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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)

Primary Purpose

Epilepsy, Monotherapy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Carbamazepine-Controlled Release
Sponsored by
UCB BIOSCIENCES GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Lacosamide, Vimpat®, Epilepsy, Monotherapy, Velocity

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • 786
  • 799
  • 780
  • 777
  • 795
  • 789
  • 776
  • 779
  • 874
  • 876
  • 873
  • 794
  • 881
  • 790
  • 798
  • 106
  • 109
  • 102
  • 103
  • 100
  • 101
  • 108
  • 104
  • 105
  • 127
  • 134
  • 128
  • 126
  • 805
  • 807
  • 803
  • 810
  • 806
  • 808
  • 811
  • 809
  • 153
  • 152
  • 155
  • 158
  • 156
  • 159
  • 185
  • 190
  • 189
  • 184
  • 180
  • 205
  • 207
  • 236
  • 233
  • 231
  • 235
  • 263
  • 258
  • 265
  • 257
  • 262
  • 270
  • 260
  • 271
  • 269
  • 256
  • 264
  • 261
  • 259
  • 496
  • 495
  • 490
  • 493
  • 289
  • 283
  • 284
  • 286
  • 282
  • 288
  • 285
  • 290
  • 291
  • 310
  • 309
  • 308
  • 314
  • 311
  • 831
  • 833
  • 834
  • 844
  • 846
  • 829
  • 843
  • 835
  • 830
  • 837
  • 828
  • 836
  • 847
  • 832
  • 525
  • 521
  • 518
  • 516
  • 517
  • 519
  • 520
  • 523
  • 524
  • 751
  • 727
  • 724
  • 728
  • 547
  • 673
  • 672
  • 676
  • 336
  • 334
  • 340
  • 342
  • 341
  • 338
  • 343
  • 360
  • 362
  • 365
  • 366
  • 361
  • 576
  • 569
  • 578
  • 570
  • 579
  • 571
  • 577
  • 572
  • 387
  • 389
  • 396
  • 394
  • 401
  • 390
  • 392
  • 397
  • 400
  • 386
  • 399
  • 594
  • 598
  • 596
  • 600
  • 595
  • 599
  • 601
  • 422
  • 413
  • 419
  • 416
  • 425
  • 426
  • 421
  • 418
  • 414
  • 424
  • 440
  • 438
  • 442
  • 651
  • 654
  • 653
  • 647
  • 699
  • 702
  • 703
  • 698
  • 622
  • 628
  • 626
  • 621
  • 625
  • 632
  • 633
  • 466
  • 472
  • 471

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lacosamide

Carbamazepine-Controlled Release (CBZ-CR)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.

Full Information

First Posted
November 16, 2010
Last Updated
January 15, 2021
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Eden Sarl
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1. Study Identification

Unique Protocol Identification Number
NCT01243177
Brief Title
Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older
Acronym
SP0993
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Eden Sarl

