Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: A phase IIb, randomized, controlled trial

Epilepsia

Volumn 54, Issue 1, 2013, Pages 89-97

  Van Paesschen, Wim ^a   Hirsch, Edouard ^b   Johnson, Martin ^c   Falter, Ursula ^c   Von Rosenstiel, Philipp ^c  

^a UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^b UNIVERSITY HOSPITAL OF STRASBOURG   (France)

^c UCB PHARMA   (Belgium)

Author keywords

Antiepileptic drugs; Clinical trial; Epilepsy; Focal seizures; Placebo controlled; SV2A ligand

Indexed keywords

BENZODIAZEPINE DERIVATIVE; BRIVARACETAM; CARBAMAZEPINE; ETIRACETAM; LAMOTRIGINE; OXCARBAZEPINE; PLACEBO; TOPIRAMATE; VALPROIC ACID;

ADOLESCENT; ADULT; AGED; ANOREXIA; ANTICONVULSANT THERAPY; ARTICLE; ATTENTION DISTURBANCE; BACKACHE; CERVICAL SPONDYLITIS; CONTROLLED STUDY; CONVULSION; CYSTITIS; DISEASE DURATION; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FALLING; FATIGUE; FEMALE; FOCAL EPILEPSY; HUMAN; IRRITABILITY; JOINT DISLOCATION; MAJOR CLINICAL STUDY; MALE; MEMORY DISORDER; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PATELLA FRACTURE; PHASE 2 CLINICAL TRIAL; POSTICTAL STATE; PRIORITY JOURNAL; PROSPECTIVE STUDY; PSYCHOMOTOR DISORDER; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; RISK REDUCTION; SIDE EFFECT; SOMNOLENCE; STATISTICAL SIGNIFICANCE; TREATMENT DURATION; TREATMENT RESPONSE; UNCONSCIOUSNESS; URINARY TRACT INFECTION; VOMITING;

ADOLESCENT; ADULT; ANTICONVULSANTS; ARABIDOPSIS PROTEINS; CARRIER PROTEINS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG THERAPY, COMBINATION; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; PYRROLIDINONES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84872056540     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2012.03598.x     Document Type: Article

References (18)

1. 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.
2. French JA, Costantini C, Brodsky A, von Rosenstiel P, N01193 Study Group. (2010) Adjunctive brivaracetam for refractory partial-onset seizures: a randomized, controlled trial. Neurology 75: 519-525.
3. Gazzola DM, Balcer LJ, French JA,. (2007) Seizure-free outcome in randomized add-on trials of the new antiepileptic drugs. Epilepsia 48: 1303-1307.
4. 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.
5. 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.
6. Kasteleijn-Nolst Trenite DG, Genton P, Parain D, Masnou P, Steinhoff BJ, Jacobs T, Pigeolet E, Stockis A, Hirsch E,. (2007) Evaluation of brivaracetam, a novel SV2A ligand, in the photosensitivity model. Neurology 69: 1027-1034.
7. 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.
8. Kwan P, Brodie MJ,. (2010) Definition of refractory epilepsy: defining the indefinable? Lancet Neurol 9: 27-29.
9. Leppik I, De RK, Edrich P, Perucca E,. (2006) Measurement of seizure freedom in adjunctive therapy studies in refractory partial epilepsy: the levetiracetam experience. Epileptic Disord 8: 118-130.
10. 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.
11. Nicolas JM, Chanteux H, Rosa M, Watanabe S, Stockis A,. (2012) Effect of gemfibrozil on the metabolism of brivaracetam in vitro and in human subjects. Drug Metab Dispos 26 April 2012; DOI: 10.1124/dmd.112.045328. [Epub ahead of print].
12. 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.
13. 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.
14. Sargentini-Maier ML, Espie P, Coquette A, Stockis A,. (2008) Pharmacokinetics and metabolism of 14C-brivaracetam, a novel SV2A ligand, in healthy subjects. Drug Metab Dispos 36: 36-45.
15. Schiller Y, Najjar Y,. (2008) Quantifying the response to antiepileptic drugs: effect of past treatment history. Neurology 70: 54-65.
16. Tai KK, Truong DD,. (2007) Brivaracetam is superior to levetiracetam in a rat model of post-hypoxic myoclonus. J Neural Transm 114: 1547-1551.
17. von Rosenstiel P, Perucca E,. (2009) Brivaracetam. In, Shorvon S, Perucca E, Engel J Jr, (Eds) The treatment of epilepsy. 3 edn. Wiley-Blackwell, Chichester, pp. 447-457.
18. Zona C, Pieri M, Carunchio I, Curcio L, Klitgaard H, Margineanu DG,. (2010) Brivaracetam (ucb 34714) inhibits Na+ current in rat cortical neurons in culture. Epilepsy Res 88: 46-54.