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A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00235443
Recruitment Status : Completed
First Posted : October 10, 2005
Results First Posted : October 5, 2009
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Neuropathy
Intervention Drug: lacosamide
Enrollment 451
Recruitment Details Trial SP745 (NCT00235443) was conducted in 93 sites in the US and 89 of these sites screened at least 1 subject. The first subject was enrolled on 13Sep2004 and the last subject completed on 25Jul2008.
Pre-assignment Details  
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day
Hide Arm/Group Description Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Period Title: Overall Study
Started 11 57 85 205 39 54
Completed 3 19 23 108 9 9
Not Completed 8 38 62 97 30 45
Reason Not Completed
Adverse Event             4             12             17             44             10             15
Lack of Efficacy             0             1             5             12             2             9
Withdrawal by Subject             3             9             25             24             10             12
Lost to Follow-up             0             8             6             6             4             3
Unsatisfactory compliance             0             2             3             4             1             0
Other reasons for premature termination             1             6             6             7             3             6
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Total of all reporting groups
Overall Number of Baseline Participants 11 57 85 205 39 54 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 57 participants 85 participants 205 participants 39 participants 54 participants 451 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  54.5%
38
  66.7%
61
  71.8%
160
  78.0%
30
  76.9%
44
  81.5%
339
  75.2%
>=65 years
5
  45.5%
19
  33.3%
24
  28.2%
45
  22.0%
9
  23.1%
10
  18.5%
112
  24.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 57 participants 85 participants 205 participants 39 participants 54 participants 451 participants
64.0  (8.16) 59.3  (10.53) 60.5  (8.55) 57.3  (9.43) 56.9  (9.52) 55.5  (10.10) 58.1  (9.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 57 participants 85 participants 205 participants 39 participants 54 participants 451 participants
Female
5
  45.5%
33
  57.9%
48
  56.5%
80
  39.0%
16
  41.0%
18
  33.3%
200
  44.3%
Male
6
  54.5%
24
  42.1%
37
  43.5%
125
  61.0%
23
  59.0%
36
  66.7%
251
  55.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 57 participants 85 participants 205 participants 39 participants 54 participants 451 participants
11 57 85 205 39 54 451
1.Primary Outcome
Title Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Hide Description Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Time Frame Throughout the study up to a maximum study period of 2.8 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 57 85 205 39 54 451
Measure Type: Number
Unit of Measure: Participants
11 52 74 196 33 50 416
2.Secondary Outcome
Title Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Hide Description Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Time Frame Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 56 80 204 38 53 442
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.15  (2.345) -4.30  (1.991) -3.70  (2.020) -3.29  (1.872) -3.54  (1.602) -2.73  (2.064) -3.49  (1.982)
3.Secondary Outcome
Title Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Hide Description Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Time Frame Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 57 81 205 39 54 447
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-47.83  (34.022) -43.06  (23.901) -35.24  (26.837) -30.06  (23.723) -36.73  (18.025) -27.70  (22.427) -33.39  (24.484)
4.Secondary Outcome
Title Patient’s Global Impression of Change (PGIC) From Baseline in Pain.
Hide Description Patient’s Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. 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 Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 45 62 182 30 42 372
Measure Type: Number
Unit of Measure: Participants
Better 10 42 50 147 26 34 309
No Change 0 3 10 15 0 1 29
Worse 1 0 2 20 4 7 34
5.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Intensity.
