Clinical trial NCT00175916: Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
Official title: An Open-label, Multicenter, Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment at a Flexible Dose up to a Maximum of 200 mg/Day in Subjects Aged 16 Years or Older Suffering From Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Brivaracetam
Epilepsy
long term
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 853
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
timeFrame: From Entry Visit until Last Visit (up to 162 months)
measure: Percentage of Participants Who Withdrew Due to an Adverse Event (AE)
timeFrame: From Entry Visit until Last Visit (up to 162 months)
measure: Percentage of Participants With at Least One Serious Adverse Event (SAE)
timeFrame: From Entry Visit until Last Visit (up to 162 months)
Secondary outcomes:
measure: Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
timeFrame: From Entry Visit until Last Visit (up to 162 months)
measure: Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
timeFrame: From Entry Visit until Last Visit (up to 162 months)
measure: Responder Rate in POS (Type I) Frequency Over the Evaluation Period
timeFrame: From Entry Visit until Last Visit (up to 162 months)
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: 935
state: California
city: Gainesville
country: United States
facility: 933
state: Florida
city: Charlottesville
country: United States
facility: 931
state: Virginia
city: Graz
country: Austria
facility: 509
city: Innsbruck
country: Austria
facility: 507
city: Linz
country: Austria
facility: 510
city: Wien
country: Austria
facility: 508
city: Edegem
country: Belgium
facility: 501
state: Antwerpen
city: Montignies sur Sambre
country: Belgium
facility: 515
state: Chaleroi
city: Brugge
country: Belgium
facility: 506
city: Gent
country: Belgium
facility: 513
city: La Louvière
country: Belgium
facility: 974
city: Leuven
country: Belgium
facility: 505
city: Vancouver
country: Canada
facility: 951
state: British Columbia
city: Montreal
country: Canada
facility: 950
state: Quebec
city: Quebec
country: Canada
facility: 952
city: Beroun
country: Czechia
facility: 545
city: Brno
country: Czechia
facility: 543
city: Brno
country: Czechia
facility: 544
city: Ceske Budejovice
country: Czechia
facility: 546
city: Ostrava Trebovice
country: Czechia
facility: 519
city: Praha 1
country: Czechia
facility: 541
city: Praha 2
country: Czechia
facility: 517
city: Praha 5
country: Czechia
facility: 542
city: Zlin
country: Czechia
facility: 518
city: Helsinki
country: Finland
facility: 900
city: Kuopio
country: Finland
facility: 581
city: Oulu
country: Finland
facility: 526
city: Oulu
country: Finland
facility: 582
city: Seinajoki
country: Finland
facility: 527
city: Tampere
country: Finland
facility: 583
city: Tampere
country: Finland
facility: 811
city: Lyon
country: France
facility: 633
state: Bron
city: Angers Cedex 1
country: France
facility: 632
city: Bethune
country: France
facility: 628
city: Dijon
country: France
facility: 630
city: Lille
country: France
facility: 624
city: Marseille
country: France
facility: 625
city: Montpellier Cedex 5
country: France
facility: 623
city: Nancy
country: France
facility: 635
city: Paris
country: France
facility: 626
city: Paris
country: France
facility: 920
city: Rennes
country: France
facility: 622
city: Roanne
country: France
facility: 528
city: St Pierre Cedex
country: France
facility: 823
city: Strasbourg
country: France
facility: 627
city: Toulouse Cedex 04
country: France
facility: 634
city: Bad Berka
country: Germany
facility: 532
city: Berlin
country: Germany
facility: 705
city: Berlin
country: Germany
facility: 708
city: Bernau
country: Germany
facility: 536
city: Bielefeld
country: Germany
facility: 707
city: Bonn
country: Germany
facility: 701
city: Erlangen
country: Germany
facility: 709
city: Frankfurt
country: Germany
facility: 703
city: Freiburg
country: Germany
facility: 711
city: Göttingen
country: Germany
facility: 537
city: Jena
country: Germany
facility: 535
city: Kehl
country: Germany
facility: 710
city: Liegau-Augustusbad
country: Germany
facility: 531
city: Mainz
country: Germany
facility: 533
city: Munchen
country: Germany
facility: 560
city: Munchen
country: Germany
facility: 706
city: Ulm
country: Germany
facility: 704
city: Hong Kong
country: Hong Kong
facility: 649
city: Shatin
country: Hong Kong
facility: 650
city: Budapest
country: Hungary
facility: 547
city: Debrecen
country: Hungary
facility: 538
city: Pecs
country: Hungary
facility: 539
city: Tel Aviv
country: Israel
facility: 970
city: Bologna
country: Italy
facility: 830
city: Foggia
country: Italy
facility: 553
city: Messina
country: Italy
facility: 831
city: Milano
country: Italy
facility: 563
city: Milano
country: Italy
facility: 832
city: Napoli
country: Italy
facility: 833
city: Pavia
country: Italy
facility: 554
city: Perugia
country: Italy
facility: 550
city: Roma
country: Italy
facility: 552
city: Roma
country: Italy
facility: 555
city: Roma
country: Italy
facility: 559
city: Siena
country: Italy
facility: 973
city: Gwangju
country: Korea, Republic of
facility: 655
city: Seoul
country: Korea, Republic of
facility: 652
city: Seoul
country: Korea, Republic of
facility: 653
city: Seoul
country: Korea, Republic of
facility: 654
city: Seoul
country: Korea, Republic of
facility: 656
city: Breda
country: Netherlands
facility: 566
city: Den Haag
country: Netherlands
facility: 567
city: Heemstede
country: Netherlands
facility: 821
city: Heeze
country: Netherlands
facility: 822
city: Fredrikstad
country: Norway
facility: 571
city: Oslo
country: Norway
facility: 568
city: Sandvika
country: Norway
facility: 569
city: Trondheim
country: Norway
facility: 570
city: Bialystok
country: Poland
facility: 575
city: Gdansk
country: Poland
facility: 741
city: Grodzisk Mazowiecki
country: Poland
facility: 978
city: Katowice
country: Poland
facility: 748
city: Katowice
country: Poland
facility: 976
city: Kielce
country: Poland
facility: 574
city: Krakow
country: Poland
facility: 975
city: Lodz
country: Poland
facility: 744
city: Lodz
country: Poland
facility: 747
city: Lublin
country: Poland
facility: 742
city: Poznan
country: Poland
facility: 977
city: Szczecin
country: Poland
facility: 746
city: Warsaw
country: Poland
facility: 573
city: Warszawa
country: Poland
facility: 576
city: Warszawa
country: Poland
facility: 577
city: Warszawa
country: Poland
facility: 743
city: Warszawa
country: Poland
facility: 745
city: Kazan
country: Russian Federation
facility: 591
city: Moscow
country: Russian Federation
facility: 578
city: Moscow
country: Russian Federation
facility: 579
city: Moscow
country: Russian Federation
facility: 584
city: Moscow
country: Russian Federation
facility: 586
city: Moscow
country: Russian Federation
facility: 588
city: Samara
country: Russian Federation
facility: 943
city: St. Petersburg
country: Russian Federation
facility: 589
city: Yaroslavl
country: Russian Federation
facility: 587
city: Belgrade
country: Serbia
facility: 961
city: Belgrade
country: Serbia
facility: 962
city: Singapore
country: Singapore
facility: 657
city: George
country: South Africa
facility: 648
city: Alcorcón
country: Spain
facility: 599
state: Madrid
city: Barcelona
country: Spain
facility: 593
city: Madrid
country: Spain
facility: 594
city: Madrid
country: Spain
facility: 783
city: Madrid
country: Spain
facility: 786
city: San Sebastian
country: Spain
facility: 596
city: Vigo
country: Spain
facility: 595
city: Zaragoza
country: Spain
facility: 597
city: Goteborg
country: Sweden
facility: 850
city: Stockholm
country: Sweden
facility: 601
city: Umea
country: Sweden
facility: 604
city: Biel
country: Switzerland
facility: 605
city: St. Gallen
country: Switzerland
facility: 607
city: Tschugg
country: Switzerland
facility: 606
city: Zurich
country: Switzerland
facility: 608
city: Taichung
country: Taiwan
facility: 671
city: Taichung
country: Taiwan
facility: 672
city: Tainan
country: Taiwan
facility: 669
city: Taoyuan
country: Taiwan
facility: 660
city: Manouba
country: Tunisia
facility: 861
city: Tunis
country: Tunisia
facility: 860
city: Donetsk
country: Ukraine
facility: 638
city: Kharkov
country: Ukraine
facility: 637
city: Kyiv
country: Ukraine
facility: 641
city: Kyiv
country: Ukraine
facility: 642
city: Lviv
country: Ukraine
facility: 639
city: Odessa
country: Ukraine
facility: 643
city: Uzhgorod
country: Ukraine
facility: 640
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.