Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
SP0993
A Multicenter, Double-blind, Double-dummy, Randomized, Positive- Controlled Study Comparing the Efficacy and Safety of Lacosamide (200 to 600 mg/Day) to Controlled Release Carbamazepine (400 to 1200 mg/Day), Used as Monotherapy in Subjects (≥ 16 Years) Newly or Recently Diagnosed With Epilepsy and Experiencing Partial-onset or Generalized Tonic-clonic Seizures.
2 other identifiers
interventional
888
29 countries
184
Brief Summary
Compare efficacy and safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR) as monotherapy in newly or recently newly diagnosed subjects with a primary efficacy endpoint of 6-month seizure freedom. Noninferiority design to show a similar risk/benefit balance between Lacosamide (LCM) and Carbamazepine-CR (CBZ-CR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2011
Typical duration for phase_3
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2010
CompletedFirst Posted
Study publicly available on registry
November 18, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
February 23, 2016
CompletedFebruary 2, 2021
January 1, 2021
4.3 years
November 16, 2010
January 25, 2016
January 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Proportion of Subjects in the Full Analysis Set (FAS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Proportion of Subjects in the Per Protocol Set (PPS) Remaining Seizure Free for 6 Consecutive Months (26 Consecutive Weeks) of Treatment Following Stabilization at the Last Evaluated Dose for Each Subject
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
6 consecutive months (26 consecutive weeks) of treatment
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Duration of the Treatment Phase (up to 113 weeks)
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Duration of the Treatment Phase (up to 113 weeks)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
An Adverse Event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A Serious Adverse Event must meet 1 or more predefined criteria like death, life-threatening, etc. Treatment-emergent AEs were defined as AEs that started on or after the date of first dose of study medication and within 30 days following the date of final study medication administration, or AEs whose intensity worsened on or after the date of first dose of study medication and within 30 days following the date of last dose.
Duration of the Treatment Phase (up to 113 weeks)
Secondary Outcomes (1)
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
12 consecutive months of treatment following stabilization at the last evaluated dose for each subject
Study Arms (2)
Lacosamide
EXPERIMENTALCarbamazepine-Controlled Release (CBZ-CR)
ACTIVE COMPARATORInterventions
Lacosamide: * Strengths: 50 mg / 100 mg * Form: tablets * Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose * Duration: up to 118 weeks
Carbamazepine-CR: * Strengths: 200 mg * Form: tablets * Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose * Duration: up to 118 weeks
Eligibility Criteria
You may qualify if:
- Subject able to comply with study requirements
- Subject is 16 years and older (female; male). Minors will be included in countries only if legally permitted
- Subject has newly or recently diagnosed Epilepsy experiencing partial onset seizures (POS) or generalized tonic-clonic seizures with at least 2 unprovoked seizures separated by 48 hours in the 12 months preceding Visit 1 out of which at least 1 seizure occured 3 months preceding Visit 1
- Subject has had an Electroencephalogram (EEG) and a brain Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI) exam of the brain within the past 12 months. If the EEG and brain CT scan or MRI exam were not performed prior to Visit 1, they need to be completed and results must be available prior to randomization at Visit 2
You may not qualify if:
- Subject has a history or presence of seizures of other types than partial-onset (IA, IB, IC with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures (eg, myoclonic, absence)
- Subject has a history or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time (ie, \< 20 minutes) with or without function regained between 2 ictal events
- Subject has a history, clinical, or Electroencephalogram (EEG) finding suggestive of Idiopathic Generalized Epilepsy (IGE) at randomization
- Subject has current or previous diagnosis of pseudoseizures, conversion disorders, or other nonepileptic ictal events that could be confused with seizures based on expert opinion and/or EEG evidence
- Subject has any medical or psychiatric condition
- Subject has a lifetime history of suicide attempt (including an actual 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
- Subject has received treatment with Phenobarbital or Primidone within 28 days prior to Visit 1
- Subject is taking Benzodiazepines for a nonepilepsy indication
- Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) (including Benzodiazepines) in the last 6 months before Visit. However, acute and subacute seizure treatment is accepted with a maximum of 2 weeks duration and if treatment was stopped at least 3 days prior to randomization
