Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000551-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacosamide | Experimental | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacosamide | Drug | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | From entry Visit 1 through end of treatment (approximately 6.5 years) |
| 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). | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| From entry Visit 1 through end of treatment (approximately 6.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. | On the Likert Scale, 0 = no pain and 10 = worst possible pain. | Baseline |
| Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 | Vienna | Austria | ||||
| 183 |
Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lacosamide | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
| Last Visit (approximately 2 years) |
| Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline. | Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain. | Baseline |
| Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. | On VAS 0 mm = no pain and 100 mm = worst possible pain. | Last Visit (approximately 2 years) |
| Patient's Global Impression of Change (PGIC) at Last Visit. | 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). | Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit. | 0 = no pain and 10 = most intense pain sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. | 0 = not sharp and 10 = most sharp sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit. | 0 = not hot and 10 = the most hot sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. | 0 = not cold and 10 = the coldest sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. | 0 = not dull and 10 = most dull sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. | 0 = not unpleasant and 10 = most unpleasant sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit. | 0 = no surface pain and 10 = most intense surface pain imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. | 0 = no deep pain and 10 = most intense deep pain imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit. | 0 = not itchy and 10 = most itchy sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit. | 0 = not sensitive and 10 = most sensitive sensation imaginable. | Baseline Visit; Last Visit (approximately 2 years) |
| Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | Baseline |
| Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | Last Visit |
| Average Pain Interference With Activity (11-point Likert Scale) at Baseline. | 0 = no interference with activity and 10 = worst possible interference with activity. | Baseline |
| Average Pain Interference With Activity (11-point Likert Scale) at Last Visit. | 0 = no interference with activity and 10 = worst possible interference with activity. | Last Visit |
| Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline. | 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. | Baseline |
| Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. | 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. | Last Visit |
| Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline. | 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. | Baseline |
| Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit. | 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. | Last Visit |
| Vienna |
| Austria |
| 003 | Antwerp | Belgium |
| 006 | Bonheiden | Belgium |
| 002 | Genk | Belgium |
| 001 | Leuven | Belgium |
| 005 | Merksem | Belgium |
| 004 | Roeselare | Belgium |
| 011 | Pleven | Bulgaria |
| 014 | Plovdiv | Bulgaria |
| 017 | Plovdiv | Bulgaria |
| 019 | Rousse | Bulgaria |
| 012 | Sofia | Bulgaria |
| 013 | Sofia | Bulgaria |
| 015 | Sofia | Bulgaria |
| 016 | Sofia | Bulgaria |
| 210 | Stara Zagora | Bulgaria |
| 010 | Varna | Bulgaria |
| 028 | Brno | Czechia |
| 220 | Chomutov | Czechia |
| 026 | Litoměřice | Czechia |
| 027 | Olomouc | Czechia |
| 024 | Ostrava-Poruba | Czechia |
| 029 | Písek | Czechia |
| 021 | Prague | Czechia |
| 022 | Prague | Czechia |
| 192 | Kuopio | Finland |
| 034 | Lisieux | France |
| 031 | Nevers | France |
| 040 | Bad Saarow | Germany |
| 052 | Beckum | Germany |
| 049 | Berlin | Germany |
| 051 | Berlin | Germany |
| 056 | Berlin | Germany |
| 242 | Berlin | Germany |
| 249 | Berlin | Germany |
| 247 | Bochum | Germany |
| 041 | Hamburg | Germany |
| 045 | Hamburg | Germany |
| 054 | Hamburg | Germany |
| 244 | Jena | Germany |
| 058 | Köthen | Germany |
| 043 | Künzing | Germany |
| 050 | Leipzig | Germany |
| 053 | Leipzig | Germany |
| 250 | Leipzig | Germany |
| 046 | Mittweida | Germany |
| 243 | München | Germany |
| 246 | Schwerin | Germany |
| 044 | Stuhr-Brinkum | Germany |
| 248 | Witten | Germany |
| 060 | Budapest | Hungary |
| 062 | Budapest | Hungary |
| 061 | Győr | Hungary |
| 262 | Kecskemét | Hungary |
| 260 | Makó | Hungary |
| 266 | Nyíregyháza | Hungary |
| 064 | Szeged | Hungary |
| 265 | Székesfehérvár | Hungary |
| 264 | Szolnok | Hungary |
| 263 | Tatabánya | Hungary |
| 261 | Veszprém | Hungary |
| 270 | Pavia | Italy |
| 273 | Pavia | Italy |
| 272 | Pozzilli | Italy |
| 092 | Bialystok | Poland |
| 293 | Bialystok | Poland |
| 094 | Bydgoszcz | Poland |
| 095 | Częstochowa | Poland |
| 091 | Gdansk | Poland |
| 093 | Gdansk | Poland |
| 294 | Krakow | Poland |
| 297 | Krakow | Poland |
| 090 | Lodz | Poland |
| 295 | Lodz | Poland |
| 291 | Radom | Poland |
| 292 | Warsaw | Poland |
| 296 | Warsaw | Poland |
| 290 | Ząbkowicki | Poland |
| 100 | Bucharest | Romania |
| 102 | Bucharest | Romania |
| 107 | Bucharest | Romania |
| 108 | Bucharest | Romania |
| 109 | Bucharest | Romania |
| 101 | Cluj-Napoca | Romania |
| 103 | Timișoara | Romania |
| 114 | Moscow | Russia |
| 115 | Moscow | Russia |
| 116 | Moscow | Russia |
| 112 | Saint Petersburg | Russia |
| 111 | Samara | Russia |
| 140 | Belgrade | Serbia |
| 143 | Belgrade | Serbia |
| 144 | Belgrade | Serbia |
| 142 | Niš | Serbia |
| 137 | Granada | Spain |
| 159 | Bath | United Kingdom |
| 154 | Bristol | United Kingdom |
| 152 | Leeds | United Kingdom |
| 150 | Morriston | United Kingdom |
