Clinical trial NCT00546351: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Lacosamide
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-10-18
Enrollment: 621
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: From entry Visit 1 through end of treatment (approximately 6.5 years)
measure: 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).
timeFrame: From entry Visit 1 through end of treatment (approximately 6.5 years)
Secondary outcomes:
measure: Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
timeFrame: Baseline
measure: Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
timeFrame: Last Visit (approximately 2 years)
measure: Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
timeFrame: Baseline
measure: Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
timeFrame: Last Visit (approximately 2 years)
measure: Patient's Global Impression of Change (PGIC) at Last Visit.
timeFrame: Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness at Final Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness at Final Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Within-Subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity at Last Visit.
timeFrame: Baseline Visit; Last Visit (approximately 2 years)
measure: Average Pain Interference With Sleep (11-point Likert Scale) at Baseline.
timeFrame: Baseline
measure: Average Pain Interference With Sleep (11-point Likert Scale) at Last Visit.
timeFrame: Last Visit
measure: Average Pain Interference With Activity (11-point Likert Scale) at Baseline.
timeFrame: Baseline
measure: Average Pain Interference With Activity (11-point Likert Scale) at Last Visit.
timeFrame: Last Visit
measure: Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Baseline.
timeFrame: Baseline
measure: Average Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS) at Last Visit.
timeFrame: Last Visit
measure: Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Baseline.
timeFrame: Baseline
measure: Average Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS) at Last Visit.
timeFrame: Last Visit
Other outcomes:
Locations:
city: Wien
country: Austria
facility: 180
city: Wien
country: Austria
facility: 183
city: Antwerp
country: Belgium
facility: 003
city: Bonheiden
country: Belgium
facility: 006
city: Genk
country: Belgium
facility: 002
city: Leuven
country: Belgium
facility: 001
city: Merksem
country: Belgium
facility: 005
city: Roeselare
country: Belgium
facility: 004
city: Pleven
country: Bulgaria
facility: 011
city: Plovdiv
country: Bulgaria
facility: 014
city: Plovdiv
country: Bulgaria
facility: 017
city: Ruse
country: Bulgaria
facility: 019
city: Sofia
country: Bulgaria
facility: 012
city: Sofia
country: Bulgaria
facility: 013
city: Sofia
country: Bulgaria
facility: 015
city: Sofia
country: Bulgaria
facility: 016
city: Stara Zagora
country: Bulgaria
facility: 210
city: Varna
country: Bulgaria
facility: 010
city: Brno
country: Czechia
facility: 028
city: Chomutov
country: Czechia
facility: 220
city: Litomerice
country: Czechia
facility: 026
city: Olomouc
country: Czechia
facility: 027
city: Ostrava-Poruba
country: Czechia
facility: 024
city: Pisek
country: Czechia
facility: 029
city: Praha 1
country: Czechia
facility: 021
city: Praha 5
country: Czechia
facility: 022
city: Kuopio
country: Finland
facility: 192
city: Lisieux
country: France
facility: 034
city: Nevers
country: France
facility: 031
city: Bad Saarow
country: Germany
facility: 040
city: Beckum
country: Germany
facility: 052
city: Berlin
country: Germany
facility: 049
city: Berlin
country: Germany
facility: 051
city: Berlin
country: Germany
facility: 056
city: Berlin
country: Germany
facility: 242
city: Berlin
country: Germany
facility: 249
city: Bochum
country: Germany
facility: 247
city: Hamburg
country: Germany
facility: 041
city: Hamburg
country: Germany
facility: 045
city: Hamburg
country: Germany
facility: 054
city: Jena
country: Germany
facility: 244
city: Köthen
country: Germany
facility: 058
city: Künzing
country: Germany
facility: 043
city: Leipzig
country: Germany
facility: 050
city: Leipzig
country: Germany
facility: 053
city: Leipzig
country: Germany
facility: 250
city: Mittweida
country: Germany
facility: 046
city: München
country: Germany
facility: 243
city: Schwerin
country: Germany
facility: 246
city: Stuhr-Brinkum
country: Germany
facility: 044
city: Witten
country: Germany
facility: 248
city: Budapest
country: Hungary
facility: 060
city: Budapest
country: Hungary
facility: 062
city: Győr
country: Hungary
facility: 061
city: Kecskemét
country: Hungary
facility: 262
city: Makó
country: Hungary
facility: 260
city: Nyíregyháza
country: Hungary
facility: 266
city: Szeged
country: Hungary
facility: 064
city: Szolnok
country: Hungary
facility: 264
city: Székesfehérvár
country: Hungary
facility: 265
city: Tatabánya
country: Hungary
facility: 263
city: Veszprém
country: Hungary
facility: 261
city: Pavia
country: Italy
facility: 270
city: Pavia
country: Italy
facility: 273
city: Pozzilli
country: Italy
facility: 272
city: Bialystok
country: Poland
facility: 092
city: Bialystok
country: Poland
facility: 293
city: Bydgoszcz
country: Poland
facility: 094
city: Częstochowa
country: Poland
facility: 095
city: Gdansk
country: Poland
facility: 091
city: Gdansk
country: Poland
facility: 093
city: Kraków
country: Poland
facility: 294
city: Kraków
country: Poland
facility: 297
city: Lodz
country: Poland
facility: 090
city: Lodz
country: Poland
facility: 295
city: Radom
country: Poland
facility: 291
city: Warszawa
country: Poland
facility: 292
city: Warszawa
country: Poland
facility: 296
city: Ząbkowicki
country: Poland
facility: 290
city: Bucharest
country: Romania
facility: 100
city: Bucharest
country: Romania
facility: 102
city: Bucharest
country: Romania
facility: 107
city: Bucharest
country: Romania
facility: 108
city: Bucharest
country: Romania
facility: 109
city: Cluj-Napoca
country: Romania
facility: 101
city: Timisoara
country: Romania
facility: 103
city: Moscow
country: Russian Federation
facility: 114
city: Moscow
country: Russian Federation
facility: 115
city: Moscow
country: Russian Federation
facility: 116
city: Samara
country: Russian Federation
facility: 111
city: St. Petersburg
country: Russian Federation
facility: 112
city: Belgrade
country: Serbia
facility: 140
city: Belgrade
country: Serbia
facility: 143
city: Belgrade
country: Serbia
facility: 144
city: Nis
country: Serbia
facility: 142
city: Granada
country: Spain
facility: 137
city: Bath
country: United Kingdom
facility: 159
city: Bristol
country: United Kingdom
facility: 154
city: Leeds
country: United Kingdom
facility: 152
city: Morriston
country: United Kingdom
facility: 150
city: Newport
country: United Kingdom
facility: 151
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References: