Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures

An International, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Brivaracetam in Subjects (>= 16 to 70 Years Old) With Partial Onset Seizures

This study will evaluate the efficacy and safety of Brivaracetam to support the submission file in the indication of adjunctive treatment in adolescents and adults with partial onset seizures.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Other: Placebo; Drug: Brivaracetam 2.5 mg; Drug: Brivaracetam 10 mg; Drug: Brivaracetam 25 mg

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
  • Fitzroy, Australia
  • West Heidelberg, Australia
  • New South Wales
    • Chatswood, New South Wales, Australia
    • Randwick, New South Wales, Australia
  • South Australia
    • Woodville, South Australia, Australia
  • Victoria
    • Clayton, Victoria, Australia
    • Fitzroy, Victoria, Australia
    • Parkville, Victoria, Australia
• Brazil
  • Campinas, Brazil
  • Curitiba, Brazil
  • Florianópolis, Brazil
  • Porto Alegre, Brazil
  • Ribeirao Preto, Brazil
  • Salvador, Brazil
  • Sao Jose do Rio Preto, Brazil
  • Sao Paulo, Brazil
  • São Paulo, Brazil
• Canada
  • Alberta
    • Edmonton, Alberta, Canada
  • Quebec
    • Greenfield Park, Quebec, Canada
    • Montreal, Quebec, Canada
    • Quebec City, Quebec, Canada
• Mexico
  • Aguascalientes, Mexico
  • Chihuahua, Mexico
  • Mexico DF, Mexico
  • Monterrey, Mexico
  • Nuevo León, Mexico
  • San Luis Potosi, Mexico
  • DF
    • Mexico, DF, Mexico
  • NL
    • Monterrey, NL, Mexico
• United States
  • Arizona
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • Arkansas
    • Little Rock, Arkansas, United States
  • California
    • Fresno, California, United States
    • Los Angeles, California, United States
    • Newport Beach, California, United States
    • Sacramento, California, United States
    • San Francisco, California, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Georgia
    • Atlanta, Georgia, United States
    • Augusta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
    • Springfield, Illinois, United States
  • Kansas
    • Wichita, Kansas, United States
  • Kentucky
    • Lexington, Kentucky, United States
    • Louisville, Kentucky, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Bethesda, Maryland, United States
  • Massachusetts
    • Burlington, Massachusetts, United States
  • Michigan
    • Detroit, Michigan, United States
    • Grand Rapids, Michigan, United States
  • Minnesota
    • Saint Paul, Minnesota, United States
  • Mississippi
    • Tupelo, Mississippi, United States
  • Missouri
    • Chesterfield, Missouri, United States
    • Saint Louis, Missouri, United States
  • New York
    • New York, New York, United States
    • Rochester, New York, United States
  • Ohio
    • Cincinnati, Ohio, United States
    • Columbus, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
  • South Carolina
    • Greenville, South Carolina, United States
  • Tennessee
    • Nashville, Tennessee, United States
  • Texas
    • Dallas, Texas, United States
    • Houston, Texas, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Virginia
    • Charlottesville, Virginia, United States
    • Richmond, Virginia, United States
  • Washington
    • Seattle, Washington, United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects were 16 to 70 years, both inclusive. Subjects under 18 years of age were only included where legally permitted and ethically accepted
• Subjects with well-characterized focal epilepsy or epileptic syndrome according to the International League Against Epilepsy (ILAE) classification
• Subjects had a history of partial onset seizures (POS) whether or not secondarily generalized (Type I seizures according to the ILAE classification)
• Subjects had at least 2 POS whether or not secondarily generalized per month during the 3 months preceding Visit 1 (V1)
• Subjects had at least 8 POS whether or not secondarily generalized during the 8-Week Baseline Period
• Subjects were uncontrolled while treated by 1 to 2 permitted concomitant antiepileptic drug(s) (AEDs). Vagal nerve stimulation (VNS) was allowed and was not counted as a concomitant AED

Exclusion Criteria:

