Trial Outcomes & Findings for Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older (NCT NCT01465997)
NCT ID: NCT01465997
Last Updated: 2018-07-18
Results Overview
Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
551 participants
Primary outcome timeframe
Up to 3.5 Years (Duration of the Treatment Phase)
Results posted on
2018-07-18
Participant Flow
Enrollment started in May 2012 and concluded in January 2017 - 551 patients. Due to the political and civil unrest in Luhansk PAREXEL was not able to conduct further site visits to one site in Ukraine and to collect further data for 2 subjects,they were excluded from SP0994, leaving 549 patients in the Enrolled Set out of 551 initially enrolled.
A total of 549 subjects gave informed consent in SP0994 and were included in the Enrolled Set, 548 subjects received at least 1 dose of study medication and were included in the Safety Set (SS). Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 dose of study medication in the current study.
Participant milestones
| Measure |
Lacosamide
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Overall Study
STARTED
|
279
|
269
|
|
Overall Study
COMPLETED
|
211
|
180
|
|
Overall Study
NOT COMPLETED
|
68
|
89
|
Reasons for withdrawal
| Measure |
Lacosamide
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Overall Study
Adverse Event
|
12
|
22
|
|
Overall Study
Lack of Efficacy
|
13
|
1
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
|
Overall Study
Withdrawal by Subject
|
32
|
35
|
|
Overall Study
investigator's decision
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
sponsor's decision
|
1
|
1
|
|
Overall Study
subject withdrew consent
|
1
|
0
|
|
Overall Study
local lab unblinded site
|
1
|
0
|
|
Overall Study
withdrew before follow-up
|
0
|
13
|
|
Overall Study
decision by site staff
|
0
|
1
|
|
Overall Study
subject left participation SP0993
|
0
|
1
|
Baseline Characteristics
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Baseline characteristics by cohort
| Measure |
Lacosamide
n=279 Participants
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR)
n=269 Participants
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
Total Title
n=548 Participants
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
230 Participants
n=5 Participants
|
225 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
41 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Age, Continuous
|
43.2 years
STANDARD_DEVIATION 17.2 • n=5 Participants
|
42.7 years
STANDARD_DEVIATION 16.7 • n=7 Participants
|
42.9 years
STANDARD_DEVIATION 17.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
298 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3.5 Years (Duration of the Treatment Phase)Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Outcome measures
| Measure |
Lacosamide (SS)
n=279 Participants
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR) (SS)
n=269 Participants
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
|
181 Participants
|
182 Participants
|
PRIMARY outcome
Timeframe: Up to 3.5 Years (Duration of the Treatment Phase)Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Outcome measures
| Measure |
Lacosamide (SS)
n=279 Participants
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR) (SS)
n=269 Participants
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
|
12 Participants
|
21 Participants
|
PRIMARY outcome
Timeframe: Up to 3.5 Years (Duration of the Treatment Phase)A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Lacosamide (SS)
n=279 Participants
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR) (SS)
n=269 Participants
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
|
32 Participants
|
22 Participants
|
Adverse Events
Lacosamide (SS)
Serious events: 32 serious events
Other events: 45 other events
Deaths: 0 deaths
Carbamazepine-Controlled Release (CBZ-CR) (SS)
Serious events: 22 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide (SS)
n=279 participants at risk
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR) (SS)
n=269 participants at risk
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Angina pectoris
|
0.72%
2/279 • Number of events 2 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Cardiac failure
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Ear and labyrinth disorders
Vestibular ataxia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Eye disorders
Exophthalmos
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Infections and infestations
Appendicitis
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/279 • During the entire study period, up to 5 years
|
1.1%
3/269 • Number of events 4 • During the entire study period, up to 5 years
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.36%
1/279 • Number of events 2 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Investigations
Hepatic enzyme increased
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.36%
1/279 • Number of events 2 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.36%
1/279 • Number of events 2 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.72%
2/279 • Number of events 2 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Cognitive disorder
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Grand mal convulsion
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Status epilepticus
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Syncope
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
White matter lesion
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Convulsion
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.74%
2/269 • Number of events 2 • During the entire study period, up to 5 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.74%
2/269 • Number of events 2 • During the entire study period, up to 5 years
|
|
Psychiatric disorders
Adjustment disorder with depressed mood
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Psychiatric disorders
Suicidal behaviour
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.74%
2/269 • Number of events 2 • During the entire study period, up to 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Reproductive system and breast disorders
Epididymitis
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/279 • During the entire study period, up to 5 years
|
0.37%
1/269 • Number of events 1 • During the entire study period, up to 5 years
|
|
Vascular disorders
Hypertension
|
0.36%
1/279 • Number of events 1 • During the entire study period, up to 5 years
|
0.00%
0/269 • During the entire study period, up to 5 years
|
Other adverse events
| Measure |
Lacosamide (SS)
n=279 participants at risk
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
|
Carbamazepine-Controlled Release (CBZ-CR) (SS)
n=269 participants at risk
200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.2%
20/279 • Number of events 40 • During the entire study period, up to 5 years
|
5.9%
16/269 • Number of events 22 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Headache
|
6.1%
17/279 • Number of events 28 • During the entire study period, up to 5 years
|
5.9%
16/269 • Number of events 26 • During the entire study period, up to 5 years
|
|
Nervous system disorders
Dizziness
|
4.3%
12/279 • Number of events 13 • During the entire study period, up to 5 years
|
6.3%
17/269 • Number of events 19 • During the entire study period, up to 5 years
|
Additional Information
UCB
Cares
Phone: +1844 599
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60