Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy
- Registration Number
- NCT01339559
- Lead Sponsor
- UCB BIOSCIENCES, Inc.
- Brief Summary
This is a Phase 3, open label, long term follow-up (LTFU), multicenter, noncomparative, and single arm study of brivaracetam (BRV).
- Detailed Description
The primary objective is to evaluate the long term safety and tolerability of BRV at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 767
- Subject completed the Treatment Period of N01358 or the evaluation period of N01258
- Male/female subject from 16 years or older. Subject under 18 years may only be included where legally permitted and ethically accepted
- Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected
- Female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible
- Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core studies
- Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject
- Poor compliance with the visit schedule or medication intake in the previous BRV study
- Planned participation in any other clinical study of another investigational drug or device during this study
- Pregnant or lactating woman
- Any medical condition which, in the Investigator's opinion, warrants exclusion
- Subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam Brivaracetam with a maximum of 200 mg/day
- Primary Outcome Measures
Name Time Method Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) From Entry Visit (Month 0) until the Last Visit (up to 84 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 Adverse Events (AEs) From Entry Visit (Month 0) until the Last Visit (up to 84 months) An AE is any untoward medical occurrence in a participant or trial subject 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 (Month 0) until the Last Visit (up to 84 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 as 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 Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period From Baseline of the previous study until the Last Visit (up to 84 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.
Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of percent change in POS frequency.Responder Rate in POS (Type I) Frequency Over the Evaluation Period From Baseline of the previous study until the Last Visit (up to 84 months) A responder is defined as a subject with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.
Note: Since N01258 was a safety study, participants were not required to meet seizure frequency requirements during the Baseline Period, and the Baseline Period was short (ie, 7 days). Therefore, participants from N01258 were excluded from efficacy summaries in the variable of responder rates in POS frequency.Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period From Baseline of the previous study until the Last Visit (up to 84 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.
Trial Locations
- Locations (184)
064
🇺🇸Port Charlotte, Florida, United States
011
🇺🇸Dallas, Texas, United States
778
🇺🇸Columbus, Ohio, United States
070
🇺🇸Columbus, Ohio, United States
071
🇺🇸Miami, Florida, United States
701
🇭🇰Hong Kong, Hong Kong
411
🇭🇺Budapest, Hungary
731
🇮🇳Nashik, Maharashtra, India
126
🇲🇽Guadalajara, Jalisco, Mexico
627
🇱🇻Daugavpils, Latvia
425
🇱🇹Alytus, Lithuania
426
🇱🇹Vilnius, Lithuania
129
🇲🇽Aguascalientes, Mexico
412
🇭🇺Budapest, Hungary
726
🇮🇳Bangalore, India
852
🇯🇵Itami, Hyogo, Japan
403
🇳🇱Zwolle, Netherlands
006
🇺🇸Tucson, Arizona, United States
077
🇨🇦Greenfield Park, Quebec, Canada
650
🇪🇪Tallinn, Estonia
477
🇵🇱Poznan, Poland
501
🇷🇺Kazan, Russian Federation
508
🇷🇺Smolensk, Russian Federation
101
🇧🇷Sao Paulo, Brazil
005
🇺🇸Peoria, Illinois, United States
009
🇺🇸Golden Valley, Minnesota, United States
042
🇺🇸Hamilton, New Jersey, United States
017
🇺🇸Winfield, Illinois, United States
023
🇺🇸Atlanta, Georgia, United States
029
🇺🇸Chicago, Illinois, United States
775
🇺🇸Little Rock, Arkansas, United States
039
🇺🇸Boise, Idaho, United States
048
🇺🇸Rome, Georgia, United States
022
🇺🇸New York, New York, United States
078
🇨🇦London, Ontario, Canada
294
🇧🇬Blagoevgrad, Bulgaria
035
🇺🇸Dallas, Texas, United States
076
