 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.

Exclusion Criteria:

- 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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03083665      |      Link to official Clinicaltrials.gov listing
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