• History or presence of seizures occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before Visit 3
• History or presence of status epilepticus during the year preceding Visit 1 or during Baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Matching Placebo tablets administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 12-week Treatment Period.	Other: Placebo; Active Substance: Placebo; Pharmaceutical Form: Film-coated tablet; Concentration: 2.5 mg, 10 mg and 25 mg; Route of Administration: Oral use
Experimental: Brivaracetam 5 mg/day; Brivaracetam 5 mg/day, 2.5 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 5 mg /day in a double-blinded way for the 12-week Treatment Period.	Drug: Brivaracetam 2.5 mg; Active Substance: Brivaracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 2.5 mg; Route of Administration: Oral use
Experimental: BRV 20mg/day; Brivaracetam 20 mg/day, 10 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 20 mg /day in a double-blinded way for the 12-week Treatment Period.	Drug: Brivaracetam 10 mg; Active Substance: Brivaracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 10 mg; Route of Administration: Oral use
Experimental: BRV 50mg/day; Brivaracetam 50 mg/day, 25 mg administered twice a day. Daily oral dose of two equal intakes, morning and evening, of Brivaracetam 50 mg /day, in a double-blinded way for the 12-week Treatment Period.	Drug: Brivaracetam 25 mg; Active Substance: Brivaracetam; Pharmaceutical Form: Film-coated tablet; Concentration: 25 mg; Route of Administration: Oral use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period	Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures; Complex partial seizures; Partial seizures evolving to generalized tonic-clonic convulsions. Partial Onset Seizure (POS) Frequency per week over the Treatment Period (TP) was calculated as: (Total Type I seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)	Baseline to 12-week Treatment Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period	The responder rate was presented as the number of responders and non-responders. A subject is a responder, if the subject has at least 50 % reduction in partial onset seizure frequency per week from Baseline to Treatment Period. Subjects with zero seizure frequency per week at Baseline were considered as non-responders.	Baseline to 12-week Treatment Period
All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period	There are three different types of seizures: Type I: Partial seizures; Type II: Generalized seizures; Type III: Unclassified epileptic seizures. All seizure frequency per week over Treatment Period (TP) was calculated as: (Total number of seizures over the TP)*7/(Total number of days with no missing seizure count in the TP)	Baseline to 12-week Treatment Period
Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week	Percent change from Baseline was calculated as percent reduction by: (weekly seizure frequency Baseline - weekly seizure frequency Treatment)*100/(weekly seizure frequency Baseline). The higher the values for percent change in Partial Onset Seizure (POS) frequency, the higher the improvement from Baseline.	Baseline to 12-week Treatment Period
Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period	Subjects were classified in 1 of the following categories based on their percent reduction from Baseline to Treatment Period in Partial Onset Seizure (POS) frequency per week: <-25 %, -25 % to <25 %, 25 % to <50 %, 50 % to <75 %, 75 % to <100 %, and 100 %. Subjects having zero for Baseline seizure frequency per week were classified in the <-25 % category.	Baseline to 12-week Treatment Period
Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period	Subjects were considered seizure free if their seizure counts for every day over the Treatment Period (TP) was zero and if they did not discontinue before the end of the TP. Seizure freedom rate was calculated as: (total number of seizure - free subjects in treatment group during TP)/(total number of evaluable Intent-To-Treat (ITT) subjects in treatment group)	Baseline to 12-week Treatment Period
Time to First Type I Seizure During the 12-week Treatment Period	The time to first Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of first Type I seizure. Subjects withdrawing during the Treatment Period before having a first Type I seizure were considered as having a first Type I seizure on the last day of their Treatment Period.	Baseline to 12-week Treatment Period
