Trial Outcomes & Findings for To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures (NCT NCT00552305)
NCT ID: NCT00552305
Last Updated: 2018-07-17
Results Overview
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
370 participants
Primary outcome timeframe
During the Treatment Period (up to 8 years)
Results posted on
2018-07-17
Participant Flow
The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.
Participant milestones
| Measure |
Lacosamide
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Overall Study
STARTED
|
370
|
|
Overall Study
COMPLETED
|
120
|
|
Overall Study
NOT COMPLETED
|
250
|
Reasons for withdrawal
| Measure |
Lacosamide
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Overall Study
Adverse Event
|
43
|
|
Overall Study
Lack of Efficacy
|
120
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Withdrawal by Subject
|
44
|
|
Overall Study
Lack of efficacy/withdrew consent
|
1
|
|
Overall Study
Lack of efficacy (LoE)/adverse event
|
3
|
|
Overall Study
Adverse event (AE)/withdrew (WD) consent
|
2
|
|
Overall Study
Unsatisfactory compliance
|
11
|
|
Overall Study
Poor compliance/lost to follow-up
|
1
|
|
Overall Study
AE/Other: prohibited drug required
|
1
|
|
Overall Study
LoE/WD consent/Other: cannot make visits
|
1
|
|
Overall Study
Other: Site closed
|
4
|
|
Overall Study
Other: Personal problems
|
1
|
|
Overall Study
Other: Unable to attend visits
|
1
|
|
Overall Study
Other: Subject underwent surgery
|
4
|
|
Overall Study
Other: Subject became pregnant
|
1
|
|
Overall Study
Other: Health problems, not drug related
|
1
|
|
Overall Study
Other: Subject moved from area
|
2
|
|
Overall Study
Other: Subject incarcerated
|
1
|
|
Overall Study
Other: Subject went to rehab
|
1
|
Baseline Characteristics
To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=370 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
364 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
40.8 years
STANDARD_DEVIATION 11.01 • n=93 Participants
|
|
Sex: Female, Male
Female
|
192 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
178 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
248 participants
n=93 Participants
|
|
Region of Enrollment
Hungary
|
13 participants
n=93 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=93 Participants
|
|
Region of Enrollment
Lithuania
|
46 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
21 participants
n=93 Participants
|
|
Region of Enrollment
United Kingdom
|
12 participants
n=93 Participants
|
|
Region of Enrollment
Switzerland
|
2 participants
n=93 Participants
|
|
Region of Enrollment
Sweden
|
24 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 8 years)Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Lacosamide
n=370 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
|
343 subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 8 years)Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Lacosamide
n=370 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
|
47 subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (up to 8 years)Population: Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Outcome measures
| Measure |
Lacosamide
n=370 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
|
125 subjects
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment Period (up to 8 years)Population: Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency. Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Outcome measures
| Measure |
Lacosamide
n=369 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
|
-50.8 percentage change
Interval -100.0 to 408.9
|
SECONDARY outcome
Timeframe: Treatment Period (up to 8 years)Population: Of the 370 subjects who were enrolled/treated in the study, 369 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP615 study.
At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Outcome measures
| Measure |
Lacosamide
n=369 Participants
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
|
51.2 percentage of subjects
|
Adverse Events
Lacosamide
Serious events: 125 serious events
Other events: 307 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=370 participants at risk
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Investigations
HEART RATE INCREASED
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
URINARY CASTS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.54%
2/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Metabolism and nutrition disorders
HYPERCALCAEMIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.81%
3/370 • Number of events 4 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.54%
2/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.54%
2/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
SPINAL COLUMN STENOSIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA MULTIFORME
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON NEOPLASM
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
CONVULSION
|
6.2%
23/370 • Number of events 26 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
1.9%
7/370 • Number of events 7 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.1%
4/370 • Number of events 5 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
HEADACHE
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
HEMIPARESIS
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
DIZZINESS
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
GRAND MAL CONVULSION
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
EPILEPSY
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK FIRST DEGREE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
BRADYCARDIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
CARDIAC FIBRILLATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Ear and labyrinth disorders
VERTIGO
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Eye disorders
VISION BLURRED
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
VOMITING
|
0.54%
2/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
COLITIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
NAUSEA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
ILEUS
|
0.27%
1/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
ENTEROCELE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
General disorders
CHEST PAIN
|
1.4%
5/370 • Number of events 6 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
1.1%
4/370 • Number of events 4 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
General disorders
OEDEMA PERIPHERAL
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
General disorders
IRRITABILITY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
PNEUMONIA
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
BRONCHITIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
APPENDICITIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
DRUG TOXICITY
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
INJURY
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
CEREBRAL HAEMORRHAGE TRAUMATIC
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
FALL
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
TREATMENT NONCOMPLIANCE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
PNEUMOTHORAX TRAUMATIC
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.27%
1/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
