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 |
NCT01710657 2014-003622-41 |
LINK LINK |
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 |
NCT01832038 2019-004756-11 |
LINK LINK |
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 |
NCT02408549 2012-001770-29 |
LINK LINK |
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
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| 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 |
LINK LINK |
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 |
NCT02710890 2014-003294-42 |
LINK LINK |
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 |
NCT04627285 2020-001478-30 |
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 |
NCT04627285 2020-001478-30 2022-502639-21-00 |
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| Epilepsy | To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures | Phase 2 |
SP0615
Completed |
NCT00552305 |
LINK
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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
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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 | |||
| 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 | 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 | 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
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"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 |
NCT00546351 2004-000551-42 |
LINK LINK |
"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 | 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 |
NCT00220415 2004-000290-58 |
LINK
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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 |
NCT00522275 2014-004398-18 |
LINK LINK |
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 |
NCT00151879 2004-002322-22 |
LINK
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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 | 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 |
NCT00515619 2004-000152-16 |
LINK LINK |
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 |
NCT00220337 2004-000960-28 |
LINK LINK |
"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 |
NCT00938431 2011-001558-27 |
LINK LINK |
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 |
NCT00350103 2005-005788-27 |
LINK LINK |
"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 |
NCT00520741 2007-005439-27 |
LINK LINK |
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 |
NCT00530855 2007-005440-25 |
LINK LINK |
"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 |
NCT00485472 2006-005048-97 |
LINK 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
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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." | |
| 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 |
LINK LINK |
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 |
NCT00655486 2014-004384-21 |
LINK LINK |
"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 |
NCT00955357 2009-011181-28 |
LINK LINK |
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 |
NCT01118949 2014-004379-22 |
LINK LINK |
"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 |
NCT01118962 2014-004375-23 |
LINK LINK |
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 |
NCT01969851 2012-001446-18 |
LINK LINK |
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 |
NCT02477839 2013-000717-20 |
LINK LINK |
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 |
NCT01921205 2012-004996-38 |
LINK LINK |
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 |
NCT01375374 2010-022534-84 |
LINK LINK |
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 |
NCT01484977 2011-002461-37 |
LINK LINK |
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 |
NCT02408523 2011-003100-21 |
LINK LINK |
"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 |
NCT01243177 2010-019765-28 |
LINK LINK |
"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 |
NCT01465997 2010-021238-74 |
LINK LINK |
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 |
NCT01235403 2010-019268-35 |
LINK LINK |
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 |
NCT02582866 2015-001549-96 |
LINK LINK |
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
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| Epilepsy | A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 (n/a) | Phase 2 |
SP616
Completed |
NCT00800215 | 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 |
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| 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 |
LINK LINK |
Jiang W. et al. China J Appl Clin Pediatr 2023; 38(11):850–6 |