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Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Primary Purpose

Epilepsy, Monotherapy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lacosamide
Carbamazepine-Controlled Release (CBZ-CR)
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

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • 786
  • 799
  • 777
  • 789
  • 776
  • 873
  • 794
  • 881
  • 790
  • 104
  • 105
  • 106
  • 101
  • 108
  • 103
  • 109
  • 127
  • 134
  • 128
  • 126
  • 805
  • 807
  • 803
  • 810
  • 811
  • 809
  • 152
  • 158
  • 156
  • 153
  • 185
  • 190
  • 184
  • 189
  • 180
  • 205
  • 207
  • 236
  • 263
  • 265
  • 257
  • 262
  • 270
  • 260
  • 269
  • 256
  • 259
  • 495
  • 490
  • 493
  • 289
  • 283
  • 284
  • 286
  • 282
  • 285
  • 290
  • 291
  • 310
  • 309
  • 308
  • 314
  • 311
  • 831
  • 833
  • 834
  • 844
  • 843
  • 835
  • 837
  • 828
  • 847
  • 832
  • 525
  • 521
  • 518
  • 517
  • 519
  • 520
  • 523
  • 524
  • 751
  • 727
  • 724
  • 728
  • 547
  • 673
  • 672
  • 676
  • 336
  • 340
  • 342
  • 341
  • 338
  • 343
  • 360
  • 362
  • 365
  • 366
  • 361
  • 576
  • 569
  • 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
  • 417
  • 419
  • 416
  • 425
  • 418
  • 414
  • 424
  • 440
  • 442
  • 438
  • 651
  • 654
  • 653
  • 699
  • 702
  • 698
  • 622
  • 626
  • 621
  • 625
  • 632
  • 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

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 of 3.5 Years)

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2011
Last Updated
June 21, 2018
Sponsor
UCB BIOSCIENCES GmbH
Collaborators
Eden Sarl
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1. Study Identification

Unique Protocol Identification Number
NCT01465997
Brief Title
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (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 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).

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lacosamide
Arm Type
Experimental
Arm Description
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)
Arm Title
Carbamazepine-Controlled Release (CBZ-CR)
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Lacosamide
Other Intervention Name(s)
VIMPAT film-coated tablets
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Carbamazepine-Controlled Release (CBZ-CR)
Other Intervention Name(s)
Tegretol® Retard Tablets 200 mg
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
Description
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.
Time Frame
Up to 3.5 Years (Duration of the Treatment Phase)
Title
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
Description
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.
Time Frame
Up to 3.5 Years (Duration of the Treatment Phase)
Title
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
Description
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.
Time Frame
Up to 3.5 Years (Duration of the Treatment Phase)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
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
777
City
Little Rock
State/Province
Arkansas
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
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
104
City
Chatswood
Country
Australia
Facility Name
105
City
Clayton
Country
Australia
Facility Name
106
City
East Gosford
Country
Australia
Facility Name
101
City
Fitzroy
Country
Australia
Facility Name
108
City
Heidelberg
Country
Australia
Facility Name
103
City
Herston
Country
Australia
Facility Name
109
City
Randwick
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
811
City
Sofia
Country
Bulgaria
Facility Name
809
City
Veliko Tarnovo
Country
Bulgaria
Facility Name
152
City
Greenfield Park
Country
Canada
Facility Name
158
City
Halifax Nova Scotia
Country
Canada
Facility Name
156
City
Hamilton
Country
Canada
Facility Name
153
City
St. John's
Country
Canada
Facility Name
185
City
Brno
Country
Czechia
Facility Name
190
City
Ostrava - Vitkovice
Country
Czechia
Facility Name
184
City
Praha 5
Country
Czechia
Facility Name
189
City
Praha 6
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
263
City
Altenburg
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
Goettingen
Country
Germany
Facility Name
269
City
Leipzig
Country
Germany
Facility Name
256
City
Marburg
Country
Germany
Facility Name
259
City
Osnabrück
Country
Germany
Facility Name
495
City
Ioannina
Country
Greece
Facility Name
490
City
Thessalonikis
Country
Greece
Facility Name
493
City
Thessalonikis
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
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
843
City
Miyazaki-shi
Country
Japan
Facility Name
835
City
Nagoya-shi
Country
Japan
Facility Name
837
City
Okayama-shi
Country
Japan
Facility Name
828
City
Saitama-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
Daejeon
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 Potosi
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
Gdansk
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
Warszawa
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
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
Zilina
Country
Slovakia
Facility Name
422
City
Badalona
Country
Spain
Facility Name
413
City
Barcelona
Country
Spain
Facility Name
417
City
Girona
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
418
City
San Sebastián
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
442
City
Linköping
Country
Sweden
Facility Name
438
City
Stockholm
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
699
City
Bangkok
Country
Thailand
Facility Name
702
City
Bangkok
Country
Thailand
Facility Name
698
City
Khon Kaen
Country
Thailand
Facility Name
622
City
Chernihiv
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
472
City
Glasgow
Country
United Kingdom
Facility Name
471
City
Stoke-on-Trent
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34265173
Citation
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.
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

Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

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