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Trial record 1 of 1 for:    NCT00761774
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An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam

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ClinicalTrials.gov Identifier: NCT00761774
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 23, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

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 108
Recruitment Details The study started to enroll patients in November 2008 and concluded in March 2017.
Pre-assignment Details Participant Flow refers to the Safety Set, which consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam
Hide Arm/Group Description This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Period Title: Overall Study
Started 108
Completed 29
Not Completed 79
Reason Not Completed
Adverse Event             17
Lack of Efficacy             37
Lost to Follow-up             2
Withdrawal by Subject             9
Non-compliance             4
End of study             2
Reclassification of seizures             1
Medical decision to read SUSAR reports             1
Sponsor decision             1
Investigator clinical judgement             1
Patient moved out of study area             1
Coordinator leaving site             1
Subject IP non-compliance             1
IP stopped by hospital physician             1
Arm/Group Title Brivaracetam
Hide Arm/Group Description This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Baseline Participants 108
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 108 participants
<=18 years
0
   0.0%
Between 18 and 65 years
103
  95.4%
>=65 years
5
   4.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants
40.8  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Female
56
  51.9%
Male
52
  48.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants
Black or African American
7
   6.5%
White
97
  89.8%
Other/Mixed
4
   3.7%
1.Primary Outcome
Title Percentage of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Hide Description Treatment-emergent Adverse events (TEAE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
90.7
2.Primary Outcome
Title Percentage of Subjects Who Withdrew Due to Adverse Event (AE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Hide Description Adverse Events (AE) are any untoward medical occurrences in a subject during administered study treatment, whether or not these events are related to study treatment.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
15.7
3.Primary Outcome
Title Percentage of Subjects With a Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (up to 9 Years)
Hide Description An SAE was any untoward medical occurrence that, at any dose resulted in death, was life threatening, required in-subject hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set consisted of all subjects who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
24.1
4.Secondary Outcome
Title Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 3 Months of the Evaluation Period (up to 9 Years)
Hide Description BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam (ES)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
38.89
5.Secondary Outcome
Title Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 6 Months, of the Evaluation Period (up to 9 Years)
Hide Description BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam (ES)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
32.41
6.Secondary Outcome
Title Percentage of Subjects on Continuous Brivaracetam Monotherapy for at Least 12 Months of the Evaluation Period (up to 9 Years)
Hide Description BRV monotherapy is defined as continuous treatment with BRV only (ie, no treatment with another anti-epileptic drug (AED)). Use of rescue AED for a duration of no more than 2 consecutive days will not disqualify a subject from being defined as on continuous monotherapy provided the use of rescue AED does not exceed more than 1 time per week.
Time Frame During the Evaluation Period (up to 9 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The Efficacy Analysis Set consisted of all subjects who took at least 1 dose of study drug and had at least 1 seizure Daily Record Card (DRC) day during the Evaluation Period.
Arm/Group Title Brivaracetam (ES)
Hide Arm/Group Description:
This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
Overall Number of Participants Analyzed 108
Measure Type: Number
Unit of Measure: percentage of participants
25
Time Frame Adverse events were collected throughout the study (up to 9 years).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description This arm consisted of subjects who received Brivaracetam (BRV) at flexible dosing up to 200 mg/day.
