Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
A Multicenter, Double-blind, Double-dummy, Follow up Study Evaluating the Long-term Safety of Lacosamide in Comparison With Controlled-release Carbamazepine Used as Monotherapy in Subjects With Partial-onset or Generalized Tonic-clonic Seizures ≥16 Years of Age Coming From the SP0993 Study.
2 other identifiers
interventional
551
29 countries
150
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).
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 2012
Longer than P75 for phase_3
150 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
First Submitted
Initial submission to the registry
November 2, 2011
CompletedFirst Posted
Study publicly available on registry
November 7, 2011
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedResults Posted
Study results publicly available
August 2, 2017
CompletedJuly 18, 2018
September 1, 2017
4.7 years
November 2, 2011
June 27, 2017
June 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
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.
Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
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.
Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
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.
Up to 3.5 Years (Duration of the Treatment Phase)
Study Arms (2)
Lacosamide
EXPERIMENTAL50 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)
ACTIVE COMPARATOR200 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)
Interventions
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)
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES GmbHlead
- Eden Sarlcollaborator
Study Sites (150)
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
Related Publications (1)
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.
PMID: 34265173DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB
- Organization
- Cares
Study Officials
- STUDY DIRECTOR
UCB Cares
+1 877 822 9493 (UCB)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
November 2, 2011
First Posted
November 7, 2011
Study Start
May 1, 2012
Primary Completion
January 1, 2017
Study Completion
January 1, 2017
Last Updated
July 18, 2018
Results First Posted
August 2, 2017
Record last verified: 2017-09