A randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of adjunctive carisbamate treatment in patients with partial-onset seizures

Epilepsia

Volumn 52, Issue 4, 2011, Pages 816-825

  Halford, Jonathan J ^a   Ben Menachem, Elinor ^b   Kwan, Patrick ^c   Ness, Seth ^d   Schmitt, Jennifer ^d   Eerdekens, Mariàlle ^e   Novak, Gerald ^d  

^a MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^b UNIVERSITY OF GOTHENBURG   (Sweden)

^c CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^d JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Adjunctive treatment; Carisbamate; Partial onset seizures

Indexed keywords

BARBITURIC ACID DERIVATIVE; CARBAMAZEPINE; CARISBAMATE; ETIRACETAM; LAMOTRIGINE; PHENYTOIN; PLACEBO; TOPIRAMATE; VALPROIC ACID;

ABSENCE; ADJUNCTIVE TREATMENT; ADJUVANT THERAPY; ADOLESCENT; ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANXIETY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; ASTHENIA; ATONIC SEIZURE; COMPLEX PARTIAL SEIZURE; CONTROLLED STUDY; CONVULSION; DECREASED APPETITE; DIPLOPIA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EPILEPSY; EUPHORIA; FATIGUE; FEMALE; FOCAL EPILEPSY; GENERALIZED EPILEPSY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MYOCLONUS EPILEPSY; NAUSEA; PATIENT COMPLIANCE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOPHARYNGITIS; SIDE EFFECT; SIMPLE PARTIAL SEIZURE; SOMNOLENCE; SUICIDAL IDEATION; TONIC CLONIC SEIZURE; TREATMENT PLANNING; VOMITING;

ADULT; ANTICONVULSANTS; CARBAMATES; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; EPILEPSIES, PARTIAL; FEMALE; HUMANS; MALE; MIDDLE AGED; OUTCOME ASSESSMENT (HEALTH CARE);

EID: 79953715648     PISSN: 00139580     EISSN: 15281167     Source Type: Journal    
DOI: 10.1111/j.1528-1167.2010.02960.x     Document Type: Article

References (15)

1. Bialer M, Johannessen SI, Levy RH, Perucca E, Tomson T, White HS,. (2009) Progress report on new antiepileptic drugs: a summary of the Ninth Eilat Conference (EILAT IX). Epilepsy Res 83: 1-43.
2. Chien S, Bialer M, Solanki B, Verhaeghe T, Doose DR, Novak G, Yao C,. (2006) Pharmacokinetic interaction study between the new antiepileptic and CNS drug RWJ-333369 and carbamazepine in healthy adults. Epilepsia 47: 1830-1840. (Pubitemid 44733929)
3. European Medicines Agency. (2006) ICH Topic E 6 (R1) guideline for good clinical practice. Accessed on 6 October 2010, Available at:.
4. Faught E, Holmes GL, Rosenfeld WE, Novak G, Neto W, Greenspan A, Schmitt J, Yuen E, Reines S, Haas M,. (2008) Randomized, controlled, dose-ranging trial of carisbamate for partial-onset seizures. Neurology 71: 1586-1593.
5. Guekht AB, Korczyn AD, Bondareva IB, Gusev EI,. (2009) Placebo responses in randomized trials of antiepileptic drugs. Epilepsy Behav 17: 64-69.
6. Halford JJ, Lapointe M,. (2009) Clinical perspectives on lacosamide. Epilepsy Curr 9: 1-9.
7. Halford J, Kälviäinen R, Ben-Menachem E, Schmitt J, Wiegand F, Novak G,. (2009) An open-label extension of two controlled studies of carisbamate as adjunctive treatment of partial onset seizures in adults. 28th Biennial meeting of the International Epilepsy Congress. Budapest, Hungary. June 28-July 2, 2009, Poster session 1.127.
8. 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.
9. Lippmann S, Rosenfeld W, Wiegand F, Schmitt J, Novak G,. (2009) Carisbamate as adjunctive treatment of partial-onset seizures in adults: results at 18 months from an ongoing open-label extension of a double-blind, randomized, dose-ranging study. 63rd Annual Meeting of the American Epilepsy Society.Boston, MA, December 4-8, 2009, Poster session 1.134.
10. Mannens GS, Hendrickx J, Janssen CG, Chien S, Van Hoof B, Verhaeghe T, Kao M, Kelley MF, Goris I, Bockx M, Verreet B, Bialer M, Meuldermans W,. (2007) The absorption, metabolism, and excretion of the novel neuromodulator RWJ-333369 (1,2-ethanediol, [1-2-chlorophenyl]-, 2-carbamate, [S]-) in humans. Drug Metab Dispos 35: 554-565. (Pubitemid 46513257)
11. Novak GP, Kelley M, Zannikos P, Klein B,. (2007) Carisbamate (RWJ-333369). Neurotherapeutics 4: 106-109. (Pubitemid 46107332)
12. Schiller Y, Najjar Y,. (2008) Quantifying the response to antiepileptic drugs: effect of past treatment history. Neurology 70: 54-65.
13. Sperling MR, Greenspan A, Cramer JA, Kwan P, Kalviainen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak G,. (2009) Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilepsia 51: 333-343.
14. White H, Srivastava A, Klein B, Zhao B, Choi YM, Gordon R, Lee SJ,. (2006) The novel investigational neuromodulator RWJ-333369 displays a broad-spectrum anticonvulsant profile in rodent seizure and epilepsy models. Epilepsia 47 (suppl 4): 200.
15. Yao C, Doose DR, Novak G, Bialer M,. (2006) Pharmacokinetics of the new antiepileptic and CNS drug RWJ-333369 following single and multiple dosing to humans. Epilepsia 47: 1822-1829. (Pubitemid 44730052)