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Trial record 2 of 3 for:    NCT00504881

Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00175916
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : July 16, 2020
Last Update Posted : December 16, 2020
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 (ucb 34714)
Enrollment 853
Recruitment Details The study started to enroll patients in September 2005 and concluded in May 2019.
Pre-assignment Details Participants Flow refers to the Safety Set (SS).
Arm/Group Title Brivaracetam
Hide Arm/Group Description Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
Period Title: Overall Study
Started 853
Completed 234
Not Completed 619
Reason Not Completed
Death             19
Adverse Event             81
Lack of Efficacy             354
Lost to Follow-up             17
Subject Choice             98
Lack of compliance             8
Patient cannot record seizures             1
Sponsor decision             17
Vigabatrin intake             1
Suicidal behaviour             1
Withdrawal by Subject             1
Seizure - free             4
Administrative reason             1
Pregnancy             1
Patient's request             2
Treating physiciant's choice             1
Moved overseas             1
Loss of job and economic burden             1
Site was closed             9
Patient went to prison             1
Arm/Group Title Brivaracetam
Hide Arm/Group Description Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period.
Overall Number of Baseline Participants 853
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set which consisted of all participants who took at least 1 dose of study medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 853 participants
<=18 years
14
   1.6%
Between 18 and 65 years
827
  97.0%
>=65 years
12
   1.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 853 participants
37.5  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 853 participants
Female
418
  49.0%
Male
435
  51.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 853 participants
White
721
  84.5%
Black
2
   0.2%
Asian
123
  14.4%
Other
7
   0.8%
1.Primary Outcome
Title Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Hide Description Treatment-emergent adverse events (TEAEs) were defined as those events which started on or after the date of first dose of investigational medicinal product (IMP), or events in which severity worsened on or after the date of first dose of study medication. The event does not necessarily have a causal relationship with that treatment or usage.
Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 853
Measure Type: Number
Unit of Measure: Percentage of participants
84.4
2.Primary Outcome
Title Percentage of Participants Who Withdrew Due to an Adverse Event (AE)
Hide Description An AE is any untoward medical occurrence in a participant or trial participant that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 853
Measure Type: Number
Unit of Measure: Percentage of participants
11.6
3.Primary Outcome
Title Percentage of Participants With at Least One Serious Adverse Event (SAE)
Hide Description

A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is an infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.
Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) consisted of all participants who took at least 1 dose of study drug.
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 853
Measure Type: Number
Unit of Measure: Percentage of participants
29.4
4.Secondary Outcome
Title Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days During the Evaluation Period
Hide Description

The 28 day adjusted seizure frequency was calculated by dividing the number of partial seizures by the number of days for which the diary was completed, and multiplying the resulting value by 28.

Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS Efficacy)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).
Overall Number of Participants Analyzed 729
Median (Inter-Quartile Range)
Unit of Measure: Seizures per 28 days
Baseline
8.4
(5.0 to 16.1)
On Treatment
4.9
(2.1 to 10.8)
5.Secondary Outcome
Title Percent Change in Partial Onset Seizure (POS) (Type I) Frequency Per 28 Days From Baseline of the Previous Study to the Evaluation Period
Hide Description

The percent change from the previous study baselines, in Partial Onset Seizure (POS) (Type I) frequency per 28 days is defined as:

(the value at the previous study baselines) minus (the value at each time-points during the evaluation period) divided by the value at the previous study baselines.

Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS Efficacy)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).
Overall Number of Participants Analyzed 729
Median (Inter-Quartile Range)
Unit of Measure: Percent change
43.1
(9.9 to 71.5)
6.Secondary Outcome
Title Responder Rate in POS (Type I) Frequency Over the Evaluation Period
Hide Description

A responder is defined as a participant with a ≥ 50% reduction in seizure frequency from the Baseline Period of the previous study.

Baseline values for seizure frequency were calculated based on the seizure diary data collected during the baseline period of the previous double-blind studies: N01114 [NCT00175929], N01252 [NCT00490035] and N01254 [NCT00504881].

Time Frame From Entry Visit until Last Visit (up to 162 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The Partial Onset Seizure (POS) Efficacy Analysis Set consisted of all participants with POS who took at least 1 dose of study drug and had at least 1 seizure diary day during the Evaluation Period.