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 62 181 30 42 370
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.6  (2.63) -4.4  (3.03) -3.1  (2.86) -2.7  (2.96) -3.5  (2.22) -2.0  (2.61) -3.0  (2.92)
6.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sharpness
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 62 181 30 42 370
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.5  (2.76) -4.2  (3.07) -3.3  (3.25) -2.8  (3.20) -3.9  (2.51) -1.9  (3.00) -3.1  (3.17)
7.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Heat
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 62 181 30 42 370
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.3  (3.74) -3.0  (3.65) -3.1  (3.44) -2.6  (3.14) -2.8  (2.58) -1.2  (2.86) -2.7  (3.26)
8.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Dullness
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 62 181 30 42 370
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.4  (2.41) -2.6  (3.03) -2.6  (2.88) -2.4  (3.34) -2.4  (3.65) -1.8  (3.23) -2.4  (3.22)
9.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Cold
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 61 180 30 42 368
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (3.34) -1.9  (3.14) -1.2  (3.13) -1.7  (3.19) -2.2  (3.64) -0.5  (3.01) -1.5  (3.20)
10.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Sensitivity
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 61 181 30 42 369
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.8  (4.78) -3.4  (3.46) -1.8  (3.10) -2.1  (3.44) -2.7  (3.24) -1.4  (3.26) -2.2  (3.42)
11.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Itchiness
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 61 181 30 42 369
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.2  (2.94) -2.0  (3.19) -1.4  (3.26) -1.1  (3.03) -2.1  (2.57) -0.5  (2.79) -1.3  (3.05)
12.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Unpleasantness
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 61 180 30 42 368
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.0  (3.56) -4.0  (3.15) -3.3  (3.08) -2.9  (2.96) -3.3  (2.85) -1.5  (2.61) -3.0  (3.04)
13.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Deep Pain
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 61 180 30 42 368
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.5  (3.34) -3.3  (3.58) -3.2  (3.35) -2.7  (3.11) -3.3  (2.94) -1.5  (2.88) -2.8  (3.21)
14.Secondary Outcome
Title Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) – Surface Pain
Hide Description Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 10 45 60 179 30 42 366
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.5  (4.30) -3.3  (3.53) -3.3  (3.28) -2.6  (2.96) -2.7  (2.89) -1.5  (2.95) -2.7  (3.15)
15.Secondary Outcome
Title Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Hide Description Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Time Frame Baseline to end of entire treatment phase visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 56 80 203 38 53 441
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.62  (2.950) -3.86  (2.050) -3.32  (2.077) -3.15  (2.150) -3.34  (1.852) -2.85  (2.427) -3.29  (2.173)
16.Secondary Outcome
Title Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Hide Description Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Time Frame Baseline to end of entire treatment phase visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 56 80 203 38 53 441
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-4.82  (2.927) -3.82  (2.185) -3.36  (2.163) -3.00  (2.038) -3.30  (1.808) -2.54  (2.261) -3.18  (2.147)
17.Secondary Outcome
Title Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Hide Description Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 45 61 179 30 42 368
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.3  (11.25) 5.5  (10.50) 5.1  (9.14) 3.7  (8.80) 3.5  (6.70) 2.1  (8.56) 4.0  (8.98)
18.Secondary Outcome
Title Change From Baseline in Quality of Life Using the SF-36 Health Survey – Mental Component Summary (MCS)
Hide Description Change from Baseline in quality of life using the SF-36 Health Survey – Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Time Frame Baseline to Termination Visit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population are subjects who took at least one dose of lacosamide (LCM).
