Treatment of restless legs syndrome with pregabalin: A double-blind, placebo-controlled study

Neurology

Volumn 74, Issue 23, 2010, Pages 1897-1904

  Garcia Borreguero, D ^a   Larrosa, O ^a   Williams, A M ^a   Albares, J ^b   Pascual, M ^b   Palacios, J C ^c   Fernandez, C ^c,d  

^a SLEEP RESEARCH INSTITUTE   (Spain)

^b INSTITUT UNIVERSITARI DEXEUS   (Spain)

^c Drug Solutions   (Spain)

^d UNIVERSIDAD COMPLUTENSE DE MADRID   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

PLACEBO; PREGABALIN;

ADULT; AGED; ALLERGY; ARTICLE; BLURRED VISION; CLINICAL GLOBAL IMPRESSION SCALE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAYTIME SOMNOLENCE; DOUBLE BLIND PROCEDURE; DRUG DOSE REGIMEN; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; EVENING DOSAGE; FEMALE; FLUID RETENTION; HEADACHE; HUMAN; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PERIODIC LIMB MOVEMENT DISORDER; POLYSOMNOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESS LEGS SYNDROME; SIDE EFFECT; SINGLE BLIND PROCEDURE; SLOW WAVE SLEEP; TREATMENT DURATION; UNSTEADINESS; VERTIGO; WAKEFULNESS; XEROSTOMIA;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANALGESICS; ANALYSIS OF VARIANCE; CHI-SQUARE DISTRIBUTION; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; EXTREMITIES; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; MALE; MIDDLE AGED; MOVEMENT; POLYSOMNOGRAPHY; RESTLESS LEGS SYNDROME; SINGLE-BLIND METHOD; TREATMENT OUTCOME; YOUNG ADULT;

EID: 77953347801     PISSN: 00283878     EISSN: 1526632X     Source Type: Journal    
DOI: 10.1212/WNL.0b013e3181e1ce73     Document Type: Article

References (35)

