Phase 3
N=853
Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT00175916 ↗Enrolled (actual)
853
Serious AEs
29.1%
Results posted
Jul 2020
Primary outcome: Primary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) — 84.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brivaracetam (ucb 34714) (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- UCB Pharma
- Primary completion
- May 2019
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 | — |
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).
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). 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.