Clinical trial NCT01465997: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Monotherapy
Keywords: Lacosamide
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: Eden Sarl
First posted: 2011-11-06
Enrollment: 551
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)
timeFrame: Up to 3.5 Years (Duration of the Treatment Phase)
measure: Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)
timeFrame: Up to 3.5 Years (Duration of the Treatment Phase)
measure: Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)
timeFrame: Up to 3.5 Years (Duration of the Treatment Phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: 786
state: Alabama
city: Huntsville
country: United States
facility: 799
state: Alabama
city: Little Rock
country: United States
facility: 777
state: Arkansas
city: Panama City
country: United States
facility: 789
state: Florida
city: Port Charlotte
country: United States
facility: 776
state: Florida
city: Raleigh
country: United States
facility: 873
state: North Carolina
city: Oklahoma City
country: United States
facility: 794
state: Oklahoma
city: Mansfield
country: United States
facility: 881
state: Texas
city: Madison
country: United States
facility: 790
state: Wisconsin
city: Chatswood
country: Australia
facility: 104
city: Clayton
country: Australia
facility: 105
city: East Gosford
country: Australia
facility: 106
city: Fitzroy
country: Australia
facility: 101
city: Heidelberg
country: Australia
facility: 108
city: Herston
country: Australia
facility: 103
city: Randwick
country: Australia
facility: 109
city: Brugge
country: Belgium
facility: 127
city: Brugge
country: Belgium
facility: 134
city: Hasselt
country: Belgium
facility: 128
city: Leuven
country: Belgium
facility: 126
city: Blagoevgrad
country: Bulgaria
facility: 805
city: Panagyurishte
country: Bulgaria
facility: 807
city: Pleven
country: Bulgaria
facility: 803
city: Russe
country: Bulgaria
facility: 810
city: Sofia
country: Bulgaria
facility: 811
city: Veliko Tarnovo
country: Bulgaria
facility: 809
city: Greenfield Park
country: Canada
facility: 152
city: Halifax Nova Scotia
country: Canada
facility: 158
city: Hamilton
country: Canada
facility: 156
city: St. John's
country: Canada
facility: 153
city: Brno
country: Czechia
facility: 185
city: Ostrava - Vitkovice
country: Czechia
facility: 190
city: Praha 5
country: Czechia
facility: 184
city: Praha 6
country: Czechia
facility: 189
city: Zlin
country: Czechia
facility: 180
city: Helsinki
country: Finland
facility: 205
city: Kuopio
country: Finland
facility: 207
city: Nancy
country: France
facility: 236
city: Altenburg
country: Germany
facility: 263
city: BAD Neustadt
country: Germany
facility: 265
city: Berlin
country: Germany
facility: 257
city: Berlin
country: Germany
facility: 262
city: Berlin
country: Germany
facility: 270
city: Goettingen
country: Germany
facility: 260
city: Leipzig
country: Germany
facility: 269
city: Marburg
country: Germany
facility: 256
city: Osnabrück
country: Germany
facility: 259
city: Ioannina
country: Greece
facility: 495
city: Thessalonikis
country: Greece
facility: 490
city: Thessalonikis
country: Greece
facility: 493
city: Balassagyarmat
country: Hungary
facility: 289
city: Budapest
country: Hungary
facility: 283
city: Budapest
country: Hungary
facility: 284
city: Debrecen
country: Hungary
facility: 286
city: Gyor
country: Hungary
facility: 282
city: Szeged
country: Hungary
facility: 285
city: Szekszárd
country: Hungary
facility: 290
city: Szombathely
country: Hungary
facility: 291
city: Bari
country: Italy
facility: 310
city: Modena
country: Italy
facility: 309
city: Padova
country: Italy
facility: 308
city: Prato
country: Italy
facility: 314
city: Roma
country: Italy
facility: 311
city: Asaka-shi
country: Japan
facility: 831
city: Hamamatsu-shi
country: Japan
facility: 833
city: Kagoshima-shi
country: Japan
facility: 834
city: Kamakura-shi
country: Japan
facility: 844
city: Miyazaki-shi
country: Japan
facility: 843
city: Nagoya-shi
country: Japan
facility: 835
city: Okayama-shi
country: Japan
