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Our Science Levetiracetam (Keppra®)

Clinical Study Information - Keppra® (levetiracetam)

Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Lay summary Publication (if available)
Epilepsy A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age Phase 3 EP0100
Ongoing
NCT03340064
Epilepsy A Placebo-controlled Study of Levetiracetam In Children (1mo to 4yrs of Age) With Partial Onset Seizures. Phase 3 N01009
Completed
NCT00175890
2004-000199-14
PDF
LINK
Pina-Garza et al. Epilepsia;2009;50(5); 1141-1149.
Epilepsy Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method Phase 3 N01020
Completed
NCT00160615 PDF
Yagi, K.,  J Japan Epilepsy Society;2-10-2012; 29;3;441-454 [In Japanese]
Epilepsy S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01031
Completed
NCT00630968 PDF
Steinhoff et al. Epilepsy Res; 2007;76(1);6-14.
Epilepsy Pharmacovigilance Study of Keppra. SPAIN - SKATE : Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01033
Completed
NCT00643500 PDF
Salas-Puig et al. Rev Neurol; 2004;16-30;38;1117–1122. [in Spanish]
Epilepsy A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy Phase 4 N01035
Completed
NCT00631150 PDF
Epilepsy Open Label Safety and Efficacy Study of Levetiracetam in Patients With Epilepsy Phase 4 N01036
Completed
NCT00160654 PDF
Kwan et al. Epilepsy Behav; 2010;18(1-2);100-105.
Epilepsy Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy Phase 4 N01037
Completed
NCT00630357 PDF
Epilepsy Pharmacokinetic Study of Levetiracetam in Epileptic Pediatric Subjects Ranging in Age From 1 Month to Less Than 4 Years Old Phase 2 N01052
Completed
NCT00544050 PDF
Glauser et al. Epilepsia; 2007;48(6);1117-1122.
Epilepsy Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures Phase 3 N01057
Completed
NCT00160550 PDF
PDF Berkovic et al. Neurology; 2007;69(18);1751-1760.
Epilepsy Monotherapy With Levetiracetam in Newly Diagnosed Patients Suffering From Epilepsy Phase 3 N01061
Completed
NCT00150735 PDF
PDF Brodie et al. Neurology; 2007;68(6);402-408.
Epilepsy Determine Effects of Adjunctive Levetiracetam on Sleep Architecture in Adults With Partial Onset Epilepsy. Phase 4 N01085
Completed
NCT00245713 PDF
Anxiety Disorder Study to Assess the Efficacy and Safety of Levetiracetam for the Treatment of Social Anxiety Disorder (Generalized Type) Phase 2 N01086
Completed
NCT00612859 PDF
Stein, M. B. et al., Journal of Clinical Psychiatry;2010;71; 5;627-631
Postherpetic Neuralgia A 16 Week Study Evaluating Levetiracetam in the Treatment of Post Herpetic Neuralgia (PHN) Phase 2 N01087
Completed
NCT00160511 PDF
Epilepsy Study on Safety and Efficacy of Levetiracetam in the Adjunctive Treatment of Female Subjects With C1 Catamenial Epilepsy Phase 4 N01088
Completed
NCT00630630 PDF
Epilepsy Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy. Phase 3 N01093
Completed
NCT00150787 PDF
Sethi et al. Neurology; 2007;69(9);937-938.
Epilepsy Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy Phase 3 N01099
Completed
NCT00160628 PDF
Heo et al. Seizure; 2007;16(5);402-409.
Epilepsy Double-blind, Placebo-controlled Study of Levetiracetam in Adults With POS Phase 3 N01102
Completed
NCT00152373 Wu et al. Epilepsia;2009;50(3) ;398-405.
Epilepsy A 19-week Cognition Study of Levetiracetam in Children With Partial Onset Seizures Phase 2 N01103
Completed
NCT00105040
2014-004396-23
PDF

LINK
Levisohn et al. Epilepsia;2009;50(11) ;2377-2389.
Parkinson's Disease Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome Dyskinesias Phase 2 N01105
Completed
NCT00160576

PDF
Ferreira, J.  Eur J Neurol;2004;11;Suppl 2;331 8th Congress of the European Federation of Neurological Societies (EFNS), September 4-7, 2004;Paris, France
Epilepsy Monotherapy With Levetiracetam in Patients Suffering From Epilepsy. Phase 3 N01127
Completed
NCT00150813 PDF
Tardive Dyskinesia Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia Phase 2 N01142
Completed
NCT00175955
2004-001302-27
PDF
Epilepsy Long-Term, Follow-Up Study Of the Safety And Efficacy Of Levetiracetam In Children With Partial Onset Seizures Phase 3 N01148
Completed
NCT00152516
2004-000200-40
LINK
LINK

Schiemann-Delgado et al.J Child Neurol; 2012;27(1);80-89.
Epilepsy A Double-blind, Placebo-controlled Study of Levetiracetam in Epilepsy Patients With Generalized Tonic-clonic Seizures Except Partial Seizures Evolving to Secondarily Generalized Seizures) Phase 3 N01159
Completed
NCT01228747
2014-004401-32
LINK
LINK

Wu L., et al. Epilepsia Open 2018 [ePub]
Epilepsy Safety and Tolerability of Levetiracetam Intravenous 15 Minute Infusion in Subjects Suffering From Partial Onset Seizures Phase 2 N01166
Completed
NCT00610454 PDF
Baulac et al. Epilepsia; 2007;48(3);589-592.
Epilepsy Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy Phase 3 N01175
Completed
NCT00175903
2004-001339-41
PDF