Time to Fifth Type I Seizure During the 12-week Treatment Period	The time to fifth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of fifth Type I seizure. Subjects withdrawing during the Treatment Period before having a fifth Type I seizure were considered as having a fifth Type I seizure on the last day of their Treatment Period.	Baseline to 12-week Treatment Period
Time to Tenth Type I Seizure During the 12-week Treatment Period	The time to tenth Partial Onset Seizure (POS) in the Treatment Period is defined as the time between beginning of the Treatment Period and the date of occurrence of tenth Type I seizure. Subjects withdrawing during the Treatment Period before having a tenth Type I seizure were considered as having a tenth Type I seizure on the last day of their Treatment Period.	Baseline to 12-week Treatment Period
Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period	The type IC/Type I seizure frequency ratio is represented by the percentage of subjects having a reduction in the ratio of Type IC seizure frequency over Type IA, IB, and IC seizure frequency from Baseline to Treatment Period.	Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Total Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.	Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Seizure Worry Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.	Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Daily Activities / Social Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-items subscales - seizure worry (5 items), overall quality of life (2 items), emotional well-being (5 items), energy / fatigue (4 items), cognitive functioning (6 items), medication effects (3 items), and social function (5 items) - and a health status item. The subscale scores, the total score and the health status item score range from 0 to 100 and higher scores indicating better function.	Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score	The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.	Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Hospital Depression Score	The Hospital Anxiety and Depression Scale (HADS) was used to evaluate anxiety and depression. The HADS was developed as a self administered scale to assess the presence and severity of both anxiety and depression simultaneously. It consists of 14 items that are scored on a 4-point severity scale ranging from 0 to 3. A score per dimension was calculated with each score ranging from 0 to 21 and higher scores indicating higher depression / anxiety. A negative value in change from Baseline shows an improvement in HADS from Baseline.	Baseline to 12-week Treatment Period
Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit	Patient's Global Evaluation Scale (P-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1= Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The subject completed it by answering to the following: 'Overall, has there been a change in your seizures since the start of the study medication?'	Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit	The Investigator's Global Evaluation Scale (I-GES) is a global assessment of the disease evolution which was performed using a seven-point scale (1 = Marked worsening to 7 = Marked improvement) with the start of the study medication as the reference time point. The investigator completed it by answering to the following: 'Assess the overall change in the severity of patient's illness, compared to start of study medication.'	Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Energy/Fatigue Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Emotional Well-Being Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Cognitive Functioning Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Medication Effects Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Overall Quality of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period
Change From Baseline to the 12-week Treatment Period in Health Status of Life Patient Weighted Quality of Life in Epilepsy Inventory-Form 31 (QOLIE-31-P) Score	The QOLIE-31-P is an adaptation of the original QOLIE-31 instrument that includes 30 items grouped into seven multi-item subscales - Seizure Worry (5 items), Overall Quality of Life (2 items), Emotional Well-Being (5 items), Energy/Fatigue (4 items), Cognitive Functioning (6 items), Medication Effects (3 items) and Daily Activities/Social Functioning (5 items) - and a Health Status item. The subscale scores, the Total score and the Health Status item score are calculated according to the scoring algorithm defined by the author with scores ranging from 0 to 100 and higher scores indicating better function. A positive value in Change from Baseline indicates an improvement from Baseline.	From Baseline to 12-week Treatment Period