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description:
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
All modal dose groups combined
Overall Number of Participants Analyzed 11 45 61 179 30 42 368
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.4  (10.66) -0.1  (12.60) 0.7  (10.78) -1.1  (11.09) -3.7  (14.34) -0.4  (12.02) -0.9  (11.60)
Time Frame 3 years, 10 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Hide Arm/Group Description Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day All modal dose groups combined
All-Cause Mortality
Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      13/57 (22.81%)      17/85 (20.00%)      52/205 (25.37%)      10/39 (25.64%)      7/54 (12.96%)      100/451 (22.17%)    
Blood and lymphatic system disorders               
Iron deficiency anaemia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Haemorrhagic anaemia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Anaemia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Cardiac disorders               
Coronary artery disease * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 3/85 (3.53%)  3 1/205 (0.49%)  1 1/39 (2.56%)  1 1/54 (1.85%)  1 7/451 (1.55%)  7
Myocardial infarction * 1  0/11 (0.00%)  0 2/57 (3.51%)  2 0/85 (0.00%)  0 1/205 (0.49%)  1 1/39 (2.56%)  1 1/54 (1.85%)  1 5/451 (1.11%)  5
Atrial fibrillation * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 2/85 (2.35%)  2 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 3/451 (0.67%)  3
Coronary artery occlusion * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 3/205 (1.46%)  3 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Angina pectoris * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Cardiac failure congestive * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Atrial flutter * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Acute myocardial infarction * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Supraventricular tachycardia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Sick sinus syndrome * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Palpitations * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Cardiac arrest * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Artioventricular block second degree * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Angina unstable * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Cardiac valve disease * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Congenital, familial and genetic disorders               
Gastrointestinal angiodysplasia haemorrhagic * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Ear and labyrinth disorders               
Vertigo * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Eye disorders               
Vision blurred * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Gastrointestinal disorders               
Nausea * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Haematemesis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Gastrooesophageal reflux disease * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Small intestinal obstruction * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
General disorders               
Chest pain * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  2 5/205 (2.44%)  5 1/39 (2.56%)  1 1/54 (1.85%)  1 8/451 (1.77%)  9
Non-cardiac chest pain * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Hepatobiliary disorders               
Cholecystitis acute * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Cholecystitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Immune system disorders               
Anaphylactic reaction * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Infections and infestations               
Pneumonia * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 2/205 (0.98%)  2 1/39 (2.56%)  1 0/54 (0.00%)  0 4/451 (0.89%)  4
Cellulitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Gastroenteritis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Appendicitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Sinusitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Osteomyelitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Gastroenteritis viral * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Bronchitis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  2
Abdominal wall abscess * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Lobar pneumonia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Abscess limb * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Injury, poisoning and procedural complications               
Ankle fracture * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Joint sprain * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Procedural pain * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Lower limb fracture * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Haemothorax * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Accidental overdose * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Tendon rupture * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Investigations               
Hepatitis C antibody positive * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Electrocardiogram PR prolongation * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Metabolism and nutrition disorders               
Diabetic ketoacidosis * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 1/205 (0.49%)  1 1/39 (2.56%)  1 0/54 (0.00%)  0 3/451 (0.67%)  3
Dehydration * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 1/39 (2.56%)  1 0/54 (0.00%)  0 2/451 (0.44%)  2
Hypoglycaemia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Diabetic foot * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Musculoskeletal and connective tissue disorders               
Osteoarthritis * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 2/205 (0.98%)  2 1/39 (2.56%)  1 0/54 (0.00%)  0 4/451 (0.89%)  4
Rotator cuff syndrome * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Arthritis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Lung neoplasm malignant * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Breast cancer * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Pituitary tumour benign * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Hodgkin's disease mixed cellularity stage unspecified * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Hepatic neoplasm malignant * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Uterine leiomyoma * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Prostate cancer * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Inflammatory carcinoma of the breast * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Nervous system disorders               
Syncope * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Cerebrovascular accident * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Presyncope * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Dizziness * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Balance disorder * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Transient ischaemic attack * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  2
Carotid artery stenosis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Paraesthesia * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Psychiatric disorders               
Depression * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Suicidal ideation * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Depression suicidal * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Anxiety * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Renal and urinary disorders               