| 151 | Newport | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lacosamide | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment. | This analysis includes all subjects (all 621) in the Safety Set (SS). | Posted | Number | participants | From entry Visit 1 through end of treatment (approximately 6.5 years) |
|
|
| ||||||||||||||||||||||||||
| Primary | 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). | A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
| This analysis includes all subjects (all 621) in the Safety Set (SS). | Posted | Number | participants | From entry Visit 1 through end of treatment (approximately 6.5 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. | On the Likert Scale, 0 = no pain and 10 = worst possible pain. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. | On the Likert Scale, 0 = no pain and 10 = worst possible pain. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline. | Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. | On VAS 0 mm = no pain and 100 mm = worst possible pain. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Patient's Global Impression of Change (PGIC) at Last Visit. | 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). | 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. | Posted | Number | percentage of participants | Last Visit (approximately 2 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit. | 0 = no pain and 10 = most intense pain sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. | 0 = not sharp and 10 = most sharp sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit. | 0 = not hot and 10 = the most hot sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. | 0 = not cold and 10 = the coldest sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. | 0 = not dull and 10 = most dull sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. | 0 = not unpleasant and 10 = most unpleasant sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit. | 0 = no surface pain and 10 = most intense surface pain imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. | 0 = no deep pain and 10 = most intense deep pain imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit. | 0 = not itchy and 10 = most itchy sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit. | 0 = not sensitive and 10 = most sensitive sensation imaginable. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline Visit; Last Visit (approximately 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. | 0 = no interference with sleep and 10 = worst possible interference with sleep. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Interference With Activity (11-point Likert Scale) at Baseline. | 0 = no interference with activity and 10 = worst possible interference with activity. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Pain Interference With Activity (11-point Likert Scale) at Last Visit. | 0 = no interference with activity and 10 = worst possible interference with activity. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit |
|
| ||||||||||||||||||||||||||
| Secondary | Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
| ||||||||||||||||||||||||||
| Secondary | Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit. | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | Last Visit |
|
|
Adverse Events (AEs) were collected from Entry Visit 1 through End of Treatment (Approximately 6.5 Years).
Adverse Events refer to the Safety Set (SS). SS includes all subjects that were administered the investigational products at least once.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lacosamide | 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years. | 132 | 621 | 169 | 621 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastroduodenitis haemorrhagic | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Perforated ulcer | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bronchitis fungal | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| QRS axis abnormal | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ketoacidosis | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Toe deformity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pleural mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Thyroid adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Epithelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Oropharyngeal cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Drop attacks | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Facial paresis | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Apallic syndrome | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Brain stem syndrome | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Psychosomatic disease | Psychiatric disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Postmenopausal haemorrhage | Reproductive system and breast disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Neuropathic ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coronary arterial stent insertion | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Transurethral prostatectomy | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Vitrectomy | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Coronary artery bypass | Surgical and medical procedures | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Venous thrombosis limb | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arterial haemorrhage | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Femoral artery occlusion | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Diabetic macroangiopathy | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.1) | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB (Study Director) | UCB Clinical Trial Call Center | 1-887-822-9493 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078334 | Lacosamide |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
| Spain |
|
| Austria |
|
| Russian Federation |
|
| United Kingdom |
|
| Italy |
|
| France |
|
| Czech Republic |
|
| Hungary |
|
| Belgium |
|
| Poland |
|
| Romania |
|
| Bulgaria |
|
| Germany |
|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|