Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: A phase III randomized, double-blind, placebo-controlled trial

Epilepsia

Volumn 55, Issue 1, 2014, Pages 57-66

  Biton, Victor ^a   Berkovic, Samuel F ^b   Abou Khalil, Bassel ^c   Sperling, Michael R ^d   Johnson, Martin E ^e   Lu, Sarah ^e  

^a Arkansas Epilepsy Program   (United States)

^b UNIVERSITY OF MELBOURNE   (Australia)

^c VANDERBILT UNIVERSITY MEDICAL CENTER   (United States)

^d THOMAS JEFFERSON UNIVERSITY   (United States)

^e UCB PHARMA   (Belgium)

Author keywords

Brivaracetam; Efficacy; Partial epilepsy; Phase III; Safety tolerability

Indexed keywords

BRIVARACETAM; CARBAMAZEPINE; ETIRACETAM; LAMOTRIGINE; OXCARBAZEPINE; PHENYTOIN; PLACEBO; VALPROIC ACID;

ADOLESCENT; ADULT; AGED; ARTICLE; COMPLEX PARTIAL SEIZURE; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAPHY; FATIGUE; FEMALE; FOCAL EPILEPSY; HEADACHE; HUMAN; INFLUENZA; INSOMNIA; IRRITABILITY; LABORATORY TEST; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MULTICENTER STUDY; NAUSEA; NEUROLOGIC EXAMINATION; PARALLEL DESIGN; PARTIAL ONSET SEIZURE; PHASE 3 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SECONDARY GENERALIZED SEIZURE; SEIZURE; SOMNOLENCE; TONIC CLONIC SEIZURE; UPPER RESPIRATORY TRACT INFECTION; URINARY TRACT INFECTION; VITAL SIGN; VOMITING; YOUNG ADULT;

BRIVARACETAM; EFFICACY; PARTIAL EPILEPSY; PHASE III; SAFETY/TOLERABILITY;

ADOLESCENT; ADULT; AGED; ANTICONVULSANTS; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PYRROLIDINONES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84892937581     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/epi.12433     Document Type: Article

References (23)

1. Ben-Menachem E, Biton V, Jatuzis D, bou-Khalil B, Doty P, Rudd GD,. (2007) Efficacy and safety of oral lacosamide as adjunctive therapy in adults with partial-onset seizures. Epilepsia 48: 1308-1317.
2. Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS,. (2010) Progress report on new antiepileptic drugs: a summary of the Tenth Eilat Conference (EILAT X). Epilepsy Res 92: 89-124.
3. Biton V, Werhahn KJ, Johnson ME, Falter U, Climos K, Schelstraete I, Brodsky A, von Rosensteil P,. (2009) Brivaracetam as adjunctive treatment of refractory partial-onset seizures in adults: results from two randomized, double-blind, placebo-controlled trials. Epilepsia 50 (Suppl. 11): 106-107.
4. Brodsky A, Costantini C, von Rosenstiel P,. (2007) Safety and tolerability of brivaracetam (ucb 34714) as adjunctive treatment in adults with refractory partial-onset seizures. Epilepsia 48 (Suppl. 6): 342.
5. Chung S, Sperling MR, Biton V, Krauss G, Hebert D, Rudd GD, Doty P,. (2010) Lacosamide as adjunctive therapy for partial-onset seizures: a randomized controlled trial. Epilepsia 51: 958-967.
6. D'Souza J, Johnson M, Borghs S,. (2012) Meta-analysis of non-psychotic behavioural treatment emergent adverse events in brivaracetam and levetiracetam development programmes. Epilepsia 53: 118.
7. French JA, Costantini C, Brodsky A, von Rosenstiel P,. (2010) Adjunctive brivaracetam for refractory partial-onset seizures: a randomized, controlled trial. Neurology 75: 519-525.
8. French JA, Krauss GL, Biton V, Squillacote D, Yang H, Laurenza A, Kumar D, Rogawski MA,. (2012) Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology 79: 589-596.
9. Gillard M, Fuks B, Leclercq K, Matagne A,. (2011) Binding characteristics of brivaracetam, a selective, high affinity SV2A ligand in rat, mouse and human brain: relationship to anti-convulsant properties. Eur J Pharmacol 664: 36-44.
10. Gil-Nagel A, Lopes-Lima J, Almeida L, Maia J, Soares-da-Silva P,. (2009) Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand 120: 281-287.
11. Halasz P, Kalviainen R, Mazurkiewicz-Beldzinska M, Rosenow F, Doty P, Hebert D, Sullivan T,. (2009) Adjunctive lacosamide for partial-onset seizures: efficacy and safety results from a randomized controlled trial. Epilepsia 50: 443-453.
12. International League Against Epilepsy. (1989) Proposal for revised classification of epilepsies and epileptic syndromes. Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia 30: 389-399.
13. Kenda BM, Matagne AC, Talaga PE, Pasau PM, Differding E, Lallemand BI, Frycia AM, Moureau FG, Klitgaard HV, Gillard MR, Fuks B, Michel P,. (2004) Discovery of 4-substituted pyrrolidone butanamides as new agents with significant antiepileptic activity. J Med Chem 47: 530-549.
14. Krauss GL, Serratosa JM, Villanueva V, Endziniene M, Hong Z, French J, Yang H, Squillacote D, Edwards HB, Zhu J, Laurenza A,. (2012) Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology 78: 1408-1415.
15. Kwan P, Johnson ME, Falter U, Pieteur VB, Brodsky A, von Rosensteil P,. (2009) Safety and tolerability of brivaracetam as adjunctive treatment in adults with refractory epilepsy: randomized, doubleblind, placebo-controlled trial. Epilepsia 50 (Suppl. 11): 107-108.
16. Matagne A, Margineanu D-G, Kenda B, Michel P, Klitgaard H,. (2008) Anti-convulsive and anti-epileptic properties of brivaracetam (ucb 34714), a high-affinity ligand for the synaptic vesicle protein, SV2A. Br J Pharmacol 154: 1662-1671.
17. Rolan P, Pigeolet E, Stockis A,. (2004) UCB 34714: single and multiple rising dose safety, tolerability, and pharmacokinetics in healthy subjects. Epilepsia 45 (Suppl. 7): 314-315.
18. Rolan P, Sargentini-Maier ML, Pigeolet E, Stockis A,. (2008) The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after multiple increasing oral doses in healthy males. Br J Clin Pharmacol 66: 71-75.
19. Sargentini-Maier ML, Rolan P, Connell J, Tytgat D, Jacobs T, Pigeolet E, Riethuisen JM, Stockis A,. (2007) The pharmacokinetics, CNS pharmacodynamics and adverse event profile of brivaracetam after single increasing oral doses in healthy males. Br J Clin Pharmacol 63: 680-688.
20. Sivenius J, Kalviainen R, Ylinen A, Riekkinen P,. (1991) Double-blind study of Gabapentin in the treatment of partial seizures. Epilepsia 32: 539-542.
21. Sperling MR, Greenspan A, Cramer JA, Kwan P, Kalviainen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G,. (2010) Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia 51: 333-343.
22. van Paesschen W, Hirsch E, Johnson M, Falter U, von Rosenstiel P,. (2013) Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIb, randomized, controlled trial. Epilepsia 54: 89-97.
23. von Rosenstiel P, Perucca E,. (2009) Brivaracetam. In, Shorvon S, Perucca E, Engel J Jr, (Ed.) The treatment of epilepsy. Wiley-Blackwell, Chichester, pp. 447-457.