A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjec… (NCT03250377) | Clinical Trial Compass
CompletedPhase 3
A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
China207 participantsStarted 2017-08-05
Plain-language summary
The purpose of the study is to evaluate the long-term safety and tolerability of Brivaracetam (BRV) in focal epilepsy subjects with partial seizures and to evaluate the maintenance of efficacy of BRV over time.
Who can participate
Age range16 Years
SexALL
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Inclusion Criteria:
* Male/female study participant from 16 years of age or older. Study participant who are not legal adults may only be included where legally permitted and ethically accepted
* Study participant completed the Treatment Period and Transition Period of EP0083 or is ongoing in N01379 sites in Japan
* Female study participants with childbearing potential are eligible if they use a medically accepted contraceptive method
* Inclusion Criteria for directly enrollers only: Study participant has 1 to \<8 partial seizures (according to the 1981 International League Against Epilepsy (ILAE) classification) during the 8 weeks prior to brivaracetam (BRV) administration
Exclusion Criteria:
* Study participant has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study
* Severe medical, neurological or psychiatric disorders, or laboratory values which may have an impact on the safety of the study participant
* Poor compliance with the visit schedule or medication intake in the previous BRV studies
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the Investigator's opinion, warrants exclusion
* Study participant has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
* Study participant has \>2 x …
What they're measuring
1
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: From Baseline until end of the safety follow up (up to 88.5 months)