Clinical trial NCT00699283: A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures
Official title: An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Epilepsy
Keywords: Epilepsy; Monotherapy
Partial Onset Seizures
Adults and Adolescents
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 62
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antiepileptic Drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of BRV in the conversion of partial onset seizure patients from combination treatment to monotherapy.


Eligibility criteria: Inclusion Criteria:

* Subjects from 16 to 75 years, both inclusive
* Well-characterized focal epilepsy or epileptic syndrome
* Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
* Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50% of the minimum recommended maintenance dose

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
* Other serious uncontrolled disease

Primary outcomes:
measure: The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
timeFrame: From Visit 4 (week 1) to the end of the Evaluation Period (week 17) (approximately 16 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Garden Grove
country: United States
state: California
city: Loma Linda
country: United States
state: California
city: Newport Beach
country: United States
state: California
city: Riverside
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Fort Collins
country: United States
state: Colorado
city: Danbury
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Waterbury
country: United States
state: Connecticut
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Danville
country: United States
state: Indiana
city: Elkhart
country: United States
state: Indiana
city: Waldorf
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Albuquerque
country: United States
state: New Mexico
city: Flushing
country: United States
state: New York
city: Schenectady
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Oberlin
country: United States
state: Ohio
city: Westerville
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Bethlehem
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Austin
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Layton
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Burlington
country: United States
state: Vermont
city: Bluefield
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Morgantown
country: United States
state: West Virginia
city: Marshfield
country: United States
state: Wisconsin
city: Bethune
country: France
city: Lille
country: France
city: Saint Brieuc
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Bernau
country: Germany
city: Bielefeld
country: Germany
city: Munchen
country: Germany
city: Munster
country: Germany
city: Ulm
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Kecskemet
country: Hungary
city: Szeged
country: Hungary
city: Bergamo
country: Italy
city: Firenze
country: Italy
city: Germaneto
country: Italy
city: Messina
country: Italy
city: Perugia
country: Italy
city: Pisa
country: Italy
city: Torino
country: Italy
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
citation: Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.