Clinical trial NCT00698581: 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: 88
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 Brivaracetam (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 Week 1 up to Week 17
Secondary outcomes:
measure: The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study
timeFrame: Baseline through Re-conversion (approximately 31 weeks)
measure: The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study
timeFrame: Baseline through Re-conversion (approximately 31 weeks)
measure: The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study
timeFrame: Baseline through Re-conversion (approximately 31 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: Pasadena
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Conyers
country: United States
state: Georgia
city: Macon
country: United States
state: Georgia
city: Peoria
country: United States
state: Illinois
city: Lexington
country: United States
state: Kentucky
city: Burlington
country: United States
state: Massachusetts
city: Las Vegas
country: United States
state: Nevada
city: Summit
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Hickory
country: United States
state: North Carolina
city: Kettering
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Germantown
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Danville
country: United States
state: Virginia
city: Charleston
country: United States
state: West Virginia
city: Waukesha
country: United States
state: Wisconsin
city: Chatswood
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Clayton
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Parkville
country: Australia
state: Victoria
city: West Heidelberg
country: Australia
state: Victoria
city: Gent
country: Belgium
city: Kortrijk
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Sakaskatoon
country: Canada
state: Saskatchewan
city: Brno
country: Czechia
city: Litomysl
country: Czechia
city: Ostava
country: Czechia
city: Ostrava-Trebovice
country: Czechia
city: Praha 2
country: Czechia
city: Praha-4
country: Czechia
city: Aschaffenburg
country: Germany
city: Halle (Saale)
country: Germany
city: Mainz
country: Germany
city: Regensburg
country: Germany
city: Goteborg
country: Sweden
city: Lund
country: Sweden
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
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.