MEDICAL DEVICE COMPLICATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT TOXICITY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
ELECTROENCEPHALOGRAM
|
1.1%
4/370 • Number of events 4 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
BIOPSY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
INVESTIGATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
ELECTROCARDIOGRAM CHANGE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
PARTIAL SEIZURES WITH SECONDARY GENERALISATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
MYASTHENIA GRAVIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
MYASTHENIA GRAVIS CRISIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
SYNCOPE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
COGNITIVE DISORDER
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
BALANCE DISORDER
|
0.27%
1/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
PSYCHOMOTOR HYPERACTIVITY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
OPTIC NEURITIS RETROBULBAR
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
COMPLEX PARTIAL SEIZURES
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
1.1%
4/370 • Number of events 4 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
DEPRESSION
|
0.81%
3/370 • Number of events 3 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
AGGRESSION
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
EPILEPTIC PSYCHOSIS
|
0.27%
1/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
HALLUCINATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
PARANOIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
ACUTE PSYCHOSIS
|
0.27%
1/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
NIGHTMARE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Renal and urinary disorders
HAEMATURIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Renal and urinary disorders
PROTEINURIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
ASPHYXIA
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.27%
1/370 • Number of events 8 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
THERAPY REGIMEN CHANGED
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
BRAIN OPERATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
HYSTERECTOMY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
SURGERY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
BRAIN LOBECTOMY
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
STENT PLACEMENT
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
VAGAL NERVE STIMULATOR REMOVAL
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Surgical and medical procedures
NASAL SEPTAL OPERATION
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.54%
2/370 • Number of events 2 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.27%
1/370 • Number of events 1 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
Other adverse events
| Measure |
Lacosamide
n=370 participants at risk
50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
|
|---|---|
|
Eye disorders
DIPLOPIA
|
17.0%
63/370 • Number of events 92 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Eye disorders
VISION BLURRED
|
12.7%
47/370 • Number of events 60 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
NAUSEA
|
17.3%
64/370 • Number of events 89 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
VOMITING
|
13.2%
49/370 • Number of events 71 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
DIARRHOEA
|
7.8%
29/370 • Number of events 40 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.4%
20/370 • Number of events 21 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
General disorders
FATIGUE
|
16.5%
61/370 • Number of events 77 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
16.5%
61/370 • Number of events 108 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
NASOPHARYNGITIS
|
16.2%
60/370 • Number of events 111 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
SINUSITIS
|
11.6%
43/370 • Number of events 62 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
INFLUENZA
|
8.6%
32/370 • Number of events 42 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
URINARY TRACT INFECTION
|
8.4%
31/370 • Number of events 48 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Infections and infestations
BRONCHITIS
|
7.6%
28/370 • Number of events 34 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
CONTUSION
|
15.4%
57/370 • Number of events 129 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
13.5%
50/370 • Number of events 117 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
7.3%
27/370 • Number of events 50 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
5.1%
19/370 • Number of events 23 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Investigations
WEIGHT INCREASED
|
5.7%
21/370 • Number of events 22 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.6%
43/370 • Number of events 63 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
8.9%
33/370 • Number of events 49 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
8.4%
31/370 • Number of events 42 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
5.7%
21/370 • Number of events 30 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.4%
20/370 • Number of events 24 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
DIZZINESS
|
39.7%
147/370 • Number of events 254 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
HEADACHE
|
20.8%
77/370 • Number of events 145 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
COORDINATION ABNORMAL
|
14.3%
53/370 • Number of events 69 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
SOMNOLENCE
|
11.1%
41/370 • Number of events 50 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
TREMOR
|
10.5%
39/370 • Number of events 55 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
7.3%
27/370 • Number of events 29 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
CONVULSION
|
7.3%
27/370 • Number of events 32 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
BALANCE DISORDER
|
7.0%
26/370 • Number of events 34 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
NYSTAGMUS
|
6.5%
24/370 • Number of events 28 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.4%
20/370 • Number of events 26 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
INSOMNIA
|
8.9%
33/370 • Number of events 35 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
DEPRESSION
|
8.9%
33/370 • Number of events 36 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Psychiatric disorders
ANXIETY
|
5.1%
19/370 • Number of events 20 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
7.8%
29/370 • Number of events 33 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
7.0%
26/370 • Number of events 34 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Skin and subcutaneous tissue disorders
RASH
|
7.6%
28/370 • Number of events 33 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
|
Vascular disorders
HYPERTENSION
|
5.1%
19/370 • Number of events 19 • The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
|
Additional Information
UCB (Study Director)
UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee UCB has \> 60 but \<= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
- Publication restrictions are in place
Restriction type: OTHER