1. Silber MH, Ehrenberg BL, Allen RP, et al. An algorithm for the management of restless legs syndrome. Mayo Clin Proc 2004;79:916-922.
2. Silber MH, Girish M, Izurieta R. Pramipexole in the management of restless legs syndrome: an extended study. Sleep 2003;26:819-821.
3. Happe S, Trenkwalder C. Role of dopamine receptor agonists in the treatment of restless legs syndrome. CNS Drugs 2004;18:27-36. (Pubitemid 38197757)
4. Trenkwalder C, Garcia-Borreguero D, Montagna P, et al. Ropinirole in the treatment of restless legs syndrome: results from a 12-week, randomised, placebo-controlled study in 10 European countries. J Psychiatr Neurol Neuro-surg 2004;75:92-97.
5. Ondo W, Romanyshyn J, Vuong KD, Lai D. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol 2004;61:1393-1397.
6. Garcia-Borreguero D, Larrosa O, De la Llave Y, Verger K, Masramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002;59:1573-1579.
7. Ehrenberg B. Importance of sleep restoration in co-morbid disease: effect of anticonvulsants. Neurology 2000;54: S33-S37. (Pubitemid 30151837)
8. Allen R, Becker PM, Bogan R, et al. Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep 2004;27:907-914.
9. Hening W, Walters AS, Allen RP, Montplaisir J, Myers A, Ferini-Strambi L. Impact, diagnosis and treatment of restless legs syndrome (RLS) in a primary care population: the REST (RLS epidemiology, symptoms, and treatment) primary care study. Sleep Med 2004;2004:3-237.
10. Kushida CA, Becker PM, Ellenbogen AL, Canafax DM, Barrett RW. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology 2009;72:439-446.
11. Kushida CA, Walters AS, Becker P, et al. A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome. Sleep 2009;32:159-168.
12. Ehrenberg B, Wagner AK, Corbett K, Rogers WH. Double-blind trial of gabapentin for periodic limb movements of sleep: preliminary results. Neurology 1998;50: A276.
13. Garcia-Borreguero D, Odin P, Schwarz C. Restless legs syndrome: an overview of the current understanding and management. Acta Neurol Scand 2004;109:303-317.
14. Richter RW, Portenoy R, Sharma U, Lamoreaux L, Bock-brader H, Knapp LE. Relief of painful diabetic peripheral neuropathy with pregabalin: a randomized, placebo-controlled trial. J Pain 2005;6:253-260.
15. Russell IJ, Crofford LJ, Leon T, et al. The effects of pre-gabalin on sleep disturbance symptoms among individuals with fibromyalgia syndrome. Sleep Med 2009;10:604-610.
16. Sommer M, Bachmann CG, Liebetanz KM, Schindehutte J, Tings T, Paulus W. Pregabalin in restless legs syndrome with and without neuropathic pain. Acta Neurol Scand 2007;115:347-350.
17. Allen RP, Picchietti D, Hening WA, Trenkwalder C, Walters AS, Montplaisir J. Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology: a report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health. Sleep Med 2003;4:101-119.
18. Guy W. National Institute of Mental Health (US), Psy-chopharmacology Research Branch, Early Clinical Drug Evaluation Program: ECDEU Assessment Manual for Psy-chopharmacology, rev. ed. Rockville, MD: US Department of Health, Education, and Welfare, Public Health Service, Alcohol, Drug Abuse, and Mental Health Administration, National Institute of Mental Health, Psychop-harmacology Research Branch, Division of Extramural Research Programs; 1976.
19. Kohnen R, Oertel WH, Stiasny-Kolster K, Benes H, Tren-kwalder C. Severity rating of restless legs syndrome: validation of the RLS-6 Scales. Sleep 2004;27:A304.
20. Hays RD, Stewart AL. Sleep measures. In: Stewart AL, Ware JE, eds. Measuring Functioning and Well-Being: The Medical Outcomes Study Approach. Durham: Duke University Press; 1992:235-259.
21. Spielberger CD. Manual for the State/Trait Anxiety Inventory (Form Y) (Self Evaluation Questionnaire). Palo Alto, CA: Consulting Psychologists Press; 1983.
22. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of the Medical Outcomes Study sleep measure. Sleep Med 2005;6:41-44.
23. The International Classification of Sleep Disorders: Diagnostic & Coding Manual, 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005.
24. Trenkwalder C, Benes H, Poewe W, et al. Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: a randomised, double-blind, placebo-controlled trial. Lancet Neurol 2008;7:595-604.
25. Jama L, Hirvonen K, Partinen M, et al. A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance. Sleep Med 2009;10:630-636.
26. Saletu M, Anderer P, Saletu-Zyhlarz GM, et al. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. J Neural Transm 2010;117:463-473.
27. Fulda S, Wetter TC. Where dopamine meets opioids: a meta-analysis of the placebo effect in restless legs syndrome treatment studies. Brain 2008;131:902-917.
28. Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a poly-somnographic dose-finding study: the PRELUDE study. Sleep Med 2006;7:407-417.
29. Oertel WH, Benes H, Garcia-Borreguero D, et al. One year open-label safety and efficacy trial with rotigotine transdermal patch in moderate to severe idiopathic restless legs syndrome. Sleep Med 2008;9:865-873.
30. Chesson AL, Jr., Wise M, Davila D, et al. Practice parameters for the treatment of restless legs syndrome and periodic limb movement disorder: An American Academy of Sleep Medicine Report: Standards of Practice Committee of the American Academy of Sleep Medicine. Sleep 1999; 22:961-968.
31. Bara-Jimenez W, Aksu M, Graham B, Sato S, Hallett M. Periodic limb movements in sleep: state-dependent excitability of the spinal flexor reflex. Neurology 2000;54: 1609-1616.
32. Luszczki JJ. Third-generation antiepileptic drugs: mechanisms of action, pharmacokinetics and interactions. Pharmacol Rep 2009;61:197-216.
33. Garcia-Borreguero D, Allen RP, Kohnen R, et al. Diagnostic standards for dopaminergic augmentation of restless legs syndrome: report from a World Association of Sleep Medicine-International Restless Legs Syndrome Study Group consensus conference at the Max Planck Institute. Sleep Med 2007;8:520-530.
34. Earley CJ, Allen RP. Restless legs syndrome augmentation associated with tramadol. Sleep Med 2006;7:592-593.
35. Vetrugno R, La Morgia C, D'Angelo R, et al. Augmentation of restless legs syndrome with long-term tramadol treatment. Mov Disord 2007;22:424-427.