A 24-week multicenter, randomized, double-blind, parallel-group, dose-ranging study of rufinamide in adults and adolescents with inadequately controlled partial seizures

Epilepsy Research

Volumn 88, Issue 2-3, 2010, Pages 255-263

  Elger, Christian E ^a   Stefan, Hermann ^b   Mann, Allison ^c   Narurkar, Milind ^c   Sun, Yijun ^c   Perdomo, Carlos ^c  

^a UNIVERSITY HOSPITAL BONN   (Germany)

^b UNIVERSITY HOSPITAL ERLANGEN   (Germany)

^c EISAI INC   (United States)

Author keywords

Antiepileptic drugs; Epilepsy; Partial onset; Randomized controlled; Refractory; Rufinamide

Indexed keywords

CARBAMAZEPINE; CLOBAZAM; CLONAZEPAM; OXCARBAZEPINE; PHENOBARBITAL; PHENYTOIN; PLACEBO; PRIMIDONE; RUFINAMIDE; VALPROIC ACID; VIGABATRIN;

ADOLESCENT; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; DIPLOPIA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG POTENTIATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; FOCAL EPILEPSY; GRANULOCYTOPENIA; HUMAN; HYPONATREMIA; HYPOTHYROIDISM; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; NYSTAGMUS; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; TREATMENT DURATION; VERTIGO; VIRUS INFECTION;

ADOLESCENT; ADULT; AGED; ANALYSIS OF VARIANCE; ANTICONVULSANTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EPILEPSIES, PARTIAL; HUMANS; INTENTION TO TREAT ANALYSIS; MIDDLE AGED; PATIENT SELECTION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TRIAZOLES;

EID: 76049084221     PISSN: 09201211     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.eplepsyres.2009.12.003     Document Type: Article

References (20)

1. Aldenkamp A.P., and Alpherts W.C. The effect of the new antiepileptic drug rufinamide on cognitive functions. Epilepsia 47 (2006) 1153-1159
2. Anhut H., Ashman P., Feuerstein T.J., Sauermann W., Saunders M., and Schmidt B. Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a double-blind, placebo-controlled study. The International Gabapentin Study Group. Epilepsia 35 (1994) 795-801
3. Arroyo S. Rufinamide. Neurotherapeutics 4 (2007) 155-162
4. Bialer M. New antiepileptic drugs that are second generation to existing antiepileptic drugs. Expert Opin. Investig. Drugs 15 (2006) 637-647
5. Brodie M.J., Rosenfeld W.E., Vazquez B., Sachdeo R., Perdomo C., Mann A., and Arroyo S. Rufinamide for the adjunctive treatment of partial seizures in adults and adolescents: a randomized placebo-controlled trial. Epilepsia 50 (2009) 1899-1909
6. Callaghan B.C., Anand K., Hesdorffer D., Hauser W.A., and French J.A. Likelihood of seizure remission in an adult population with refractory epilepsy. Ann. Neurol. 62 (2007) 382-389
7. Elger C.E., Helmstaedter C., and Kurthen M. Chronic epilepsy and cognition. Lancet Neurol. 3 (2004) 663-672
8. Glauser T., Kluger G., Sachdeo R., Krauss G., Perdomo C., and Arroyo S. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology 70 (2008) 1950-1958
9. Hakimian S., Cheng-Hakimian A., Anderson G.D., and Miller J.W. Rufinamide: a new anti-epileptic medication. Expert Opin. Pharmacother. 8 (2007) 1931-1940
10. Jain K.K. An assessment of rufinamide as an anti-epileptic in comparison with other drugs in clinical development. Expert Opin. Investig. Drugs 9 (2000) 829-840
11. Johannessen Landmark C., and Johannessen S.I. Pharmacological management of epilepsy: recent advances and future prospects. Drugs 68 (2008) 1925-1939
12. Luciano A.L., and Shorvon S.D. Results of treatment changes in patients with apparently drug-resistant chronic epilepsy. Ann. Neurol. 62 (2007) 375-381
13. Marson A.G., Appleton R., Baker G.A., Chadwick D.W., Doughty J., Eaton B., Gamble C., Jacoby A., Shackley P., Smith D.F., Tudur-Smith C., Vanoli A., and Williamson P.R. A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial. Health Technol. Assess. 11 (2007) iii-iv, ix-x, 1-134
14. McNamara J.O. Drugs effective in the therapy of the epilepsies. In: Hardman G.E., and Limbird L.E. (Eds). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. (2001), McGraw Hill Publishing Co., New York 521-548
15. [No authors listed], 1990. Gabapentin in partial epilepsy. UK Gabapentin Study Group. Lancet 335, 1114-1117.
16. Pålhagen S., Canger R., Henriksen O., van Parys J.A., Rivière M.E., and Karolchyk M.A. Rufinamide: a double-blind, placebo-controlled proof of principle trial in patients with epilepsy. Epilepsy Res. 43 (2001) 115-124
17. Perucca E., and Levy R.H. Combination therapy and drug interactions. In: Levy R.H., Mattson R.H., Meldrum B.S., and Perucca E. (Eds). Antiepileptic Drugs. 5th ed. (2002), Lippincott, Williams & Wilkins, Philadelphia 96-102
18. Perucca E., Cloyd J., Critchley D., and Fuseau E. Rufinamide: clinical pharmacokinetics and concentration-response relationships in patients with epilepsy. Epilepsia 49 (2008) 1123-1141
19. Swinyard E.A., Wolf H.H., Franklin M.R., White H.S., Woodhead J.H., Kupferberg H.J., and Stables J.P. The early evaluation of anticonvulsant drugs: the profile of the anticonvulsant activity and acute toxicity of 145107 and some prototype antiepileptic drugs in mice and rats. Contract No. N01-NS-2361 (1987), Epilepsy branch of the National Institute of Neurological and Communicative Disorders and Stroke, Bethesda, MD
20. White H.S., Franklin M.R., Kupferberg H.J., Schmutz M., Stables J.P., and Wolf H.H. The anticonvulsant profile of rufinamide (CGP 33101) in rodent seizure models. Epilepsia 49 (2008) 1213-1220