Arm/Group Title Brivaracetam (POS Efficacy)
Hide Arm/Group Description:
Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Partial Onset Seizure Efficacy Set (POS Efficacy).
Overall Number of Participants Analyzed 729
Measure Type: Number
Unit of Measure: Percentage of participants
43.6
Time Frame From Entry Visit until Last Visit (up to 162 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brivaracetam (SS)
Hide Arm/Group Description Brivaracetam (BRV) was administered with a maximum of 200 mg/day, twice, daily, incremented by 50 mg/day on a weekly basis, during the Up-Titration. During the Down- Titration Period, the BRV dose was decreased in steps of a maximum of 50 mg/day on a weekly basis. A last down-titration step at 20 mg/day for 1 week was included prior to the Post-Treatment Period. Participants formed the Safety Set (SS).
All-Cause Mortality
Brivaracetam (SS)
Affected / at Risk (%)
Total   19/853 (2.23%)    
Hide Serious Adverse Events
Brivaracetam (SS)
Affected / at Risk (%) # Events
Total   248/853 (29.07%)    
Blood and lymphatic system disorders   
Anaemia macrocytic * 1  1/853 (0.12%)  1
Cardiac disorders   
Supraventricular tachycardia * 1  2/853 (0.23%)  2
Acute coronary syndrome * 1  1/853 (0.12%)  1
Angina pectoris * 1  1/853 (0.12%)  1
Atrial flutter * 1  1/853 (0.12%)  1
Cardiac disorder * 1  1/853 (0.12%)  1
Cardiac failure * 1  1/853 (0.12%)  1
Coronary artery disease * 1  1/853 (0.12%)  1
Myocardial infarction * 1  1/853 (0.12%)  1
Sinus tachycardia * 1  1/853 (0.12%)  1
Congenital, familial and genetic disorders   
Baltic myoclonic epilepsy * 1  2/853 (0.23%)  5
Ear and labyrinth disorders   
Vertigo * 1  4/853 (0.47%)  6
Hypoacusis * 1  2/853 (0.23%)  2
Tinnitus * 1  1/853 (0.12%)  1
Vertigo positional * 1  1/853 (0.12%)  1
Endocrine disorders   
Hypothyroidism * 1  1/853 (0.12%)  1
Thyroiditis * 1  1/853 (0.12%)  1
Eye disorders   
Cataract * 1  2/853 (0.23%)  2
Corneal erosion * 1  1/853 (0.12%)  1
Opsoclonus myoclonus * 1  1/853 (0.12%)  1
Vision blurred * 1  1/853 (0.12%)  1
Visual impairment * 1  1/853 (0.12%)  1
Gastrointestinal disorders   
Abdominal pain * 1  5/853 (0.59%)  5
Vomiting * 1  3/853 (0.35%)  3
Constipation * 1  2/853 (0.23%)  2
Diarrhoea * 1  2/853 (0.23%)  4
Dysphagia * 1  2/853 (0.23%)  4
Gastric ulcer * 1  2/853 (0.23%)  2
Gastritis * 1  2/853 (0.23%)  2
Gastrointestinal haemorrhage * 1  2/853 (0.23%)  2
Nausea * 1  2/853 (0.23%)  2
Abdominal hernia * 1  1/853 (0.12%)  1
Abdominal pain upper * 1  1/853 (0.12%)  1
Anal fissure * 1  1/853 (0.12%)  1
Colitis * 1  1/853 (0.12%)  1
Colitis ulcerative * 1  1/853 (0.12%)  1
Duodenitis * 1  1/853 (0.12%)  1
Enteritis * 1  1/853 (0.12%)  1
Gastric polyps * 1  1/853 (0.12%)  1
Ileus * 1  1/853 (0.12%)  1
Inguinal hernia * 1  1/853 (0.12%)  3
Intestinal obstruction * 1  1/853 (0.12%)  4
Pancreatitis * 1  1/853 (0.12%)  1
