Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
- Conditions
- EpilepsyMonotherapy
- Interventions
- Drug: Carbamazepine-Controlled Release (CBZ-CR)
- Registration Number
- NCT01465997
- Lead Sponsor
- UCB BIOSCIENCES GmbH
- Brief Summary
Compare safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with primary safety variables including spontaneous reports of Adverse Events (AEs), withdrawal of subjects due to AEs, reporting of Serious AEs (SAEs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 551
- Subject/legal representative is considered reliable and capable of adhering to the protocol
- 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
- Subject is receiving any investigational drugs or using any experimental devices in addition to LCM or CBZ-CR
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carbamazepine-Controlled Release (CBZ-CR) 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) Lacosamide 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)
- Primary Outcome Measures
Name Time Method Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years) Up to 3.5 Years (Duration of the Treatment Phase) Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years) Up to 3.5 Years (Duration of the Treatment Phase) Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years) Up to 3.5 Years (Duration of the Treatment Phase) A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (150)
205
🇫🇮Helsinki, Finland
105
🇦🇺Clayton, Australia
794
🇺🇸Oklahoma City, Oklahoma, United States
106
🇦🇺East Gosford, Australia
101
🇦🇺Fitzroy, Australia
265
🇩🇪BAD Neustadt, Germany
259
🇩🇪Osnabrück, Germany
289
ðŸ‡ðŸ‡ºBalassagyarmat, Hungary
128
🇧🇪Hasselt, Belgium
314
🇮🇹Prato, Italy
158
🇨🇦Halifax Nova Scotia, Canada
811
🇧🇬Sofia, Bulgaria
833
🇯🇵Hamamatsu-shi, Japan
283
ðŸ‡ðŸ‡ºBudapest, Hungary
805
🇧🇬Blagoevgrad, Bulgaria
834
🇯🇵Kagoshima-shi, Japan
256
🇩🇪Marburg, Germany
269
🇩🇪Leipzig, Germany
286
ðŸ‡ðŸ‡ºDebrecen, Hungary
189
🇨🇿Praha 6, Czechia
291
ðŸ‡ðŸ‡ºSzombathely, Hungary
285
ðŸ‡ðŸ‡ºSzeged, Hungary
134
🇧🇪Brugge, Belgium
126
🇧🇪Leuven, Belgium
310
🇮🇹Bari, Italy
152
🇨🇦Greenfield Park, Canada
153
🇨🇦St. John's, Canada
284
ðŸ‡ðŸ‡ºBudapest, Hungary
282
ðŸ‡ðŸ‡ºGyor, Hungary
190
🇨🇿Ostrava - Vitkovice, Czechia
751
🇱🇻Riga, Latvia
185
🇨🇿Brno, Czechia
184
🇨🇿Praha 5, Czechia
521
🇰🇷Daegu, Korea, Republic of
728
🇱🇹Vilnius, Lithuania
844
🇯🇵Kamakura-shi, Japan
810
🇧🇬Russe, Bulgaria
493
🇬🇷Thessalonikis, Greece
311
🇮🇹Roma, Italy
309
🇮🇹Modena, Italy
413
🇪🇸Barcelona, Spain
699
🇹ðŸ‡Bangkok, Thailand
626
🇺🇦Kharkov, Ukraine
418
🇪🇸San Sebastián, Spain
835
🇯🇵Nagoya-shi, Japan
525
🇰🇷Busan, Korea, Republic of
847
🇯🇵Sapporo, Japan
601
🇸🇰Zilina, Slovakia
425
🇪🇸Madrid, Spain
422
🇪🇸Badalona, Spain
828
🇯🇵Saitama-shi, Japan
414
🇪🇸Santiago de Compostela, Spain
