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Trial record 1 of 1 for:    NCT01728077
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Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

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ClinicalTrials.gov Identifier: NCT01728077
Recruitment Status : Completed
First Posted : November 16, 2012
Results First Posted : August 2, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Brivaracetam
Enrollment 26
Recruitment Details This study started to enroll subjects in October 2012 and concluded in August 2016.
Pre-assignment Details Participant Flow refers to the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam Focal Epilepsy Brivaracetam Generalized Epilepsy
Hide Arm/Group Description This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day.
Period Title: Overall Study
Started 19 7
Completed 11 2
Not Completed 8 5
Reason Not Completed
Lack of Efficacy             3             1
Lost to Follow-up             1             0
Subject choice             2             3
Death             0             1
Patient moving             1             0
Non compliance             1             0
Arm/Group Title Brivaracetam Focal Epilepsy Brivaracetam Generalized Epilepsy Total Title
Hide Arm/Group Description This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. [Not Specified]
Overall Number of Baseline Participants 19 7 26
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set, which consisted of all subjects who received at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 7 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
7
 100.0%
26
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Arithmetic mean (standard deviation) Number Analyzed 19 participants 7 participants 26 participants
38.6  (10.9) 30.7  (13.2) 36.5  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 7 participants 26 participants
Female
7
  36.8%
5
  71.4%
12
  46.2%
Male
12
  63.2%
2
  28.6%
14
  53.8%
1.Primary Outcome
Title Incidence of Treatment Emergent Adverse Events (TEAEs) During Evaluation Period
Hide Description TEAEs were defined as AEs that had onset on or after the day of first study medication dose. An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Time Frame From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: percentage of subjects
78.9 71.4
2.Primary Outcome
Title Percentage of Subjects Withdrawn Due to an Adverse Event (AE) During the Evaluation Period
Hide Description An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment. Results are presented as the percentage of subjects withdrawn due to an AE.
Time Frame From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: percentage of subjects
0 14.3
3.Primary Outcome
Title Occurrence of a Serious Adverse Event (SAE) During the Evaluation Period
Hide Description SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity or are a congenital anomaly/birth defects. Results are presented as the percentage of subjects with at least one SAE during this study.
Time Frame From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Safety Set (SS), which consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
Overall Number of Participants Analyzed 19 7
Measure Type: Number
Unit of Measure: percentage of subjects
26.3 28.6
4.Secondary Outcome
Title Frequency of Partial-Onset Seizure (POS) Type I Per 28 Days During the Evaluation Period for Subjects With Focal-onset Epilepsy
Hide Description The POS frequency is standardized to a 28-day duration. Results are presented as the median number of seizures per 28 days.
Time Frame From Entry Visit (Month 0) to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 46 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam Focal Epilepsy (EAS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: Seizures per 28 days
0.4
(0 to 124)
5.Secondary Outcome
Title Percentage of Change in Partial-Onset-Seizure (POS) Type I Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected
Hide Description The POS frequency is standardized to a 28-day duration. Results are presented as the median percentage of reduction per 28 days. Negative values indicate improvement from Baseline.
Time Frame From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam Focal Epilepsy (EAS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: percentage of change
-56.3
(-97 to 717)
6.Secondary Outcome
Title 50 % Responder Rate in Partial-Onset-Seizure (POS) Type I Frequency From Baseline of the Previous Study to the Evaluation Period for Subjects With Focal-onset Epilepsy Entering N01372 From a Study Where Baseline Seizure Data Was Collected
Hide Description The POS frequency is standardized to a 28-day duration. A responder is defined as a subject with a >=50% reduction in seizure frequency from the Baseline Period of the previous study. Results are presented as the percentage of subjects with 50 % responder rate in POS Type I frequency.
Time Frame From Baseline of the previous study to the Last Evaluation Period Visit or Early Discontinuation Visit (up to 49 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Efficacy Analysis Set (EAS), which consisted of subjects who took at least one dose of study drug and had at least one seizure daily record card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam Focal Epilepsy (EAS)
Hide Arm/Group Description:
This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Efficacy Analysis Set (EAS).
