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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00464269
Registration number
NCT00464269
Ethics application status
Date submitted
19/04/2007
Date registered
23/04/2007
Date last updated
21/07/2022
Titles & IDs
Public title
Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures
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Scientific title
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
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Secondary ID [1]
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2006-006345-14
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Secondary ID [2]
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N01253
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Epilepsy
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Condition category
Condition code
Neurological
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Epilepsy
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Other interventions - Placebo
Treatment: Drugs - Brivaracetam 2.5 mg
Treatment: Drugs - Brivaracetam 10 mg
Treatment: Drugs - Brivaracetam 25 mg
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.
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.
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.
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.
Other interventions: Placebo
Active Substance: Placebo
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg, 10 mg and 25 mg
Route of Administration: Oral use
Treatment: Drugs: Brivaracetam 2.5 mg
Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 2.5 mg
Route of Administration: Oral use
Treatment: Drugs: Brivaracetam 10 mg
Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 10 mg
Route of Administration: Oral use
Treatment: Drugs: Brivaracetam 25 mg
Active Substance: Brivaracetam
Pharmaceutical Form: Film-coated tablet
Concentration: 25 mg
Route of Administration: Oral use
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
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Assessment method [1]
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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)
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Timepoint [1]
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Baseline to 12-week Treatment Period
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Secondary outcome [1]
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Responder Rate for Partial Onset Seizure (Type I) Frequency Per Week Over the 12-week Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to 12-week Treatment Period
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Secondary outcome [2]
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All Seizure Frequency (Type I+II+III) Per Week Over the 12-week Treatment Period
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Assessment method [2]
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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)
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Timepoint [2]
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Baseline to 12-week Treatment Period
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Secondary outcome [3]
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Percent Change From Baseline to the 12-week Treatment Period in Partial Onset Seizure (Type I) Frequency Per Week
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to 12-week Treatment Period
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Secondary outcome [4]
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Categorized Percentage Change From Baseline in Seizure Frequency for Partial Onset Seizure (Type I) Over the 12-week Treatment Period
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to 12-week Treatment Period
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Secondary outcome [5]
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Seizure Freedom Rate (All Seizure Types) Over the 12-week Treatment Period
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Assessment method [5]
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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)
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Timepoint [5]
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Baseline to 12-week Treatment Period
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Secondary outcome [6]
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Time to First Type I Seizure During the 12-week Treatment Period
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to 12-week Treatment Period
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Secondary outcome [7]
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Time to Fifth Type I Seizure During the 12-week Treatment Period
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline to 12-week Treatment Period
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Secondary outcome [8]
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Time to Tenth Type I Seizure During the 12-week Treatment Period
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to 12-week Treatment Period
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Secondary outcome [9]
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Reduction of Type IC/Type I Seizure Frequency Ratio From Baseline to the 12- Week Treatment Period
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline to 12-week Treatment Period
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Secondary outcome [10]
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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
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline to 12-week Treatment Period
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Secondary outcome [11]
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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
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline to 12-week Treatment Period
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Secondary outcome [12]
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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
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Assessment method [12]
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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.
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Timepoint [12]
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Baseline to 12-week Treatment Period
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Secondary outcome [13]
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Change From Baseline to the 12-week Treatment Period in Hospital Anxiety Score
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline to 12-week Treatment Period
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Secondary outcome [14]
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Change From Baseline to the 12-week Treatment Period in Hospital Depression Score
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Assessment method [14]
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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.
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Timepoint [14]
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Baseline to 12-week Treatment Period
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Secondary outcome [15]
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Patient's Global Evaluation Scale (P-GES) Evaluated at Last Visit or Early Discontinuation Visit
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Assessment method [15]
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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?'
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Timepoint [15]
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Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
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Secondary outcome [16]
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Investigator's Global Evaluation Scale (I-GES) Evaluated at Last Visit or Early Discontinuation Visit
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Assessment method [16]
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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.'
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Timepoint [16]
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Baseline to Last Visit or Early Discontinuation Visit in the 12-week Treatment Period
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Secondary outcome [17]
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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
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Assessment method [17]
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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.
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Timepoint [17]
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From Baseline to 12-week Treatment Period
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Secondary outcome [18]
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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
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Assessment method [18]
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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.
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Timepoint [18]
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From Baseline to 12-week Treatment Period
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Secondary outcome [19]
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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
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Assessment method [19]
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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.
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Timepoint [19]
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From Baseline to 12-week Treatment Period
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Secondary outcome [20]
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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
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Assessment method [20]
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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.
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Timepoint [20]
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From Baseline to 12-week Treatment Period
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Secondary outcome [21]
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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
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Assessment method [21]
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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.
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Timepoint [21]
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From Baseline to 12-week Treatment Period
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Secondary outcome [22]
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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
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Assessment method [22]
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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.
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Timepoint [22]
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From Baseline to 12-week Treatment Period
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Eligibility
Key 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
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Minimum age
16
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2009
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Sample size
Target
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Accrual to date
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Final
400
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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- Chatswood
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Recruitment hospital [2]
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- Randwick
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Recruitment hospital [3]
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- Woodville
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Recruitment hospital [4]
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- Clayton
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Recruitment hospital [5]
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- Fitzroy
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Recruitment hospital [6]
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0
- Parkville
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Recruitment hospital [7]
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- Adelaide
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Recruitment hospital [8]
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- West Heidelberg
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Recruitment postcode(s) [1]
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- Chatswood
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Recruitment postcode(s) [2]
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- Randwick
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Recruitment postcode(s) [3]
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- Woodville
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Recruitment postcode(s) [4]
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- Clayton
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Recruitment postcode(s) [5]
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- Fitzroy
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Recruitment postcode(s) [6]
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- Parkville
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Recruitment postcode(s) [7]
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- Adelaide
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Recruitment postcode(s) [8]
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- West Heidelberg
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
Arizona
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0
0
United States of America
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State/province [2]
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0
Arkansas
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0
0
United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Georgia
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0
United States of America
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Illinois
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United States of America
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State/province [7]
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Kansas
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0
United States of America
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State/province [8]
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0
Kentucky
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0
0
United States of America
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State/province [9]
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0
Maryland
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0
0
United States of America
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State/province [10]
0
0
Massachusetts
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0
0
United States of America
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0
0
Michigan
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0
0
United States of America
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0
Minnesota
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0
0
United States of America
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State/province [13]
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Mississippi
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0
0
United States of America
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Missouri
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0
United States of America
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New York
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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0
United States of America
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Tennessee
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0
United States of America
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Texas
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United States of America
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Utah
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Virginia
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0
United States of America
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Washington
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0
United States of America
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Wisconsin
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0
0
Brazil
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0
0
Campinas
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0
Brazil
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Curitiba
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0
0
Brazil
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Florianópolis
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0
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Brazil
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Porto Alegre
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Brazil
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Ribeirao Preto
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Brazil
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Salvador
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Country [32]
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Brazil
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State/province [32]
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Sao Jose do Rio Preto
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Country [33]
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Brazil
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State/province [33]
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Sao Paulo
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Brazil
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São Paulo
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Canada
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Alberta
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Quebec
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Mexico
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DF
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Mexico
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NL
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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Mexico DF
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Mexico
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Monterrey
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Mexico
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Nuevo León
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Mexico
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San Luis Potosi
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
UCB Pharma
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00464269
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Public notes
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Contacts
Principal investigator
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UCB Clinical Trial Call Center
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+1 877 822 9493 (UCB)
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00464269
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