Trial Outcomes & Findings for Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures (NCT NCT00522275)
NCT ID: NCT00522275
Last Updated: 2018-07-18
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
PHASE3
Target enrollment
308 participants
Primary outcome timeframe
During the Treatment Period (Maximum 6 years)
Results posted on
2018-07-18
Participant Flow
Participant milestones
| Measure |
Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Overall Study
STARTED
|
308
|
|
Overall Study
COMPLETED
|
138
|
|
Overall Study
NOT COMPLETED
|
170
|
Reasons for withdrawal
| Measure |
Lacosamide
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Overall Study
Adverse Event
|
35
|
|
Overall Study
Lack of Efficacy
|
80
|
|
Overall Study
Subject withdrew consent
|
16
|
|
Overall Study
Protocol deviation
|
1
|
|
Overall Study
Unsatisfactory compliance
|
11
|
|
Overall Study
Lost to Follow-up
|
8
|
|
Overall Study
Other: Subject wants to become pregnant
|
2
|
|
Overall Study
Other: Subject is pregnant
|
2
|
|
Overall Study
Other: Subject relocated
|
2
|
|
Overall Study
Other: Subject arrested
|
1
|
|
Overall Study
Other: Site / clinic closed
|
4
|
|
Overall Study
Other: Travel to / from site difficulty
|
3
|
|
Overall Study
Other: Sponsor request
|
2
|
|
Overall Study
Other: Subject ran out of medication
|
1
|
|
Overall Study
Other: Subject had surgery for epilepsy
|
2
|
Baseline Characteristics
Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=308 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
295 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
38.2 years
STANDARD_DEVIATION 12.46 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
162 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
308 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the Treatment Period (Maximum 6 years)Population: Of the 308 subjects who entered the study, 308 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=308 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
|
288 subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (Maximum 6 years)Population: Of the 308 subjects who entered the study, 308 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=308 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
|
33 subjects
|
PRIMARY outcome
Timeframe: During the Treatment Period (Maximum 6 years)Population: Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Outcome measures
| Measure |
Lacosamide
n=308 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
|
71 subjects
|
SECONDARY outcome
Timeframe: Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)Population: Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 study.
Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Outcome measures
| Measure |
Lacosamide
n=307 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
|
-48.5 percentage change
Interval -100.0 to 567.7
|
SECONDARY outcome
Timeframe: Treatment Period (Maximum 6 years)Population: Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 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.
Outcome measures
| Measure |
Lacosamide
n=307 Participants
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
|
48.2 percentage of subjects
|
Adverse Events
Lacosamide
Serious events: 71 serious events
Other events: 265 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lacosamide
n=308 participants at risk
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Cardiac disorders
Angina pectoris
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Eye disorders
Diplopia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
4/308 • Number of events 4 • Maximum of 6 years
|
|
Gastrointestinal disorders
Nausea
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.32%
1/308 • Number of events 2 • Maximum of 6 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Mesenteric vein thrombosis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
General disorders
Chest pain
|
1.6%
5/308 • Number of events 6 • Maximum of 6 years
|
|
General disorders
Asthenia
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
General disorders
Pyrexia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Immune system disorders
Hypersensitivity
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Pneumonia
|
1.6%
5/308 • Number of events 5 • Maximum of 6 years
|
|
Infections and infestations
Cystitis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Enterobacter pneumonia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Meningitis viral
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Wound infection
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Influenza
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Infections and infestations
Salpingitis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Investigations
Hepatic enzyme increased
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Investigations
Blood pressure increased
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.97%
3/308 • Number of events 4 • Maximum of 6 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Convulsion
|
3.6%
11/308 • Number of events 13 • Maximum of 6 years
|
|
Nervous system disorders
Dizziness
|
1.3%
4/308 • Number of events 4 • Maximum of 6 years
|
|
Nervous system disorders
Status epilepticus
|
0.97%
3/308 • Number of events 3 • Maximum of 6 years
|
|
Nervous system disorders
Coordination abnormal
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Nervous system disorders
Complex partial seizures
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Headache
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Grand mal convulsion
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Myoclonus
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Mental status changes
|