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Monotherapy
Keywords
Lacosamide, Vimpat®, Epilepsy, Monotherapy, Velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
888 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Title
Carbamazepine-Controlled Release (CBZ-CR)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
Vimpat®
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Carbamazepine-Controlled Release
Other Intervention Name(s)
Tegretol® Retard Tablets 200 mg
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Time Frame
6 consecutive months (26 consecutive weeks) of treatment following stabilization at the last evaluated dose for each subject
Title
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
Description
The proportion of subjects remaining seizure free for 6 months (26 weeks) was estimated using Kaplan-Meier methods.
Time Frame
6 consecutive months (26 consecutive weeks) of treatment
Title
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Description
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.
Time Frame
Duration of the Treatment Phase (up to 113 weeks)
Title
Number of Subjects Who Withdraw From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (up to 113 Weeks)
Description
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.
Time Frame
Duration of the Treatment Phase (up to 113 weeks)
Title
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (up to 113 Weeks)
Description
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.
Time Frame
Duration of the Treatment Phase (up to 113 weeks)
Secondary Outcome Measure Information:
Title
Proportion of Subjects Remaining Seizure Free for 12 Consecutive Months (52 Consecutive Weeks) Following Stabilization at the Last Evaluated Dose for Each Subject
Description
The proportion of subjects remaining seizure free for 12 months (52 weeks) was estimated using Kaplan-Meier methods.
Time Frame
12 consecutive months of treatment following stabilization at the last evaluated dose for each subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
786
City
Alabaster
State/Province
Alabama
Country
United States
Facility Name
799
City
Huntsville
State/Province
Alabama
Country
United States
Facility Name
780
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
777
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
795
City
Ocala
State/Province
Florida
Country
United States
Facility Name
789
City
Panama City
State/Province
Florida
Country
United States
Facility Name
776
City
Port Charlotte
State/Province
Florida
Country
United States
Facility Name
779
City
Manhattan
State/Province
Kansas
Country
United States
Facility Name
874
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
876
City
Hickory
State/Province
North Carolina
Country
United States
Facility Name
873
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
794
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
881
City
Mansfield
State/Province
Texas
Country
United States
Facility Name
790
City
Madison
State/Province
Wisconsin
Country
United States
Facility Name
798
City
Casper
State/Province
Wyoming
Country
United States
Facility Name
106
City
East Gosford
State/Province
New South Wales
Country
Australia
Facility Name
109
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
102
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
103
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
100
City
Woodville
State/Province
South Australia
Country
Australia
Facility Name
101
City
Fitzroy
State/Province
Victoria
Country
Australia
Facility Name
108
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
104
City
Chatswood
Country
Australia
Facility Name
105
City
Clayton
Country
Australia
Facility Name
127
City
Brugge
Country
Belgium
Facility Name
134
City
Brugge
Country
Belgium
Facility Name
128
City
Hasselt
Country
Belgium
Facility Name
126
City
Leuven
Country
Belgium
Facility Name
805
City
Blagoevgrad
Country
Bulgaria
Facility Name
807
City
Panagyurishte
Country
Bulgaria
Facility Name
803
City
Pleven
Country
Bulgaria
Facility Name
810
City
Russe
