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Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00546351
Recruitment Status : Completed
First Posted : October 18, 2007
Results First Posted : April 19, 2012
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Painful Diabetic Neuropathy
Intervention Drug: Lacosamide
Enrollment 621
Recruitment Details The study started in May 2004 with subjects from Austria, Belgium, Bulgaria, Czech Republic, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russia, Serbia, Spain, and United Kingdom. The primary completion date occurred in January 2011, with study completion in January 2011.
Pre-assignment Details Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Period Title: Overall Study
Started 621
Completed 385
Not Completed 236
Reason Not Completed
Adverse Event             76
Lack of Efficacy             15
Withdrawal by Subject             109
Lost to Follow-up             9
Protocol Deviation             1
Unsatisfactory compliance             9
Other reasons for premature termination             17
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Baseline Participants 621
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 621 participants
<=18 years
0
   0.0%
Between 18 and 65 years
500
  80.5%
>=65 years
121
  19.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 621 participants
56.8  (9.51)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 621 participants
Female
296
  47.7%
Male
325
  52.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 621 participants
Serbia 54
Finland 1
Spain 2
Austria 9
Russian Federation 30
United Kingdom 19
Italy 7
France 6
Czech Republic 57
Hungary 76
Belgium 19
Poland 101
Romania 61
Bulgaria 62
Germany 117
1.Primary Outcome
Title Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame From entry Visit 1 through end of treatment (approximately 6.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all subjects (all 621) in the Safety Set (SS).
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 621
Measure Type: Number
Unit of Measure: participants
416
2.Primary Outcome
Title Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Hide Description

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • Is fatal
  • Is life-threatening
  • Results in persistent or significant disability/incapacity
  • Requires inpatient hospitalization
  • Prolongs existing inpatient hospitalization
  • Is a congenital anomaly/birth defect
  • Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Time Frame From entry Visit 1 through end of treatment (approximately 6.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis includes all subjects (all 621) in the Safety Set (SS).
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 621
Measure Type: Number
Unit of Measure: participants
132
3.Secondary Outcome
Title Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
Hide Description On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.

Data was not available for 1 subject at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 620
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.45  (1.371)
4.Secondary Outcome
Title Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
Hide Description On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Time Frame Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.

Data was not available for 2 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 619
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.01  (2.246)
5.Secondary Outcome
Title Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Hide Description Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 213 are included in this analysis.

Data was not available for 408 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 213
Mean (Standard Deviation)
Unit of Measure: units on a scale
65.83  (15.986)
6.Secondary Outcome
Title Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
Hide Description On VAS 0 mm = no pain and 100 mm = worst possible pain.
Time Frame Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 214 are included in this analysis.

Data was not available for 407 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 214
Mean (Standard Deviation)
Unit of Measure: units on a scale
30.47  (23.940)
7.Secondary Outcome
Title Patient's Global Impression of Change (PGIC) at Last Visit.
Hide Description

The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).

Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).

Time Frame Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 551 are included in this analysis.

Data was not available for 70 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 551
Measure Type: Number
Unit of Measure: percentage of participants
Better 82.6
No Change 11.4
Worse 6.0
8.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
Hide Description 0 = no pain and 10 = most intense pain sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects of the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (2.38)
9.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
Hide Description 0 = not sharp and 10 = most sharp sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.0  (2.23)
10.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
Hide Description 0 = not hot and 10 = the most hot sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.35)
11.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
Hide Description 0 = not cold and 10 = the coldest sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.1  (2.19)
12.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
Hide Description 0 = not dull and 10 = most dull sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.11)
13.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
Hide Description 0 = not unpleasant and 10 = most unpleasant sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.

Data was not available for 428 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (2.24)
14.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
Hide Description 0 = no surface pain and 10 = most intense surface pain imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.

Data was not available for 428 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.2  (2.17)
15.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
Hide Description 0 = no deep pain and 10 = most intense deep pain imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 193 are included in this analysis.

Data was not available for 428 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.4  (2.39)
16.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
Hide Description 0 = not itchy and 10 = most itchy sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (2.06)
17.Secondary Outcome
Title Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
Hide Description 0 = not sensitive and 10 = most sensitive sensation imaginable.
Time Frame Baseline Visit; Last Visit (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 195 are included in this analysis.

