Pregabalin in partial seizures: A pragmatic 21-week, open-label study (PREPS)

European Journal of Neurology

Volumn 17, Issue 5, 2010, Pages 726-732

  Ryvlin, P ^a   Kalviainen R ^b   Von Raison, F ^c   Giordano, S ^c   Emir, B ^c   Chatamra, K ^d  

^a HOSPICES CIVILS DE LYON   (France)

^b KUOPIO UNIVERSITY HOSPITAL   (Finland)

^c PFIZER INC   (United States)

^d PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

Efficacy; Epilepsy; Open label; Partial seizures; Pregabalin; Tolerability

Indexed keywords

CARBAMAZEPINE; CLOBAZAM; ETIRACETAM; LAMOTRIGINE; OXCARBAZEPINE; PREGABALIN; TOPIRAMATE;

ADULT; ARTICLE; ASTHENIA; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIPLOPIA; DIZZINESS; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EUROPE; FATIGUE; FEMALE; FOCAL EPILEPSY; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OPEN STUDY; PRIORITY JOURNAL; SIDE EFFECT; SOMNOLENCE; VERTIGO; WEIGHT GAIN;

ADULT; ANTICONVULSANTS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EPILEPSIES, PARTIAL; EUROPE; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; PROSPECTIVE STUDIES; RETROSPECTIVE STUDIES; TIME FACTORS; TREATMENT OUTCOME;

EID: 77950914996     PISSN: 13515101     EISSN: 14681331     Source Type: Journal    
DOI: 10.1111/j.1468-1331.2009.02916.x     Document Type: Article

References (24)

1. Arroyo S, Anhut H, Kugler AR, et al. Pregabalin add-on treatment: a randomized, double-blind, placebo-controlled, dose-response study in adults with partial seizures. Epilepsia 2004 45 : 20 27. (Pubitemid 38063660)
2. Beydoun A, Uthman BM, Kugler AR, et al. Safety and efficacy of two pregabalin regimens for add-on treatment of partial epilepsy. Neurology 2005 64 : 475 480. (Pubitemid 40189866)
3. French JA, Kugler AR, Robbins JL, Knapp LE, Garofalo EA. Dose-response trial of pregabalin adjunctive therapy in patients with partial seizures. Neurology 2003 60 : 1631 1637. (Pubitemid 36618090)
4. Elger CE, Brodie MJ, Anhut H, Lee CM, Barrett JA. Pregabalin add-on treatment in patients with partial seizures: a novel evaluation of flexible-dose and fixed-dose treatment in a double-blind, placebo-controlled study. Epilepsia 2005 46 : 1926 1936. (Pubitemid 44922003)
5. Ryvlin P, Perucca E, Rheims S. Pregabalin for the management of partial epilepsy. Neuropsychiatr Dis Treat 2008 4 : 1211 1224.
6. Freynhagen R, Strojek K, Griesing T, Whalen E, Balkenohl M. Efficacy of pregabalin in neuropathic pain evaluated in a 12-week, randomised, double-blind, multicentre, placebo-controlled trial of flexible- and fixed-dose regimens. Pain 2005 115 : 254 263. (Pubitemid 40725282)
7. Siddall PJ, Cousins MJ, Otte A, Griesing T, Chambers R, Murphy TK. Pregabalin in central neuropathic pain associated with spinal cord injury: a placebo-controlled trial. Neurology 2006 67 : 1792 1800. (Pubitemid 44900755)
8. Montgomery SA, Tobias K, Zornberg GL, Kasper S, Pande AC. Efficacy and safety of pregabalin in the treatment of generalized anxiety disorder: a 6-week, multicenter, randomized, double-blind, placebo-controlled comparison of pregabalin and venlafaxine. J Clin Psychiatry 2006 67 : 771 782. (Pubitemid 43946184)
9. Ben-Menachem E. Pregabalin pharmacology and its relevance to clinical practice. Epilepsia 2004 45 (Suppl. 6 13 18. (Pubitemid 39350325)
10. Brodie MJ, Wilson EA, Wesche DL, et al. Pregabalin drug interaction studies: lack of effect on the pharmacokinetics of carbamazepine, phenytoin, lamotrigine, and valproate in patients with partial epilepsy. Epilepsia 2005 46 : 1407 1413. (Pubitemid 43919479)
11. 2δ subunit of a calcium channel. J Biol Chem 1996 271 : 5768 5776. (Pubitemid 26083915)
12. Taylor CP, Angelotti T, Fauman E. Pharmacology and mechanism of action of pregabalin: the calcium channel alpha2-delta subunit as a target for antiepileptic drug discovery. Epilepsy Res 2007 73 : 137 150.
13. Arikkath J, Campbell KP. Auxiliary subunits: essential components of the voltage-gated calcium channel complex. Curr Opin Neurobiol 2003 13 : 298 307. (Pubitemid 36792242)
14. Ryvlin P. Defining success in clinical trials - profiling pregabalin, the newest AED. Eur J Neurol 2005 12 (Suppl. 4 12 21. (Pubitemid 41597611)
15. Brodie MJ. Pregabalin as adjunctive therapy for partial seizures. Epilepsia 2004 45 (Suppl. 6 19 27.
16. Commission on Classification and Terminology of the International League Against Epilepsy. 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.
17. Hays RD, Stewart AL. Sleep measures. In : Stewart AL, Ware JE eds. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach.
18. National Institute of Mental Health. CGI: Clinical Global Impressions. In : Guy W, Bonato RR eds. Manual for the ECDEU Assessment Battery.2. Rev ed.
19. French JA. Proof of efficacy trials: endpoints. Epilepsy Res 2001 45 : 53 56.
20. Morrell MJ, McLean MJ, Willmore LJ, et al. Efficacy of gabapentin as adjunctive therapy in a large, multicenter study. The Steps Study Group. Seizure 2000 9 : 241 248.
21. Morrell MJ, Leppik I, French J, Ferrendelli J, Han J, Magnus L. The KEEPER trial: levetiracetam adjunctive treatment of partial-onset seizures in an open-label community-based study. Epilepsy Res 2003 54 : 153 161. (Pubitemid 36776733)
22. Xu X, Brandenburg NA, McDermott AM, Bazil CW. Sleep disturbances reported by refractory partial-onset epilepsy patients receiving polytherapy. Epilepsia 2006 47 : 1176 1183. (Pubitemid 44086753)
23. De Haas S, Otte A, de Weerd A, van Erp G, Cohen A, van Gerven J. Exploratory polysomnographic evaluation of pregabalin on sleep disturbance in patients with epilepsy. J Clin Sleep Med 2007 3 : 473 478. (Pubitemid 47378250)
24. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study Sleep measure. Sleep Med 2005 6 : 41 44.