Clinical trial NCT00761774: An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Official title: An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Used 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: Epilepsy
Monotherapy
Partial Onset Seizures
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 108
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: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

• 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.

Primary outcomes:
measure: 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)
timeFrame: During the Evaluation Period (up to 9 years)
measure: 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)
timeFrame: During the Evaluation Period (up to 9 years)
measure: 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)
timeFrame: During the Evaluation Period (up to 9 years)
Secondary outcomes:
measure: Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
timeFrame: During the Evaluation Period (up to 9 years)
measure: Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
timeFrame: During the Evaluation Period (up to 9 years)
measure: Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
timeFrame: During the Evaluation Period (up to 9 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: 304
state: Arizona
city: Fresno
country: United States
facility: 281
state: California
city: Pasadena
country: United States
facility: 288
state: California
city: Riverside
country: United States
facility: 240
state: California
city: Sacramento
country: United States
facility: 245
state: California
city: Peoria
country: United States
facility: 285
state: Illinois
city: Indianapolis
country: United States
facility: 224
state: Indiana
city: Lexington
country: United States
facility: 266
state: Kentucky
city: Waldorf
country: United States
facility: 231
state: Maryland
city: Burlington
country: United States
facility: 278
state: Massachusetts
city: New York
country: United States
facility: 270
state: New York
city: Hickory
country: United States
facility: 284
state: North Carolina
city: Columbus
country: United States
facility: 241
state: Ohio
city: Oklahoma City
country: United States
facility: 265
state: Oklahoma
city: Germantown
country: United States
facility: 297
state: Tennessee
city: Austin
country: United States
facility: 260
state: Texas
city: Bedford
country: United States
facility: 236
state: Texas
city: Dallas
country: United States
facility: 267
state: Texas
city: Houston
country: United States
facility: 268
state: Texas
city: Layton
country: United States
facility: 211
state: Utah
city: Ogden
country: United States
facility: 235
state: Utah
city: Burlington
country: United States
facility: 218
state: Vermont
city: Danville
country: United States
facility: 279
state: Virginia
city: Charleston
country: United States
facility: 277
state: West Virginia
city: Marshfield
country: United States
facility: 213
state: Wisconsin
city: Chatswood
country: Australia
facility: 400
state: New South Wales
city: Adelaide
country: Australia
facility: 404
state: South Australia
city: Fitzroy
country: Australia
facility: 402
state: Victoria
city: Parkville
country: Australia
facility: 401
state: Victoria
city: Gent
country: Belgium
facility: 004
city: Kortrijk
country: Belgium
facility: 003
city: Calgary
country: Canada
facility: 205
state: Alberta
city: Edmonton
country: Canada
facility: 203
state: Alberta
city: Toronto
country: Canada
facility: 206
state: Ontario
city: Brno
country: Czechia
facility: 023
city: Litomysl
country: Czechia
facility: 020
city: Ostava
country: Czechia
facility: 021
city: Ostrava-Trebovice
country: Czechia
facility: 024
city: Praha 4
country: Czechia
facility: 026
city: Bethune
country: France
facility: 040
city: Toulouse Cedex 09
country: France
facility: 041
city: Berlin
country: Germany
facility: 055
city: Bernau
country: Germany
facility: 056
city: Bielefeld
country: Germany
facility: 054
city: Mainz
country: Germany
facility: 063
city: Munchen
country: Germany
facility: 051
city: Regensburg
country: Germany
facility: 065
city: Budapest
country: Hungary
facility: 072
city: Budapest
country: Hungary
facility: 074
city: Bergamo
country: Italy
facility: 084
city: Messina
country: Italy
facility: 082
city: Orbassano
country: Italy
facility: 085
city: Perugia
country: Italy
facility: 083
city: Pisa
country: Italy
facility: 080
city: Madrid
country: Spain
facility: 090
city: Goteborg
country: Sweden
facility: 100
city: Lund
country: Sweden
facility: 102
city: Stockholm
country: Sweden
facility: 101
Study officials:
affiliation: +1 844 599 2273(UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Markham A. Brivaracetam: First Global Approval. Drugs. 2016 Mar;76(4):517-22. doi: 10.1007/s40265-016-0555-6.