Data was not available for 426 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.31)
18.Secondary Outcome
Title Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
Hide Description 0 = no interference with sleep and 10 = worst possible interference with sleep.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.

Data was not available for 1 subject at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 620
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.98  (1.850)
19.Secondary Outcome
Title Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
Hide Description 0 = no interference with sleep and 10 = worst possible interference with sleep.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.

Data was not available for 2 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 619
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.73  (2.281)
20.Secondary Outcome
Title Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
Hide Description 0 = no interference with activity and 10 = worst possible interference with activity.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 620 are included in this analysis.

Data was not available for 1 subject at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 620
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.11  (1.660)
21.Secondary Outcome
Title Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
Hide Description 0 = no interference with activity and 10 = worst possible interference with activity.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 619 are included in this analysis.

Data was not available for 2 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 619
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.89  (2.349)
22.Secondary Outcome
Title Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
Hide Description The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.

Data was not available for 33 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 588
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.8  (8.04)
23.Secondary Outcome
Title Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
Hide Description The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.

Data was not available for 69 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: units on a scale
38.4  (9.41)
24.Secondary Outcome
Title Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
Hide Description The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 588 are included in this analysis.

Data was not available for 33 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 588
Mean (Standard Deviation)
Unit of Measure: units on a scale
42.8  (11.04)
25.Secondary Outcome
Title Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
Hide Description The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame Last Visit
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 621 subjects in the Safety Set (SS), 552 are included in this analysis.

Data was not available for 69 subjects at the time of this measurement.

Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Overall Number of Participants Analyzed 552
Mean (Standard Deviation)
Unit of Measure: units on a scale
44.5  (10.90)
Time Frame Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Event Reporting Description Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
 
