Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
NCT ID: NCT01465997
Last Updated: 2018-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
551 participants
INTERVENTIONAL
2012-05-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)
Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Interventions
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Lacosamide
50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Carbamazepine-Controlled Release (CBZ-CR)
200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject has remained seizure free and completed the Maintenance Phase of the SP0993; or subject has experienced 1 or more seizures on the first or second target dose during the SP0993 Maintenance Phase
* Subject is expected to benefit from participation in SP0994 in the opinion of the investigator
Exclusion Criteria
* Subject experienced a seizure at the third target dose during the Evaluation Phase or Maintenance Phase of the SP0993 study
* Subject is taking benzodiazepines for a non-epilepsy indication
* Subject meets a withdrawal criterion from the previous study SP0993
* Subject is experiencing an ongoing SAE from the previous study SP0993
* Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response (Yes) to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening. Or subject has a positive response (Yes) to either Question 4 or Question 5 of the C-SSRS at Screening in the "Since Last Visit" version
ALL
No
Sponsors
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Eden Sarl
INDUSTRY
UCB BIOSCIENCES GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
+1 877 822 9493 (UCB)
Locations
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786
Alabaster, Alabama, United States
799
Huntsville, Alabama, United States
777
Little Rock, Arkansas, United States
789
Panama City, Florida, United States
776
Port Charlotte, Florida, United States
873
Raleigh, North Carolina, United States
794
Oklahoma City, Oklahoma, United States
881
Mansfield, Texas, United States
790
Madison, Wisconsin, United States
104
Chatswood, , Australia
105
Clayton, , Australia
106
East Gosford, , Australia
101
Fitzroy, , Australia
108
Heidelberg, , Australia
103
Herston, , Australia
109
Randwick, , Australia
127
Bruges, , Belgium
134
Bruges, , Belgium
128
Hasselt, , Belgium
126
Leuven, , Belgium
805
Blagoevgrad, , Bulgaria
807
Panagyurishte, , Bulgaria
803
Pleven, , Bulgaria
810
Rousse, , Bulgaria
811
Sofia, , Bulgaria
809
Veliko Tarnovo, , Bulgaria
152
Greenfield Park, , Canada
158
Halifax Nova Scotia, , Canada
156
Hamilton, , Canada
153
St. John's, , Canada
185
Brno, , Czechia
190
Ostrava - Vitkovice, , Czechia
184
Prague, , Czechia
189
Prague, , Czechia
180
Zlín, , Czechia
205
Helsinki, , Finland
207
Kuopio, , Finland
236
Nancy, , France
263
Altenburg, , Germany
265
Bad Neustadt an der Saale, , Germany
257
Berlin, , Germany
262
Berlin, , Germany
270
Berlin, , Germany
260
Göttingen, , Germany
269
Leipzig, , Germany
256
Marburg, , Germany
259
Osnabrück, , Germany
495
Ioannina, , Greece
490
Thessalonikis, , Greece
493
Thessalonikis, , Greece
289
Balassagyarmat, , Hungary
283
Budapest, , Hungary
284
Budapest, , Hungary
286
Debrecen, , Hungary
282
Győr, , Hungary
285
Szeged, , Hungary
290
Szekszárd, , Hungary
291
Szombathely, , Hungary
310
Bari, , Italy
309
Modena, , Italy
308
Padua, , Italy
314
Prato, , Italy
311
Roma, , Italy
831
Asaka-shi, , Japan
833
Hamamatsu, , Japan
834
Kagoshima, , Japan
844
Kamakura-shi, , Japan
843
Miyazaki, , Japan
835
Nagoya, , Japan
837
Okayama, , Japan
828
Saitama-shi, , Japan
847
Sapporo, , Japan
832
Shizuoka, , Japan
751
Riga, , Latvia
727
Alytus, , Lithuania
724
Kaunas, , Lithuania
728
Vilnius, , Lithuania
547
San Luis Potosí City, , Mexico
673
Manila, , Philippines
672
Pasig, , Philippines
676
Quezon City, , Philippines
336
Gdansk, , Poland
340
Katowice, , Poland
342
Lublin, , Poland
341
Poznan, , Poland
338
Szczecin, , Poland
343
Warsaw, , Poland
360
Coimbra, , Portugal
362
Lisbon, , Portugal
365
Lisbon, , Portugal
366
Porto, , Portugal
361
Santa Maria da Feira, , Portugal
576
Bucharest, , Romania
569
Cluj-Napoca, , Romania
570
Iași, , Romania
579
Iași, , Romania
571
Sibiu, , Romania
577
Sibiu, , Romania
572
Târgu Mureş, , Romania
387
Kazan', , Russia
389
Kazan', , Russia
396
Kirov, , Russia
394
Moscow, , Russia
401
Moscow, , Russia
390
Nizhny Novgorod, , Russia
392
Novosibirsk, , Russia
397
Saint Petersburg, , Russia
400
Saint Petersburg, , Russia
386
Smolensk, , Russia
399
Yaroslavl, , Russia
594
Dolný Kubín, , Slovakia
598
Dubnica nad Váhom, , Slovakia
596
Hlohovec, , Slovakia
600
Krompachy, , Slovakia
595
Levoča, , Slovakia
599
Tornaľa, , Slovakia
601
Žilina, , Slovakia
525
Busan, , South Korea
521
Daegu, , South Korea
518
Daejeon, , South Korea
517
Seoul, , South Korea
519
Seoul, , South Korea
520
Seoul, , South Korea
523
Seoul, , South Korea
524
Seoul, , South Korea
422
Badalona, , Spain
413
Barcelona, , Spain
417
Girona, , Spain
416
Madrid, , Spain
425
Madrid, , Spain
419
San Cristóbal de La Laguna, , Spain
418
San Sebastián, , Spain
414
Santiago de Compostela, , Spain
424
Seville, , Spain
440
Gothenburg, , Sweden
442
Linköping, , Sweden
438
Stockholm, , Sweden
651
Aarau, , Switzerland
654
Biel, , Switzerland
653
Lugano, , Switzerland
699
Bangkok, , Thailand
702
Bangkok, , Thailand
698
Khon Kaen, , Thailand
622
Chernihiv, , Ukraine
626
Kharkiv, , Ukraine
621
Luhansk, , Ukraine
625
Odesa, , Ukraine
632
Simferopol, , Ukraine
472
Glasgow, , United Kingdom
471
Stoke-on-Trent, , United Kingdom
Countries
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References
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Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.
Related Links
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FDA Safety Alerts and Recalls
Other Identifiers
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2010-021238-74
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SP0994
Identifier Type: -
Identifier Source: org_study_id
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