Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
- Registration Number
- NCT00546351
- Lead Sponsor
- UCB Pharma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 621
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Lacosamide Lacosamide 50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
- Primary Outcome Measures
Name Time Method 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). 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). 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
Name Time Method Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit. Last Visit (approximately 2 years) On VAS 0 mm = no pain and 100 mm = worst possible pain.
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit. Baseline Visit; Last Visit (approximately 2 years) 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. Baseline Visit; Last Visit (approximately 2 years) 0 = no surface pain and 10 = most intense surface pain imaginable.
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit. Baseline On the Likert Scale, 0 = no pain and 10 = worst possible pain.
Patient's Global Impression of Change (PGIC) at Last Visit. Last Visit (approximately 2 years) 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. Baseline Visit; Last Visit (approximately 2 years) 0 = no pain and 10 = most intense pain sensation imaginable.
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit. Baseline Visit; Last Visit (approximately 2 years) 0 = not cold and 10 = the coldest sensation imaginable.
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit. Last Visit (approximately 2 years) 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. Baseline Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit. Baseline Visit; Last Visit (approximately 2 years) 0 = not dull and 10 = most dull sensation imaginable.
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit. Baseline Visit; Last Visit (approximately 2 years) 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. Baseline Visit; Last Visit (approximately 2 years) 0 = not hot and 10 = the most hot sensation imaginable.
Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit. 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. 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. Last Visit 0 = no interference with activity and 10 = worst possible interference with activity.
Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit. Baseline Visit; Last Visit (approximately 2 years) 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. Baseline Visit; Last Visit (approximately 2 years) 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. Baseline Visit; Last Visit (approximately 2 years) 0 = not sensitive and 10 = most sensitive sensation imaginable.
Average Pain Interference With Sleep (11-point Likert Scale) at Baseline. Baseline 0 = no interference with sleep and 10 = worst possible interference with sleep.
Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit. 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. 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. 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 - Physical Component Summary (PCS) at Baseline. 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.
Trial Locations
- Locations (101)
004
🇧🇪Roeselare, Belgium
002
🇧🇪Genk, Belgium
005
🇧🇪Merksem, Belgium
011
🇧🇬Pleven, Bulgaria
014
🇧🇬Plovdiv, Bulgaria
013
🇧🇬Sofia, Bulgaria
017
🇧🇬Plovdiv, Bulgaria
019
🇧🇬Ruse, Bulgaria
012
🇧🇬Sofia, Bulgaria
094
🇵🇱Bydgoszcz, Poland
091
🇵🇱Gdansk, Poland
093
🇵🇱Gdansk, Poland
294
🇵🇱Kraków, Poland
296
🇵🇱Warszawa, Poland
290
🇵🇱Ząbkowicki, Poland
107
🇷🇴Bucharest, Romania
108
🇷🇴Bucharest, Romania
114
🇷🇺Moscow, Russian Federation
100
🇷🇴Bucharest, Romania
140
🇷🇸Belgrade, Serbia
142
🇷🇸Nis, Serbia
137
🇪🇸Granada, Spain
034
🇫🇷Lisieux, France
180
🇦🇹Wien, Austria
183
🇦🇹Wien, Austria
006
🇧🇪Bonheiden, Belgium
024
🇨🇿Ostrava-Poruba, Czechia
220
🇨🇿Chomutov, Czechia
003
🇧🇪Antwerp, Belgium
001
🇧🇪Leuven, Belgium
010
🇧🇬Varna, Bulgaria
015
🇧🇬Sofia, Bulgaria
016
🇧🇬Sofia, Bulgaria
210
🇧🇬Stara Zagora, Bulgaria
027
🇨🇿Olomouc, Czechia
021
🇨🇿Praha 1, Czechia
040
🇩🇪Bad Saarow, Germany
052
🇩🇪Beckum, Germany
026
🇨🇿Litomerice, Czechia
029
🇨🇿Pisek, Czechia
028
🇨🇿Brno, Czechia
192
🇫🇮Kuopio, Finland
043
🇩🇪Künzing, Germany
272
🇮🇹Pozzilli, Italy
058
🇩🇪Köthen, Germany
060
🇭🇺Budapest, Hungary
046
🇩🇪Mittweida, Germany
248
🇩🇪Witten, Germany
260
🇭🇺Makó, Hungary
270
🇮🇹Pavia, Italy
265
🇭🇺Székesfehérvár, Hungary
092
🇵🇱Bialystok, Poland
095
🇵🇱Częstochowa, Poland
266
🇭🇺Nyíregyháza, Hungary
263
🇭🇺Tatabánya, Hungary
264
🇭🇺Szolnok, Hungary
293
🇵🇱Bialystok, Poland
102
🇷🇴Bucharest, Romania
109
🇷🇴Bucharest, Romania
143
🇷🇸Belgrade, Serbia
116
🇷🇺Moscow, Russian Federation
115
🇷🇺Moscow, Russian Federation
101
🇷🇴Cluj-Napoca, Romania
103
🇷🇴Timisoara, Romania
111
🇷🇺Samara, Russian Federation
151
🇬🇧Newport, United Kingdom
031
🇫🇷Nevers, France
056
🇩🇪Berlin, Germany
244
🇩🇪Jena, Germany
054
🇩🇪Hamburg, Germany
243
🇩🇪München, Germany
050
🇩🇪Leipzig, Germany
250
🇩🇪Leipzig, Germany
022
🇨🇿Praha 5, Czechia
051
🇩🇪Berlin, Germany
247
🇩🇪Bochum, Germany
045
🇩🇪Hamburg, Germany
049
🇩🇪Berlin, Germany
242
🇩🇪Berlin, Germany
249
🇩🇪Berlin, Germany
041
🇩🇪Hamburg, Germany
053
🇩🇪Leipzig, Germany
246
🇩🇪Schwerin, Germany
061
🇭🇺Győr, Hungary
044
🇩🇪Stuhr-Brinkum, Germany
062
🇭🇺Budapest, Hungary
262
🇭🇺Kecskemét, Hungary
064
🇭🇺Szeged, Hungary
261
🇭🇺Veszprém, Hungary
273
🇮🇹Pavia, Italy
297
🇵🇱Kraków, Poland
291
🇵🇱Radom, Poland
292
🇵🇱Warszawa, Poland
295
🇵🇱Lodz, Poland
090
🇵🇱Lodz, Poland
152
🇬🇧Leeds, United Kingdom
112
🇷🇺St. Petersburg, Russian Federation
154
🇬🇧Bristol, United Kingdom
144
🇷🇸Belgrade, Serbia
159
🇬🇧Bath, United Kingdom
150
🇬🇧Morriston, United Kingdom