Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy (NCT01364597) | Clinical Trial Compass
CompletedPhase 3
Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy
United States257 participantsStarted 2011-08-01
Plain-language summary
This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.
Who can participate
Age range28 Days – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All Subjects:
* Informed Consent form (ICF) is signed and dated by the parent(s) or legal representative(s)
* Subject/legal representative is considered reliable and capable of adhering to the protocol
* For female subjects:
* Subject is not of childbearing potential
OR if women of childbearing potential, and sexually active only if:
* Adequate Contraceptive method
* Negative pregnancy test
* Understands the consequences and potential risks of inadequately protected sexual activity, understands and properly uses contraceptive methods, and is willing to inform the Investigator of any contraception changes
Long Term Follow-up Subjects:
\- Male or female subjects having participated in a core study with a confirmed diagnosis of epilepsy and for whom a reasonable benefit from long-term administration of BRV is expected
Directly Enrolled Subjects:
* Subject is a male or female ≥4 years to \<17 years of age
* Subject has a clinical diagnosis of partial-onset seizures (POS) according to the International League Against Epilepsy (ILAE) classification
* Subject has an EEG compatible with the clinical diagnosis of POS
* Subject has been observed to have uncontrolled POS after an adequate course of treatment (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED; concurrently or sequentially)
* Subject had at least 1 seizure (POS) during the 3 weeks before the Screening Visit (ScrV)
* Subject is taking at least 1 AED. All AEDs need to be…
What they're measuring
1
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Study
Timeframe: From Baseline to end of study (up to 10 years)
2
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) During the Study
Timeframe: From Baseline to end of study (up to 10 years)