Renal failure acute * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Urinary incontinence * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Nephrolithiasis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Reproductive system and breast disorders               
Benign prostatic hyperplasia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Cystocele * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Respiratory, thoracic and mediastinal disorders               
Chronic obstructive pulmonary disease * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 1/39 (2.56%)  1 0/54 (0.00%)  0 2/451 (0.44%)  2
Sleep apnoea syndrome * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Dyspnoea * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Pulmonary oedema * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Pneumothorax * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Lung infiltration * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Hypoxia * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Nasal septum deviation * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Skin and subcutaneous tissue disorders               
Skin ulcer * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Surgical and medical procedures               
Knee arthroplasty * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Toe amputation * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Shoulder operation * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Vascular disorders               
Peripheral vascular disorder * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 1/451 (0.22%)  1
Deep vein thrombosis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 1/451 (0.22%)  1
Aortic dilatation * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide 100mg/Day Lacosamide 200mg/Day Lacosamide 300mg/Day Lacosamide 400mg/Day Lacosamide 500mg/Day Lacosamide 600mg/Day Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/11 (90.91%)      47/57 (82.46%)      68/85 (80.00%)      183/205 (89.27%)      28/39 (71.79%)      43/54 (79.63%)      379/451 (84.04%)    
Blood and lymphatic system disorders               
Anaemia * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 4/85 (4.71%)  4 10/205 (4.88%)  10 1/39 (2.56%)  1 1/54 (1.85%)  1 18/451 (3.99%)  18
Cardiac disorders               
Atrial fibrillation * 1  0/11 (0.00%)  0 3/57 (5.26%)  3 1/85 (1.18%)  1 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 5/451 (1.11%)  5
Bundle branch block right * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 2/39 (5.13%)  3 1/54 (1.85%)  1 4/451 (0.89%)  5
Coronary artery disease * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 2/39 (5.13%)  2 0/54 (0.00%)  0 3/451 (0.67%)  3
Ear and labyrinth disorders               
Vertigo * 1  0/11 (0.00%)  0 3/57 (5.26%)  3 2/85 (2.35%)  5 8/205 (3.90%)  9 1/39 (2.56%)  1 3/54 (5.56%)  3 17/451 (3.77%)  21
Eye disorders               
Vision blurred * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 3/85 (3.53%)  3 11/205 (5.37%)  12 1/39 (2.56%)  1 2/54 (3.70%)  2 17/451 (3.77%)  18
Cataract * 1  1/11 (9.09%)  2 0/57 (0.00%)  0 1/85 (1.18%)  1 3/205 (1.46%)  4 0/39 (0.00%)  0 0/54 (0.00%)  0 5/451 (1.11%)  7
Visual disturbance * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 2/451 (0.44%)  2
Gastrointestinal disorders               
Nausea * 1  1/11 (9.09%)  1 8/57 (14.04%)  10 13/85 (15.29%)  21 33/205 (16.10%)  37 6/39 (15.38%)  6 4/54 (7.41%)  5 65/451 (14.41%)  80
Diarrhoea * 1  1/11 (9.09%)  1 5/57 (8.77%)  6 5/85 (5.88%)  5 19/205 (9.27%)  25 5/39 (12.82%)  5 2/54 (3.70%)  4 37/451 (8.20%)  46
Vomiting * 1  0/11 (0.00%)  0 5/57 (8.77%)  5 4/85 (4.71%)  4 12/205 (5.85%)  14 3/39 (7.69%)  4 2/54 (3.70%)  6 26/451 (5.76%)  33
Constipation * 1  1/11 (9.09%)  2 2/57 (3.51%)  2 3/85 (3.53%)  4 7/205 (3.41%)  7 1/39 (2.56%)  1 3/54 (5.56%)  3 17/451 (3.77%)  19
