Phase 3
Completed N=766
Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
Source: ClinicalTrials.gov NCT01339559 ↗Enrolled (actual)
766
Serious AEs
18.3%
Results posted
Jun 2020
Primary outcomePrimary: Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 83.9 Percentage of participants
Summary
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) |
83.9 | — |
| PRIMARY Percentage of Participants Who Withdrew Due to Adverse Events (AEs) |
11.9 | — |
| PRIMARY Percentage of Participants With at Least One Serious Adverse Event (SAE) |
18.4 | — |
| SECONDARY Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period |
9.7; 4.2 | — |
| SECONDARY Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period |
52.0 | — |
| SECONDARY Responder Rate in POS (Type I) Frequency Over the Evaluation Period |
51.7 | — |
Eligibility Criteria
Inclusion Criteria
- Subject completed the Treatment Period of N01358 or the evaluation period of N01258
- Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
- Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
- Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
Exclusion Criteria
- Subject 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 studies
- Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with the visit schedule or medication intake in the previous BRV study
- 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
- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Data sourced from ClinicalTrials.gov (NCT01339559). 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. Informational only — not medical advice.