Randomized, multicenter, dose-ranging trial of retigabine for partial-onset seizures

Neurology

Volumn 68, Issue 15, 2007, Pages 1197-1204

  Porter, R J ^a,f   Partiot, A ^b   Sachdeo, R ^c   Nohria, V ^d   Alves, W M ^e  

^a UNIVERSITY OF PENNSYLVANIA   (United States)

^b Shire Pharmaceuticals   (United States)

^c ROBERT WOOD JOHNSON UNIVERSITY HOSPITAL   (United States)

^d EMORY UNIVERSITY   (United States)

^e Valeant Research and Development   (United States)

^f NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BARBITURIC ACID DERIVATIVE; BENZODIAZEPINE; CARBAMAZEPINE; GABAPENTIN; LAMOTRIGINE; OXCARBAZEPINE; PHENYTOIN; RETIGABINE; TOPIRAMATE; VALPROIC ACID;

ABDOMINAL PAIN; ABNORMAL THINKING; ABNORMAL VISION; ACCIDENTAL INJURY; ADOLESCENT; ADULT; AGED; AMNESIA; ARTICLE; ASTHENIA; ATAXIA; CLINICAL ASSESSMENT; CLINICAL TRIAL; CONFUSION; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CONVULSION; COORDINATION DISORDER; DIARRHEA; DIPLOPIA; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOCAL EPILEPSY; GAIT DISORDER; HEADACHE; HUMAN; INFECTION; LABORATORY TEST; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NERVOUSNESS; NEUROLOGIC EXAMINATION; PAIN; PARESTHESIA; PHYSICAL EXAMINATION; PHYSICIAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SOMNOLENCE; SPEECH DISORDER; TREATMENT RESPONSE; TREMOR; VERTIGO; WEIGHT GAIN;

ADOLESCENT; ADULT; AGED; ANTICONVULSANTS; AUSTRALIA; CARBAMATES; DOSE-RESPONSE RELATIONSHIP, DRUG; EPILEPSIES, PARTIAL; EUROPE; FEMALE; HUMANS; MALE; MIDDLE AGED; PHENYLENEDIAMINES; RISK ASSESSMENT; RISK FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 34247252905     PISSN: 00283878     EISSN: None     Source Type: Journal    
DOI: 10.1212/01.wnl.0000259034.45049.00     Document Type: Article

References (17)

1. Rundfeldt C, Netzer R. The novel anticonvulsant retigabine activates M-currents in Chinese hamster ovary-cells transfected with human KCNQ2/3 subunits. Neurosci Lett 2000;282:73-76.
2. Kapetanovic IM, Rundfeldt C. D 23129: a new anticonvulsant compound. CNS Drug Rev 1996;2:308-321.
3. Kapetanovic IM, Yonekawa WD, Kupferberg HJ. The effects of D 23129, a new experimental anticonvulsant drug, on neurotransmitter amino acids in the rat hippocampus in vitro. Epilepsy Res 1995;22:167-173.
4. Rostock A, Tober C, Rundfeldt C, et al. D 23129: a new anticonvulsant with a broad spectrum activity in animal models of epileptic seizures. Epilepsy Res 1996;23:211-223.
5. Dailey JW, Cheong JH, Ko KH, Adams-Curtis LE, Jobe PC. Anticonvulsant properties of D 20443 genetically epilepsy-prone rats: prediction of clinical response. Neurosci Lett 1995;195:77-80.
6. Tober C, Rostock A, Rundfeldt C, Bartsch R. D 23129: a potent anticonvulsant in the amygdala kindling model of complex partial seizures. Eur J Pharmacol 1996;303:163-169.
7. Ferron GM, Paul J, Fruncillo R, et al. Multiple-dose, linear, dose-proportional pharmacokinetics of retigabine in healthy volunteers. J Clin Pharmacol 2002;42:175-182.
8. Hempel R, Schupke H, McNeilly PJ, et al. Metabolism of retigabine (D-23129), a novel anticonvulsant. Drug Metab Dispos 1999;27:613-622.
9. Valeant Pharmaceuticals. Data on file. 2006.
10. Hermann R, Knebel NG, Niebch G, Richards L, Borlak J, Locher M. Pharmacokinetic interaction between retigabine and lamotrigine in healthy subjects. Eur J Clin Pharmacol 2003;58:795-802.
11. US Food and Drug Administration. "COSTART" coding symbols for thesaurus of adverse (sic) reaction terms, 5th ed. Rockville, MD: U.S. Department of Health and Human Services; 1995.
12. Pierce MW, Shu VS. Handling seizure data: special problems. Epilepsy Res Suppl 1993;10:175-178.
13. Johnson AL. Statistical aspects of the measurement of clinical care in epilepsy. In: Meinardi H. Quantitative assessment in epilepsy care. New York: Plenum Press, 1993.
14. Rom DM, Costello RJ, Connell LT. On closed test procedures for dose-response analysis. Stat Med 1994;13:1583-1596.
15. Marson AG, Kadir ZA, Hutton JL, Chadwick DW. The new antiepileptic drugs: a systematic review of their efficacy and tolerability. Epilepsia 1997;38:859-880.
16. Cereghino JJ, Biton V, Abou-Khalil B, Dreifuss F, Gauer LJ, Leppik I. Levetiracetam for partial seizures: results of a double-blind, randomized clinical trial. Neurology 2000;55:236-242.
17. Faught E, Ayala R, Montouris GG, Leppik IE. Randomized controlled trial of zonisamide for the treatment of refractory partial-onset seizures. Neurology 2001;57:1774-1779.