- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00546351
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
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 Overview
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Wien, Austria
- 180
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Wien, Austria
- 183
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Antwerp, Belgium
- 003
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Bonheiden, Belgium
- 006
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Genk, Belgium
- 002
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Leuven, Belgium
- 001
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Merksem, Belgium
- 005
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Roeselare, Belgium
- 004
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Pleven, Bulgaria
- 011
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Plovdiv, Bulgaria
- 014
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Plovdiv, Bulgaria
- 017
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Ruse, Bulgaria
- 019
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Sofia, Bulgaria
- 012
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Sofia, Bulgaria
- 013
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Sofia, Bulgaria
- 015
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Sofia, Bulgaria
- 016
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Stara Zagora, Bulgaria
- 210
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Varna, Bulgaria
- 010
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Brno, Czechia
- 028
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Chomutov, Czechia
- 220
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Litomerice, Czechia
- 026
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Olomouc, Czechia
- 027
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Ostrava-Poruba, Czechia
- 024
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Pisek, Czechia
- 029
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Praha 1, Czechia
- 021
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Praha 5, Czechia
- 022
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Kuopio, Finland
- 192
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Lisieux, France
- 034
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Nevers, France
- 031
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Bad Saarow, Germany
- 040
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Beckum, Germany
- 052
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Berlin, Germany
- 049
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Berlin, Germany
- 051
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Berlin, Germany
- 056
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Berlin, Germany
- 242
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Berlin, Germany
- 249
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Bochum, Germany
- 247
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Hamburg, Germany
- 041
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Hamburg, Germany
- 045
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Hamburg, Germany
- 054
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Jena, Germany
- 244
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Köthen, Germany
- 058
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Künzing, Germany
- 043
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Leipzig, Germany
- 050
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Leipzig, Germany
- 053
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Leipzig, Germany
- 250
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Mittweida, Germany
- 046
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München, Germany
- 243
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Schwerin, Germany
- 246
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Stuhr-Brinkum, Germany
- 044
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Witten, Germany
- 248
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Budapest, Hungary
- 060
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Budapest, Hungary
- 062
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Győr, Hungary
- 061
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Kecskemét, Hungary
- 262
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Makó, Hungary
- 260
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Nyíregyháza, Hungary
- 266
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Szeged, Hungary
- 064
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Szolnok, Hungary
- 264
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Székesfehérvár, Hungary
- 265
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Tatabánya, Hungary
- 263
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Veszprém, Hungary
- 261
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Pavia, Italy
- 270
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Pavia, Italy
- 273
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Pozzilli, Italy
- 272
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Bialystok, Poland
- 092
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Bialystok, Poland
- 293
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Bydgoszcz, Poland
- 094
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Częstochowa, Poland
- 095
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Gdansk, Poland
- 091
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Gdansk, Poland
- 093
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Kraków, Poland
- 294
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Kraków, Poland
- 297
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Lodz, Poland
- 090
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Lodz, Poland
- 295
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Radom, Poland
- 291
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Warszawa, Poland
- 292
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Warszawa, Poland
- 296
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Ząbkowicki, Poland
- 290
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Bucharest, Romania
- 100
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Bucharest, Romania
- 102
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Bucharest, Romania
- 107
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Bucharest, Romania
- 108
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Bucharest, Romania
- 109
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Cluj-Napoca, Romania
- 101
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Timisoara, Romania
- 103
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Moscow, Russian Federation
- 114
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Moscow, Russian Federation
- 115
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Moscow, Russian Federation
- 116
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Samara, Russian Federation
- 111
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St. Petersburg, Russian Federation
- 112
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Belgrade, Serbia
- 140
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Belgrade, Serbia
- 143
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Belgrade, Serbia
- 144
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Nis, Serbia
- 142
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Granada, Spain
- 137
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Bath, United Kingdom
- 159
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Bristol, United Kingdom
- 154
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Leeds, United Kingdom
- 152
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Morriston, United Kingdom
- 150
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Newport, United Kingdom
- 151
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
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50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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).
Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years)
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Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
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From entry Visit 1 through end of treatment (approximately 6.5 years)
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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).
Time Frame: From entry Visit 1 through end of treatment (approximately 6.5 years)
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A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:
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From entry Visit 1 through end of treatment (approximately 6.5 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
Time Frame: Baseline
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On the Likert Scale, 0 = no pain and 10 = worst possible pain.
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Baseline
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Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
Time Frame: Last Visit (approximately 2 years)
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On the Likert Scale, 0 = no pain and 10 = worst possible pain.
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Last Visit (approximately 2 years)
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Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Time Frame: Baseline
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Visual Analog Scale (VAS) 0 mm = no pain and 100 mm = worst possible pain.
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Baseline
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Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
Time Frame: Last Visit (approximately 2 years)
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On VAS 0 mm = no pain and 100 mm = worst possible pain.
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Last Visit (approximately 2 years)
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Patient's Global Impression of Change (PGIC) at Last Visit.
Time Frame: Last Visit (approximately 2 years)
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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)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = no pain and 10 = most intense pain sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not sharp and 10 = most sharp sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not hot and 10 = the most hot sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not cold and 10 = the coldest sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not dull and 10 = most dull sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not unpleasant and 10 = most unpleasant sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = no surface pain and 10 = most intense surface pain imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = no deep pain and 10 = most intense deep pain imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not itchy and 10 = most itchy sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
Time Frame: Baseline Visit; Last Visit (approximately 2 years)
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0 = not sensitive and 10 = most sensitive sensation imaginable.
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Baseline Visit; Last Visit (approximately 2 years)
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Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
Time Frame: Baseline
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0 = no interference with sleep and 10 = worst possible interference with sleep.
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Baseline
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Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
Time Frame: Last Visit
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0 = no interference with sleep and 10 = worst possible interference with sleep.
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Last Visit
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Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
Time Frame: Baseline
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0 = no interference with activity and 10 = worst possible interference with activity.
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Baseline
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Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
Time Frame: Last Visit
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0 = no interference with activity and 10 = worst possible interference with activity.
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Last Visit
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Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
Time Frame: Baseline
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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.
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Baseline
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Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
Time Frame: Last Visit
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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.
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Last Visit
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Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
Time Frame: Baseline
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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.
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Baseline
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Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
Time Frame: 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.
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Last Visit
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetes Complications
- Diabetes Mellitus
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Pain
- Diabetic Neuropathies
- Molecular Mechanisms of Pharmacological Action
- Membrane Transport Modulators
- Anticonvulsants
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lacosamide
Other Study ID Numbers
- SP0746
- 2004-000551-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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