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Briviact®️ (brivaracetam)

Disease area
studied
Abbreviated title Phase Study ID Registry database Study results Lay 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 Behav 2020;  [ePub]
Epilepsy A Study to Evaluate the Safety and Tolerability of Intravenous Brivaracetam (BRV) as Replacement for Oral Brivaracetam in Japanese Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization Phase 3 EP0118
Ongoing

 Epilepsy Effect of Brivaracetam in Photosensitive Epileptic Subjects Phase 2  N01069
Completed
 
PDF
Kasteleijn-Nolst Trenite D.G., et al. Neurology 2007; 69(10):1027–34
 Epilepsy A Study of Brivaracetam in Subjects With Partial Onset Seizures Phase 2  N01114
Completed
NCT00175929
2004-001856-35
LINK

PDF
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
Completed
NCT00175916
2004-002140-10

LINK
PDF
Tremor A randomized placebo-controlled, 2-way crossover, multicenter, single-blind study to explore the efficacy of ucb 34714 in a minimum of 40 subjects suffering from mild to moderate essential tremor after 14 days of multiple oral doses up to 400 mg b.i.d., 50 mg or 200 mg capsules Phase 2 N01129
Completed
PDF
Epilepsy Monocenter, open label, unilateral metabolic interaction study of ucb 34714 (100, 200 and 400 mg daily) on carbamazepine (≥ 600 mg daily) during a four-week bid administration period in 9 adult male subjects suffering from epilepsy Phase 1 N01133
Completed
PDF
Epilepsy Multicenter, open label, unilateral metabolic interaction study of ucb 34714 (100, 200 and 400 mg daily) on carbamazepine (>=600 mg daily) during a four-week bid administration period in 9 adult male subjects suffering from epilepsy and treated with carbamazepine and valproate (>=500 mg daily) Phase 1 N01135
Completed
PDF
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
LINK

PDF
Epilepsy A Monocenter, Open-Label, Unilateral Interaction Study of ucb 34714 (400 mg daily) on Stable Phenytoin Monotherapy During a 45 day b.i.d. Administration Period in 15 Adult Subjects Suffering from Epilepsy Phase 1 N01172
Completed
PDF
Unverricht-Lundborg Disease Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults Phase 3 N01187
Completed
NCT00357669
2006-000169-12
LINK
PDF
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 LINK
PDF
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
PDF
O'Brien T.J., Epilepsia 2020; 61(4):636–46
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

PDF
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

PDF
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
PDF
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

PDF
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

PDF
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

PDF
Liu E. et al. Paediatr Drugs 2019; 21(4):291–301
Epilepsy Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy Phase 3 N01266
Ongoing
NCT01364597
2011-000374-60
PDF
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

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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

PDF
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
PDF
Arnold S., et al. Epilepsy Res 2020 [ePub]
Electroencephalographic Neonatal Seizures A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures Phase 2 / 3 N01349
Ongoing
Epilepsy Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™) Phase 3 N01358
Completed
NCT01261325
2010-019361-28
LINK
LINK
PDF
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
LINK
PDF
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
Completed
NCT01339559
2010-020345-27

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Epilepsy Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures Phase 2 N01394
Terminated
NCT02088957
LINK
PDF
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
PDF
Yates, S. L. et al. Epilepsy Behav;2015;52;Pt A;165-168