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   132/621 (21.26%)    
Blood and lymphatic system disorders   
Anaemia * 1  2/621 (0.32%)  2
Cardiac disorders   
Angina pectoris * 1  6/621 (0.97%)  6
Coronary artery disease * 1  5/621 (0.81%)  5
Myocardial infarction * 1  3/621 (0.48%)  3
Bundle branch block right * 1  2/621 (0.32%)  2
Bundle branch block left * 1  2/621 (0.32%)  2
Acute myocardial infarction * 1  2/621 (0.32%)  2
Myocardial ischaemia * 1  2/621 (0.32%)  2
Cardiac failure * 1  2/621 (0.32%)  4
Hypertensive cardiomyopathy * 1  1/621 (0.16%)  1
Cardiac arrest * 1  1/621 (0.16%)  1
Angina unstable * 1  1/621 (0.16%)  1
Ventricular fibrillation * 1  1/621 (0.16%)  1
Cardiogenic shock * 1  1/621 (0.16%)  1
Cardiac failure congestive * 1  1/621 (0.16%)  1
Atrial fibrillation * 1  1/621 (0.16%)  1
Congenital, familial and genetic disorders   
Spondylolisthesis * 1  1/621 (0.16%)  1
Ear and labyrinth disorders   
Vertigo * 1  1/621 (0.16%)  1
Tympanic membrane perforation * 1  1/621 (0.16%)  1
Endocrine disorders   
Goitre * 1  1/621 (0.16%)  1
Eye disorders   
Cataract * 1  5/621 (0.81%)  5
Retinal haemorrhage * 1  1/621 (0.16%)  2
Retinal detachment * 1  1/621 (0.16%)  1
Blindness unilateral * 1  1/621 (0.16%)  1
Vitreous haemorrhage * 1  1/621 (0.16%)  2
Eye haemorrhage * 1  1/621 (0.16%)  1
Gastrointestinal disorders   
Pancreatitis * 1  2/621 (0.32%)  2
Diarrhoea * 1  1/621 (0.16%)  1
Umbilical hernia * 1  1/621 (0.16%)  1
Reflux oesophagitis * 1  1/621 (0.16%)  1
Gastrointestinal haemorrhage * 1  1/621 (0.16%)  1
Gastroduodenitis haemorrhagic * 1  1/621 (0.16%)  1
Gastritis * 1  1/621 (0.16%)  1
Diverticular perforation * 1  1/621 (0.16%)  1
Abdominal pain * 1  1/621 (0.16%)  1
General disorders   
Systemic inflammatory response syndrome * 1  1/621 (0.16%)  1
Pain * 1  1/621 (0.16%)  1
Perforated ulcer * 1  1/621 (0.16%)  1
Oedema peripheral * 1  1/621 (0.16%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/621 (0.16%)  1
Cholecystitis acute * 1  1/621 (0.16%)  1
Immune system disorders   
Hypersensitivity * 1  1/621 (0.16%)  1
Infections and infestations   
Pyelonephritis acute * 1  2/621 (0.32%)  2
Gangrene * 1  2/621 (0.32%)  2
Superinfection * 1  1/621 (0.16%)  1
Sepsis * 1  1/621 (0.16%)  1
Chronic sinusitis * 1  1/621 (0.16%)  1
Bronchitis fungal * 1  1/621 (0.16%)  1
Tubo-ovarian abscess * 1  1/621 (0.16%)  2
Erysipelas * 1  1/621 (0.16%)  1
Bronchopneumonia * 1  1/621 (0.16%)  1
Bronchitis bacterial * 1  1/621 (0.16%)  1
Appendicitis * 1  1/621 (0.16%)  1
Upper respiratory tract infection * 1  1/621 (0.16%)  1
Lung infection * 1  1/621 (0.16%)  1
Localised infection * 1  1/621 (0.16%)  1
Abscess limb * 1  1/621 (0.16%)  1
Injury, poisoning and procedural complications   
Accidental overdose * 1  1/621 (0.16%)  1
Patella fracture * 1  1/621 (0.16%)  1
Forearm fracture * 1  1/621 (0.16%)  1
Ulna fracture * 1  1/621 (0.16%)  1
Lower limb fracture * 1  1/621 (0.16%)  1
Hand fracture * 1  1/621 (0.16%)  1
Epicondylitis * 1  1/621 (0.16%)  1
Traumatic brain injury * 1  1/621 (0.16%)  1
Radius fracture * 1  1/621 (0.16%)  1
Investigations   
Gamma-glutamyltransferase increased * 1  1/621 (0.16%)  1
QRS axis abnormal * 1  1/621 (0.16%)  1
Electrocardiogram QT prolonged * 1  1/621 (0.16%)  1
Metabolism and nutrition disorders   
Diabetes mellitus * 1  4/621 (0.64%)  4
Hyperglycaemia * 1  2/621 (0.32%)  2
Ketoacidosis * 1  1/621 (0.16%)  1
Hypoglycaemia * 1  1/621 (0.16%)  1
Gout * 1  1/621 (0.16%)  1
Diabetes mellitus inadequate control * 1  1/621 (0.16%)  1
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  7/621 (1.13%)  8
Spinal osteoarthritis * 1  2/621 (0.32%)  12
Polyarthritis * 1  1/621 (0.16%)  6
Fistula * 1  1/621 (0.16%)  1
Toe deformity * 1  1/621 (0.16%)  1
Arthritis * 1  1/621 (0.16%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Uterine cancer * 1  2/621 (0.32%)  2
