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Lacosamide (Vimpat®)

Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available)
Epilepsy 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) Phase 3 SP0993
Completed
NCT01243177
2010-019765-28
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"Baulac, M., et al. Lancet Neurol;2017;16;1;43-54 "
Neuropathic Pain A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Phase 3 SP0874
Completed
NCT00350103
2005-005788-27
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"Bongardt, S. et al. Ann Neurol;2008;64;Suppl 12;S25. 133rd Annual Meeting of the American Neurological Association (ANA), September 21-24, 2008;Salt Lake City, USA. "
Neuropathic Pain Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy. Phase 3 SP0746
Completed
NCT00546351
2004-000551-42
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"Bretschneider, M. et al. J Pain;2006;7;4 Suppl 1;S43. 25th Annual Scientific Meeting of the American Pain Society (APS), May 3-6, 2006;San Antonio, USA. Hidvegi, T. et al. Eur J Neurol;2008;15;Suppl 3;324-325. 12th Congress of the European Federation of Neurological Societies (EFNS), August 23-26, 2008;Madrid, Spain."
Osteoarthritis Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee Phase 2 SP0905
Terminated
NCT00485472
2006-005048-97
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"Daniels , T. et al. Epilepsy Curr;2011;11;1 Suppl. 1:abs 1.284. 64th Annual Meeting of the American Epilepsy Society (AES), December 3-7, 2010;San Antonio, USA."
Fibromyalgia Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome. Phase 2 SP0887
Completed
NCT00401830 LINK
"Daniels, T. et al. Epilepsy Curr;2011;11;1 Suppl. 1:abs 1.284. 64th Annual Meeting of the American Epilepsy Society (AES), December 3-7, 2010;San Antonio, USA."
Migraine disorders A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis Phase 2 SP0906
Completed
NCT00440518 PDF
"Daniels, T. et al. Epilepsy Curr;2011;11;1 Suppl. 1:abs 1.284. 64th Annual Meeting of the American Epilepsy Society (AES), December 3-7, 2010;San Antonio, USA."
Epilepsy An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy Phase 2 SP848
Completed
NCT00938912
2011-001559-35
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"Ferreira, J. et al 2016; [abstract 1.269] 70th Annual Meeting of the American Epilepsy Society (AES), December 2-6, 2016;Houston, USA www.aesnet.org "
Neuropathic Pain A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy Phase 2 SP0745
Completed
NCT00235443 LINK
"Graf, R. et al. Eur J Neurol;2007;14(Suppl. 1):260, abs P2389. 11th Congress European Federation of Neurological Societies (EFNS); August 25-28, 2007; Brussels, Belgium"
Epilepsy Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3 SP0926
Completed
NCT00655486
2014-004384-21
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"Leroy, R.F. et al. Epilepsia;2011;52;Suppl. 6;29. 29th International Epilepsy Congress (IEC), August 28-September 1, 2011;Rome, Italy."
Neuropathic Pain A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy Phase 3 SP0830
Completed
NCT00220337
2004-000960-28
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"Simpson, K.H. et al. Eur J Pain;2006;10;Suppl 1;S167. Pain in Europe: 5th Congress of the European Federation of IASP Chapters (EFIC), September 13-16, 2006;Istanbul, Turkey."
Epilepsy A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications (VALOR) Phase 3 SP0982
Completed
NCT02408523
2011-003100-21
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"Vossler D.G.,et al. J Neurol Neurosurg Psychiatry 2020; 91(10):1067-1075. "
Epilepsy Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures Phase 3 SP0904
Completed
NCT00530855
2007-005440-25
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"Vossler, D. G., W et al. Epilepsia;2016;57;10;1625-1633 "
Epilepsy Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy Phase 2 SP0961
Completed
NCT01118949
2014-004379-22
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"Wechsler, RT.et al Epilepsy Res;2017;130;13-20 "
Epilepsy eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (VERVE) Phase 3 SP0980
Completed
NCT01484977
2011-002461-37
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Baulac, M., et al. Acta Neurol Scand;2017;135;4;434-441
Epilepsy Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF) Phase 4 SP1007
Completed
NCT01235403
2010-019268-35
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Baulac, M., et al. Epileptic Disord.;2017;19;2;186-194
Epilepsy Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older Phase 3 SP0994
Completed
NCT01465997
2010-021238-74
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Ben‐Menachem E., Epilepsia 2019; 60(12):2437–47
Epilepsy A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 Phase 3 SP1042
Completed
NCT02582866
2015-001549-96
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Ben-Menachem E., et al. Epilepsia Open 2021; 6(3):618–23
Epilepsy A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 (n/a) Phase 2 SP0616
Completed
NCT00800215 PDF Biton,V. et al. Epilepsia;2008;49(3);418-424.
Epilepsy SPM 927 (400mg/Day and 600mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization Phase 3 SP0754
Completed
NCT00136019 PDF PDF Chung , S. et al. Epilepsia;2010;51;958-967.
Epilepsy Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide (VICTOR) Phase 3 SP0978
Terminated
NCT01375374
2010-022534-84
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Elger et al. Epilepsy Behav;7-15-2016;13;62;1-5
Epilepsy A MULTICENTER, OPEN-LABEL STUDY TO INVESTIGATE THE SAFETY AND TOLERABILITY OF INTRAVENOUS LACOSAMIDE AS REPLACEMENT FOR ORAL LACOSAMIDE IN CHILDREN (≥4 TO <17 YEARS OF AGE) WITH EPILEPSY Phase 2 EP0060
Completed
NCT02710890
2014-003294-42
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Farkas M.K., et al. Epilepsia Open 2022 [ePub]
Epilepsy Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures Phase 3 SP0969
Completed
NCT01921205
2012-004996-38
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Farkas V. et al. Neurology 2019; 93(12):e1212-e1226
Epilepsy A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures Phase 2 SP0847
Completed
NCT00938431
2011-001558-27
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Ferreira J.A., et al. Seizure 2019; 71:166–73
Epilepsy Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3 SP0925
Completed
NCT00655551
2014-004378-40
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Fountain, N.B. et al. Epilepsia;2013;54(1);58-65.
