Phase 3
Completed N=853
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Source: ClinicalTrials.gov NCT00175916 ↗Enrolled (actual)
853
Serious AEs
29.1%
Results posted
Jul 2020
Primary outcomePrimary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 84.4 Percentage of participants
◆ Published Evidence
Established
25citations · ~5 / year
Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis.
Summary
This trial, evaluating the long-term safety and tolerability of brivaracetam, will give subjects suffering from epilepsy, who may have benefited from brivaracetam, the opportunity to continue the treatment. The study will also evaluate the maintenance of efficacy over time of brivaracetam for subjects with partial onset seizures (POS)/primary generalized seizures (PGS).
Linked Publications (3)
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Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis.
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Brivaracetam: First Global Approval.
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Safety, tolerability, and efficacy of brivaracetam as adjunctive therapy in patients with focal seizures, generalized onset seizures, or Unverricht-Lundborg disease: An open-label, long-term follow-up trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) |
84.4 | — |
| PRIMARY Percentage of Participants Who Withdrew Due to an Adverse Event (AE) |
11.6 | — |
| PRIMARY Percentage of Participants With at Least One Serious Adverse Event (SAE) |
29.4 | — |
| SECONDARY Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period |
8.4; 4.9 | — |
| SECONDARY Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period |
43.1 | — |
| SECONDARY Responder Rate in POS (Type I) Frequency Over the Evaluation Period |
43.6 | — |
Eligibility Criteria
Inclusion Criteria
- Male/female subjects from 16 years (where legally permitted and ethically accepted) or 18 years onwards suffering from epilepsy and having completed a previous study with brivaracetam as adjunctive treatment, which allowed access to this study
- Subjects with POS/PGS: inpatients or outpatients with epilepsy who participated in previous brivaracetam studies / programs which allow access to the present study
- Subjects with ULD: inpatients or outpatients with epilepsy who were treated with brivaracetam in previous studies / programs which allow access to the present study
- Subjects for whom the Investigator believes a reasonable benefit from the long-term administration of brivaracetam may be expected
Exclusion Criteria
- Severe medical, neurological and psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with visit schedule or medication intake in previous brivaracetam study
- Participation in any clinical study of another investigational drug or device during the study
- Pregnant or lactating woman
Data sourced from ClinicalTrials.gov (NCT00175916) and the linked publication. 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.