Gastrooesophageal reflux disease * 1  1/11 (9.09%)  1 1/57 (1.75%)  2 2/85 (2.35%)  2 7/205 (3.41%)  7 2/39 (5.13%)  2 1/54 (1.85%)  1 14/451 (3.10%)  15
Abdominal pain * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 3/85 (3.53%)  3 4/205 (1.95%)  4 0/39 (0.00%)  0 3/54 (5.56%)  3 11/451 (2.44%)  11
Stomach discomfort * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 1/85 (1.18%)  1 4/205 (1.95%)  4 2/39 (5.13%)  2 0/54 (0.00%)  0 8/451 (1.77%)  8
Dysphagia * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 1/205 (0.49%)  1 1/39 (2.56%)  1 0/54 (0.00%)  0 3/451 (0.67%)  3
Abdominal pain lower * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Haemorrhoids * 1  1/11 (9.09%)  2 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 1/39 (2.56%)  1 0/54 (0.00%)  0 2/451 (0.44%)  3
Gastrointestinal motility disorder * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
General disorders               
Oedema peripheral * 1  1/11 (9.09%)  2 9/57 (15.79%)  11 8/85 (9.41%)  9 21/205 (10.24%)  24 2/39 (5.13%)  3 3/54 (5.56%)  5 44/451 (9.76%)  54
Fatigue * 1  3/11 (27.27%)  3 6/57 (10.53%)  6 8/85 (9.41%)  9 22/205 (10.73%)  24 3/39 (7.69%)  5 0/54 (0.00%)  0 42/451 (9.31%)  47
Chest pain * 1  1/11 (9.09%)  1 2/57 (3.51%)  2 3/85 (3.53%)  5 8/205 (3.90%)  8 0/39 (0.00%)  0 5/54 (9.26%)  6 19/451 (4.21%)  22
Pyrexia * 1  0/11 (0.00%)  0 3/57 (5.26%)  3 0/85 (0.00%)  0 5/205 (2.44%)  5 3/39 (7.69%)  3 2/54 (3.70%)  2 13/451 (2.88%)  13
Gait disturbance * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 0/85 (0.00%)  0 5/205 (2.44%)  6 0/39 (0.00%)  0 0/54 (0.00%)  0 7/451 (1.55%)  8
Chest discomfort * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 2/205 (0.98%)  2 3/39 (7.69%)  3 0/54 (0.00%)  0 6/451 (1.33%)  6
Asthenia * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 3/54 (5.56%)  3 5/451 (1.11%)  5
Irritability * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 0/39 (0.00%)  0 1/54 (1.85%)  1 3/451 (0.67%)  3
Infections and infestations               
Upper respiratory tract infection * 1  1/11 (9.09%)  1 10/57 (17.54%)  11 14/85 (16.47%)  18 28/205 (13.66%)  50 8/39 (20.51%)  11 12/54 (22.22%)  13 73/451 (16.19%)  104
Nasopharyngitis * 1  2/11 (18.18%)  3 3/57 (5.26%)  4 3/85 (3.53%)  4 25/205 (12.20%)  33 2/39 (5.13%)  2 3/54 (5.56%)  6 38/451 (8.43%)  52
Sinusitis * 1  0/11 (0.00%)  0 3/57 (5.26%)  7 6/85 (7.06%)  7 19/205 (9.27%)  26 3/39 (7.69%)  5 2/54 (3.70%)  2 33/451 (7.32%)  47
Urinary tract infection * 1  1/11 (9.09%)  3 5/57 (8.77%)  6 7/85 (8.24%)  8 12/205 (5.85%)  19 2/39 (5.13%)  3 3/54 (5.56%)  5 30/451 (6.65%)  44
Bronchitis * 1  3/11 (27.27%)  3 2/57 (3.51%)  2 7/85 (8.24%)  8 10/205 (4.88%)  14 2/39 (5.13%)  2 2/54 (3.70%)  2 26/451 (5.76%)  31
Influenza * 1  1/11 (9.09%)  1 5/57 (8.77%)  5 1/85 (1.18%)  1 15/205 (7.32%)  21 0/39 (0.00%)  0 2/54 (3.70%)  2 24/451 (5.32%)  30
Ear infection * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 6/205 (2.93%)  10 0/39 (0.00%)  0 3/54 (5.56%)  3 10/451 (2.22%)  14
Gastroenteritis viral * 1  0/11 (0.00%)  0 2/57 (3.51%)  2 1/85 (1.18%)  1 5/205 (2.44%)  7 2/39 (5.13%)  2 0/54 (0.00%)  0 10/451 (2.22%)  12
Fungal infection * 1  0/11 (0.00%)  0 3/57 (5.26%)  4 0/85 (0.00%)  0 3/205 (1.46%)  5 0/39 (0.00%)  0 0/54 (0.00%)  0 6/451 (1.33%)  9
Skin infection * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 0/205 (0.00%)  0 1/39 (2.56%)  1 3/54 (5.56%)  3 5/451 (1.11%)  5
Laryngitis * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 3/205 (1.46%)  3 0/39 (0.00%)  0 0/54 (0.00%)  0 5/451 (1.11%)  5
Injury, poisoning and procedural complications               
Fall * 1  2/11 (18.18%)  2 4/57 (7.02%)  4 4/85 (4.71%)  6 14/205 (6.83%)  15 0/39 (0.00%)  0 4/54 (7.41%)  4 28/451 (6.21%)  31
