Brivaracetam (Briviact®) Disease area studied Abbreviated title Phase Study ID Registry database Study results Plain language 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 Completed NCT034057142016-002452-25 LINKLINK Farkas M.K. et al. Epilepsia 2022; 63(4):855–64 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 Completed NCT030836652019-001203-21 LINK Inoue Y., et al.Epilepsia Open 2024; 9(3):1007–20 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 LINK Szaflarski J.P, et al. Epilepsy Behav 2020; 109:107127 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 Completed NCT03685630 Inoue Y. et al. Shinyaku to Rinsho 2022; 71(11):1187–97- [In Japanese] Epilepsy A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy Phase 3 EP0132 Ongoing NCT051092342020-002769-33 Epilepsy A Study to Test the Safety and Tolerability of Brivaracetam in Pediatric Study Participants With Seizures Phase 3 EP0156 Ongoing NCT047156462020-003664-29 Epilepsy A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy Phase 3 EP0224 Ongoing NCT063153222023-508095-11-0 Epilepsy Effect of Brivaracetam in Photosensitive Epileptic Subjects Phase 2 N01069 Completed NCT00401648 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 NCT001759292004-001856-35 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 NCT001759162004-002140-10 LINKLINK PDF Ben-Menachem E., et al. Epilepsy Res 2021; 170:106526 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 NCT001606672004-000975-32 LINKLINK PDF Epilepsy A Monocenter, Open-Label, Unilateral Interaction Study of ucb34714 (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 Moseley B.D. et al. [abstract 2.207] available on Annual Meeting Abstract Database www.aesnet.org Unverricht-Lundborg Disease Brivaracetam as add-on Treatment of Unverricht-Lundborg Disease in Adolescents and Adults Phase 3 N01187 Completed NCT003576692006-000169-12 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 NCT001508002014-004397-42 LINKLINK 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 NCT003682512006-001536-46 LINKLINK 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 NCT004900352006-006344-59 LINKLINK PDF 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 NCT004642692006-006345-14 LINK PDF 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 NCT005048812006-006346-34 LINKLINK 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 NCT014055082008-004714-27 LINKLINK 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 NCT004224222006-006536-22 LINKLINK 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 Completed NCT013645972011-000374-60 LINKLINK PDF PDF Lagae L.,et al. Epilepsia 2023; 64(11):2934–46 Epilepsy A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy (EXPAND) Phase 2/3 N01269 Ongoing NCT046666102020-002750-242023-510428-55-00 Bast T., et al.Epilepsia Open 2022; 7(4):588–97 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 NCT006985812008-000144-14 LINKLINK PDF 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 NCT006992832008-000145-58 LINKLINK 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 NCT007617742008-001433-98 LINKLINK PDF Arnold S., et al. Epilepsy Res 2020 166:106404 Electroencephalographic Neonatal Seizures A Study to Test the Pharmacokinetics, Efficacy, and Safety of Brivaracetam in Newborns With Repeated Electroencephalographic Seizures Phase 2/Phase 3 N01349 Terminated NCT033254392015-002756-27 LINK Pressler R., et al. Epilepsia Open 2024; 9(2):522–33 Epilepsy Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™) Phase 3 N01358 Completed NCT012613252010-019361-28 LINKLINK PDF PDF Klein et al., Epilepsia;2015;56;12;1890-1898 Epilepsy Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy Phase 3 N01372 Completed NCT017280772012-000827-42 LINKLINK 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 NCT013395592010-020345-27 LINKLINK PDF Toledo M., et al. Epilepsy Behav 2021; 118:107897 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 NCT016532622011-005177-23 LINKLINK PDF Yates et al. Epilepsy Behav;2015;52;Pt A;165-168