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of subjects
54.5
Time Frame Adverse events collection started at Day 0 and continued up to 30 days after last intake of study medication.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Hide Arm/Group Description This arm includes subjects with focal epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS). This arm includes subjects with generalized epilepsy, who received a flexible dose of Brivaracetam (BRV) tablets, administered twice a day, starting with an individual dose that they had reached at the completion of study N01395 (feeder study). The BRV dose could have been increased or decreased in increments of 50mg/day based on the individual subject's seizure control and/or tolerability, but was to not exceed 200mg/day. This arm is part of the Safety Set (SS).
All-Cause Mortality
Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/19 (26.32%)      2/7 (28.57%)    
Blood and lymphatic system disorders     
Leukocytosis * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Cardiac disorders     
Cardio-respiratory arrest * 1  0/19 (0.00%)  0 1/7 (14.29%)  1
Myocardial infarction * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
General disorders     
Chest pain * 1  1/19 (5.26%)  2 0/7 (0.00%)  0
Drowning * 1  0/19 (0.00%)  0 1/7 (14.29%)  1
Infections and infestations     
Pneumonia * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Sepsis * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Metabolism and nutrition disorders     
Hypomagnesaemia * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Nervous system disorders     
Convulsion * 1  2/19 (10.53%)  3 0/7 (0.00%)  0
Status epilepticus * 1  1/19 (5.26%)  1 1/7 (14.29%)  1
Psychiatric disorders     
Conversion disorder * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Dyspnoea * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Vascular disorders     
Hypertension * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
Hypertensive emergency * 1  1/19 (5.26%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam Focal Epilepsy (SS) Brivaracetam Generalized Epilepsy (SS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/19 (68.42%)      5/7 (71.43%)    
Gastrointestinal disorders     
Nausea * 1  2/19 (10.53%)  3 1/7 (14.29%)  1
Diarrhoea * 1  1/19 (5.26%)  1 1/7 (14.29%)  1
Vomiting * 1  1/19 (5.26%)  1 1/7 (14.29%)  1
General disorders     
Fatigue * 1  3/19 (15.79%)  3 0/7 (0.00%)  0
Oedema peripheral * 1  2/19 (10.53%)  3 0/7 (0.00%)  0
Infections and infestations     
Urinary tract infection * 1  2/19 (10.53%)  3 2/7 (28.57%)  3
Bronchitis * 1  2/19 (10.53%)  2 1/7 (14.29%)  1
Upper respiratory tract * 1  1/19 (5.26%)  1 2/7 (28.57%)  3
Nasopharyngitis * 1  2/19 (10.53%)  4 0/7 (0.00%)  0
Pharyngitis streptococcal * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
Sinusitis * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
Investigations     
Crystal urine present * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
Gamma-glutamyltransferase increased * 1  1/19 (5.26%)  1 1/7 (14.29%)  1
Neutrophil count increased * 1  2/19 (10.53%)  3 0/7 (0.00%)  0
Protein urine present * 1  2/19 (10.53%)  3 0/7 (0.00%)  0
Urinary casts * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
White blood cell count increased * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain * 1  3/19 (15.79%)  3 1/7 (14.29%)  2
Nervous system disorders     
Headache * 1  7/19 (36.84%)  68 1/7 (14.29%)  1
Convulsion * 1  3/19 (15.79%)  3 0/7 (0.00%)  0
Dizziness * 1  3/19 (15.79%)  29 0/7 (0.00%)  0
Psychiatric disorders     
Anxiety * 1  2/19 (10.53%)  3 0/7 (0.00%)  0
Depression * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
Reproductive system and breast disorders     
Dysmenorrhoea * 1  1/19 (5.26%)  20 1/7 (14.29%)  1
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  2/19 (10.53%)  2 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA15.0
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01728077    
Other Study ID Numbers: N01372
2012-000827-42 ( EudraCT Number )
First Submitted: October 26, 2012
First Posted: November 16, 2012
Results First Submitted: July 10, 2017
Results First Posted: August 2, 2017
Last Update Posted: July 11, 2018