facility: 837
city: Saitama-shi
country: Japan
facility: 828
city: Sapporo
country: Japan
facility: 847
city: Shizuoka-shi
country: Japan
facility: 832
city: Busan
country: Korea, Republic of
facility: 525
city: Daegu
country: Korea, Republic of
facility: 521
city: Daejeon
country: Korea, Republic of
facility: 518
city: Seoul
country: Korea, Republic of
facility: 517
city: Seoul
country: Korea, Republic of
facility: 519
city: Seoul
country: Korea, Republic of
facility: 520
city: Seoul
country: Korea, Republic of
facility: 523
city: Seoul
country: Korea, Republic of
facility: 524
city: Riga
country: Latvia
facility: 751
city: Alytus
country: Lithuania
facility: 727
city: Kaunas
country: Lithuania
facility: 724
city: Vilnius
country: Lithuania
facility: 728
city: San Luis Potosi
country: Mexico
facility: 547
city: Manila
country: Philippines
facility: 673
city: Pasig City
country: Philippines
facility: 672
city: Quezon City
country: Philippines
facility: 676
city: Gdansk
country: Poland
facility: 336
city: Katowice
country: Poland
facility: 340
city: Lublin
country: Poland
facility: 342
city: Poznan
country: Poland
facility: 341
city: Szczecin
country: Poland
facility: 338
city: Warszawa
country: Poland
facility: 343
city: Coimbra
country: Portugal
facility: 360
city: Lisboa
country: Portugal
facility: 362
city: Lisboa
country: Portugal
facility: 365
city: Porto
country: Portugal
facility: 366
city: Santa Maria da Feira
country: Portugal
facility: 361
city: Bucuresti
country: Romania
facility: 576
city: Cluj-napoca
country: Romania
facility: 569
city: Iasi
country: Romania
facility: 570
city: Iasi
country: Romania
facility: 579
city: Sibiu
country: Romania
facility: 571
city: Sibiu
country: Romania
facility: 577
city: Targu Mures
country: Romania
facility: 572
city: Kazan
country: Russian Federation
facility: 387
city: Kazan
country: Russian Federation
facility: 389
city: Kirov
country: Russian Federation
facility: 396
city: Moscow
country: Russian Federation
facility: 394
city: Moscow
country: Russian Federation
facility: 401
city: Nizhny Novgorod
country: Russian Federation
facility: 390
city: Novosibirsk
country: Russian Federation
facility: 392
city: Saint-Petersburg
country: Russian Federation
facility: 397
city: Saint-Petersburg
country: Russian Federation
facility: 400
city: Smolensk
country: Russian Federation
facility: 386
city: Yaroslavl
country: Russian Federation
facility: 399
city: Dolni Kubin
country: Slovakia
facility: 594
city: Dubnica Nad Vahom
country: Slovakia
facility: 598
city: Hlohovec
country: Slovakia
facility: 596
city: Krompachy
country: Slovakia
facility: 600
city: Levoca
country: Slovakia
facility: 595
city: Tornala
country: Slovakia
facility: 599
city: Zilina
country: Slovakia
facility: 601
city: Badalona
country: Spain
facility: 422
city: Barcelona
country: Spain
facility: 413
city: Girona
country: Spain
facility: 417
city: La Laguna
country: Spain
facility: 419
city: Madrid
country: Spain
facility: 416
city: Madrid
country: Spain
facility: 425
city: San Sebastián
country: Spain
facility: 418
city: Santiago de Compostela
country: Spain
facility: 414
city: Sevilla
country: Spain
facility: 424
city: Göteborg
country: Sweden
facility: 440
city: Linköping
country: Sweden
facility: 442
city: Stockholm
country: Sweden
facility: 438
city: Aarau
country: Switzerland
facility: 651
city: Biel
country: Switzerland
facility: 654
city: Lugano
country: Switzerland
facility: 653
city: Bangkok
country: Thailand
facility: 699
city: Bangkok
country: Thailand
facility: 702
city: Khon Kaen
country: Thailand
facility: 698
city: Chernihiv
country: Ukraine
facility: 622
city: Kharkov
country: Ukraine
facility: 626
city: Luhansk
country: Ukraine
facility: 621
city: Odesa
country: Ukraine
facility: 625
city: Simferopol
country: Ukraine
facility: 632
city: Glasgow
country: United Kingdom
facility: 472
city: Stoke-on-Trent
country: United Kingdom
facility: 471
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
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.