Country
Bulgaria
Facility Name
806
City
Sofia
Country
Bulgaria
Facility Name
808
City
Sofia
Country
Bulgaria
Facility Name
811
City
Sofia
Country
Bulgaria
Facility Name
809
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
153
City
St John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
152
City
Greenfield Park
State/Province
Quebec
Country
Canada
Facility Name
155
City
Calgary
Country
Canada
Facility Name
158
City
Halifax Nova Scotia
Country
Canada
Facility Name
156
City
Hamilton
Country
Canada
Facility Name
159
City
Veilleux
Country
Canada
Facility Name
185
City
Brno
Country
Czechia
Facility Name
190
City
Ostrava - Vitkovice
Country
Czechia
Facility Name
189
City
Prague
Country
Czechia
Facility Name
184
City
Praha 5
Country
Czechia
Facility Name
180
City
Zlin
Country
Czechia
Facility Name
205
City
Helsinki
Country
Finland
Facility Name
207
City
Kuopio
Country
Finland
Facility Name
236
City
Nancy
Country
France
Facility Name
233
City
Paris
Country
France
Facility Name
231
City
Strasbourg
Country
France
Facility Name
235
City
Toulouse Cedex 9
Country
France
Facility Name
263
City
Altenburg
Country
Germany
Facility Name
258
City
Aschaffenburg
Country
Germany
Facility Name
265
City
Bad Neustadt
Country
Germany
Facility Name
257
City
Berlin
Country
Germany
Facility Name
262
City
Berlin
Country
Germany
Facility Name
270
City
Berlin
Country
Germany
Facility Name
260
City
Göttingen
Country
Germany
Facility Name
271
City
Köln
Country
Germany
Facility Name
269
City
Leipzig
Country
Germany
Facility Name
256
City
Marburg
Country
Germany
Facility Name
264
City
Muenchen
Country
Germany
Facility Name
261
City
Münster
Country
Germany
Facility Name
259
City
Osnabruck
Country
Germany
Facility Name
496
City
Alexandroupoli
Country
Greece
Facility Name
495
City
Ioannina
Country
Greece
Facility Name
490
City
Thessalonikis
Country
Greece
Facility Name
493
City
Thessaloníki
Country
Greece
Facility Name
289
City
Balassagyarmat
Country
Hungary
Facility Name
283
City
Budapest
Country
Hungary
Facility Name
284
City
Budapest
Country
Hungary
Facility Name
286
City
Debrecen
Country
Hungary
Facility Name
282
City
Gyor
Country
Hungary
Facility Name
288
City
Pecs
Country
Hungary
Facility Name
285
City
Szeged
Country
Hungary
Facility Name
290
City
Szekszárd
Country
Hungary
Facility Name
291
City
Szombathely
Country
Hungary
Facility Name
310
City
Bari
Country
Italy
Facility Name
309
City
Modena
Country
Italy
Facility Name
308
City
Padova
Country
Italy
Facility Name
314
City
Prato
Country
Italy
Facility Name
311
City
Roma
Country
Italy
Facility Name
831
City
Asaka-shi
Country
Japan
Facility Name
833
City
Hamamatsu-shi
Country
Japan
Facility Name
834
City
Kagoshima-shi
Country
Japan
Facility Name
844
City
Kamakura-shi
Country
Japan
Facility Name
846
City
Kawasaki-shi
Country
Japan
Facility Name
829
City
Kokubunji-shi
Country
Japan
Facility Name
843
City
Miyakonojo
Country
Japan
Facility Name
835
City
Nagoya-shi
Country
Japan
Facility Name
830
City
Nara-shi
Country
Japan
Facility Name
837
City
Okayama-shi
Country
Japan
Facility Name
828
City
Saitama-shi
Country
Japan
Facility Name
836
City
Sapporo-shi
Country
Japan
Facility Name
847
City
Sapporo
Country
Japan
Facility Name
832
City
Shizuoka-shi
Country
Japan
Facility Name
525
City
Busan
Country
Korea, Republic of
Facility Name
521
City
Daegu
Country
Korea, Republic of
Facility Name
518
City
Dajeon
Country
Korea, Republic of
Facility Name
516
City
Seoul
Country
Korea, Republic of
Facility Name
517
City
Seoul
Country
Korea, Republic of
Facility Name
519
City
Seoul
Country
Korea, Republic of
Facility Name
520
City
Seoul
Country
Korea, Republic of
Facility Name
523
City
Seoul
Country
Korea, Republic of
Facility Name
524
City
Seoul
Country
Korea, Republic of
Facility Name
751
City
Riga
Country
Latvia
Facility Name
727
City
Alytus
Country
Lithuania
Facility Name
724
City
Kaunas
Country
Lithuania
Facility Name
728
City
Vilnius
Country
Lithuania
Facility Name
547
City
San Luis Potosí
Country
Mexico
Facility Name
673
City
Manila
Country
Philippines
Facility Name
672
City
Pasig City