Proctocolitis * 1  1/853 (0.12%)  1
General disorders   
Pyrexia * 1  5/853 (0.59%)  5
Death * 1  4/853 (0.47%)  4
Fatigue * 1  2/853 (0.23%)  2
Unevaluable event * 1  2/853 (0.23%)  4
Chest pain * 1  1/853 (0.12%)  1
Device failure * 1  1/853 (0.12%)  1
Drowning * 1  1/853 (0.12%)  1
Gait disturbance * 1  1/853 (0.12%)  1
Haemorrhagic cyst * 1  1/853 (0.12%)  1
Implant site haematoma * 1  1/853 (0.12%)  1
Irritability * 1  1/853 (0.12%)  1
Sudden death * 1  1/853 (0.12%)  1
Hepatobiliary disorders   
Cholelithiasis * 1  3/853 (0.35%)  3
Biliary colic * 1  2/853 (0.23%)  2
Cholecystitis * 1  1/853 (0.12%)  1
Cholecystitis acute * 1  1/853 (0.12%)  1
Immune system disorders   
Anaphylactic reaction * 1  1/853 (0.12%)  1
Immunodeficiency * 1  1/853 (0.12%)  1
Infections and infestations   
Pneumonia * 1  9/853 (1.06%)  14
Sepsis * 1  6/853 (0.70%)  6
Upper respiratory tract infection * 1  4/853 (0.47%)  4
Urinary tract infection * 1  4/853 (0.47%)  4
Appendicitis * 1  2/853 (0.23%)  2
Postoperative wound infection * 1  2/853 (0.23%)  2
Pyelonephritis * 1  2/853 (0.23%)  2
Septic shock * 1  2/853 (0.23%)  2
Skin infection * 1  2/853 (0.23%)  2
Bronchitis * 1  1/853 (0.12%)  1
Bronchopneumonia * 1  1/853 (0.12%)  2
Device related infection * 1  1/853 (0.12%)  1
Ear infection * 1  1/853 (0.12%)  1
Gastroenteritis viral * 1  1/853 (0.12%)  1
Herpes zoster * 1  1/853 (0.12%)  1
Incision site infection * 1  1/853 (0.12%)  1
Infected bites * 1  1/853 (0.12%)  1
Localised infection * 1  1/853 (0.12%)  1
Lung infection * 1  1/853 (0.12%)  1
Pneumonia mycoplasmal * 1  1/853 (0.12%)  1
Pulmonary tuberculosis * 1  1/853 (0.12%)  1
Respiratory tract infection * 1  1/853 (0.12%)  1
Tooth infection * 1  1/853 (0.12%)  1
Tuberculosis * 1  1/853 (0.12%)  1
Urosepsis * 1  1/853 (0.12%)  1
Vestibular neuronitis * 1  1/853 (0.12%)  1
Viral infection * 1  1/853 (0.12%)  1
Injury, poisoning and procedural complications   
Head injury * 1  10/853 (1.17%)  11
Clavicle fracture * 1  5/853 (0.59%)  5
Contusion * 1  5/853 (0.59%)  5
Ankle fracture * 1  4/853 (0.47%)  4
Fall * 1  4/853 (0.47%)  8
Femur fracture * 1  4/853 (0.47%)  4
Laceration * 1  4/853 (0.47%)  4
Concussion * 1  3/853 (0.35%)  3
Extradural haematoma * 1  3/853 (0.35%)  3
Facial bones fracture * 1  3/853 (0.35%)  3
Hand fracture * 1  3/853 (0.35%)  3
Spinal fracture * 1  3/853 (0.35%)  3
Toxicity to various agents * 1  3/853 (0.35%)  3
Hip fracture * 1  2/853 (0.23%)  2
Jaw fracture * 1  2/853 (0.23%)  2
Ligament rupture * 1  2/853 (0.23%)  2
Lower limb fracture * 1  2/853 (0.23%)  2
Meniscus lesion * 1  2/853 (0.23%)  2
Poisoning * 1  2/853 (0.23%)  2
Skull fracture * 1  2/853 (0.23%)  2
Skull fractured base * 1  2/853 (0.23%)  2
Thermal burn * 1  2/853 (0.23%)  2
Tibia fracture * 1  2/853 (0.23%)  2
Upper limb fracture * 1  2/853 (0.23%)  2
Accident * 1  1/853 (0.12%)  1
Accidental exposure * 1  1/853 (0.12%)  1
