Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy
- Registration Number
- NCT00175916
- Lead Sponsor
- UCB Pharma
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 853
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam (ucb 34714) Flexible dosing, can up and down titrate as needed.
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) From Entry Visit until Last Visit (up to 162 months) Treatment-emergent adverse events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants Who Withdrew Due to an Adverse Event (AE) From Entry Visit until Last Visit (up to 162 months) An AE is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Percentage of Participants With at Least One Serious Adverse Event (SAE) From Entry Visit until Last Visit (up to 162 months) A serious adverse event (SAE) is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires in patient hospitalization or prolongation of existing hospitalization
* Is a congenital anomaly or birth defect
* Is an infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
- Secondary Outcome Measures
Name Time Method Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period From Entry Visit until Last Visit (up to 162 months) The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period From Entry Visit until Last Visit (up to 162 months) The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:
(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].Responder Rate in POS (Type I) Frequency Over the Evaluation Period From Entry Visit until Last Visit (up to 162 months) A responder is defined as a participant with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.
Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 \[NCT00175929\], N01252 \[NCT00490035\] and N01254 \[NCT00504881\].
Trial Locations
- Locations (153)
506
🇧🇪Brugge, Belgium
505
🇧🇪Leuven, Belgium
509
🇦🇹Graz, Austria
507
🇦🇹Innsbruck, Austria
510
🇦🇹Linz, Austria
501
🇧🇪Edegem, Antwerpen, Belgium
951
🇨🇦Vancouver, British Columbia, Canada
672
🇨🇳Taichung, Taiwan
547
🇭🇺Budapest, Hungary
822
🇳🇱Heeze, Netherlands
571
🇳🇴Fredrikstad, Norway
641
🇺🇦Kyiv, Ukraine
643
🇺🇦Odessa, Ukraine
974
🇧🇪La Louvière, Belgium
630
🇫🇷Dijon, France
656
🇰🇷Seoul, Korea, Republic of
568
🇳🇴Oslo, Norway
569
🇳🇴Sandvika, Norway
573
🇵🇱Warsaw, Poland
596
🇪🇸San Sebastian, Spain
595
🇪🇸Vigo, Spain
976
🇵🇱Katowice, Poland
950
🇨🇦Montreal, Quebec, Canada
952
🇨🇦Quebec, Canada
710
🇩🇪Kehl, Germany
560
🇩🇪Munchen, Germany
625
🇫🇷Marseille, France
577
🇵🇱Warszawa, Poland
513
🇧🇪Gent, Belgium
550
🇮🇹Perugia, Italy
575
🇵🇱Bialystok, Poland
545
🇨🇿Beroun, Czechia
935
🇺🇸San Francisco, California, United States
933
🇺🇸Gainesville, Florida, United States
931
🇺🇸Charlottesville, Virginia, United States
508
🇦🇹Wien, Austria
515
🇧🇪Montignies sur Sambre, Chaleroi, Belgium
543
🇨🇿Brno, Czechia
546
🇨🇿Ceske Budejovice, Czechia
544
🇨🇿Brno, Czechia
519
🇨🇿Ostrava Trebovice, Czechia
541
🇨🇿Praha 1, Czechia
517
🇨🇿Praha 2, Czechia
542
🇨🇿Praha 5, Czechia
518
🇨🇿Zlin, Czechia
900
🇫🇮Helsinki, Finland
581
🇫🇮Kuopio, Finland
526
🇫🇮Oulu, Finland
527
🇫🇮Seinajoki, Finland
582
🇫🇮Oulu, Finland
583
🇫🇮Tampere, Finland
811
🇫🇮Tampere, Finland
628
🇫🇷Bethune, France
633
🇫🇷Lyon, Bron, France
632
🇫🇷Angers Cedex 1, France
624
🇫🇷Lille, France
635
🇫🇷Nancy, France
623
🇫🇷Montpellier Cedex 5, France
626
🇫🇷Paris, France
920
🇫🇷Paris, France
622
🇫🇷Rennes, France
528
🇫🇷Roanne, France
634
🇫🇷Toulouse Cedex 04, France
823
🇫🇷St Pierre Cedex, France
627
🇫🇷Strasbourg, France
532
🇩🇪Bad Berka, Germany
705
🇩🇪Berlin, Germany
531
🇩🇪Liegau-Augustusbad, Germany
708
🇩🇪Berlin, Germany
536
🇩🇪Bernau, Germany
707
🇩🇪Bielefeld, Germany
709
🇩🇪Erlangen, Germany
703
🇩🇪Frankfurt, Germany
537
🇩🇪Göttingen, Germany
701
🇩🇪Bonn, Germany
711
🇩🇪Freiburg, Germany
535
🇩🇪Jena, Germany
533
🇩🇪Mainz, Germany
706
🇩🇪Munchen, Germany
538
🇭🇺Debrecen, Hungary
704
🇩🇪Ulm, Germany
649
🇭🇰Hong Kong, Hong Kong
650
🇭🇰Shatin, Hong Kong
539
🇭🇺Pecs, Hungary
970
🇮🇱Tel Aviv, Israel
830
🇮🇹Bologna, Italy
553
🇮🇹Foggia, Italy
831
🇮🇹Messina, Italy
833
🇮🇹Napoli, Italy
563
🇮🇹Milano, Italy
832
🇮🇹Milano, Italy
554
🇮🇹Pavia, Italy
552
🇮🇹Roma, Italy
653
🇰🇷Seoul, Korea, Republic of
555
🇮🇹Roma, Italy
654
🇰🇷Seoul, Korea, Republic of
559
🇮🇹Roma, Italy
973
🇮🇹Siena, Italy
652
🇰🇷Seoul, Korea, Republic of
655
🇰🇷Gwangju, Korea, Republic of
566
🇳🇱Breda, Netherlands
567
🇳🇱Den Haag, Netherlands
821
🇳🇱Heemstede, Netherlands
570
🇳🇴Trondheim, Norway
741
🇵🇱Gdansk, Poland
978
🇵🇱Grodzisk Mazowiecki, Poland
748
🇵🇱Katowice, Poland
574
🇵🇱Kielce, Poland
744
🇵🇱Lodz, Poland
747
🇵🇱Lodz, Poland
977
🇵🇱Poznan, Poland
975
🇵🇱Krakow, Poland
746
🇵🇱Szczecin, Poland
576
🇵🇱Warszawa, Poland
745
🇵🇱Warszawa, Poland
742
🇵🇱Lublin, Poland
743
🇵🇱Warszawa, Poland
578
🇷🇺Moscow, Russian Federation
579
🇷🇺Moscow, Russian Federation
584
🇷🇺Moscow, Russian Federation
586
🇷🇺Moscow, Russian Federation
588
🇷🇺Moscow, Russian Federation
943
🇷🇺Samara, Russian Federation
589
🇷🇺St. Petersburg, Russian Federation
587
🇷🇺Yaroslavl, Russian Federation
962
🇷🇸Belgrade, Serbia
961
🇷🇸Belgrade, Serbia
657
🇸🇬Singapore, Singapore
648
🇿🇦George, South Africa
593
🇪🇸Barcelona, Spain
599
🇪🇸Alcorcón, Madrid, Spain
591
🇷🇺Kazan, Russian Federation
783
🇪🇸Madrid, Spain
597
🇪🇸Zaragoza, Spain
786
🇪🇸Madrid, Spain
604
🇸🇪Umea, Sweden
850
🇸🇪Goteborg, Sweden
601
🇸🇪Stockholm, Sweden
605
🇨🇭Biel, Switzerland
607
🇨🇭St. Gallen, Switzerland
608
🇨🇭Zurich, Switzerland
606
🇨🇭Tschugg, Switzerland
671
🇨🇳Taichung, Taiwan
660
🇨🇳Taoyuan, Taiwan
861
🇹🇳Manouba, Tunisia
638
🇺🇦Donetsk, Ukraine
669
🇨🇳Tainan, Taiwan
860
🇹🇳Tunis, Tunisia
642
🇺🇦Kyiv, Ukraine
637
🇺🇦Kharkov, Ukraine
639
🇺🇦Lviv, Ukraine
640
🇺🇦Uzhgorod, Ukraine
594
🇪🇸Madrid, Spain