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.
2 other identifiers
interventional
621
15 countries
101
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2004
Longer than P75 for phase_3
101 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 16, 2007
CompletedFirst Posted
Study publicly available on registry
October 18, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
April 19, 2012
CompletedSeptember 21, 2023
August 1, 2023
6.7 years
October 16, 2007
December 21, 2011
August 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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: * 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
From entry Visit 1 through end of treatment (approximately 6.5 years)
Secondary Outcomes (23)
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Baseline Visit.
Baseline
Average Daily Pain Score Using an 11-point Likert Scale (0-10) at Last Visit.
Last Visit (approximately 2 years)
Average Pain Score as Measured by a 100 mm Visual Analog Scale (VAS) at Baseline.
Baseline
Average Pain Score as Measured by a 100 mm Visual Analogue Scale (VAS) at Last Visit.
Last Visit (approximately 2 years)
Patient's Global Impression of Change (PGIC) at Last Visit.
Last Visit (approximately 2 years)
- +18 more secondary outcomes
Study Arms (1)
Lacosamide
EXPERIMENTAL50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Interventions
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Study Sites (101)
180
Vienna, Austria
183
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB Clinical Trial Call Center
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2007
First Posted
October 18, 2007
Study Start
May 1, 2004
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
September 21, 2023
Results First Posted
April 19, 2012
Record last verified: 2023-08