Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
NCT ID: NCT00175916
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
853 participants
INTERVENTIONAL
2005-09-30
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brivaracetam
Flexible dosing, can up and down titrate as needed.
Brivaracetam (ucb 34714)
10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
Interventions
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Brivaracetam (ucb 34714)
10 mg and 25 mg tablets. Flexible dosing up to 200 mg/day, twice daily. For each subject, the study will last from study entry until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures; or until the Sponsor decides to close the study; until a managed access program, named patient program, compassionate use program, or similar type of access program is established as allowed per country-specific requirements in addition to legal and regulatory guidelines, or until the investigational product development is stopped by the Sponsor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 844 599 2273 (UCB)
Locations
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935
San Francisco, California, United States
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
900
Helsinki, , Finland
581
Kuopio, , Finland
526
Oulu, , Finland
582
Oulu, , Finland
527
Seinäjoki, , Finland
583
Tampere, , Finland
811
Tampere, , Finland
633
Lyon, Bron, France
632
Angers, , France
628
Béthune, , France
630
Dijon, , France
624
Lille, , France
625
Marseille, , France
623
Montpellier, , France
635
Nancy, , France
626
Paris, , France
920
Paris, , France
622
Rennes, , France
528
Roanne, , France
823
Saint-Pierre-des-Corps, , France
627
Strasbourg, , France
634
Toulouse, , France
532
Bad Berka, , Germany
705
Berlin, , Germany
708
Berlin, , Germany
536
Bernau, , Germany
707
Bielefeld, , Germany
701
Bonn, , Germany
709
Erlangen, , Germany
703
Frankfurt, , Germany
711
Freiburg im Breisgau, , Germany
537
Göttingen, , Germany
535
Jena, , Germany
710
Kehl, , Germany
531
Liegau-Augustusbad, , Germany
533
Mainz, , Germany
560
München, , Germany
706
München, , Germany
704
Ulm, , Germany
649
Hong Kong, , Hong Kong
650
Shatin, , Hong Kong
547
Budapest, , Hungary
538
Debrecen, , Hungary
539
Pécs, , Hungary
970
Tel Aviv, , Israel
830
Bologna, , Italy
553
Foggia, , Italy
831
Messina, , Italy
563
Milan, , Italy
832
Milan, , Italy
833
Napoli, , Italy
554
Pavia, , Italy
550
Perugia, , Italy
552
Roma, , Italy
555
Roma, , Italy
559
Roma, , Italy
973
Siena, , Italy
566
Breda, , Netherlands
821
Heemstede, , Netherlands
822
Heeze, , Netherlands
567
The Hague, , Netherlands
571
Fredrikstad, , Norway
568
Oslo, , Norway
569
Sandvika, , Norway
570
Trondheim, , Norway
575
Bialystok, , Poland
741
Gdansk, , Poland
978
Grodzisk Mazowiecki, , Poland
748
Katowice, , Poland
976
Katowice, , Poland
574
Kielce, , Poland
975
Krakow, , Poland
744
Lodz, , Poland
747
Lodz, , Poland
742
Lublin, , Poland
977
Poznan, , Poland
746
Szczecin, , Poland
573
Warsaw, , Poland
576
Warsaw, , Poland
577
Warsaw, , Poland
743
Warsaw, , Poland
745
Warsaw, , Poland
591
Kazan', , Russia
578
Moscow, , Russia
579
Moscow, , Russia
584
Moscow, , Russia
586
Moscow, , Russia
588
Moscow, , Russia
589
Saint Petersburg, , Russia
943
Samara, , Russia
587
Yaroslavl, , Russia
961
Belgrade, , Serbia
962
Belgrade, , Serbia
657
Singapore, , Singapore
648
George, , South Africa
655
Gwangju, , South Korea
652
Seoul, , South Korea
653
Seoul, , South Korea
654
Seoul, , South Korea
656
Seoul, , South Korea
599
Alcorcón, Madrid, Spain
593
Barcelona, , Spain
596
Donostia / San Sebastian, , Spain
594
Madrid, , Spain
783
Madrid, , Spain
786
Madrid, , Spain
595
Vigo, , Spain
597
Zaragoza, , Spain
850
Gothenburg, , Sweden
601
Stockholm, , Sweden
604
Umeå, , Sweden
605
Biel, , Switzerland
607
Sankt Gallen, , Switzerland
606
Tschugg, , Switzerland
608
Zurich, , Switzerland
671
Taichung, , Taiwan
672
Taichung, , Taiwan
669
Tainan City, , Taiwan
660
Taoyuan District, , Taiwan
861
Manouba, , Tunisia
860
Tunis, , Tunisia
638
Donetsk, , Ukraine
637
Kharkiv, , Ukraine
641
Kyiv, , Ukraine
642
Kyiv, , Ukraine
639
Lviv, , Ukraine
643
Odesa, , Ukraine
640
Uzhhorod, , Ukraine
Countries
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References
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Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
Ben-Menachem E, Baulac M, Hong SB, Cleveland JM, Reichel C, Schulz AL, Wagener G, Brandt C. 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. Epilepsy Res. 2021 Feb;170:106526. doi: 10.1016/j.eplepsyres.2020.106526. Epub 2020 Dec 4.
Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Product Information
FDA Safety Alerts and Recalls
Other Identifiers
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2004-002140-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
N01125
Identifier Type: -
Identifier Source: org_study_id
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