Safety and Efficacy of Lacosamide as Additional Therapy in Patients Suffering From Epileptic Tonic-Clonic Seizures
NCT ID: NCT02408549
Last Updated: 2023-12-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2015-08-03
2023-03-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Lacosamide
Start dose
SP0982 completers at V1:
* LCM 10 mg/kg/day for pediatric subjects weighing \<30 kg
* LCM 8 mg/kg/day for pediatric subjects weighing ≥ 30kg to \<50 kg
* LCM 400 mg/day (200 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg
SP0982 Baseline failures at V1:
* LCM 2 mg/kg/day for pediatric subjects weighing \<50 kg
* LCM 100 mg/day (50 mg bid) for adult subjects (≥18 years of age) or pediatric subjects weighing ≥50 kg
Oral solution (pediatric subjects \<50 kg):
* Minimum LCM dose: 4 mg/kg/day
* Maximum LCM dose: 12 mg/kg/day
Tablets (pediatric subjects ≥50kg):
* Minimum LCM dose: 200 mg/day
* Minimum LCM dose: 600 mg/day
Tablets (adult subjects):
* Minimum LCM dose: 200 mg/day
* Maximum LCM dose: 800 mg/day
Lacosamide Tablet
* Active substance: Lacosamide
* Pharmaceutical form: Tablet
* Concentration: 50 mg and 100 mg
* Route of Administration: Oral administration
Lacosamide Oral Solution
* Active substance: Lacosamide
* Pharmaceutical form: Oral solution
* Concentration: 10 mg/ml
* Route of Administration: Oral administration
Interventions
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Lacosamide Tablet
* Active substance: Lacosamide
* Pharmaceutical form: Tablet
* Concentration: 50 mg and 100 mg
* Route of Administration: Oral administration
Lacosamide Oral Solution
* Active substance: Lacosamide
* Pharmaceutical form: Oral solution
* Concentration: 10 mg/ml
* Route of Administration: Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject meets the withdrawal criteria for SP0982 or is experiencing an ongoing serious adverse event (SAE)
* Subject has an active suicidal ideation as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the "Since Last Visit" version of the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Subject has \>=2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>ULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%). For all subjects who entered EP0012 directly with a Baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a Baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the electronic Case Report form (eCRF). Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation.
4 Years
ALL
No
Sponsors
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UCB BIOSCIENCES, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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EP0012 5
Little Rock, Arkansas, United States
EP0012 8
Santa Monica, California, United States
Ep0012 31
Colorado Springs, Colorado, United States
Ep0012 42
Loxahatchee Groves, Florida, United States
Ep0012 13
Panama City, Florida, United States
EP0012 2
Port Charlotte, Florida, United States
Ep0012 15
Boise, Idaho, United States
Ep0012 21
Peoria, Illinois, United States
Ep0012 25
Golden Valley, Minnesota, United States
Ep0012 43
New York, New York, United States
Ep0012 53
Austin, Texas, United States
Ep0012 50
Greenville, Texas, United States
Ep0012 34
Houston, Texas, United States
Ep0012 38
San Antonio, Texas, United States
Ep0012 27
Renton, Washington, United States
Ep0012 23
Madison, Wisconsin, United States
Ep0012 980
Chatswood, , Australia
Ep0012 985
Heidelberg, , Australia
Ep0012 986
Melbourne, , Australia
Ep0012 981
Parkville, , Australia
Ep0012 181
Curitiba, , Brazil
Ep0012 180
Florianópolis, , Brazil
Ep0012 186
Passo Fundo, , Brazil
Ep0012 185
Porto Alegre, , Brazil
Ep0012 188
Rio de Janeiro, , Brazil
Ep0012 183
São Paulo, , Brazil
Ep0012 500
Blagoevgrad, , Bulgaria
Ep0012 501
Sofia, , Bulgaria
Ep0012 971
Beijing, , China
Ep0012 976
Changchun, , China
Ep0012 972
Shanghai, , China
Ep0012 550
Ostrava- Poruba, , Czechia
Ep0012 553
Prague, , Czechia
Ep0012 556
Prague, , Czechia
Ep0012 552
Zlín, , Czechia
Ep0012 255
Bron, , France
Ep0012 252
Lille, , France
Ep0012 251
Nancy, , France
Ep0012 303
Erlangen, , Germany
Ep0012 314
Freiburg im Breisgau, , Germany
Ep0012 311
Marburg, , Germany
Ep0012 600
Budapest, , Hungary
Ep0012 603
Szeged, , Hungary
Ep0012 850
Rehovot, , Israel
Ep0012 851
Tel Litwinsky, , Israel
Ep0012 351
Torino, , Italy
Ep0012 906
Fukuoka, , Japan
Ep0012 910
Gifu, , Japan
Ep0012 903
Hamamatsu, , Japan
Ep0012 902
Hiroshima, , Japan
Ep0012 912
Kagoshima, , Japan
Ep0012 914
Kodaira, , Japan
Ep0012 909
Kokubunji-shi, , Japan
Ep0012 901
Niigata, , Japan
Ep0012 911
Omura-shi, , Japan
Ep0012 900
Sapporo, , Japan
Ep0012 908
Shinjuku-ku, , Japan
Ep0012 161
Guadalajara, , Mexico
Ep0012 657
Częstochowa, , Poland
Ep0012 655
Gdansk, , Poland
Ep0012 652
Gliwice, , Poland
Ep0012 651
Katowice, , Poland
Ep0012 653
Katowice, , Poland
Ep0012 654
Katowice, , Poland
Ep0012 656
Tyniec Mały, , Poland
Ep0012 650
Warsaw, , Poland
Ep0012 659
Warsaw, , Poland
Ep0012 451
Lisbon, , Portugal
Ep0012 704
Iași, , Romania
Ep0012 700
Timișoara, , Romania
Ep0012 750
Kazan', , Russia
Ep0012 758
Pyatigorsk, , Russia
Ep0012 755
Saint Petersburg, , Russia
Ep0012 756
Saint Petersburg, , Russia
Ep0012 752
Samara, , Russia
Ep0012 757
Yekaterinburg, , Russia
Ep0012 821
Bardejov, , Slovakia
Ep0012 823
Hlohovec, , Slovakia
Ep0012 940
Daegu, , South Korea
Ep0012 941
Seoul, , South Korea
Ep0012 944
Seoul, , South Korea
Ep0012 402
Barcelona, , Spain
Ep0012 406
Córdoba, , Spain
Ep0012 407
Madrid, , Spain
Ep0012 403
Seville, , Spain
Ep0012 961
Taichung, , Taiwan
Ep0012 960
Taipei, , Taiwan
Countries
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References
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Vossler DG, Farkas MK, Poverennova I, Watanabe M, Conrath P, Dimova S, McClung C, Roebling R, Williams P, O'Brien TJ; EP0012 Study Group. Long-term safety and efficacy of adjunctive lacosamide in the treatment of generalized onset tonic-clonic seizures: An open-label extension trial. Epilepsia. 2024 Dec;65(12):3488-3500. doi: 10.1111/epi.18158. Epub 2024 Oct 26.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-001770-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EP0012
Identifier Type: -
Identifier Source: org_study_id