Accidental overdose * 1  1/853 (0.12%)  1
Bursa injury * 1  1/853 (0.12%)  1
Cartilage injury * 1  1/853 (0.12%)  1
Chest injury * 1  1/853 (0.12%)  1
Craniocerebral injury * 1  1/853 (0.12%)  1
Face injury * 1  1/853 (0.12%)  1
Femoral neck fracture * 1  1/853 (0.12%)  1
Fibula fracture * 1  1/853 (0.12%)  1
Forearm fracture * 1  1/853 (0.12%)  1
Fracture * 1  1/853 (0.12%)  1
Incorrect dose administered * 1  1/853 (0.12%)  1
Joint dislocation * 1  1/853 (0.12%)  1
Lumbar vertebral fracture * 1  1/853 (0.12%)  1
Muscle rupture * 1  1/853 (0.12%)  1
Near drowning * 1  1/853 (0.12%)  1
Open wound * 1  1/853 (0.12%)  1
Overdose * 1  1/853 (0.12%)  1
Postoperative hernia * 1  1/853 (0.12%)  1
Radius fracture * 1  1/853 (0.12%)  1
Rib fracture * 1  1/853 (0.12%)  1
Road traffic accident * 1  1/853 (0.12%)  1
Spinal column injury * 1  1/853 (0.12%)  1
Traumatic haematoma * 1  1/853 (0.12%)  1
Wound * 1  1/853 (0.12%)  1
Wrist fracture * 1  1/853 (0.12%)  1
Investigations   
Investigation * 1  1/853 (0.12%)  1
Thyroid function test abnormal * 1  1/853 (0.12%)  1
Metabolism and nutrition disorders   
Hyponatraemia * 1  6/853 (0.70%)  6
Dehydration * 1  1/853 (0.12%)  1
Diabetes mellitus * 1  1/853 (0.12%)  1
Histamine intolerance * 1  1/853 (0.12%)  1
Hyperkalaemia * 1  1/853 (0.12%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion * 1  7/853 (0.82%)  7
Back pain * 1  4/853 (0.47%)  5
Arthralgia * 1  2/853 (0.23%)  2
Intervertebral disc disorder * 1  2/853 (0.23%)  2
Bursitis * 1  1/853 (0.12%)  1
Femoroacetabular impingement * 1  1/853 (0.12%)  1
Groin pain * 1  1/853 (0.12%)  1
Haemarthrosis * 1  1/853 (0.12%)  1
Lumbar spinal stenosis * 1  1/853 (0.12%)  2
Musculoskeletal pain * 1  1/853 (0.12%)  1
Pain in extremity * 1  1/853 (0.12%)  1
Rhabdomyolysis * 1  1/853 (0.12%)  1
Spinal osteoarthritis * 1  1/853 (0.12%)  1
Systemic lupus erythematosus * 1  1/853 (0.12%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate cancer * 1  4/853 (0.47%)  4
Astrocytoma * 1  1/853 (0.12%)  1
Basal cell carcinoma * 1  1/853 (0.12%)  1
Breast cancer * 1  1/853 (0.12%)  1
Breast cancer metastatic * 1  1/853 (0.12%)  2
Chronic lymphocytic leukaemia * 1  1/853 (0.12%)  1
Colon cancer * 1  1/853 (0.12%)  1
Ependymoma * 1  1/853 (0.12%)  1
Fibroma * 1  1/853 (0.12%)  1
Lung neoplasm malignant * 1  1/853 (0.12%)  1
Mesothelioma * 1  1/853 (0.12%)  1
Mixed oligo-astrocytoma * 1  1/853 (0.12%)  1
Neoplasm prostate * 1  1/853 (0.12%)  1
Ovarian neoplasm * 1  1/853 (0.12%)  1
Prostate cancer recurrent * 1  1/853 (0.12%)  1
Testicular neoplasm * 1  1/853 (0.12%)  2
Uterine leiomyoma * 1  1/853 (0.12%)  1
Nervous system disorders   
Convulsion * 1  36/853 (4.22%)  54
Epilepsy * 1  11/853 (1.29%)  13
Status epilepticus * 1  10/853 (1.17%)  12
Grand mal convulsion * 1  8/853 (0.94%)  12
Myoclonus * 1  9/853 (1.06%)  20
Myoclonic epilepsy * 1  4/853 (0.47%)  11