LINK
Trinka et al. J Neurol Neurosurg Psychiatry;2013;84(10);1138-1147
Pohlmann-Eden, B., et al. BMC Neurol;2016;16;1;149.
Epilepsy A Double-blind Confirmatory Trial of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures Phase 3 N01221
Completed
NCT00280696
2014-004333-57
PDF
Inoue, Y. et al., Psychiatry Clin Neurosci; 2015;69;10;640-648
Epilepsy A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures Phase 3 N01222
Completed
NCT00367432
2014-004334-26
LINK
LINK


Yagi, K., Japan J Clin Psychopharm;2016;19; 1027-1040 [In Japanese]
Epilepsy An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures Phase 3 N01223
Completed
NCT01063764
2014-004335-39
LINK
LINK

Nakamura et al. Brain Nerve; 2013;65(9);1083-1092. [in Japanese]
Epilepsy A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR Phase 3 N01235
Completed
NCT00368069
2006-000987-10
LINK
LINK

Peltola et al. Epilepsia;2009;50(3); 406-414.
Epilepsy Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903). Phase 3 N01237
Completed
NCT00291655
2006-000173-29
LINK
LINK


Epilepsy Cross Sectional Study to Evaluate the Acceptability of Oral Solution of Levetiracetam Phase 4 N01242
Completed
NCT00319605 Matías-Guíu et al. Methods Find Exp Clin Pharmacol;2010; 32(7);507-516.
Epilepsy Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy Phase 2 N01274
Completed
NCT00535392
2006-005722-23
LINK
LINK

PDF Weinstock et al. J Child Neurol; 2013;28(11);1423-1429.
Epilepsy Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy Phase 2 N01275
Completed
NCT00505934
2007-003517-13
LINK
LINK

PDF Weinstock et al. J Child Neurol; 2013;28(11);1423-1429.
Epilepsy Conversion to Monotherapy Study With Keppra XR for Partial Seizures Phase 3 N01280
Completed
NCT00419094 LINK
Chung et al. Epilepsy Res; 2012;101(1-2);92-102.
Epilepsy Long Term Follow-up Study With Keppra XR (Levetiracetam XR) for Partial Seizures Phase 3 N01281
Completed
NCT00419393 LINK
LINK
Chung, S., et al. Epilepsy Res;2016; 120;7-12
Epilepsy Study Evaluating the Pharmacokinetics of Keppra Extended Release (XR) in Children and Adults With Epilepsy Phase 2 N01340
Completed
NCT00961441
2014-004376-39
LINK
LINK

Naritoku et al. Epilepsy Curr; 2011;11;1 Suppl.1.
64th Annual Meeting of the American Epilepsy Society (AES), December 3-7, 2010;San Antonio, USA.
Epilepsy Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures Phase 4 N01353
Completed
NCT01229735
2014-004402-15
LINK
LINK
Lee, B. et al. Epilepsia;2016;57;Suppl. 2;165-166
12th European Congress on Epileptology (ECE), September 11-15, 2016;Prague, Czech Republic
Epilepsy An Open Label Study of L059 (Levetiracetam) in Japanese Epilepsy Subjects With Generalized Tonic-clonic Seizures Phase 3 N01361
Completed
NCT01398956
2016-002879-96

LINK
LINK
Epilepsy A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures Phase 3 N01363
Completed
NCT01292837
2014-004382-25
LINK
LINK

Ohtsuka, Y. et al Japan J Clin Psychopharm;2016;19;3;347-359
 [in Japanese]
Epilepsy Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures Phase 3 N01364
Completed
NCT01954121
2015-004586-84
LINK
LINK
Epilepsy Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subject With Partial Epilepsy Phase 4 N01367
Completed
NCT01498822
2014-002713-32
LINK
LINK

Kim, J. H. et al Epilepsia; 2017;58;4; e70-e74
not applicable (pharmacokinetics study) Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients Phase 4 N01373
Completed
NCT01491113 LINK
Yamamoto, J. et al., Clin Drug Investig; 2014;34;11;819-828
Epilepsy An Open Label Study of Levetiracetam Monotherapy in Newly Diagnosed Epilepsy With Partial Onset Seizure Phase 3 N01375
Completed
NCT01506882
2014-004377-16
LINK
LINK
Kaneko, S. et al. ,J Japan Epilepsy Society; 2015;32;3;519-532 [ In Japanese]
Epilepsy An Open Label Study of L059 Intravenous (IV) in Japanese Epilepsy Subjects With Partial Onset Seizures Phase 2 N01378
Completed
NCT01407523 LINK
Inoue, Y. et al.,  Jpn J Clin Psychopharmacol;2014; 17;413-422 [In Japanese]
Epilepsy A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy Phase 3 N157
Completed
NCT00150709 PDF
Glauser et al. Epilepsia;2005;46; Suppl 6;102.
26th International Epilepsy Congress (IEC), August 28-September 1, 2005;Paris, France.
Epilepsy Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures Phase 3 N159
Completed
NCT00615615 PDF
Glauser et al. Neurology; 2006;66(11);1654-1660.
Epilepsy A Safety and Efficacy Follow-up Study With Levetiracetam in Children (4-17 Years Old) Suffering From Absence Seizures Phase 2 N164
Completed
NCT00545012 PDF
Epilepsy Bridging Study of L059 (Levetiracetam) in Patients With Epilepsy by Double Blind Method Phase 2 N165
Completed
NCT00600509 PDF
Yagi, K. et al.,  J Japan Epilepsy Society; 7-5-2010;28;1;3-16 [In Japanese]
Epilepsy Levetiracetam as add-on Treatment of Myoclonic Jerks in Adolescents + Adults Phase 3 N166
Completed
NCT00150774 PDF
Rosenfeld et al. Epilepsy Res; 2009;85(1);72-80.
Epilepsy Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy Phase 3 N167
Completed
NCT00150748
2004-001997-13
PDF

LINK
Delanty et al. Epilepsia; 2012;53(1);111-119.