Back to resultsStudy Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Primary Purpose
Painful Diabetic Neuropathy
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring Lacosamide
Eligibility Criteria
Inclusion Criteria:
- Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
- SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor
Exclusion Criteria:
- Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
- Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
- Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
- Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacosamide
Arm Description
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Outcomes
Primary Outcome Measures
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.
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:
Is fatal
Is life-threatening
Results in persistent or significant disability/incapacity
Requires inpatient hospitalization
Prolongs existing inpatient hospitalization
Is a congenital anomaly/birth defect
Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Secondary Outcome Measures
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
0 = no interference with sleep and 10 = worst possible interference with sleep.
Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
0 = no interference with activity and 10 = worst possible interference with activity.
Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
0 = no interference with activity and 10 = worst possible interference with activity.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00546351
Brief Title
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
Official Title
A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Diabetic Neuropathy
Keywords
Lacosamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
621 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat
Intervention Description
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Primary Outcome Measure Information:
Title
Number of Participants Experiencing the Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Description
Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame
From entry Visit 1 through end of treatment (approximately 6.5 years)
Title
Number of Participants Experiencing the Occurrence of at Least One Serious Adverse Event (SAE) During the Evaluation Period From Entry Visit 1 Through End of Treatment (Approximately 6.5 Years).
Description
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
Is fatal
Is life-threatening
Results in persistent or significant disability/incapacity
Requires inpatient hospitalization
Prolongs existing inpatient hospitalization
Is a congenital anomaly/birth defect
Is considered to be an important medical event. Such an event may not be immediately life threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent one of the other outcomes listed in the definitions above
Time Frame
From entry Visit 1 through end of treatment (approximately 6.5 years)
Secondary Outcome Measure Information:
Title
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
Description
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Time Frame
Baseline
Title
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
Description
On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Time Frame
Last Visit (approximately 2 years)
Title
Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Description
Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
Time Frame
Baseline
Title
Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
Description
On VAS 0 mm = no pain and 100 mm = worst possible pain.
Time Frame
Last Visit (approximately 2 years)
Title
Patient's Global Impression of Change (PGIC) at Last Visit.
Description
The PGIC is a 7-point self-administered categorical rating scale in which the subject rated the change in pain since starting trial medication (from much worse [score of 1] to much better [score of 7]).
Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Time Frame
Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
Description
0 = no pain and 10 = most intense pain sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
Description
0 = not sharp and 10 = most sharp sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
Description
0 = not hot and 10 = the most hot sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
Description
0 = not cold and 10 = the coldest sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
Description
0 = not dull and 10 = most dull sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
Description
0 = not unpleasant and 10 = most unpleasant sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
Description
0 = no surface pain and 10 = most intense surface pain imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
Description
0 = no deep pain and 10 = most intense deep pain imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
Description
0 = not itchy and 10 = most itchy sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
Description
0 = not sensitive and 10 = most sensitive sensation imaginable.
Time Frame
Baseline Visit; Last Visit (approximately 2 years)
Title
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
Description
0 = no interference with sleep and 10 = worst possible interference with sleep.
Time Frame
Baseline
Title
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
Description
0 = no interference with sleep and 10 = worst possible interference with sleep.
Time Frame
Last Visit
Title
Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
Description
0 = no interference with activity and 10 = worst possible interference with activity.
Time Frame
Baseline
Title
Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
Description
0 = no interference with activity and 10 = worst possible interference with activity.
Time Frame
Last Visit
Title
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
Description
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame
Baseline
Title
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
Description
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame
Last Visit
Title
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
Description
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame
Baseline
Title
Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
Description
