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Our Science Lacosamide (Vimpat®)

Clinical Study Information - Vimpat® (lacosamide)

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

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
Ongoing
NCT01832038
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
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
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 Yamamoto T., et al. [abstract 1.292] available on Annual Meeting Abstract Database www.aesnet.org
 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
Ongoing
NCT02710890
2014-003294-42
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 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
PDF

LINK
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
PDF

LINK
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

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
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
PDF

LINK

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

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


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 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
 

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
Ongoing
NCT02477839
2013-000717-20
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
Farkas V. et al. Ann Neurol 2017;  82(Suppl. 21):S287-S290 46th Annual Meeting of the Child Neurology Society (CNS), October 04-07, 2017;  Missouri, USA
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
Ongoing
NCT02408523
2011-003100-21
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

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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LINK
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 A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994 Phase 3 SP1042
Ongoing
NCT02582866
2015-001549-96