Seizure cluster * 1  4/853 (0.47%)  4
Somnolence * 1  3/853 (0.35%)  3
Cerebrovascular accident * 1  2/853 (0.23%)  2
Complex partial seizures * 1  2/853 (0.23%)  2
Headache * 1  2/853 (0.23%)  2
Hypoaesthesia * 1  2/853 (0.23%)  2
Partial seizures with secondary generalisation * 1  2/853 (0.23%)  2
Altered state of consciousness * 1  1/853 (0.12%)  1
Ataxia * 1  1/853 (0.12%)  2
Aura * 1  1/853 (0.12%)  1
Balance disorder * 1  1/853 (0.12%)  1
Brachial plexopathy * 1  1/853 (0.12%)  1
Cerebral haematoma * 1  1/853 (0.12%)  2
Cerebral infarction * 1  1/853 (0.12%)  1
Coordination abnormal * 1  1/853 (0.12%)  1
Dizziness * 1  1/853 (0.12%)  1
Dysarthria * 1  1/853 (0.12%)  1
Encephalitis * 1  1/853 (0.12%)  1
Hemiplegia * 1  1/853 (0.12%)  1
Hydrocephalus * 1  1/853 (0.12%)  1
Migraine * 1  1/853 (0.12%)  1
Partial seizures * 1  1/853 (0.12%)  1
Presyncope * 1  1/853 (0.12%)  1
Psychomotor hyperactivity * 1  1/853 (0.12%)  1
Radiculitis lumbosacral * 1  1/853 (0.12%)  1
Status migrainosus * 1  1/853 (0.12%)  2
Subarachnoid haemorrhage * 1  1/853 (0.12%)  1
Toxic encephalopathy * 1  1/853 (0.12%)  1
Tremor * 1  1/853 (0.12%)  1
Pregnancy, puerperium and perinatal conditions   
Pregnancy * 1  4/853 (0.47%)  4
Abortion * 1  1/853 (0.12%)  1
Abortion complete * 1  1/853 (0.12%)  1
Foetal growth restriction * 1  1/853 (0.12%)  1
Pregnancy on contraceptive * 1  1/853 (0.12%)  1
Pregnancy on oral contraceptive * 1  1/853 (0.12%)  1
Psychiatric disorders   
Suicidal ideation * 1  7/853 (0.82%)  7
Depression * 1  6/853 (0.70%)  7
Psychotic disorder * 1  3/853 (0.35%)  4
Aggression * 1  3/853 (0.35%)  3
Suicide attempt * 1  3/853 (0.35%)  3
Abnormal behaviour * 1  2/853 (0.23%)  2
Acute psychosis * 1  2/853 (0.23%)  2
Anxiety * 1  2/853 (0.23%)  2
Confusional state * 1  2/853 (0.23%)  2
Depressed mood * 1  2/853 (0.23%)  2
Dysthymic disorder * 1  2/853 (0.23%)  2
Suicidal behaviour * 1  2/853 (0.23%)  2
Agitation * 1  1/853 (0.12%)  1
Conversion disorder * 1  1/853 (0.12%)  2
Decreased interest * 1  1/853 (0.12%)  1
Delirium tremens * 1  1/853 (0.12%)  1
Dissociative disorder * 1  1/853 (0.12%)  1
Insomnia * 1  1/853 (0.12%)  1
Mental disorder * 1  1/853 (0.12%)  4
Panic attack * 1  1/853 (0.12%)  1
Panic disorder * 1  1/853 (0.12%)  1
Polydipsia psychogenic * 1  1/853 (0.12%)  1
Restlessness * 1  1/853 (0.12%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  3/853 (0.35%)  6
Bladder pain * 1  1/853 (0.12%)  1
Calculus bladder * 1  1/853 (0.12%)  1
Calculus ureteric * 1  1/853 (0.12%)  1
Calculus urinary * 1  1/853 (0.12%)  1
Dysuria * 1  1/853 (0.12%)  1
Renal failure acute * 1  1/853 (0.12%)  1
Urinary tract disorder * 1  1/853 (0.12%)  1
Reproductive system and breast disorders   
Ovarian cyst * 1  4/853 (0.47%)  4
Epididymitis * 1  1/853 (0.12%)  1
Menometrorrhagia * 1  1/853 (0.12%)  1
Menorrhagia * 1  1/853 (0.12%)  1