0.97%
3/308 • Number of events 3 • Maximum of 6 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.97%
3/308 • Number of events 3 • Maximum of 6 years
|
|
Psychiatric disorders
Depression
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/308 • Number of events 2 • Maximum of 6 years
|
|
Psychiatric disorders
Aggression
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Psychotic disorder
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Sleep attacks
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Abnormal behaviour
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Paranoia
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Psychiatric disorders
Anxiety
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Renal and urinary disorders
Haematuria
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Renal and urinary disorders
Renal failure
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Reproductive system and breast disorders
Priapism
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.65%
2/308 • Number of events 2 • Maximum of 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.32%
1/308 • Number of events 2 • Maximum of 6 years
|
|
Skin and subcutaneous tissue disorders
Angioneurotic oedema
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Surgical and medical procedures
Vagal nerve stimulator implantation
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
|
Vascular disorders
Thrombosis
|
0.32%
1/308 • Number of events 1 • Maximum of 6 years
|
Other adverse events
| Measure |
Lacosamide
n=308 participants at risk
Up to 800 mg/day lacosamide (flexible dosing)
|
|---|---|
|
Eye disorders
Diplopia
|
14.9%
46/308 • Number of events 72 • Maximum of 6 years
|
|
Eye disorders
Vision blurred
|
9.1%
28/308 • Number of events 39 • Maximum of 6 years
|
|
Gastrointestinal disorders
Nausea
|
18.2%
56/308 • Number of events 78 • Maximum of 6 years
|
|
Gastrointestinal disorders
Vomiting
|
15.3%
47/308 • Number of events 66 • Maximum of 6 years
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
25/308 • Number of events 32 • Maximum of 6 years
|
|
Gastrointestinal disorders
Constipation
|
7.1%
22/308 • Number of events 22 • Maximum of 6 years
|
|
General disorders
Fatigue
|
11.7%
36/308 • Number of events 45 • Maximum of 6 years
|
|
General disorders
Irritability
|
6.2%
19/308 • Number of events 21 • Maximum of 6 years
|
|
General disorders
Gait disturbance
|
5.8%
18/308 • Number of events 22 • Maximum of 6 years
|
|
Infections and infestations
Nasopharyngitis
|
17.2%
53/308 • Number of events 83 • Maximum of 6 years
|
|
Infections and infestations
Upper respiratory tract infection
|
13.0%
40/308 • Number of events 54 • Maximum of 6 years
|
|
Infections and infestations
Sinusitis
|
10.4%
32/308 • Number of events 46 • Maximum of 6 years
|
|
Infections and infestations
Influenza
|
8.4%
26/308 • Number of events 28 • Maximum of 6 years
|
|
Infections and infestations
Urinary tract infection
|
8.1%
25/308 • Number of events 37 • Maximum of 6 years
|
|
Infections and infestations
Bronchitis
|
5.5%
17/308 • Number of events 23 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Contusion
|
18.5%
57/308 • Number of events 90 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Fall
|
15.3%
47/308 • Number of events 93 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
12.3%
38/308 • Number of events 69 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Joint sprain
|
6.2%
19/308 • Number of events 20 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Excoriation
|
5.8%
18/308 • Number of events 38 • Maximum of 6 years
|
|
Injury, poisoning and procedural complications
Head injury
|
5.5%
17/308 • Number of events 21 • Maximum of 6 years
|
|
Investigations
Weight increased
|
5.5%
17/308 • Number of events 17 • Maximum of 6 years
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.5%
17/308 • Number of events 17 • Maximum of 6 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
34/308 • Number of events 46 • Maximum of 6 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.8%
18/308 • Number of events 26 • Maximum of 6 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
16/308 • Number of events 24 • Maximum of 6 years
|
|
Nervous system disorders
Dizziness
|
50.0%
154/308 • Number of events 260 • Maximum of 6 years
|
|
Nervous system disorders
Headache
|
21.8%
67/308 • Number of events 91 • Maximum of 6 years
|
|
Nervous system disorders
Convulsion
|
14.3%
44/308 • Number of events 62 • Maximum of 6 years
|
|
Nervous system disorders
Tremor
|
13.3%
41/308 • Number of events 57 • Maximum of 6 years
|
|
Nervous system disorders
Balance disorder
|
13.3%
41/308 • Number of events 51 • Maximum of 6 years
|
|
Nervous system disorders
Nystagmus
|
11.0%
34/308 • Number of events 37 • Maximum of 6 years
|
|
Nervous system disorders
Coordination abnormal
|
8.4%
26/308 • Number of events 30 • Maximum of 6 years
|
|
Nervous system disorders
Somnolence
|
8.1%
25/308 • Number of events 28 • Maximum of 6 years
|
|
Nervous system disorders
Memory impairment
|
6.5%
20/308 • Number of events 21 • Maximum of 6 years
|
|
Psychiatric disorders
Depression
|
11.4%
35/308 • Number of events 45 • Maximum of 6 years
|
|
Psychiatric disorders
Insomnia
|
9.1%
28/308 • Number of events 38 • Maximum of 6 years
|
|
Psychiatric disorders
Anxiety
|
5.5%
17/308 • Number of events 20 • Maximum of 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
8.8%
27/308 • Number of events 29 • Maximum of 6 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
20/308 • Number of events 23 • Maximum of 6 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
20/308 • Number of events 21 • Maximum of 6 years
|
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