All-Cause Mortality
Brivaracetam (SS)
Affected / at Risk (%)
Total   1/108 (0.93%)    
Hide Serious Adverse Events
Brivaracetam (SS)
Affected / at Risk (%) # Events
Total   26/108 (24.07%)    
Cardiac disorders   
Angina pectoris * 1  3/108 (2.78%)  3
Atrial fibrillation * 1  2/108 (1.85%)  2
Cardiac failure congestive * 1  1/108 (0.93%)  1
Gastrointestinal disorders   
Abdominal pain * 1  1/108 (0.93%)  1
Pancreatitis acute * 1  1/108 (0.93%)  1
Vomiting * 1  1/108 (0.93%)  1
General disorders   
Sudden unexplained death in epilepsy * 1  1/108 (0.93%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/108 (0.93%)  1
Cholecystitis acute * 1  1/108 (0.93%)  1
Cholelithiasis * 1  2/108 (1.85%)  2
Infections and infestations   
Pneumonia * 1  1/108 (0.93%)  1
Urinary tract infection * 1  1/108 (0.93%)  1
Injury, poisoning and procedural complications   
Contusion * 1  2/108 (1.85%)  3
Craniocerebral injury * 1  1/108 (0.93%)  1
Facial bones fracture * 1  1/108 (0.93%)  1
Intentional overdose * 1  1/108 (0.93%)  1
Joint injury * 1  1/108 (0.93%)  1
Laceration * 1  1/108 (0.93%)  1
Snake bite * 1  1/108 (0.93%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/108 (0.93%)  1
Pain in extremity * 1  1/108 (0.93%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  1/108 (0.93%)  1
Malignant melanoma * 1  1/108 (0.93%)  1
Nervous system disorders   
Convulsion * 1  5/108 (4.63%)  7
Dysarthria * 1  1/108 (0.93%)  1
Epilepsy * 1  1/108 (0.93%)  1
Grand mal convulsion * 1  2/108 (1.85%)  4
Hemiparesis * 1  1/108 (0.93%)  1
Migraine * 1  1/108 (0.93%)  1
Monoplegia * 1  1/108 (0.93%)  1
Postictal state * 1  1/108 (0.93%)  1
Psychiatric disorders   
Anxiety * 1  1/108 (0.93%)  1
Factitious disorder * 1  1/108 (0.93%)  1
Psychotic disorder * 1  1/108 (0.93%)  2
Somnambulism * 1  1/108 (0.93%)  2
Suicide attempt * 1  1/108 (0.93%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/108 (0.93%)  1
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  1/108 (0.93%)  1
Epistaxis * 1  1/108 (0.93%)  1
Social circumstances   
Pregnancy of partner * 1  1/108 (0.93%)  1
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brivaracetam (SS)
Affected / at Risk (%) # Events
Total   81/108 (75.00%)    
Gastrointestinal disorders   
Diarrhoea * 1  12/108 (11.11%)  16
Abdominal pain * 1  9/108 (8.33%)  12
Nausea * 1  9/108 (8.33%)  11
Toothache * 1  7/108 (6.48%)  10
Vomiting * 1  6/108 (5.56%)  9
General disorders   
Fatigue * 1  17/108 (15.74%)  19
Chest pain * 1  9/108 (8.33%)  10
Oedema peripheral * 1  6/108 (5.56%)  7
Infections and infestations   
Nasopharyngitis * 1  19/108 (17.59%)  42
Bronchitis * 1  8/108 (7.41%)  13
Upper respiratory tract infection * 1  8/108 (7.41%)  11
Viral infection * 1  6/108 (5.56%)  8
Injury, poisoning and procedural complications   
Fall * 1  15/108 (13.89%)  19
Contusion * 1  9/108 (8.33%)  11
Investigations   
Weight increased * 1  6/108 (5.56%)  6
Musculoskeletal and connective tissue disorders   
Back pain * 1  12/108 (11.11%)  12
Arthralgia * 1  10/108 (9.26%)  16
Nervous system disorders   
Convulsion * 1  17/108 (15.74%)  28
Headache * 1  15/108 (13.89%)  20
Dizziness * 1  14/108 (12.96%)  18
Migraine * 1  7/108 (6.48%)  11
Paraesthesia * 1  6/108 (5.56%)  6
Tremor * 1  6/108 (5.56%)  7
Psychiatric disorders   
Depression * 1  18/108 (16.67%)  21
Anxiety * 1  15/108 (13.89%)  24
Insomnia * 1  15/108 (13.89%)  16
Suicidal ideation * 1  6/108 (5.56%)  7
Skin and subcutaneous tissue disorders   
Rash * 1  13/108 (12.04%)  16
Vascular disorders   
Hypertension * 1  6/108 (5.56%)  8
1
Term from vocabulary, MedDRA15.0
*
Indicates events were collected by non-systematic assessment
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: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00761774    
Other Study ID Numbers: N01315
2008-001433-98 ( EudraCT Number )
First Submitted: September 26, 2008
First Posted: September 30, 2008
Results First Submitted: March 20, 2018
Results First Posted: April 23, 2018
Last Update Posted: July 11, 2018