An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
- Registration Number
- NCT00761774
- Lead Sponsor
- UCB Pharma
- Brief Summary
The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16 years and older with epilepsy. This study permits continued access to treatment for subjects who participated in a previous epilepsy study. The study will explore the long-term safety and efficacy of brivaracetam.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- Subjects with epilepsy who participated in previous brivaracetam trials which allow access to the present trial.
- Subjects from whom the Investigator believes a reasonable potential benefit from the long-term administration of brivaracetam may be expected.
• Severe medical, neurological and psychiatric disorders, including current suicidal ideation or behaviour, or laboratory values which may have an impact on the safety of the subject, as determined by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brivaracetam Brivaracetam Brivaracetam at flexible dosing up to 200mg /day
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) During the Evaluation Period (up to 9 years) Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) During the Evaluation Period (up to 9 years) An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years) During the Evaluation Period (up to 9 years) Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years) During the Evaluation Period (up to 9 years) BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years) During the Evaluation Period (up to 9 years) BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years) During the Evaluation Period (up to 9 years) BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Trial Locations
- Locations (58)
281
🇺🇸Fresno, California, United States
285
🇺🇸Peoria, Illinois, United States
245
🇺🇸Sacramento, California, United States
266
🇺🇸Lexington, Kentucky, United States
270
🇺🇸New York, New York, United States
260
🇺🇸Austin, Texas, United States
236
🇺🇸Bedford, Texas, United States
279
🇺🇸Danville, Virginia, United States
400
🇦🇺Chatswood, New South Wales, Australia
004
🇧🇪Gent, Belgium
401
🇦🇺Parkville, Victoria, Australia
205
🇨🇦Calgary, Alberta, Canada
020
🇨🇿Litomysl, Czechia
023
🇨🇿Brno, Czechia
021
🇨🇿Ostava, Czechia
024
🇨🇿Ostrava-Trebovice, Czechia
026
🇨🇿Praha 4, Czechia
054
🇩🇪Bielefeld, Germany
055
🇩🇪Berlin, Germany
083
🇮🇹Perugia, Italy
090
🇪🇸Madrid, Spain
100
🇸🇪Goteborg, Sweden
102
🇸🇪Lund, Sweden
101
🇸🇪Stockholm, Sweden
203
🇨🇦Edmonton, Alberta, Canada
051
🇩🇪Munchen, Germany
231
🇺🇸Waldorf, Maryland, United States
297
🇺🇸Germantown, Tennessee, United States
211
🇺🇸Layton, Utah, United States
003
🇧🇪Kortrijk, Belgium
218
🇺🇸Burlington, Vermont, United States
277
🇺🇸Charleston, West Virginia, United States
040
🇫🇷Bethune, France
041
🇫🇷Toulouse Cedex 09, France
056
🇩🇪Bernau, Germany
072
🇭🇺Budapest, Hungary
063
🇩🇪Mainz, Germany
080
🇮🇹Pisa, Italy
065
🇩🇪Regensburg, Germany
074
🇭🇺Budapest, Hungary
084
🇮🇹Bergamo, Italy
082
🇮🇹Messina, Italy
085
🇮🇹Orbassano, Italy
240
🇺🇸Riverside, California, United States
224
🇺🇸Indianapolis, Indiana, United States
278
🇺🇸Burlington, Massachusetts, United States
241
🇺🇸Columbus, Ohio, United States
267
🇺🇸Dallas, Texas, United States
268
🇺🇸Houston, Texas, United States
235
🇺🇸Ogden, Utah, United States
213
🇺🇸Marshfield, Wisconsin, United States
404
🇦🇺Adelaide, South Australia, Australia
206
🇨🇦Toronto, Ontario, Canada
402
🇦🇺Fitzroy, Victoria, Australia
288
🇺🇸Pasadena, California, United States
284
🇺🇸Hickory, North Carolina, United States
304
🇺🇸Phoenix, Arizona, United States
265
🇺🇸Oklahoma City, Oklahoma, United States