Trial Outcomes & Findings for Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures (NCT NCT00530855)
NCT ID: NCT00530855
Last Updated: 2018-07-18
Results Overview
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
322 participants
Primary outcome timeframe
From Visit 1 to End of Study (approximately 2 years)
Results posted on
2018-07-18
Participant Flow
This Multicenter, Open-Label Study started to enroll Subjects in February 2008.
Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Participant milestones
| Measure |
Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Overall Study
STARTED
|
322
|
|
Overall Study
COMPLETED
|
210
|
|
Overall Study
NOT COMPLETED
|
112
|
Reasons for withdrawal
| Measure |
Lacosamide
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Overall Study
Lack of Efficacy
|
20
|
|
Overall Study
Withdrawal by Subject
|
30
|
|
Overall Study
Fatal Serious AE
|
3
|
|
Overall Study
Non Fatal Serious AE
|
7
|
|
Overall Study
Non Fatal Non Serious AE
|
12
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Unsatisfactory compliance of subject
|
11
|
|
Overall Study
Lost to Follow-up
|
9
|
|
Overall Study
Other reason for premature termination
|
17
|
Baseline Characteristics
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=322 Participants
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
301 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
mean (standard deviation)
|
40.7 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
258 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 to End of Study (approximately 2 years)Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Outcome measures
| Measure |
Lacosamide
n=322 Participants
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
|
292 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 to End of Study (approximately 2 years)Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Outcome measures
| Measure |
Lacosamide
n=322 Participants
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
|
479.1 days
Standard Deviation 271.9
|
SECONDARY outcome
Timeframe: From Visit 1 to End of Study (approximately 2 years)Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Outcome measures
| Measure |
Lacosamide
n=322 Participants
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
|
296 Participants
|
SECONDARY outcome
Timeframe: From Visit 1 to End of Study (approximately 2 years)Population: All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Outcome measures
| Measure |
Lacosamide
n=322 Participants
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
|
22 Participants
|
Adverse Events
Lacosamide
Serious events: 56 serious events
Other events: 238 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=322 participants at risk
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Cardiac disorders
Angina unstable
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Cardiac disorders
Bradycardia
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Cardiac disorders
Cardiac tamponade
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Eye disorders
Vision blurred
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Gastrointestinal disorders
Melaena
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
General disorders
Pyrexia
|
0.31%
1/322 • Number of events 2 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
General disorders
Sudden unexplained death in epilepsy
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
General disorders
Chest pain
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
General disorders
Pain
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Appendicitis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Bacteraemia
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Gastroenteritis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Pneumonia
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Sepsis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Cellulitis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Urinary tract infection
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.62%
2/322 • Number of events 2 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.31%
1/322 • Number of events 2 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.31%
1/322 • Number of events 3 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Investigations
Electroencephalogram
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Investigations
Heart rate decreased
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Convulsion
|
5.3%
17/322 • Number of events 19 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Status epilepticus
|
1.2%
4/322 • Number of events 6 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Syncope
|
0.93%
3/322 • Number of events 3 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Postictal state
|
0.62%
2/322 • Number of events 2 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Complicated migraine
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Dizziness
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Hydrocephalus
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Brain oedema
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Dyskinesia
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Grand mal convulsion
|
0.31%
1/322 • Number of events 2 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Migraine
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Acute psychosis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Confusional state
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Delirium
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Suicidal ideation
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Postictal psychosis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Vascular disorders
Hypotension
|
0.31%
1/322 • Number of events 1 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
Other adverse events
| Measure |
Lacosamide
n=322 participants at risk
Lacosamide tablets for dosing 100 -800 mg/day
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
46/322 • Number of events 68 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Gastrointestinal disorders
Vomiting
|
8.4%
27/322 • Number of events 37 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
23/322 • Number of events 27 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
20/322 • Number of events 30 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
General disorders
Fatigue
|
12.4%
40/322 • Number of events 44 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.0%
45/322 • Number of events 53 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
38/322 • Number of events 53 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Infections and infestations
Influenza
|
5.9%
19/322 • Number of events 23 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Fall
|
9.6%
31/322 • Number of events 44 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.8%
25/322 • Number of events 49 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.8%
22/322 • Number of events 32 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.6%
31/322 • Number of events 41 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
17/322 • Number of events 18 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Dizziness
|
27.6%
89/322 • Number of events 142 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Headache
|
17.1%
55/322 • Number of events 81 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Convulsion
|
9.0%
29/322 • Number of events 42 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Nervous system disorders
Tremor
|
8.1%
26/322 • Number of events 30 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Anxiety
|
7.5%
24/322 • Number of events 26 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Insomnia
|
6.2%
20/322 • Number of events 24 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Psychiatric disorders
Depression
|
5.3%
17/322 • Number of events 21 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
20/322 • Number of events 31 • Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Phone: +1 877 822 9493
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60