Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome

Journal of Neural Transmission

Volumn 117, Issue 4, 2010, Pages 463-473

  Saletu, Michael ^a   Anderer, Peter ^a,b   Saletu Zyhlarz, Gerda Maria ^a   Parapatics, Silvia ^b   Gruber, Georg ^b   Nia, Saba ^a   Saletu, Bernd ^a,c  

^a MEDICAL UNIVERSITY OF VIENNA   (Austria)

^b Vienna   (Austria)

^c Rudolfinerhaus   (Austria)

Author keywords

Acute effects; Gabapentin; Polysomnography; Psychometry; Restless legs syndrome; Ropinirole

Indexed keywords

GABAPENTIN; PLACEBO; ROPINIROLE;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG DOSE INCREASE; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG HALF LIFE; EVENING DOSAGE; FEMALE; HUMAN; LATENT PERIOD; MALE; MENTAL PERFORMANCE; PARALLEL DESIGN; PERIODIC LIMB MOVEMENT DISORDER; POLYSOMNOGRAPHY; PRIORITY JOURNAL; PSYCHOMETRY; RANDOMIZED CONTROLLED TRIAL; REM SLEEP; RESTLESS LEGS SYNDROME; SINGLE BLIND PROCEDURE; SLEEP PARAMETERS; SLEEP QUALITY; WAKEFULNESS;

AMINES; ANTI-DYSKINESIA AGENTS; CYCLOHEXANECARBOXYLIC ACIDS; FEMALE; GAMMA-AMINOBUTYRIC ACID; HUMANS; INDOLES; MALE; MENTAL PROCESSES; MIDDLE AGED; PLACEBOS; POLYSOMNOGRAPHY; PSYCHOMETRICS; RESPIRATION; RESTLESS LEGS SYNDROME; SINGLE-BLIND METHOD; SLEEP; SLEEP STAGES; SLEEP, REM; TIME FACTORS; TREATMENT OUTCOME;

EID: 77952241446     PISSN: 03009564     EISSN: 14351463     Source Type: Journal    
DOI: 10.1007/s00702-009-0361-3     Document Type: Article

References (39)