Contusion * 1  0/11 (0.00%)  0 2/57 (3.51%)  4 8/85 (9.41%)  12 9/205 (4.39%)  11 2/39 (5.13%)  2 3/54 (5.56%)  3 24/451 (5.32%)  32
Excoriation * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 6/205 (2.93%)  6 0/39 (0.00%)  0 1/54 (1.85%)  1 9/451 (2.00%)  9
Muscle strain * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 2/85 (2.35%)  2 3/205 (1.46%)  3 2/39 (5.13%)  2 1/54 (1.85%)  1 8/451 (1.77%)  8
Limb injury * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 4/205 (1.95%)  5 1/39 (2.56%)  1 0/54 (0.00%)  0 7/451 (1.55%)  8
Wound * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 0/85 (0.00%)  0 3/205 (1.46%)  3 0/39 (0.00%)  0 1/54 (1.85%)  1 6/451 (1.33%)  6
Wound dehiscence * 1  1/11 (9.09%)  2 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  2
Investigations               
Blood glucose increased * 1  0/11 (0.00%)  0 3/57 (5.26%)  4 3/85 (3.53%)  4 10/205 (4.88%)  10 2/39 (5.13%)  4 3/54 (5.56%)  4 21/451 (4.66%)  26
Gamma-glutamyltransferase increased * 1  0/11 (0.00%)  0 2/57 (3.51%)  2 6/85 (7.06%)  6 5/205 (2.44%)  5 0/39 (0.00%)  0 1/54 (1.85%)  3 14/451 (3.10%)  16
Weight increased * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 2/85 (2.35%)  2 4/205 (1.95%)  4 0/39 (0.00%)  0 3/54 (5.56%)  4 10/451 (2.22%)  11
Metabolism and nutrition disorders               
Hypoglycaemia * 1  0/11 (0.00%)  0 3/57 (5.26%)  3 0/85 (0.00%)  0 8/205 (3.90%)  10 1/39 (2.56%)  1 3/54 (5.56%)  3 15/451 (3.33%)  17
Diabetes mellitus * 1  0/11 (0.00%)  0 4/57 (7.02%)  4 1/85 (1.18%)  1 4/205 (1.95%)  5 1/39 (2.56%)  1 0/54 (0.00%)  0 10/451 (2.22%)  11
Hypercholesterolaemia * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 1/85 (1.18%)  1 2/205 (0.98%)  2 3/39 (7.69%)  3 1/54 (1.85%)  1 8/451 (1.77%)  8
Musculoskeletal and connective tissue disorders               
Back pain * 1  0/11 (0.00%)  0 2/57 (3.51%)  4 8/85 (9.41%)  10 25/205 (12.20%)  29 2/39 (5.13%)  2 3/54 (5.56%)  4 40/451 (8.87%)  49
Arthralgia * 1  0/11 (0.00%)  0 5/57 (8.77%)  5 6/85 (7.06%)  7 19/205 (9.27%)  26 1/39 (2.56%)  3 5/54 (9.26%)  5 36/451 (7.98%)  46
Pain in extremity * 1  1/11 (9.09%)  3 2/57 (3.51%)  3 7/85 (8.24%)  8 19/205 (9.27%)  29 1/39 (2.56%)  1 2/54 (3.70%)  2 32/451 (7.10%)  46
Muscle spasms * 1  1/11 (9.09%)  3 6/57 (10.53%)  6 3/85 (3.53%)  4 10/205 (4.88%)  12 1/39 (2.56%)  1 2/54 (3.70%)  2 23/451 (5.10%)  28
Musculoskeletal pain * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 3/85 (3.53%)  3 12/205 (5.85%)  13 0/39 (0.00%)  0 1/54 (1.85%)  1 16/451 (3.55%)  17
Muscular weakness * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 1/85 (1.18%)  1 6/205 (2.93%)  7 1/39 (2.56%)  1 1/54 (1.85%)  1 10/451 (2.22%)  11
Plantar fasciitis * 1  1/11 (9.09%)  1 2/57 (3.51%)  2 0/85 (0.00%)  0 1/205 (0.49%)  1 2/39 (5.13%)  2 0/54 (0.00%)  0 6/451 (1.33%)  6
Neck pain * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 0/85 (0.00%)  0 4/205 (1.95%)  4 0/39 (0.00%)  0 0/54 (0.00%)  0 6/451 (1.33%)  6
Joint swelling * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 3/85 (3.53%)  3 2/205 (0.98%)  2 0/39 (0.00%)  0 0/54 (0.00%)  0 6/451 (1.33%)  6
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Benign neoplasm of skin * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Nervous system disorders               
Dizziness * 1  2/11 (18.18%)  2 11/57 (19.30%)  15 23/85 (27.06%)  31 47/205 (22.93%)  59 9/39 (23.08%)  13 7/54 (12.96%)  7 99/451 (21.95%)  127
Headache * 1  1/11 (9.09%)  1 10/57 (17.54%)  10 8/85 (9.41%)  15 31/205 (15.12%)  37 4/39 (10.26%)  4 2/54 (3.70%)  3 56/451 (12.42%)  70
Tremor * 1  1/11 (9.09%)  1 4/57 (7.02%)  5 7/85 (8.24%)  8 21/205 (10.24%)  30 5/39 (12.82%)  6 0/54 (0.00%)  0 38/451 (8.43%)  50
Balance disorder * 1  0/11 (0.00%)  0 2/57 (3.51%)  2 7/85 (8.24%)  7 21/205 (10.24%)  21 2/39 (5.13%)  3 5/54 (9.26%)  5 37/451 (8.20%)  38
