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Clinical Study Information - brivaracetam

Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Study summary Publication (if available)
Epilepsy A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy Phase 2 EP0065
Ongoing
Epilepsy
A Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam in Asian Subjects (>=16 to 80 Years of Age) With Epilepsy Phase 3 EP0083
Ongoing
NCT03083665
Epilepsy A Study to Test the Safety/ Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization Phase 3 EP0085
Ongoing
NCT03250377
Epilepsy  A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting   Phase 2 EP0087
Completed
NCT03021018
 Epilepsy A Study of Brivaracetam in Subjects With Partial Onset Seizures Phase 2  N01114
Completed
NCT00175929
2004-001856-35

LINK

Van Paesschen et al. Epilepsia;2013;54;1;89-97.
Epilepsy Follow-up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Suffering From Epilepsy Phase 3 N01125
Ongoing
NCT00175916
2004-002140-10
Postherpetic Neuralgia A Study Assessing Efficacy of Brivaracetam in Subjects With Persistent Pain After Shingles (Post-herpetic Neuralgia) Phase 2 N01162
Completed
NCT00160667
2004-000975-32

LINK

Unverricht-Lundborg Disease Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults Phase 3 N01187
Completed
NCT00357669
2006-000169-12
Kalviainen, R.,et al Epilepsia;2016; 57;2;210-221
Epilepsy
A Dose-ranging Study With Brivaracetam in Patients From 16 to 65 Years With Refractory Partial Onset Seizures.
Phase 2 N01193
Completed
NCT00175825 French et al. Neurology;2010; 75;6;519-525.
Epilepsy Open-label Follow up Trial to Evaluate Long-term Safety and Efficacy of Brivaracetam in Subjects Aged 16 Years or Older Suffering From Epilepsy. Phase 3 N01199
Completed
NCT00150800

LINK
Unverricht-Lundborg Disease
Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults
Phase 3 N01236
Completed
NCT00368251
2006-001536-46
LINK
LINK

Kalviainen, R.,et al Epilepsia;2016; 57;2;210-221
Epilepsy Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures Phase 3 N01252
Completed
NCT00490035
2006-006344-59
LINK
LINK

Ryvlin et al. Epilepsia; 2014;55;1;47-56.
Epilepsy Double-blind, Randomized Study Evaluating the Efficacy and Safety of Brivaracetam in Adults With Partial Onset Seizures Phase 3 N01253
Completed
NCT00464269
2006-006345-14
LINK
Biton et al. Epilepsia; 2014;55;1;57-66.
Epilepsy Brivaracetam as add-on Treatment in Adolescents and Adults Suffering From Epilepsy Phase 3 N01254
Completed
NCT00504881
2006-006346-34
LINK
LINK

Kwan et al. Epilepsia; 2014;55;1;38-46.
Epilepsy Safety and Tolerability of Intravenous Brivaracetam (Infusion or Bolus) as Adjunctive Antiepileptic Therapy Phase 3 N01258
Completed
NCT01405508
2008-004714-27
LINK
LINK

Klein et al. Epilepsia;2016; 57;7;1130-1138
Epilepsy Open-label, Pharmacokinetic, Safety and Efficacy Study of Adjunctive Brivaracetam in Children With Epilepsy. Phase 2 N01263
Completed
NCT00422422
2006-006536-22
LINK 
Liu et al. Epilepsy Curr;2014;14; Suppl. s1; 390-391.
67th Annual Meeting of the American Epilepsy Society (AES), December 6-10, 2013; Washington, USA
Epilepsy Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy Phase 3 N01266
Ongoing
NCT01364597
2011-000374-60
Badalamenti V. et al.  Ann Neurol 2017;  82(Suppl. 21):S278-S279
46th Annual Meeting of the Child Neurology Society (CNS), October 04-07, 2017;  Missouri, USA
Epilepsy A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures Phase 3 N01276
Terminated
NCT00698581
2008-000144-14
LINK
LINK

Arnold S., et al. Epilepsy Res 2018; 141:73–82
Epilepsy A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures Phase 3 N01306
Terminated
NCT00699283
2008-000145-58
LINK
LINK

Arnold S., et al. Epilepsy Res 2018; 141:73–82
Epilepsy An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam Phase 3 N01315
Completed
NCT00761774
2008-001433-98
LINK
Fakhoury T.  et al [abstract 2.286] available on Annual Meeting Abstract Database www.aesnet.org
Epilepsy Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™) Phase 3 N01358
Completed
NCT01261325
2010-019361-28
LINK
LINK
Klein, P. et al., Epilepsia; e-pub 10-16-2015;
Epilepsy Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy Phase 3 N01372
Completed
NCT01728077
2012-000827-42
 
LINK
Borghs S., et al.  [abstract 2.287]  available on Annual Meeting Abstract Database www.aesnet.org
Epilepsy Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™) Phase 3 N01379
Ongoing
NCT01339559
2010-020345-27
Epilepsy Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures Phase 2 N01394
Completed
NCT02088957
2011-005177-23
LINK
Epilepsy Effect of Brivaracetam (BRV) on Nonpsychotic Behavioral Side Effects in Subjects Treated Previously With Levetiracetam (LEV) Phase 3 N01395
Completed
NCT01653262
2011-005177-23
LINK
LINK
Yates, S. L. et al. Epilepsy Behav;2015;52;Pt A;165-168