Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome

Neurology

Volumn 77, Issue 15, 2011, Pages 1473-1481

  Ng, Y T ^a,d   Conry, J A ^b   Drummond, R ^c   Stolle, J ^c   Weinberg, M A ^c  

^a BARROW NEUROLOGICAL INSTITUTE   (United States)

^b CHILDREN'S NATIONAL MEDICAL CENTER   (United States)

^c LUNDBECK RESEARCH USA   (United States)

^d UNIVERSITY OF OKLAHOMA COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLOBAZAM; PLACEBO; VALPROATE SEMISODIUM; VALPROIC ACID;

ADOLESCENT; ADULT; ARTICLE; CHILD; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; HUMAN; LENNOX GASTAUT SYNDROME; LETHARGY; MAINTENANCE DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SEIZURE; SOMNOLENCE; SYMPTOM; UPPER RESPIRATORY TRACT INFECTION;

EID: 82955235708     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e318232de76     Document Type: Article

References (30)

1. Niedermeyer E. The Lennox-Gastaut Syndrome and its frontiers. Clin Electroencephalogr 1986;17:117-126. (Pubitemid 16073742)
2. Michoulas A, Farrell K. Medical management of Lennox- Gastaut syndrome. CNS Drugs 2010;24:363-374.
3. Ng YT, Collins SD. Clobazam. Neurotherapeutics 2007; 4:138-144. (Pubitemid 46107321)
4. Conry JA, Ng YT, Paolicchi JM, et al. Clobazam in the treatment of Lennox-Gastaut syndrome. Epilepsia 2009; 50:1158-1166.
5. Vassella F, Pavlincova E, Schneider HJ, Rudin HJ, Karbowski K. Treatment of infantile spasms and Lennox- Gastaut syndrome with clonazepam (Rivotril). Epilepsia 1973;14:165-175.
6. Sachdeo RC, Glauser TA, Ritter F, Reife R, Lim P, Pledger G. A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome: Topiramate YL Study Group. Neurology 1999;52:1882-1887. (Pubitemid 29260904)
7. Felbamate Study Group in Lennox-Gastaut Syndrome. Efficacy of felbamate in childhood epileptic encephalopathy (Lennox-Gastaut syndrome). N Engl J Med 1993;328: 29-33.
8. Motte J, Trevathan E, Arvidsson JF, Barrera MN, Mullens EL, Manasco P. Lamotrigine for generalized seizures associated with the Lennox-Gastaut syndrome: Lamictal Lennox-Gastaut Study Group. N Engl J Med 1997;337: 1807-1812. (Pubitemid 28006785)
9. Glauser T, Kluger G, Sachdeo R, Krauss G, Perdomo C, Arroyo S. Rufinamide for generalized seizures associated with Lennox-Gastaut syndrome. Neurology 2008;70: 1950-1958.
10. Dreifuss FE, Bancaud J, Henriksen O. Proposal for revised clinical and electroencephalographic classification of epileptic seizures: from the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia 1981;22:489-501.
11. Riss J, Cloyd J, Gates J, Collins S. Benzodiazepines in epilepsy: pharmacology and pharmacokinetics. Acta Neurol Scand 2008;118:69-86.
12. Hancock EC, Cross HH. Treatment of Lennox-Gastaut syndrome. Cochrane Database Syst Rev 2009;3: CD003277.
13. Felbatol® [package insert]. Somerset, NJ: MEDA Pharmaceuticals, Inc.; 2009.
14. Topamax® [package insert]. Titusville, NJ: Ortho- McNeil-Janssen Pharmaceuticals, Inc.; 2009.
15. Banzel® [package insert]. Woodcliff Lake, NJ: Eisai Inc.; 2010.
16. Klonopin® [package insert]. South San Francisco, CA: Genentech USA, Inc.; 2010.
17. Lamictal® [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2010.
18. Gastaut H, Low MD. Antiepileptic properties of clobazam, a 1-5 benzodiazepine, in man. Epilepsia 1979;20:437-446. (Pubitemid 9208031)
19. Allen JW, Oxley J, Robertson MM, Trimble MR, Richens A, Jawad SS. Clobazam as adjunctive treatment in refractory epilepsy. BMJ (Clin Res Ed) 1983;286:1246-1247. (Pubitemid 13112080)
20. Canadian Clobazam Cooperative Group. Clobazam in treatment of refractory epilepsy: the Canadian experience: a retrospective study. Epilepsia 1991;32:407-416.
21. Jan MM, Shaabat AO. Clobazam for the treatment of intractable childhood epilepsy. Saudi Med J 2000;21:622-624. (Pubitemid 30490668)
22. Silva RC, Montenegro MA, Guerreiro CA, Guerreiro MM. Clobazam as add-on therapy in children with epileptic encephalopathy. Can J Neurol Sci 2006;33:209-213. (Pubitemid 43845176)
23. Sugai K. Clobazam as a new antiepileptic drug and clorazepate dipotassium as an alternative antiepileptic drug in Japan. Epilepsia 2004;45(suppl 8):20-25. (Pubitemid 39648264)
24. Koeppen D, Baruzzi A, Capozza M, et al. Clobazam in therapy-resistant patients with partial epilepsy: a doubleblind placebo-controlled crossover study. Epilepsia 1987; 28:495-506. (Pubitemid 17146597)
25. Shorvon SD. The use of clobazam, midazolam, and nitrazepam in epilepsy. Epilepsia 1998;39(suppl 1):S15-S23. (Pubitemid 28063387)
26. Mehndiratta MM, Krishnamurthy M, Rajesh KN, Singh G. Clobazam monotherapy in drug naïve adult patients with epilepsy. Seizure 2003;12:226-228. (Pubitemid 36701662)
27. McKernan RM, Rosahl TW, Reynolds DS, et al. Sedative but not anxiolytic properties of benzodiazepines are mediated by the GABA(A) receptor alpha1 subtype. Nat Neurosci 2000;3:587-592. (Pubitemid 30332078)
28. Nakajima H. A pharmacological profile of clobazam (Mystan), a new antiepileptic drug [in Japanese]. Nippon Yakurigaku Zasshi 2001;118:117-122. (Pubitemid 32734656)
29. Data on file. Deerfield, IL: Lundbeck Inc.
30. Singh A, Guberman AH, Boisvert D. Clobazam in longterm epilepsy treatment: sustained responders versus those developing tolerance. Epilepsia 1995;36:798-803.