Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
NCT ID: NCT00546351
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
621 participants
INTERVENTIONAL
2004-05-31
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Interventions
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Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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UCB Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Clinical Trial Call Center
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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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
Countries
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Other Identifiers
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2004-000551-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0746
Identifier Type: -
Identifier Source: org_study_id
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