Hypoaesthesia * 1  1/11 (9.09%)  1 3/57 (5.26%)  3 3/85 (3.53%)  4 15/205 (7.32%)  23 2/39 (5.13%)  3 4/54 (7.41%)  4 28/451 (6.21%)  38
Somnolence * 1  0/11 (0.00%)  0 4/57 (7.02%)  4 6/85 (7.06%)  6 14/205 (6.83%)  15 0/39 (0.00%)  0 1/54 (1.85%)  1 25/451 (5.54%)  26
Memory impairment * 1  2/11 (18.18%)  2 1/57 (1.75%)  1 4/85 (4.71%)  4 8/205 (3.90%)  8 2/39 (5.13%)  2 1/54 (1.85%)  1 18/451 (3.99%)  18
Pallanaesthesia * 1  0/11 (0.00%)  0 4/57 (7.02%)  4 1/85 (1.18%)  2 8/205 (3.90%)  11 1/39 (2.56%)  1 2/54 (3.70%)  3 16/451 (3.55%)  21
Amnesia * 1  2/11 (18.18%)  2 1/57 (1.75%)  2 1/85 (1.18%)  1 11/205 (5.37%)  13 1/39 (2.56%)  1 0/54 (0.00%)  0 16/451 (3.55%)  19
Hyporeflexia * 1  0/11 (0.00%)  0 1/57 (1.75%)  6 1/85 (1.18%)  1 11/205 (5.37%)  17 1/39 (2.56%)  3 0/54 (0.00%)  0 14/451 (3.10%)  27
Coordination abnormal * 1  0/11 (0.00%)  0 3/57 (5.26%)  4 3/85 (3.53%)  3 4/205 (1.95%)  4 0/39 (0.00%)  0 1/54 (1.85%)  1 11/451 (2.44%)  12
Disturbance in attention * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 4/205 (1.95%)  4 0/39 (0.00%)  0 2/54 (3.70%)  2 7/451 (1.55%)  7
Carpal tunnel syndrome * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 2/205 (0.98%)  2 0/39 (0.00%)  0 2/54 (3.70%)  2 5/451 (1.11%)  5
Psychiatric disorders               
Depression * 1  1/11 (9.09%)  1 7/57 (12.28%)  7 3/85 (3.53%)  3 7/205 (3.41%)  7 4/39 (10.26%)  4 3/54 (5.56%)  3 25/451 (5.54%)  25
Insomnia * 1  0/11 (0.00%)  0 1/57 (1.75%)  1 3/85 (3.53%)  3 13/205 (6.34%)  15 1/39 (2.56%)  1 1/54 (1.85%)  1 19/451 (4.21%)  21
Renal and urinary disorders               
Nephrolithiasis * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 2/85 (2.35%)  2 4/205 (1.95%)  7 2/39 (5.13%)  2 1/54 (1.85%)  1 9/451 (2.00%)  12
Proteinuria * 1  0/11 (0.00%)  0 0/57 (0.00%)  0 1/85 (1.18%)  1 2/205 (0.98%)  2 2/39 (5.13%)  3 0/54 (0.00%)  0 5/451 (1.11%)  6
Respiratory, thoracic and mediastinal disorders               
Cough * 1  0/11 (0.00%)  0 2/57 (3.51%)  2 5/85 (5.88%)  8 13/205 (6.34%)  13 3/39 (7.69%)  3 4/54 (7.41%)  5 27/451 (5.99%)  31
Upper respiratory tract congestion * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 0/85 (0.00%)  0 3/205 (1.46%)  3 0/39 (0.00%)  0 0/54 (0.00%)  0 5/451 (1.11%)  5
Skin and subcutaneous tissue disorders               
Rash * 1  1/11 (9.09%)  1 6/57 (10.53%)  9 1/85 (1.18%)  1 9/205 (4.39%)  11 2/39 (5.13%)  3 0/54 (0.00%)  0 19/451 (4.21%)  25
Pruritus * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 4/85 (4.71%)  5 8/205 (3.90%)  9 1/39 (2.56%)  1 3/54 (5.56%)  3 18/451 (3.99%)  20
Skin ulcer * 1  0/11 (0.00%)  0 2/57 (3.51%)  4 2/85 (2.35%)  2 3/205 (1.46%)  5 2/39 (5.13%)  2 2/54 (3.70%)  2 11/451 (2.44%)  15
Actinic keratosis * 1  1/11 (9.09%)  1 1/57 (1.75%)  1 0/85 (0.00%)  0 1/205 (0.49%)  1 0/39 (0.00%)  0 0/54 (0.00%)  0 3/451 (0.67%)  3
Surgical and medical procedures               
Wound treatment * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Peripheral nerve transposition * 1  1/11 (9.09%)  1 0/57 (0.00%)  0 0/85 (0.00%)  0 0/205 (0.00%)  0 0/39 (0.00%)  0 0/54 (0.00%)  0 1/451 (0.22%)  1
Vascular disorders               
Hypertension * 1  1/11 (9.09%)  1 2/57 (3.51%)  2 4/85 (4.71%)  7 10/205 (4.88%)  11 1/39 (2.56%)  1 3/54 (5.56%)  4 21/451 (4.66%)  26
*
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 days but <= 180 days to review results communications prior to public release and may delete information that 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 results shall be published regardless of outcome.
Results Point of Contact
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00235443     History of Changes
Other Study ID Numbers: SP0745
First Submitted: October 6, 2005
First Posted: October 10, 2005
Results First Submitted: August 31, 2009
Results First Posted: October 5, 2009
Last Update Posted: July 17, 2018