Collaborators and Investigators

• Sponsor: UCB Pharma

Publications and helpful links

General Publications

• 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.
• Ben-Menachem E, Mameniskiene R, Quarato PP, Klein P, Gamage J, Schiemann J, Johnson ME, Whitesides J, McDonough B, Eckhardt K. Efficacy and safety of brivaracetam for partial-onset seizures in 3 pooled clinical studies. Neurology. 2016 Jul 19;87(3):314-23. doi: 10.1212/WNL.0000000000002864. Epub 2016 Jun 22.
• Brodie MJ, Whitesides J, Schiemann J, D'Souza J, Johnson ME. Tolerability, safety, and efficacy of adjunctive brivaracetam for focal seizures in older patients: A pooled analysis from three phase III studies. Epilepsy Res. 2016 Nov;127:114-118. doi: 10.1016/j.eplepsyres.2016.08.018. Epub 2016 Aug 18.
• Moseley BD, Sperling MR, Asadi-Pooya AA, Diaz A, Elmouft S, Schiemann J, Whitesides J. Efficacy, safety, and tolerability of adjunctive brivaracetam for secondarily generalized tonic-clonic seizures: Pooled results from three Phase III studies. Epilepsy Res. 2016 Nov;127:179-185. doi: 10.1016/j.eplepsyres.2016.09.003. Epub 2016 Sep 3.
• Brandt C, Borghs S, Elmoufti S, Mueller K, Townsend R, de la Loge C. Health-related quality of life in double-blind Phase III studies of brivaracetam as adjunctive therapy of focal seizures: A pooled, post-hoc analysis. Epilepsy Behav. 2017 Apr;69:80-85. doi: 10.1016/j.yebeh.2016.11.031. Epub 2017 Feb 23.
• Klein P, Johnson ME, Schiemann J, Whitesides J. Time to onset of sustained >/=50% responder status in patients with focal (partial-onset) seizures in three phase III studies of adjunctive brivaracetam treatment. Epilepsia. 2017 Feb;58(2):e21-e25. doi: 10.1111/epi.13631. Epub 2016 Dec 18.
• Asadi-Pooya AA, Sperling MR, Chung S, Klein P, Diaz A, Elmoufti S, Schiemann J, Whitesides J. Efficacy and tolerability of adjunctive brivaracetam in patients with prior antiepileptic drug exposure: A post-hoc study. Epilepsy Res. 2017 Mar;131:70-75. doi: 10.1016/j.eplepsyres.2017.02.007. Epub 2017 Feb 27. Erratum In: Epilepsy Res. 2017 Nov;137:165-166.
• Benbadis S, Klein P, Schiemann J, Diaz A, Elmoufti S, Whitesides J. Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis. Epilepsy Behav. 2018 Mar;80:129-134. doi: 10.1016/j.yebeh.2017.12.024. Epub 2018 Feb 3.
• Brodie MJ, Fakhoury T, McDonough B, Colson AO, Stockis A, Elmoufti S, Whitesides J. Brivaracetam-induced elevation of carbamazepine epoxide levels: A post-hoc analysis from the clinical development program. Epilepsy Res. 2018 Sep;145:55-62. doi: 10.1016/j.eplepsyres.2018.06.002. Epub 2018 Jun 4.
• Klein P, Laloyaux C, Elmoufti S, Gasalla T, Martin MS. Time course of 75%-100% efficacy response of adjunctive brivaracetam. Acta Neurol Scand. 2020 Aug;142(2):175-180. doi: 10.1111/ane.13287. Epub 2020 Jun 9.
• Moseley BD, Dimova S, Elmoufti S, Laloyaux C, Asadi-Pooya AA. Long-term efficacy and tolerability of adjunctive brivaracetam in adults with focal to bilateral tonic-clonic (secondary generalized) seizures: Post hoc pooled analysis. Epilepsy Res. 2021 Oct;176:106694. doi: 10.1016/j.eplepsyres.2021.106694. Epub 2021 Jun 24.
• Ryvlin P, Dimova S, Elmoufti S, Floricel F, Laloyaux C, Nondonfaz X, Biton V. Tolerability and efficacy of adjunctive brivaracetam in adults with focal seizures by concomitant antiseizure medication use: Pooled results from three phase 3 trials. Epilepsia. 2022 Aug;63(8):2024-2036. doi: 10.1111/epi.17304. Epub 2022 Jun 10.
• Bresnahan R, Panebianco M, Marson AG. Brivaracetam add-on therapy for drug-resistant epilepsy. Cochrane Database Syst Rev. 2022 Mar 14;3:CD011501. doi: 10.1002/14651858.CD011501.pub3. Review.
• Lee SK, Heo K, Kim SE, Lee SA, Elmoufti S, Laloyaux C, Hur B. Effect of Number of Previous Antiseizure Medications on Efficacy and Tolerability of Adjunctive Brivaracetam for Uncontrolled Focal Seizures: Post Hoc Analysis. Adv Ther. 2021 Jul;38(7):4082-4099. doi: 10.1007/s12325-021-01816-5. Epub 2021 Jun 21.
• Biton V, Berkovic SF, Abou-Khalil B, Sperling MR, Johnson ME, Lu S. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia. 2014 Jan;55(1):57-66. doi: 10.1111/epi.12433. Epub 2013 Nov 8.
• Mukuria C, Young T, Keetharuth A, Borghs S, Brazier J. Sensitivity and responsiveness of the EQ-5D-3L in patients with uncontrolled focal seizures: an analysis of Phase III trials of adjunctive brivaracetam. Qual Life Res. 2017 Mar;26(3):749-759. doi: 10.1007/s11136-016-1483-3. Epub 2016 Dec 21.

Helpful Links

• FDA Safety Alerts and Recalls
• Product Information

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: April 19, 2007
• First Submitted That Met QC Criteria: April 20, 2007
• First Posted (Estimate): April 23, 2007

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; Brivaracetam; Partial Onset Seizures, Adolescents & Adults
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Anticonvulsants; Brivaracetam
• Other Study ID Numbers: N01253; 2006-006345-14 (EudraCT Number)