Brivaracetam (Briviact®)
| Disease area studied | Abbreviated title | Phase | Study ID | Registry database | Study results | Plain language summary | Publication (if available) |
|---|---|---|---|---|---|---|---|
| Epilepsy | Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy | Phase 3 |
N01266
Completed |
NCT01364597 2011-000374-60 |
LINK LINK |
Lagae L.,et al. Epilepsia 2023; 64(11):2934–46 | |
| 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
|
"Kalviainen, R.,et al Epilepsia;2016;57;2;210-221 " | |
| 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 | 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 LINK |
"Liu E. et al. Paediatr Drugs 2019; 21(4):291–301 " | |
| 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 LINK |
Arnold S., et al. Epilepsy Res 2020 166:106404 | |
| 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 |
NCT04666610 2020-002750-24 |
Bast T., et al.Epilepsia Open 2022; 7(4):588–97 | ||
| 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 LINK |
Ben-Menachem E., et al. Epilepsy Res 2021; 170:106526 | |
| 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 | 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 |
Borghs S., et al. [abstract 2.287] available on Annual Meeting Abstract Database www.aesnet.org | |
| 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 |
NCT03405714 2016-002452-25 |
LINK LINK |
Farkas M.K. et al. Epilepsia 2022; 63(4):855–64 | |
| 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
|
French et al. Neurology;2010;75;6;519-525. | |
| 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 | Effect of Brivaracetam in Photosensitive Epileptic Subjects | Phase 2 |
N01069
Completed |
NCT00401648 | Kasteleijn-Nolst Trenite D.G., et al. Neurology 2007; 69(10):1027–34 | ||
| Epilepsy | Brivaracetam Efficacy and Safety Study in Subjects With Partial Onset Seizures (BRITE™) | Phase 3 |
N01358
Completed |
NCT01261325 2010-019361-28 |
LINK LINK |
Klein et al., Epilepsia;2015;56;12;1890-1898 | |
| 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 |
NCT03325439 2015-002756-27 |
LINK
|
Pressler R., et al. Epilepsia Open 2023 [ePub] | |
| 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 | 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 |
Moseley B.D. et al. [abstract 2.207] available on Annual Meeting Abstract Database www.aesnet.org | |||
| 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 2014-004397-42 |
LINK LINK |
O'Brien T.J., Epilepsia 2020; 61(4):636–46 | |
| 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 | 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 | Brivaracetam Safety and Efficacy Follow-up Study in Subjects With Epilepsy (BRITE™) | Phase 3 |
N01379
Completed |
NCT01339559 2010-020345-27 |
LINK LINK |
Toledo M., et al. Epilepsy Behav 2021; 118:107897 | |
| 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 | 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 et al. Epilepsy Behav;2015;52;Pt A;165-168 | |
| 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 |
NCT03083665 2019-001203-21 |
LINK
|
Inoue Y., et al. [abstract 1.286] 77th Annual Meeting of American Epilepsy Society (AES), December 01-05, 2023; Orlando, USA AES Annual Meeting Abstract Database. www.aesnet.org | |
| 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 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 |
NCT05109234 2020-002769-33 |
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| Epilepsy | A Study to Test the Safety and Tolerability of Brivaracetam in Pediatric Study Participants With Seizures | Phase 3 |
EP0156
Ongoing |
NCT04715646 2020-003664-29 |
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| 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 |
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| 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 |
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| 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 |
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| 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 |
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| Epilepsy | Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures | Phase 2 |
N01394
Terminated |
NCT02088957 |
LINK
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