417
🇪🇸Girona, Spain
673
🇵ðŸ‡Manila, Philippines
336
🇵🇱Gdansk, Poland
517
🇰🇷Seoul, Korea, Republic of
724
🇱🇹Kaunas, Lithuania
440
🇸🇪Göteborg, Sweden
523
🇰🇷Seoul, Korea, Republic of
424
🇪🇸Sevilla, Spain
419
🇪🇸La Laguna, Spain
577
🇷🇴Sibiu, Romania
599
🇸🇰Tornala, Slovakia
653
🇨ðŸ‡Lugano, Switzerland
471
🇬🇧Stoke-on-Trent, United Kingdom
472
🇬🇧Glasgow, United Kingdom
595
🇸🇰Levoca, Slovakia
495
🇬🇷Ioannina, Greece
490
🇬🇷Thessalonikis, Greece
622
🇺🇦Chernihiv, Ukraine
571
🇷🇴Sibiu, Romania
180
🇨🇿Zlin, Czechia
156
🇨🇦Hamilton, Canada
837
🇯🇵Okayama-shi, Japan
519
🇰🇷Seoul, Korea, Republic of
520
🇰🇷Seoul, Korea, Republic of
290
ðŸ‡ðŸ‡ºSzekszárd, Hungary
270
🇩🇪Berlin, Germany
600
🇸🇰Krompachy, Slovakia
777
🇺🇸Little Rock, Arkansas, United States
786
🇺🇸Alabaster, Alabama, United States
799
🇺🇸Huntsville, Alabama, United States
776
🇺🇸Port Charlotte, Florida, United States
881
🇺🇸Mansfield, Texas, United States
789
🇺🇸Panama City, Florida, United States
873
🇺🇸Raleigh, North Carolina, United States
790
🇺🇸Madison, Wisconsin, United States
104
🇦🇺Chatswood, Australia
109
🇦🇺Randwick, Australia
103
🇦🇺Herston, Australia
108
🇦🇺Heidelberg, Australia
807
🇧🇬Panagyurishte, Bulgaria
809
🇧🇬Veliko Tarnovo, Bulgaria
803
🇧🇬Pleven, Bulgaria
236
🇫🇷Nancy, France
257
🇩🇪Berlin, Germany
262
🇩🇪Berlin, Germany
260
🇩🇪Goettingen, Germany
263
🇩🇪Altenburg, Germany
308
🇮🇹Padova, Italy
831
🇯🇵Asaka-shi, Japan
843
🇯🇵Miyazaki-shi, Japan
832
🇯🇵Shizuoka-shi, Japan
518
🇰🇷Daejeon, Korea, Republic of
524
🇰🇷Seoul, Korea, Republic of
727
🇱🇹Alytus, Lithuania
672
🇵ðŸ‡Pasig City, Philippines
342
🇵🇱Lublin, Poland
547
🇲🇽San Luis Potosi, Mexico
676
🇵ðŸ‡Quezon City, Philippines
341
🇵🇱Poznan, Poland
361
🇵🇹Santa Maria da Feira, Portugal
576
🇷🇴Bucuresti, Romania
569
🇷🇴Cluj-napoca, Romania
579
🇷🇴Iasi, Romania
387
🇷🇺Kazan, Russian Federation
572
🇷🇴Targu Mures, Romania
394
🇷🇺Moscow, Russian Federation
401
🇷🇺Moscow, Russian Federation
389
🇷🇺Kazan, Russian Federation
396
🇷🇺Kirov, Russian Federation
392
🇷🇺Novosibirsk, Russian Federation
390
🇷🇺Nizhny Novgorod, Russian Federation
400
🇷🇺Saint-Petersburg, Russian Federation
386
🇷🇺Smolensk, Russian Federation
397
🇷🇺Saint-Petersburg, Russian Federation
594
🇸🇰Dolni Kubin, Slovakia
596
🇸🇰Hlohovec, Slovakia
598
🇸🇰Dubnica Nad Vahom, Slovakia
399
🇷🇺Yaroslavl, Russian Federation
625
🇺🇦Odesa, Ukraine
416
🇪🇸Madrid, Spain
438
🇸🇪Stockholm, Sweden
651
🇨ðŸ‡Aarau, Switzerland
442
🇸🇪Linköping, Sweden
702
🇹ðŸ‡Bangkok, Thailand
621
🇺🇦Luhansk, Ukraine
654
🇨ðŸ‡Biel, Switzerland
698
🇹ðŸ‡Khon Kaen, Thailand
632
🇺🇦Simferopol, Ukraine
207
🇫🇮Kuopio, Finland
360
🇵🇹Coimbra, Portugal
362
🇵🇹Lisboa, Portugal
340
🇵🇱Katowice, Poland
343
🇵🇱Warszawa, Poland
366
🇵🇹Porto, Portugal
338
🇵🇱Szczecin, Poland
570
🇷🇴Iasi, Romania
365
🇵🇹Lisboa, Portugal
127
🇧🇪Brugge, Belgium