Phase 3
Completed N=108
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Source: ClinicalTrials.gov NCT00761774 ↗Enrolled (actual)
108
Serious AEs
24.1%
Results posted
Apr 2018
Primary outcomePrimary: Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) — 90.7 percentage of participants
Summary
The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) |
90.7 | — |
| PRIMARY Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) |
15.7 | — |
| PRIMARY Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) |
24.1 | — |
| SECONDARY Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) |
38.89 | — |
| SECONDARY Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) |
32.41 | — |
| SECONDARY Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) |
25 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
- Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.
Exclusion Criteria
- Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.
Data sourced from ClinicalTrials.gov (NCT00761774). 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.