The SF-36 Health Survey measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS = physical functioning, role-physical, bodily pain, and general health; MCS = vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0 = worst score (or quality of life) and 100 = best score.
Time Frame
Last Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who completed Study SP743 (NCT00238524) or SP874 (NCT00350103) and, in the investigator's opinion, might benefit from long-term administration of SP746 (NCT00546351). Exception: subjects who prematurely discontinued
SP743 (NCT00238524) or SP874 (NCT00350103) due to lack of efficacy or due to intolerability to trial medication (after Visit 5but prior to entering the Maintenance Phase) may be eligible to participate in SP746 (NCT00546351), after consultation with the medical monitor
Exclusion Criteria:
Subject has clinically relevant ECG abnormalities, or a QTc interval ≥500 ms, and/or a QTc interval increase of ≥60 ms from the mean pre-dose QTc value at Visit 2 of SP743 (NCT00238524) or SP874 (NCT00350103)
Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥3 times the upper limit of the normal range (ULN) with total bilirubin ≥2 times ULN or transaminases (AST and/or ALT) ≥5 times ULN
Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial
Subject is a pregnant or nursing female, or is of childbearing potential and is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
180
City
Wien
Country
Austria
Facility Name
183
City
Wien
Country
Austria
Facility Name
003
City
Antwerp
Country
Belgium
Facility Name
006
City
Bonheiden
Country
Belgium
Facility Name
002
City
Genk
Country
Belgium
Facility Name
001
City
Leuven
Country
Belgium
Facility Name
005
City
Merksem
Country
Belgium
Facility Name
004
City
Roeselare
Country
Belgium
Facility Name
011
City
Pleven
Country
Bulgaria
Facility Name
014
City
Plovdiv
Country
Bulgaria
Facility Name
017
City
Plovdiv
Country
Bulgaria
Facility Name
019
City
Ruse
Country
Bulgaria
Facility Name
012
City
Sofia
Country
Bulgaria
Facility Name
013
City
Sofia
Country
Bulgaria
Facility Name
015
City
Sofia
Country
Bulgaria
Facility Name
016
City
Sofia
Country
Bulgaria
Facility Name
210
City
Stara Zagora
Country
Bulgaria
Facility Name
010
City
Varna
Country
Bulgaria
Facility Name
028
City
Brno
Country
Czechia
Facility Name
220
City
Chomutov
Country
Czechia
Facility Name
026
City
Litomerice
Country
Czechia
Facility Name
027
City
Olomouc
Country
Czechia
Facility Name
024
City
Ostrava-Poruba
Country
Czechia
Facility Name
029
City
Pisek
Country
Czechia
Facility Name
021
City
Praha 1
Country
Czechia
Facility Name
022
City
Praha 5
Country
Czechia
Facility Name
192
City
Kuopio
Country
Finland
Facility Name
034
City
Lisieux
Country
France
Facility Name
031
City
Nevers
Country
France
Facility Name
040
City
Bad Saarow
Country
Germany
Facility Name
052
City
Beckum
Country
Germany
Facility Name
049
City
Berlin
Country
Germany
Facility Name
051
City
Berlin
Country
Germany
Facility Name
056
City
Berlin
Country
Germany
Facility Name
242
City
Berlin
Country
Germany
Facility Name
249
City
Berlin
Country
Germany
Facility Name
247
City
Bochum
Country
Germany
Facility Name
041
City
Hamburg
Country
Germany
Facility Name
045
City
Hamburg
Country
Germany
Facility Name
054
City
Hamburg
Country
Germany
Facility Name
244
City
Jena
Country
Germany
Facility Name
058
City
Köthen
Country
Germany
Facility Name
043
City
Künzing
Country
Germany
Facility Name
050
City
Leipzig
Country
Germany
Facility Name
053
City
Leipzig
Country
Germany
Facility Name
250
City
Leipzig
Country
Germany
Facility Name
046
City
Mittweida
Country
Germany
Facility Name
243
City
München
Country
Germany
Facility Name
246
City
Schwerin
Country
Germany
Facility Name
044
City
Stuhr-Brinkum
Country
Germany
Facility Name
248
City
Witten
Country
Germany
Facility Name
060
City
Budapest
Country
Hungary
Facility Name
062
City
Budapest
Country
Hungary
Facility Name
061
City
Győr
Country
Hungary
Facility Name
262
City
Kecskemét
Country
Hungary
Facility Name
260
City
Makó
Country
Hungary
Facility Name
266
City
Nyíregyháza
Country
Hungary
Facility Name
064
City
Szeged
Country
Hungary
Facility Name
264
City
Szolnok
Country
Hungary
Facility Name
265
City
Székesfehérvár
Country
Hungary
Facility Name
263
City
Tatabánya
Country
Hungary
Facility Name
261
City
Veszprém
Country
Hungary
Facility Name
270
City
Pavia
Country
Italy
Facility Name
273
City
Pavia
Country
Italy
Facility Name
272
City
Pozzilli
Country
Italy
Facility Name
092
City
Bialystok
Country
Poland
Facility Name
293
City
Bialystok
Country
Poland
Facility Name
094
City
Bydgoszcz
Country
Poland
Facility Name
095
City
Częstochowa
Country
Poland
Facility Name
091
City
Gdansk
Country
Poland
Facility Name
093
City
Gdansk
Country
Poland
Facility Name
294
City
Kraków
Country
Poland
Facility Name
297
City
Kraków
Country
Poland
Facility Name
090
City
Lodz
Country
Poland
Facility Name
295
City
Lodz
Country
Poland
Facility Name
291
City
Radom
Country
Poland
Facility Name
292
City
Warszawa
Country
Poland
Facility Name
296
City
Warszawa
Country
Poland
Facility Name
290
City
Ząbkowicki
Country
Poland
Facility Name
100
City
Bucharest
Country
Romania
Facility Name
102
City
Bucharest
Country
Romania
Facility Name
107
City
Bucharest
Country
Romania
Facility Name
108
City
Bucharest
Country
Romania
Facility Name
109
City
Bucharest
Country
Romania
Facility Name
101
City
Cluj-Napoca
Country
Romania
Facility Name
103
City
Timisoara
Country
Romania
Facility Name
114
City
Moscow
Country
Russian Federation
Facility Name
115
City
Moscow
Country
Russian Federation
Facility Name
116
City
Moscow
Country
Russian Federation
Facility Name
111
City
Samara
Country
Russian Federation
Facility Name
112
City
St. Petersburg
Country
Russian Federation
Facility Name
140
City
Belgrade
Country
Serbia
Facility Name
143
City
Belgrade
Country
Serbia
Facility Name
144
City
Belgrade
Country
Serbia
Facility Name
142
City
Nis
Country
Serbia
Facility Name
137
City
Granada
Country
Spain
Facility Name
159
City
Bath
Country
United Kingdom
Facility Name
154
City
Bristol
Country
United Kingdom
Facility Name
152
City
Leeds
Country
United Kingdom
Facility Name
150
City
Morriston
Country
United Kingdom
Facility Name
151
City
Newport
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
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