Country
Philippines
Facility Name
676
City
Quezon City
Country
Philippines
Facility Name
336
City
Gdańsk
Country
Poland
Facility Name
334
City
Katowice
Country
Poland
Facility Name
340
City
Katowice
Country
Poland
Facility Name
342
City
Lublin
Country
Poland
Facility Name
341
City
Poznan
Country
Poland
Facility Name
338
City
Szczecin
Country
Poland
Facility Name
343
City
Warsaw
Country
Poland
Facility Name
360
City
Coimbra
Country
Portugal
Facility Name
362
City
Lisboa
Country
Portugal
Facility Name
365
City
Lisboa
Country
Portugal
Facility Name
366
City
Porto
Country
Portugal
Facility Name
361
City
Santa Maria da Feira
Country
Portugal
Facility Name
576
City
Bucuresti
Country
Romania
Facility Name
569
City
Cluj-Napoca
Country
Romania
Facility Name
578
City
Craiova
Country
Romania
Facility Name
570
City
Iasi
Country
Romania
Facility Name
579
City
Iasi
Country
Romania
Facility Name
571
City
Sibiu
Country
Romania
Facility Name
577
City
Sibiu
Country
Romania
Facility Name
572
City
Targu Mures
Country
Romania
Facility Name
387
City
Kazan
Country
Russian Federation
Facility Name
389
City
Kazan
Country
Russian Federation
Facility Name
396
City
Kirov
Country
Russian Federation
Facility Name
394
City
Moscow
Country
Russian Federation
Facility Name
401
City
Moscow
Country
Russian Federation
Facility Name
390
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
392
City
Novosibirsk
Country
Russian Federation
Facility Name
397
City
Saint Petersburg
Country
Russian Federation
Facility Name
400
City
Saint-Petersburg
Country
Russian Federation
Facility Name
386
City
Smolensk
Country
Russian Federation
Facility Name
399
City
Yaroslavl
Country
Russian Federation
Facility Name
594
City
Dolni Kubin
Country
Slovakia
Facility Name
598
City
Dubnica nad Vahom
Country
Slovakia
Facility Name
596
City
Hlohovec
Country
Slovakia
Facility Name
600
City
Krompachy
Country
Slovakia
Facility Name
595
City
Levoca
Country
Slovakia
Facility Name
599
City
Tornala
Country
Slovakia
Facility Name
601
City
Žilina
Country
Slovakia
Facility Name
422
City
Badalona
Country
Spain
Facility Name
413
City
Barcelona
Country
Spain
Facility Name
419
City
La Laguna
Country
Spain
Facility Name
416
City
Madrid
Country
Spain
Facility Name
425
City
Madrid
Country
Spain
Facility Name
426
City
Madrid
Country
Spain
Facility Name
421
City
Murcia (El Palmar)
Country
Spain
Facility Name
418
City
San Sebastian
Country
Spain
Facility Name
414
City
Santiago de Compostela
Country
Spain
Facility Name
424
City
Sevilla
Country
Spain
Facility Name
440
City
Göteborg
Country
Sweden
Facility Name
438
City
Stockholm
Country
Sweden
Facility Name
442
City
Umea
Country
Sweden
Facility Name
651
City
Aarau
Country
Switzerland
Facility Name
654
City
Biel
Country
Switzerland
Facility Name
653
City
Lugano
Country
Switzerland
Facility Name
647
City
St. Gallen
Country
Switzerland
Facility Name
699
City
Bangkok
Country
Thailand
Facility Name
702
City
Bangkok
Country
Thailand
Facility Name
703
City
Bangkok
Country
Thailand
Facility Name
698
City
Khon Kaen
Country
Thailand
Facility Name
622
City
Chernihiv
Country
Ukraine
Facility Name
628
City
Dnipropetrovsk
Country
Ukraine
Facility Name
626
City
Kharkov
Country
Ukraine
Facility Name
621
City
Luhansk
Country
Ukraine
Facility Name
625
City
Odesa
Country
Ukraine
Facility Name
632
City
Simferopol
Country
Ukraine
Facility Name
633
City
Vinnytsa
Country
Ukraine
Facility Name
466
City
Birmingham
Country
United Kingdom
Facility Name
472
City
Glasgow
Country
United Kingdom
Facility Name
471
City
Stoke-on-Trent
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27889312
Citation
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. Erratum In: Lancet Neurol. 2017 Feb;16(2):102.
Results Reference
result
PubMed Identifier
33200428
Citation
Mintzer 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.
Results Reference
result
PubMed Identifier
28290119
Citation
Lindauer 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.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

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