- Prior use of Felbamate or Vigabatrin is not allowed
- Benzodiazepines as rescue therapy for Epilepsy may have been used as needed in this time period, but not more frequently than once per week
- Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion, has a history of alcohol or drug abuse within the previous 2 years
- Asian ancestry and tests positive for HLA-B\*1502 allele
- Asian ancestry and tests positive for HLA-A\*3101 allele
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB BIOSCIENCES GmbHlead
- Eden Sarlcollaborator
Study Sites (184)
786
Alabaster, Alabama, United States
799
Huntsville, Alabama, United States
780
Phoenix, Arizona, United States
777
Little Rock, Arkansas, United States
795
Ocala, Florida, United States
789
Panama City, Florida, United States
776
Port Charlotte, Florida, United States
779
Manhattan, Kansas, United States
874
Charlotte, North Carolina, United States
876
Hickory, North Carolina, United States
873
Raleigh, North Carolina, United States
794
Oklahoma City, Oklahoma, United States
881
Mansfield, Texas, United States
790
Madison, Wisconsin, United States
798
Casper, Wyoming, United States
106
East Gosford, New South Wales, Australia
109
Randwick, New South Wales, Australia
102
Westmead, New South Wales, Australia
103
Herston, Queensland, Australia
100
Woodville, South Australia, Australia
101
Fitzroy, Victoria, Australia
108
Heidelberg, Victoria, Australia
104
Chatswood, Australia
105
Clayton, 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
806
Sofia, Bulgaria
808
Sofia, Bulgaria
811
Sofia, Bulgaria
809
Veliko Tarnovo, Bulgaria
153
St. John's, Newfoundland and Labrador, Canada
152
Greenfield Park, Quebec, Canada
155
Calgary, Canada
158
Halifax Nova Scotia, Canada
156
Hamilton, Canada
159
Veilleux, 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
233
Paris, France
231
Strasbourg, France
235
Toulouse, France
263
Altenburg, Germany
258
Aschaffenburg, Germany
265
Bad Neustadt an der Saale, Germany
257
Berlin, Germany
262
Berlin, Germany
270
Berlin, Germany
271
Cologne, Germany
260
Göttingen, Germany
269
Leipzig, Germany
256
Marburg, Germany
264
München, Germany
261
Münster, Germany
259
Osnabrück, Germany
496
Alexandroupoli, Greece
495
Ioannina, Greece
493
Thessaloniki, Greece
490
Thessalonikis, Greece
289
Balassagyarmat, Hungary
283
Budapest, Hungary
284
Budapest, Hungary
286
Debrecen, Hungary
282
Győr, Hungary
288
Pécs, 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
846
Kawasaki-shi, Japan
829
Kokubunji-shi, Japan
843
Miyakonojō, Japan
835
Nagoya, Japan
830
Nara, Japan
837
Okayama, Japan
828
Saitama-shi, Japan
836
Sapporo, 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
334
Katowice, 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
578
Craiova, 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
Dajeon, South Korea
516
Seoul, 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
418
Donostia / San Sebastian, Spain
416
Madrid, Spain
425
Madrid, Spain
426
Madrid, Spain
421
Murcia (El Palmar), Spain
419
San Cristóbal de La Laguna, Spain
414
Santiago de Compostela, Spain
424
Seville, Spain
440
Gothenburg, Sweden
438
Stockholm, Sweden
442
Umeå, Sweden
651
Aarau, Switzerland
654
Biel, Switzerland
653
Lugano, Switzerland
647
Sankt Gallen, Switzerland
699
Bangkok, Thailand
702
Bangkok, Thailand
703
Bangkok, Thailand
698
Khon Kaen, Thailand
622
Chernihiv, Ukraine
628
Dnipropetrovsk, Ukraine
626
Kharkiv, Ukraine
621
Luhansk, Ukraine
625
Odesa, Ukraine
632
Simferopol, Ukraine
633
Vinnytsa, Ukraine
466
Birmingham, United Kingdom
472
Glasgow, United Kingdom
471
Stoke-on-Trent, United Kingdom
Related Publications (3)
Baulac M, Rosenow F, Toledo M, Terada K, Li T, De Backer M, Werhahn KJ, Brock M. Efficacy, safety, and tolerability of lacosamide monotherapy versus controlled-release carbamazepine in patients with newly diagnosed epilepsy: a phase 3, randomised, double-blind, non-inferiority trial. Lancet Neurol. 2017 Jan;16(1):43-54. doi: 10.1016/S1474-4422(16)30292-7. Epub 2016 Nov 24.
PMID: 27889312RESULTMintzer S, Dimova S, Zhang Y, Steiniger-Brach B, De Backer M, Chellun D, Roebling R. Effects of lacosamide and carbamazepine on lipids in a randomized trial. Epilepsia. 2020 Dec;61(12):2696-2704. doi: 10.1111/epi.16745. Epub 2020 Nov 17.
PMID: 33200428RESULTLindauer A, Laveille C, Stockis A. Time-to-Seizure Modeling of Lacosamide Used in Monotherapy in Patients with Newly Diagnosed Epilepsy. Clin Pharmacokinet. 2017 Nov;56(11):1403-1413. doi: 10.1007/s40262-017-0530-8.
PMID: 28290119DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- UCB (Study Director)
- Organization
- UCB 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
- 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 16, 2010
First Posted
November 18, 2010
Study Start
April 1, 2011
Primary Completion
July 1, 2015
Study Completion
August 1, 2015
Last Updated
February 2, 2021
Results First Posted
February 23, 2016
Record last verified: 2021-01