Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Completed · Phase 3
Conditions studied: Epilepsy
In brief
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).
Key facts
- Study ID
- NCT00175916
- Run by
- UCB Pharma
- People needed
- 853
- Starts
- 2005-09-01
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2021-08-17
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 933 — Gainesville, Florida, United States
- 931 — Charlottesville, Virginia, United States
- 509 — Graz, Austria
- 507 — Innsbruck, Austria
- 510 — Linz, Austria
- 508 — Vienna, Austria
- 501 — Edegem, Antwerpen, Belgium
- 515 — Montignies-sur-Sambre, Chaleroi, Belgium
- 506 — Bruges, Belgium
- 513 — Ghent, Belgium
- 974 — La Louvière, Belgium
- 505 — Leuven, Belgium
- 951 — Vancouver, British Columbia, Canada
- 950 — Montreal, Quebec, Canada
- 952 — Québec, Quebec, Canada
- 545 — Beroun, Czechia
- 543 — Brno, Czechia
- 544 — Brno, Czechia
- 546 — České Budějovice, Czechia
- 519 — Ostrava Trebovice, Czechia
- 517 — Prague, Czechia
- 541 — Prague, Czechia
- 542 — Prague, Czechia
- 518 — Zlín, Czechia
- 935 — San Francisco, California, United States
Full record on ClinicalTrials.gov
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