1. K Abt 1991 Planning controlled clinical trials on the basis of descriptive data analysis Stat Med 10 777 795 10.1002/sim.4780100513 1:STN:280:DyaK3M3pslalsA%3D%3D 2068431
2. CH Adler RA Hauser K Sethi JN Caviness L Marlor, et al. 2004 Ropinirole for restless legs syndrome: a placebo-controlled crossover trial Neurology 62 1405 1407 1:CAS:528:DC%2BD2cXivV2jsLg%3D 15111683
3. RP Allen CJ Earley 2001 Restless legs syndrome: a review of clinical and pathophysiologic features J Clin Neurophysiol 18 128 147 10.1097/00004691- 200103000-00004 1:STN:280:DC%2BD3Mznslykuw%3D%3D 11435804
4. RP Allen D Picchietti WA Hening C Trenkwalder AS Walters, et al. 2003 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 4 101 119 10.1016/S1389-9457(03)00010-8 14592341 (Pubitemid 36527231)
5. R Allen PM Becker R Bogan M Schmidt CA Kushida, et al. 2004 Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome Sleep 27 907 914 15453549
6. American Sleep Disorders Association (1997) The International classification of sleep disorders, revised. Diagnostic and coding manual. American Sleep Disorders Association, Rochester
7. Atlas Task Force 1993 Recording and scoring leg movements Sleep 16 748 759
8. Atlas Task Force of the American Sleep Disorders Association 1992 EEG arousals: scoring rules and examples: a preliminary report from the Sleep Disorders Atlas Task Force of the American Sleep Disorders Association Sleep 15 173 184
9. DL Bliwise A Freeman CD Ingram DB Rye S Chakravorty, et al. 2005 Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome Sleep Med 6 141 147 10.1016/j.sleep.2004.12.002 1:STN:280:DC%2BD2M%2Foslantw%3D%3D 15716217 (Pubitemid 40247176)
10. RK Bogan JM Fry MH Schmidt SW Carson SY Ritchie 2006 Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial Mayo Clin Proc 81 17 27 10.4065/81.1.17 1:CAS:528:DC%2BD28XntVCisA%3D%3D 16438474
11. DJ Buysse CF Reynolds 3rd TH Monk SR Berman DJ Kupfer 1989 The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research Psychiatry Res 28 193 213 10.1016/0165-1781(89)90047-4 1:STN:280: DyaL1Mzhs1Wmsg%3D%3D 2748771 (Pubitemid 19144991)
12. 2+ channel alpha2delta ligands: novel modulators of neurotransmission Trends Pharmacol Sci 28 75 82 10.1016/j.tips.2006.12.006 1:CAS:528:DC%2BD2sXhtlCmu7k%3D 17222465 (Pubitemid 46161838)
13. G Ferber K Abt K Fichte R Luthringer 1999 IPEG guideline on statistical design and analysis for pharmacodynamic trials. International Pharmaco-EEG Group Neuropsychobiology 39 92 100 10.1159/000026567 1:STN:280:DyaK1M7nt1amuw%3D%3D 10072666
14. D Garcia-Borreguero O Larrosa Y de la Llave K Verger X Masramon, et al. 2002 Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study Neurology 59 1573 1579 1:STN:280:DC%2BD38nptVejsw%3D%3D 12451200
15. Grünberger J (1977) Psychodiagnostik des Alkoholkranken-Ein methodischer Beitrag zur Bestimmung der Organizität in der Psychiatrie. Maudrich, Wien
16. J Grünberger L Linzmayer 1991 Computergesteuerte klinisch-psychodiagnostische Methoden in der Psychiatrie Neuropsychiatrie 4 89 98
17. S Happe G Klösch B Saletu J Zeitlhofer 2001 Treatment of idiopathic restless legs syndrome (RLS) with gabapentin Neurology 57 1717 1719 1:CAS:528:DC%2BD38XnvVI%3D 11706121
18. S Happe C Sauter G Klösch B Saletu J Zeitlhofer 2003 Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome Neuropsychobiology 48 82 86 10.1159/000072882 1:CAS:528:DC%2BD3sXnsVOqur8%3D 14504416 (Pubitemid 37176872)
19. MW Johns 1991 A new method for measuring daytime sleepiness: the Epworth sleepiness scale Sleep 14 540 545 1:STN:280:DyaK387ovVSksw%3D%3D 1798888
20. JE Mezzich MA Ruiperez C Perez G Yoon J Liu, et al. 2000 The Spanish version of the quality of life index: presentation and validation J Nerv Ment Dis 188 301 305 10.1097/00005053-200005000-00008 1:STN:280: DC%2BD3c3ovFersg%3D%3D 10830568 (Pubitemid 30314045)
21. H Micozkadioglu FN Ozdemir A Kut S Sezer U Saatci, et al. 2004 Gabapentin versus levodopa for the treatment of restless legs syndrome in hemodialysis patients: an open-label study Ren Fail 26 393 397 10.1081/JDI-120039823 1:CAS:528:DC%2BD2cXntlyit7g%3D 15462107 (Pubitemid 39167616)
22. JM Monti D Monti 2007 The involvement of dopamine in the modulation of sleep and waking Sleep Med Rev 11 113 133 10.1016/j.smrv.2006.08.003 17275369 (Pubitemid 46330853)