Breast cancer * 1  2/621 (0.32%)  2
Pleural mesothelioma * 1  1/621 (0.16%)  1
Lipoma * 1  1/621 (0.16%)  1
Thyroid adenoma * 1  1/621 (0.16%)  1
Rectal cancer * 1  1/621 (0.16%)  1
Ovarian adenoma * 1  1/621 (0.16%)  1
Malignant melanoma in situ * 1  1/621 (0.16%)  1
Lymphoma * 1  1/621 (0.16%)  1
Epithelioma * 1  1/621 (0.16%)  1
Oropharyngeal cancer stage unspecified * 1  1/621 (0.16%)  1
Ovarian cancer * 1  1/621 (0.16%)  1
Benign breast neoplasm * 1  1/621 (0.16%)  1
Nervous system disorders   
Loss of consciousness * 1  2/621 (0.32%)  3
Presyncope * 1  2/621 (0.32%)  2
Diabetic neuropathy * 1  2/621 (0.32%)  2
Carpal tunnel syndrome * 1  2/621 (0.32%)  2
Ischaemic stroke * 1  2/621 (0.32%)  2
Syncope * 1  1/621 (0.16%)  1
Encephalopathy * 1  1/621 (0.16%)  1
Transient ischaemic attack * 1  1/621 (0.16%)  1
Drop attacks * 1  1/621 (0.16%)  1
Dizziness * 1  1/621 (0.16%)  1
Carotid artery stenosis * 1  1/621 (0.16%)  1
Paraesthesia * 1  1/621 (0.16%)  1
Facial paresis * 1  1/621 (0.16%)  1
Cerebral ischaemia * 1  1/621 (0.16%)  1
Apallic syndrome * 1  1/621 (0.16%)  1
Cerebrovascular accident * 1  1/621 (0.16%)  1
Brain stem syndrome * 1  1/621 (0.16%)  1
Psychiatric disorders   
Psychosomatic disease * 1  1/621 (0.16%)  1
Renal and urinary disorders   
Renal colic * 1  1/621 (0.16%)  1
Proteinuria * 1  1/621 (0.16%)  1
Nephropathy * 1  1/621 (0.16%)  1
Reproductive system and breast disorders   
Benign prostatic hyperplasia * 1  3/621 (0.48%)  3
Ovarian cyst * 1  2/621 (0.32%)  2
Postmenopausal haemorrhage * 1  1/621 (0.16%)  1
Respiratory, thoracic and mediastinal disorders   
Sleep apnoea syndrome * 1  1/621 (0.16%)  1
Pulmonary fibrosis * 1  1/621 (0.16%)  1
Nasal polyps * 1  1/621 (0.16%)  1
Chronic obstructive pulmonary disease * 1  1/621 (0.16%)  1
Snoring * 1  1/621 (0.16%)  1
Pulmonary congestion * 1  1/621 (0.16%)  1
Asthma * 1  1/621 (0.16%)  1
Respiratory failure * 1  1/621 (0.16%)  1
Haemoptysis * 1  1/621 (0.16%)  1
Skin and subcutaneous tissue disorders   
Skin ulcer * 1  1/621 (0.16%)  2
Neuropathic ulcer * 1  1/621 (0.16%)  1
Hyperkeratosis * 1  1/621 (0.16%)  1
Surgical and medical procedures   
Knee operation * 1  1/621 (0.16%)  1
Coronary arterial stent insertion * 1  1/621 (0.16%)  1
Transurethral prostatectomy * 1  1/621 (0.16%)  1
Vitrectomy * 1  1/621 (0.16%)  1
Coronary artery bypass * 1  1/621 (0.16%)  1
Vascular disorders   
Hypertension * 1  4/621 (0.64%)  4
Peripheral arterial occlusive disease * 1  2/621 (0.32%)  2
Intermittent claudication * 1  2/621 (0.32%)  2
Circulatory collapse * 1  2/621 (0.32%)  2
Hypertensive crisis * 1  2/621 (0.32%)  2
Venous thrombosis limb * 1  1/621 (0.16%)  1
Arterial haemorrhage * 1  1/621 (0.16%)  1
Femoral artery occlusion * 1  1/621 (0.16%)  1
Femoral arterial stenosis * 1  1/621 (0.16%)  1
Diabetic macroangiopathy * 1  1/621 (0.16%)  1
Deep vein thrombosis * 1  1/621 (0.16%)  1
Arterial stenosis limb * 1  1/621 (0.16%)  1
Arterial stenosis * 1  1/621 (0.16%)  1
Thrombosis * 1  1/621 (0.16%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   169/621 (27.21%)    
Ear and labyrinth disorders   
Vertigo * 1  34/621 (5.48%)  44
Infections and infestations   
Nasopharyngitis * 1  49/621 (7.89%)  63
Musculoskeletal and connective tissue disorders   
Back pain * 1  31/621 (4.99%)  41
Nervous system disorders   
Dizziness * 1  45/621 (7.25%)  49
Headache * 1  38/621 (6.12%)  45
Vascular disorders   
Hypertension * 1  40/621 (6.44%)  45
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: 1-887-822-9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00546351    
Other Study ID Numbers: SP0746
2004-000551-42 ( EudraCT Number )
First Submitted: October 16, 2007
First Posted: October 18, 2007
Results First Submitted: December 21, 2011
Results First Posted: April 19, 2012
Last Update Posted: August 28, 2017