Menstrual disorder * 1  1/853 (0.12%)  1
Pelvic fluid collection * 1  1/853 (0.12%)  1
Postmenopausal haemorrhage * 1  1/853 (0.12%)  1
Uterine polyp * 1  1/853 (0.12%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  2/853 (0.23%)  3
Acute respiratory failure * 1  1/853 (0.12%)  1
Dyspnoea * 1  1/853 (0.12%)  1
Interstitial lung disease * 1  1/853 (0.12%)  1
Lung disorder * 1  1/853 (0.12%)  1
Pneumonia aspiration * 1  1/853 (0.12%)  1
Pulmonary embolism * 1  1/853 (0.12%)  1
Vocal cord polyp * 1  1/853 (0.12%)  1
Skin and subcutaneous tissue disorders   
Angioedema * 1  1/853 (0.12%)  1
Dermatomyositis * 1  1/853 (0.12%)  1
Hidradenitis * 1  1/853 (0.12%)  1
Rash * 1  1/853 (0.12%)  1
Swelling face * 1  1/853 (0.12%)  1
Surgical and medical procedures   
Artificial urinary sphincter implant * 1  1/853 (0.12%)  1
Cataract operation * 1  1/853 (0.12%)  1
Cholecystectomy * 1  1/853 (0.12%)  1
Gallbladder operation * 1  1/853 (0.12%)  1
Hernia repair * 1  1/853 (0.12%)  1
Radiotherapy * 1  1/853 (0.12%)  1
Shoulder operation * 1  1/853 (0.12%)  1
Tonsillectomy * 1  1/853 (0.12%)  1
Tracheostomy * 1  1/853 (0.12%)  1
Urethral repair * 1  1/853 (0.12%)  1
Vascular disorders   
Circulatory collapse * 1  1/853 (0.12%)  1
Haematoma * 1  1/853 (0.12%)  1
Hypertension * 1  1/853 (0.12%)  1
Hypertensive crisis * 1  1/853 (0.12%)  1
Venous thrombosis * 1  1/853 (0.12%)  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   569/853 (66.71%)    
Ear and labyrinth disorders   
Vertigo * 1  58/853 (6.80%)  114
Gastrointestinal disorders   
Diarrhoea * 1  78/853 (9.14%)  112
Nausea * 1  55/853 (6.45%)  78
Vomiting * 1  53/853 (6.21%)  89
General disorders   
Fatigue * 1  84/853 (9.85%)  106
Infections and infestations   
Nasopharyngitis * 1  157/853 (18.41%)  332
Urinary tract infection * 1  75/853 (8.79%)  125
Influenza * 1  66/853 (7.74%)  104
Upper respiratory tract infection * 1  50/853 (5.86%)  127
Bronchitis * 1  47/853 (5.51%)  68
Injury, poisoning and procedural complications   
Fall * 1  47/853 (5.51%)  62
Contusion * 1  45/853 (5.28%)  68
Musculoskeletal and connective tissue disorders   
Back pain * 1  77/853 (9.03%)  99
Arthralgia * 1  52/853 (6.10%)  73
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Somnolence * 1  73/853 (8.56%)  104
Nervous system disorders   
Headache * 1  186/853 (21.81%)  419
Dizziness * 1  123/853 (14.42%)  191
Convulsion * 1  112/853 (13.13%)  158
Psychiatric disorders   
Insomnia * 1  71/853 (8.32%)  95
Depression * 1  65/853 (7.62%)  80
Vascular disorders   
Hypertension * 1  43/853 (5.04%)  53
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: NCT00175916    
Other Study ID Numbers: N01125
2004-002140-10 ( EudraCT Number )
First Submitted: September 9, 2005
First Posted: September 15, 2005
Results First Submitted: May 27, 2020
Results First Posted: July 16, 2020
Last Update Posted: December 16, 2020