23. JM Monti M Hawkins H Jantos L D'Angelo M Fernandez 1988 Biphasic effects of dopamine D-2 receptor agonists on sleep and wakefulness in the rat Psychopharmacology 95 395 400 10.1007/BF00181955 1:CAS:528:DyaL1cXkvVKhsbk%3D 3137628
24. J Montplaisir S Boucher G Poirier G Lavigne O Lapierre, et al. 1997 Clinical, polysomnographic, and genetic characteristics of restless legs syndrome: a study of 133 patients diagnosed with new standard criteria Mov Disord 12 61 65 10.1002/mds.870120111 1:STN:280:DyaK2s7ksVahuw%3D%3D 8990055 (Pubitemid 27032881)
25. W Ondo J Romanyshyn KD Vuong D Lai 2004 Long-term treatment of restless legs syndrome with dopamine agonists Arch Neurol 61 1393 1397 10.1001/archneur.61.9.1393 15364685 (Pubitemid 39202222)
26. Rechtschaffen A, Kales A (1968) A manual of standardized terminology, techniques and scoring system for sleep stages of human subjects. BIS/BRI, UCLA, Los Angeles
27. B Saletu R Frey M Krupka P Anderer J Grünberger, et al. 1991 Sleep laboratory studies on the single-dose effects of serotonin reuptake inhibitors paroxetine and fluoxetine on human sleep and awakening qualities Sleep 14 439 447 1:STN:280:DyaK387gtFSiug%3D%3D 1836894
28. B Saletu G Gruber M Saletu N Brandstätter C Hauer, et al. 2000 Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 1. Findings on objective and subjective sleep and awakening quality Neuropsychobiology 41 181 189 10.1159/000026658 1:CAS:528:DC%2BD3cXksFSgtLs%3D 10828727 (Pubitemid 30258976)
29. M Saletu P Anderer B Saletu C Hauer M Mandl, et al. 2000 Sleep laboratory studies in restless legs syndrome patients as compared with normals and acute effects of ropinirole. 2. Findings on periodic leg movements, arousals and respiratory variables Neuropsychobiology 41 190 199 10.1159/000026659 1:CAS:528:DC%2BD3cXksFSgtLg%3D 10828728 (Pubitemid 30258977)
30. M Saletu P Anderer G Saletu-Zyhlarz C Hauer B Saletu 2002 Acute placebo-controlled sleep laboratory studies and clinical follow-up with pramipexole in restless legs syndrome Eur Arch Psychiatry Clin Neurosci 252 185 194 1:STN:280:DC%2BD38vnvF2msw%3D%3D 12242580
31. M Saletu P Anderer B Högl G Saletu-Zyhlarz A Kunz, et al. 2003 Acute double-blind, placebo-controlled sleep laboratory and clinical follow-up studies with a combination treatment of rr-L-dopa and sr-L-dopa in restless legs syndrome J Neural Transm 110 611 626 10.1007/s00702-003-0814-z 1:CAS:528:DC%2BD3sXntlKhs7w%3D 12768357 (Pubitemid 36683515)
32. ML Thorp CD Morris SP Bagby 2001 A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients Am J Kidney Dis 38 104 108 10.1053/ajkd.2001.25202 1:CAS:528:DC%2BD3MXlsVOls7w%3D 11431189
33. C Trenkwalder D Garcia-Borreguero P Montagna E Lainey AW de Weerd, et al. 2004 Ropinirole in the treatment of restless legs syndrome: results from the TREAT RLS 1 study, a 12 week, randomised, placebo controlled study in 10 European countries J Neurol Neurosurg Psychiatry 75 92 97 1:STN:280: DC%2BD2c%2FjvVSguw%3D%3D 14707315
34. C Trenkwalder WA Hening P Montagna WH Oertel RP Allen, et al. 2008 Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice Mov Disord 23 2267 2302 10.1002/mds.22254 18925578
35. L Vignatelli M Billiard P Clarenbach D Garcia-Borreguero D Kaynak, et al. 2006 EFNS guidelines on management of restless legs syndrome and periodic limb movement disorder in sleep Eur J Neurol 13 1049 1065 10.1111/j.1468-1331.2006. 01410.x 1:STN:280:DC%2BD28rmt1SgsA%3D%3D 16987157 (Pubitemid 44434310)
36. D Von Zerssen D Koeller E Rey 1970 Die Befindlichkeitsskala (B-S)-ein einfaches Instrument zur Objektivierung von Befindlichkeitsstörungen, insbesondere im Rahmen von Längsschnittuntersuchungen Arzneim Forsch Drug Res 20 915 918 1:STN:280:DyaE3M%2FgsFSnug%3D%3D
37. AS Walters C LeBrocq A Dhar W Hening R Rosen, et al. 2003 Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome Sleep Med 4 121 132 10.1016/S1389-9457(02)00258-7 14592342 (Pubitemid 36527232)
38. AS Walters WG Ondo T Dreykluft R Grunstein D Lee, et al. 2004 Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study Mov Disord 19 1414 1423 10.1002/mds.20257 15390050 (Pubitemid 40104048)
39. TC Wetter K Stiasny J Winkelmann A Buhlinger U Brandenburg, et al. 1999 A randomized controlled study of pergolide in patients with restless legs syndrome Neurology 52 944 950 1:CAS:528:DyaK1MXit1Wnt7o%3D 10102410