Clinical trial NCT00175825: A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled, 4 Parallel Groups, Dose-ranging Trial Evaluating the Efficacy and Safety of Brivaracetam Used as Adjunctive Treatment at Doses of 5, 20 and 50 mg/Day in b.i.d. Administration (Oral Tablets of 2.5 or 10 mg) for a Maximum of 7 Weeks in Subjects From 16 to 65 Years With Refractory Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Epilepsy: partial onset seizures
brivaracetam
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 210
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.


Eligibility criteria: Inclusion Criteria:

* Male/female from 16 to 65 years
* Well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
* History of partial onset seizures
* Subjects having at least 4 partial onset seizures during the 4-week Baseline Period and at least 2 partial onset seizures during the 3 months prior to Visit 1
* Subjects taking 1 or 2 concomitant Antiepileptic drugs (AED(s)) that have been at a stable dose.

Exclusion Criteria:

* Seizure type IA non-motor as only seizure type
* Seizures occurring only in clusters
* Status epilepticus during the last 2 years before Visit 1
* History of cerebrovascular accident (CVA)
* Presence of any sign suggesting rapidly progressing brain disorder or brain tumor

Primary outcomes:
measure: Partial Onset Seizure Frequency Per Week During the 7-week Treatment Period
timeFrame: During the 7-week Treatment Period
Secondary outcomes:
measure: Percentage Change From Baseline in Partial Onset Seizure Frequency Per Week (Type I) Over the 7-week Treatment Period
timeFrame: Baseline, during the 7-week Treatment Period
measure: Seizure Frequency Per Week for All Seizures (Types I +II +III) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Absolute Change From Baseline in Seizure Frequency Per Week for Partial Onset Seizures (Type I) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Absolute Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Percentage Change From Baseline in Seizure Frequency Per Week for All Seizures (Types I + II + III) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Responder Rate in Partial Onset Seizures (Type I) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Percentage of Subjects With Categorized Response to the Treatment in Partial Onset Seizures (Type I) Over the Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Percentage of Subjects Who Are Seizure Free During the 7-week Treatment Period
timeFrame: During the 7-week Treatment Period
measure: Number of Seizure-free Days Per 4 Weeks
timeFrame: Baseline, during the 7-week Treatment Period
measure: Time to Nth (n= 1, 5, 10) Seizure During the 7-week Treatment Period
timeFrame: During the 7-week Treatment Period
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Paducah
country: United States
state: Kentucky
city: Ruston
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Burlington
country: United States
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Tupelo
country: United States
state: Mississippi
city: Chesterfield
country: United States
state: Missouri
city: Great Falls
country: United States
state: Montana
city: Englewood Cliffs
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Wilmington
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Woonsocket
country: United States
state: Rhode Island
city: Greenville
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Florianopolis
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
city: Bangalore
country: India
city: Hyderabad
country: India
city: Lucknow
country: India
city: Parel Mumbai
country: India
city: Trivandrum
country: India
city: Aguascalientes
country: Mexico
city: Chichuahua
country: Mexico
city: Chihuahua
country: Mexico
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Valle Oriente Garza Garcia
country: Mexico
city: Zapopan
country: Mexico
Study officials:
affiliation: +1 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: Toledo M, Whitesides J, Schiemann J, Johnson ME, Eckhardt K, McDonough B, Borghs S, Kwan P. Safety, tolerability, and seizure control during long-term treatment with adjunctive brivaracetam for partial-onset seizures. Epilepsia. 2016 Jul;57(7):1139-51. doi: 10.1111/epi.13416. Epub 2016 Jun 6.
citation: Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3(3):CD011501. doi: 10.1002/14651858.CD011501.pub3.
citation: Brandt C, Klein P, Badalamenti V, Gasalla T, Whitesides J. Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis. Epilepsy Behav. 2020 Feb;103(Pt A):106864. doi: 10.1016/j.yebeh.2019.106864. Epub 2020 Jan 12.