Lacosamide (Vimpat®) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language summary Publication (if available) Epilepsy A Study to Evaluate the Efficacy and Safety of Adjunctive Therapy With Lacosamide in Adults With Partial Onset Seizures Phase 3 EP0008 Completed NCT017106572014-003622-41 LINKLINK PDF Hong, Z et al., Epilepsy Res;2016;127;267-275 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 NCT018320382019-004756-11 LINKLINK Inoue Y. et al. Epilepsy Res 2021; 48:106705 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 Completed NCT024085492012-001770-29 LINKLINK O'Brien T.J., [abstract 128] 74th Annual Meeting of the American Epilepsy Society (AES), December 04-08, 2020; Online www.aesnet.org 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 PDF 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 NCT019645602012-005012-26 LINKLINK PDF PDF Potter B., et al. Ann Neurol 2021; 90(Suppl. 26):S130-S132 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 & New Remedies 2019; 56(1):1–10 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 NCT027108902014-003294-42 LINKLINK Farkas M.K., et al. Trial Epilepsia Open 2023; 8(1):146–53 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 NCT046272852020-001478-30 Oshima Y. et al., Shinryo to Shinyaku 2022; 59(1):33–44 [In Japanese] 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 NCT046272852020-001478-302022-502639-21-00 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 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. 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. 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 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. 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" Neuropathic Pain Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy. Phase 3 SP0746 Completed NCT005463512004-000551-42 LINKLINK "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." 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 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 NCT002204152004-000290-58 LINK PDF PDF Halasz, P. et al. Epilepsia;2009;50:443-453. Epilepsy Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures Phase 3 SP0756 Completed NCT005222752014-004398-18 LINKLINK Husain, A. et al. Epilepsia;2012;53(3);521-528. Epilepsy Safety and Tolerability of Intravenous SPM 927 as Replacement for Oral SPM 927 in Subjects With Partial Seizures Phase 3 SP0757 Completed NCT001518792004-002322-22 LINK PDF Krauss, G. et al. Epilepsia;2010;51(6);951-957. 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 Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures Phase 3 SP0774 Completed NCT005156192004-000152-16 LINKLINK Rosenow, F. et al., Acta Neurol Scand;2016;133;2;136-144 Neuropathic Pain A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy Phase 3 SP0830 Completed NCT002203372004-000960-28 LINKLINK PDF "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 Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures Phase 2 SP0847 Completed NCT009384312011-001558-27 LINKLINK PDF Ferreira J.A., et al. Seizure 2019; 71:166–73 Neuropathic Pain A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Phase 3 SP0874 Completed NCT003501032005-005788-27 LINKLINK PDF "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. " 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." Epilepsy Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT) Phase 3 SP0902 Completed NCT005207412007-005439-27 LINKLINK PDF PDF Wechsler, R.T. et al. Epilepsia;2014;55(7):1088–1098. 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 NCT005308552007-005440-25 LINKLINK PDF "Vossler, D. G., W et al. Epilepsia;2016;57;10;1625-1633 " Osteoarthritis Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee Phase 2 SP0905 Terminated NCT004854722006-005048-97 LINKLINK "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 Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3 SP0925 Completed NCT006555512014-004378-40 LINKLINK Fountain, N.B. et al. Epilepsia;2013;54(1);58-65. Epilepsy Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures Phase 3 SP0926 Completed NCT006554862014-004384-21 LINKLINK "Leroy, R.F. et al. Epilepsia;2011;52;Suppl. 6;29. 29th International Epilepsy Congress (IEC), August 28-September 1, 2011;Rome, Italy." Epilepsy Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures Phase 4 SP0954 Completed NCT009553572009-011181-28 LINKLINK Waldman Zadeh, W. et al., Seizure;2015;31;72-79 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 NCT011189492014-004379-22 LINKLINK "Wechsler, RT.et al Epilepsy Res;2017;130;13-20 " 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 NCT011189622014-004375-23 LINKLINK Wechsler, RT.et al Epilepsy Res;2017;130;13-20 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 NCT019698512012-001446-18 LINKLINK Auvin S., et al. Epilepsia 2023; 64(11):2947–57 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 NCT024778392013-000717-20 LINKLINK Bozorg A., et al. Ann Clin Transl Neurol 2024; 11(3):780–90 Makedonska I.et al. Ann Clin Transl Neurol 2024; 11(3):768–79 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 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 NCT019212052012-004996-38 LINKLINK PDF Farkas V. et al. Neurology 2019; 93(12):e1212-e1226 Epilepsy Hormonal and Lipid Levels in Male Subjects After a Switch From Carbamazepine to Lacosamide (VICTOR) Phase 3 SP0978 Terminated NCT013753742010-022534-84 LINKLINK Elger et al. Epilepsy Behav;7-15-2016;13;62;1-5 Epilepsy eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam (VERVE) Phase 3 SP0980 Completed NCT014849772011-002461-37 LINKLINK Baulac, M., et al. Acta Neurol Scand;2017;135;4;434-441 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 NCT024085232011-003100-21 LINKLINK PDF "Vossler D.G.,et al. J Neurol Neurosurg Psychiatry 2020; 91(10):1067-1075. " 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 NCT012431772010-019765-28 LINKLINK PDF PDF "Baulac, M., et al. Lancet Neurol;2017;16;1;43-54 " Exploratory post hoc analysis : Terada K., et al. Seizure 2023;112:62–7 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 NCT014659972010-021238-74 LINKLINK PDF Ben‐Menachem E., Epilepsia 2019; 60(12):2437–47 Epilepsy Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF) Phase 4 SP1007 Completed NCT012354032010-019268-35 LINKLINK Baulac, M., et al. Epileptic Disord.;2017;19;2;186-194 Epilepsy A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 Phase 3 SP1042 Completed NCT025828662015-001549-96 LINKLINK Ben-Menachem E., et al. Epilepsia Open 2021; 6(3):618–23 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 PDF Epilepsy A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 (n/a) Phase 2 SP616 Completed NCT00800215 PDF Biton,V. et al. Epilepsia;2008;49(3);418-424. Epilepsy Lacosamide in Adults for the Treatment of Epileptic Partial Seizures Phase 2 SP667 Completed PDF Epilepsy An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy Phase 2 SP848 Completed NCT009389122011-001559-35 LINKLINK PDF Jiang W. et al. China J Appl Clin Pediatr 2023; 38(11):850–6
