Efficacy and safety of remacemide versus carbamazepine in newly diagnosed epilepsy: Comparison by sequential analysis

Epilepsy and Behavior

Volumn 3, Issue 2, 2002, Pages 140-146

  Brodie, Martin J ^a   Wroe, Stephen J ^b   Dean, Andrew D P ^c   Holdich, Thomas A H ^c   Whitehead, John ^d   Stevens, John W ^c  

^a WESTERN INFIRMARY   (United Kingdom)

^b IPSWICH HOSPITAL   (United Kingdom)

^c ASTRAZENECA   (United Kingdom)

^d UNIVERSITY OF READING   (United Kingdom)

Author keywords

Carbamazepine; Clinical trial; Efficacy; Epilepsy; Monotherapy; Remacemide; Sequential design; Side effects

Indexed keywords

CARBAMAZEPINE; REMACEMIDE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; AGED; ARTICLE; BACKACHE; CHILD; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DIARRHEA; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; DYSPEPSIA; ELECTROENCEPHALOGRAPHY; FATIGUE; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; METHODOLOGY; NAUSEA AND VOMITING; PATIENT CARE; PHARYNGITIS; RANDOMIZED CONTROLLED TRIAL; RASH; RECURRENT DISEASE; SEQUENTIAL ANALYSIS; SOMNOLENCE; TIME; TONIC CLONIC SEIZURE; TREATMENT OUTCOME; VERTIGO; VIRUS INFECTION;

EID: 0036554690     PISSN: 15255050     EISSN: None     Source Type: Journal    
DOI: 10.1006/ebeh.2002.0337     Document Type: Article

References (21)

1. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med 2000;343:314-9.
2. Kwan P, Brodie MJ. Effectiveness of first antiepileptic drug. Epilepsia 2001;42:1255-60.
3. Brodie MJ, French JA. Management of epilepsy in adolescents and adults. Lancet 2000;356:323-9.
4. Palmer GC, Harris EW, Ray R, Stagnitto ML, Schmiesing RJ. Classification of compounds for prevention of NMDA-induced seizures/mortality, or maximal electroshock and pentylenetetrazol seizures in mice and antagonism of MK801 in vitro. Arch Int Pharmacodyn Ther 1992;317:16-34.
5. Crawford P, Richens A, Mawer G, Cooper P, Hutchison JB. A double-blind, placebo-controlled cross-over study of remacemide hydrochloride as adjunctive therapy in patients with refractory epilepsy. Seizure 1992;1(Suppl.A):7-13.
6. Richens A, Mawer G, Crawford P, Harrison B. A placebo-controlled, double-blind cross-over trial of adjunctive one month remacemide hydrochloride treatment in patients with epilepsy. Seizure 2000;9:537-43.
7. Devinsky O, Vazquez B, Faught E, et al. A double-blind, placebo-controlled study of remacemide hydrochloride in patients with refractory epilepsy following presurgical assessment. Seizure, in press.
8. Brodie MJ, Dichter MA. Antiepileptic drugs. N Engl J Med 1996;334:168-75.
9. Commission on Classification of Terminology of the ILAE. Proposal for revised clinical classification of epileptic seizures. Epilepsia 1981;22:489-501.
10. Schachter SC, Tarsy D. Remacemide: current status and clinical applications. Exp Opin Invest Drugs 2000;9:871-83
11. Brodie MJ, Richens A, Yuen AWC and the UK Lamotrigine/Carbamazepine Monotherapy Trial Group. Double-blind comparison of lamotrigine and carbamazepine in newly diagnosed epilepsy. Lancet 1995;345:476-9.
12. Chadwick DW, Anhut H, Greiner MJ, et al. A double-blind trial of gabapentin monotherapy for newly diagnosed partial seizures. Neurology 1998;51:1282-8.
13. Chadwick D and the Vigabatrin European Monotherapy Study Group. Safety and efficacy of vigabatrin and carbamazepine in newly diagnosed epilepsy: a multicentre randomised double-blind study. Lancet 1999;354:13-9.
14. Whitehead J. The design and analysis of sequential clinical trials. rev. 2nd ed. Chichester: Wiley, 1997.
15. Cox DR. Regression models and life-tables. J R Stat Soc [B] 1972;34:187-220.
16. Whitehead J. Monotherapy trials: sequential design. Epilepsy Res 2001;45:81-7.
17. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
18. Beydoun A, Milling CJ. Active-control comparative equivalency monotherapy trials in epilepsy: are they scientifically valid? Epilepsy Behav 2001;2:187-92.
19. Chadwick D, Privitera M. Placebo-controlled studies in neurology: where do they stop? Neurology 1999;52:682-5.
20. Singer PA, Benatar SR. Beyond Helsinki: a vision for global health ethics. Br Med J 2001;322:747-8.
21. Karlawish JHT, French J. The ethical and scientific shortcomings of current monotherapy epilepsy trials in newly diagnosed patients. Epilepsy Behav 2001;2:193-200.