🇨🇦Toronto, Ontario, Canada
301
🇫🇷Bethune, France
335
🇩🇪Muenchen, Germany
328
🇩🇪Ulm, Germany
251
🇨🇿Ostrava, Czechia
902
🇩🇪Erlangen, Germany
201
🇦🇹Linz, Austria
275
🇫🇮Kuopio, Finland
100
🇧🇷Florianopolis, Brazil
777
🇺🇸Dallas, Texas, United States
916
🇨🇿Kromeriz, Czechia
331
🇩🇪Göttingen, Germany
015
🇺🇸Philadelphia, Pennsylvania, United States
286
🇧🇬Sofia, Bulgaria
652
🇪🇪Tallinn, Estonia
651
🇪🇪Tartu, Estonia
384
🇮🇹Reggio Calabria, Italy
079
🇨🇦Montreal, Canada
104
🇧🇷Belo Horizonte, Brazil
256
🇨🇿Ostrava, Czechia
054
🇺🇸Tulsa, Oklahoma, United States
252
🇨🇿Praha 1, Czechia
327
🇩🇪Kiel, Germany
380
🇮🇹Firenze, Italy
376
🇮🇹Perugia, Italy
227
🇧🇪Leuven, Belgium
287
🇧🇬Sofia, Bulgaria
332
🇩🇪Bielefeld, Germany
334
🇩🇪Osnabruck, Germany
917
🇨🇿Brno, Czechia
253
🇨🇿Praha 4, Czechia
250
🇨🇿Zlin, Czechia
377
🇮🇹Monserrato, Italy
386
🇮🇹Napoli, Italy
750
🇰🇷Seoul, Korea, Republic of
528
🇪🇸Barcelona, Spain
330
🇩🇪Ravensburg, Germany
900
🇩🇪Marburg, Germany
379
🇮🇹Milano, Italy
729
🇮🇳Madurai, India
375
🇮🇹Pisa, Italy
607
🇬🇧Newcastle, United Kingdom
753
🇰🇷Busan, Korea, Republic of
526
🇪🇸Valladolid, Spain
725
🇮🇳Mumbai, India
130
🇲🇽Mexico City, Mexico
378
🇮🇹Bari, Italy
751
🇰🇷Seoul, Korea, Republic of
754
🇰🇷Seoul, Korea, Republic of
854
🇯🇵Yokohama-City, Japan
125
🇲🇽Distrito Federal, Mexico
629
🇱🇻Jekabpils, Latvia
628
🇱🇻Riga, Latvia
485
🇵🇱Gdansk, Poland
793
🇵🇱Krakow, Poland
483
🇵🇱Lublin, Poland
795
🇵🇱Katowice, Poland
540
🇪🇸Barcelona, Spain
503
🇷🇺Moscow, Russian Federation
529
🇪🇸Barcelona, Spain
535
🇪🇸Barcelona, Spain
800
🇨🇳Tainan, Taiwan
600
🇬🇧London, United Kingdom
551
🇸🇪Goteborg, Sweden
552
🇸🇪Linkoping, Sweden
539
🇪🇸San Sebastian, Spain
532
🇪🇸Santiago de Compostela, Spain
602
🇬🇧Morriston, Swansea, United Kingdom
806
🇨🇳Kaohsiung City, Taiwan
537
🇪🇸Valencia, Spain
801
🇨🇳Taichung, Taiwan
803
🇨🇳Taoyuan, Taiwan
601
🇬🇧Truro, United Kingdom
605
🇬🇧Middlesborough, United Kingdom
034
🇺🇸Cleveland, Ohio, United States
020
🇺🇸Ames, Iowa, United States
098
🇺🇸Poughkeepsie, New York, United States
069
🇺🇸Iowa City, Iowa, United States
002
🇺🇸Toledo, Ohio, United States
049
🇺🇸Houston, Texas, United States
043
🇺🇸Oklahoma City, Oklahoma, United States
001
🇺🇸Phoenix, Arizona, United States
008
🇺🇸Bethesda, Maryland, United States
013
🇺🇸Phoenix, Arizona, United States
060
🇺🇸Aurora, Colorado, United States
025
🇺🇸San Francisco, California, United States
776
🇺🇸Nashville, Tennessee, United States
003
🇺🇸Durham, North Carolina, United States
091
🇺🇸Oklahoma City, Oklahoma, United States
057
🇺🇸Milwaukee, Wisconsin, United States
036
🇺🇸Charlottesville, Virginia, United States
068
🇺🇸Waldorf, Maryland, United States
032
🇺🇸Lebanon, New Hampshire, United States
099
🇺🇸New York, New York, United States
010
🇺🇸Asheville, North Carolina, United States
050
🇺🇸Mansfield, Texas, United States
913
🇨🇿Ostrava Poruba, Czechia
329
🇩🇪Berlin, Germany
305
🇫🇷Montpellier, France
326
🇩🇪Bernau, Germany
727
🇮🇳Hyderabad, India
855
🇯🇵Hiroshima, Japan
383
🇮🇹Pozzilli, Italy
127
🇲🇽Culiacan, Mexico
128
🇲🇽Guadalajara, Jalisco, Mexico
400
🇳🇱Heeze, Netherlands
475
🇵🇱Bialystok, Poland
038
🇵🇷San Juan, Puerto Rico
480
🇵🇱Katowice, Poland
476
🇵🇱Krakow, Poland
481
🇵🇱Katowice, Poland
791
🇵🇱Gdansk, Poland
478
🇵🇱Katowice, Poland
794
🇵🇱Warszawa, Poland
527
🇪🇸Valencia, Spain
550
🇸🇪Stockholm, Sweden
603
🇬🇧Birmingham, United Kingdom
608
🇬🇧Salford, United Kingdom
276
🇫🇮Tampere, Finland
202
🇦🇹Innsbruck, Austria
851
🇯🇵Shizuoka, Japan
625
🇱🇻Valmiera, Latvia
427
🇱🇹Kaunas, Lithuania
027
🇺🇸Orlando, Florida, United States
075
🇨🇦Calgary, Alberta, Canada
226
🇧🇪Hechtel-Eksel, Belgium
413
🇭🇺Szekszard, Hungary
728
🇮🇳Mumbai, India
203
🇦🇹Wien, Austria
414
🇭🇺Hajdú-Bihar, Hungary
850
🇯🇵Osaka, Japan
479
🇵🇱Poznan, Poland
509
🇷🇺Nizhny Novgorod, Russian Federation
021
🇺🇸Port Royal, South Carolina, United States
028
🇺🇸Charleston, South Carolina, United States
080
🇨🇦Saskatoon, Saskatchewan, Canada
410
🇭🇺Budapest, Hungary
502
🇷🇺Moscow, Russian Federation
401
🇳🇱Heemstede, Netherlands
482
🇵🇱Poznan, Poland
488
🇵🇱Warszawa, Poland
506
🇷🇺Kazan, Russian Federation
061
🇺🇸Austin, Texas, United States
780
🇺🇸Lexington, Kentucky, United States
052
🇺🇸Madison, Wisconsin, United States
056
🇺🇸Spokane, Washington, United States
700
🇭🇰Hong Kong, Hong Kong