Epilepsy A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Trial to Investigate the Efficacy and Safety of SPM 927 (200mg/Day and 400mg/Day) as Adjunctive Therapy in Subjects With Partial Seizures With or Without Secondary Generalization Phase 3 SP0755
Completed
NCT00220415
2004-000290-58
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PDF Halasz, P. et al. Epilepsia;2009;50:443-453.
Epilepsy A Study to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial Onset Seizures Phase 3 EP0008
Completed
NCT01710657
2014-003622-41
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PDF Hong, Z et al., Epilepsy Res;2016;127;267-275
Epilepsy Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures Phase 3 SP0756
Completed
NCT00522275
2014-004398-18
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Husain, A. et al. Epilepsia;2012;53(3);521-528.
Epilepsy Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures Phase 3 EP0009
Completed
NCT01832038
2019-004756-11
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Inoue Y. et al. Epilepsy Res 2021; 48:106705
Repeated Electroencephalographic Neonatal Seizures A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Lacosamide in Neonates With Repeated Electroencephalographic Neonatal Seizures (LENS) Phase 2/3 SP0968
Ongoing
NCT04519645 Jayakar A., et al. 2022 [ abstract 2.477] 76th annual meeting of American Epilepsy Society (AES), December 02-06, 2022; Nashville, USA Online www.aesnet.org
Epilepsy Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures Phase 3 SP0757
Completed
NCT00151879
2004-002322-22
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Krauss, G. et al. Epilepsia;2010;51(6);951-957.
Neuropathic Pain An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain Phase 2 SP0647
Completed
NCT00237458 LINK
McCleane,G. et al. J Neuropath Pain Sympt Palliat;2005;1(1);25-28.
Epilepsy An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy Phase 3 EP0012
Ongoing
NCT02408549
2012-001770-29
O'Brien T.J., [abstract 128] 74th Annual Meeting of the American Epilepsy Society (AES), December 04-08, 2020; Online www.aesnet.org
Epilepsy A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment Phase 3 EP0081
Ongoing
NCT04627285
2020-001478-30
Oshima Y. et al., Shinryo to Shinyaku 2022; 59(1):33–44 [In Japanese]
Epilepsy A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures Phase 3 EP0034
Completed
NCT01964560
2012-005012-26
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Potter B., et al. Ann Neurol 2021; 90(Suppl. 26):S130-S132
Epilepsy To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures Phase 2 SP0615
Completed
NCT00552305 LINK
Rosenfeld, W. et al., Epilepsy Behav;2014;41;164-170
Epilepsy Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures Phase 3 SP0774
Completed
NCT00515619
2004-000152-16
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Rosenow, F. et al., Acta Neurol Scand;2016;133;2;136-144
Neuropathic Pain An Open-label follow-on Trial to Assess the Long-term Safety and Efficacy of Oral SPM 927 in Subjects With Diabetic Neuropathy Phase 2 SP0665
Completed
NCT00861042 Shaibani, A. et al. Eur J Pain;2009;13(5);458-463.
Neuropathic Pain Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy Phase 3 SP0768
Completed
NCT00135109 PDF Shaibani,A. et al. J Pain;2009;10(8);818-828.
Epilepsy A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures Phase 3 EP0057
Completed
NCT02124564 LINK
Terada K, et al. Shinryo to Shinyaku - Medical Consultation &amp; New Remedies 2019; 56(1):1–10
Epilepsy Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures Phase 4 SP0954
Completed
NCT00955357
2009-011181-28
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Waldman Zadeh, W. et al., Seizure;2015;31;72-79
Epilepsy Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT) Phase 3 SP0902
Completed
NCT00520741
2007-005439-27
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Wechsler, R.T. et al. Epilepsia;2014;55(7):1088–1098.
Epilepsy Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy Phase 2 SP0962
Completed
NCT01118962
2014-004375-23
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Wechsler, RT.et al Epilepsy Res;2017;130;13-20
Neuropathic Pain A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy Phase 2 SP0742
Completed
NCT00235469 PDF Wymer, J.et al. Clin J Pain;2009;25(5);376-385.
Neuropathic Pain A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy Phase 3 SP0743
Completed
NCT00238524 PDF Ziegler, D. et al. Diabetes Care;2010;33(4);839-841.
Epilepsy Open-label Study to Evaluate the Safety and Tolerability of iv Lacosamide in Japanese Adults With Partial-onset Seizures Phase 3 EP0024
Completed
NCT02192814 LINK
Epilepsy A Study to Test the Long-term Use of Oral Lacosamide in Pediatric Study Participants Who Completed NCT01964560 (EP0034) or NCT00938912 (SP848) and Received Lacosamide Treatment Phase 3 EP0151
Ongoing
NCT04627285
2020-001478-30
Postherpetic Neuralgia An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN) Phase 2 SP0690
Completed
NCT00238511 PDF
Epilepsy A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures. Phase 3 SP0966
Completed
NCT01969851
2012-001446-18
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Epilepsy A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥1 Month to <4 Years of Age With Partial-onset Seizures Phase 3 SP0967
Completed
NCT02477839
2013-000717-20
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Epilepsy A Multicenter, Open-Label Study to Investigate the Pharmacokinetics of Commercial Lacosamide Oral Formulation as Therapy in Children (Aged 1 Month to 17 Years) With Epilepsy Phase 1 SP1047
Completed
2014-002629-36 LINK
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