Disease area studied	Abbreviated title	Phase	Study ID	Registry database	Study results	Lay 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	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	NCT01832038 2019-004756-11	LINK		Inoue Y. et al. Epilepsia 2019; 60(Suppl.2):62, abs p116
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			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
Epilepsy	Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures	Phase 3	EP0034 Ongoing	NCT01964560 2012-005012-26	PDF		Potter B, et al. Neurology 2018; 90(15 Suppl.) abs. P1,027 70th Annual meeting of American Academy of Neurology (AAN), April 21-April 27, 2018; Los Angeles, USA
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
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	A Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous SPM 927 (n/a)	Phase 2	SP0616 Completed	NCT00800215	PDF		Biton et al. Epilepsia; 2008;49(3);418-424.
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 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 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 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 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 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 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 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 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 PDF	PDF	Halasz 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 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 PDF		Krauss 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 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;7-2-2015;
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 PDF		Simpson 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 PDF		Ferreira, J. A., et al. Eur J Paediatr Neurol;2015;19;Suppl. 1;S56-S57, abs PP07.5-225 11th Congress of the European Paediatric Neurology Society (EPNS), May 27-30, 2015;Vienna, Austria
Epilepsy	An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy	Phase 2	SP0848 Ongoing	NCT00938912 2011-001559-35	PDF		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 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 PDF		Bongardt 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 et al. Epilepsy Curr;2010;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 PDF		Wechsler 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 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	NCT00485472 2006-005048-97	LINK LINK		Daniels et al. Epilepsy Curr;2010;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	LINK		Daniels et al. Epilepsy Curr;2010;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 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 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 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
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
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 PDF		Baulac, M., et al. Lancet Neurol;2017; 16;1;43-54
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 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	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
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

Our Company

Disease Areas

Our Science

UCB Worldwide

Our Products

Newsroom

Patients

Investors

HCP

Clinical Studies

Advantage Hers

Choose a Country

Vimpat® (lacosamide)