A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome

Sleep

Volumn 32, Issue 2, 2009, Pages 159-168

  Kushida, Clete A ^a   Walters, Arthur S ^b   Becker, Philip ^c   Thein, Stephen G ^d   Perkins, A Thomas ^e   Roth, Thomas ^f   Canafax, Daniel ^g   Barrett, Ronald W ^h  

^a STANFORD UNIVERSITY   (United States)

^b SETON HALL UNIVERSITY   (United States)

^c Sleep Medicine Associates of Texas PA   (United States)

^d Pacific Research Network   (United States)

^e Raleigh Neurology Associates   (United States)

^f HENRY FORD HOSPITAL   (United States)

^g ARYx Therapeutics   (United States)

^h XenoPort Inc   (United States)

Author keywords

GSK1838262; Polysomnography; Restless legs syndrome; RLS; Sleep; Sleep stages; XP13512

Indexed keywords

GABAPENTIN ENACARBIL; PLACEBO;

ADULT; ANXIETY; ARTICLE; BALANCE DISORDER; BEDTIME DOSAGE; CHEST TIGHTNESS; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DISEASE SEVERITY; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG DOSE REDUCTION; DRUG DOSE TITRATION; DRUG EFFECT; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HUMAN; HYPESTHESIA; INSOMNIA; MALE; MULTICENTER STUDY; NAUSEA; NIGHT SLEEP; PATIENT COMPLIANCE; POLYSOMNOGRAPHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REM SLEEP; RESTLESS LEGS SYNDROME; RHINOPHARYNGITIS; SCORING SYSTEM; SIDE EFFECT; SLEEP STAGE; SLEEP TIME; SLOW WAVE SLEEP; SOMNOLENCE; TREATMENT DURATION; TREATMENT RESPONSE; UNITED STATES; UNSPECIFIED SIDE EFFECT; WAKEFULNESS; XEROSTOMIA;

EID: 62549108197     PISSN: 01618105     EISSN: 15509109     Source Type: Journal    
DOI: 10.1093/sleep/32.2.159     Document Type: Article

References (36)

1. Allen RP, Walters AS, Montplaisir J, et al. Restless legs syndrome prevalence and impact: REST general population study. Arch Intern Med 2005;165:1286-92.
2. Högl B, Kiechl S, Willeit J, et al. Restless legs syndrome: a community-based study of prevalence, severity, and risk factors. Neurology 2005;64:1920-4.
3. Nichols DA, Allen RP, Grauke JH, et al. Restless legs syndrome symptoms in primary care: a prevalence study. Arch Intern Med 2003;163:2323-9.
4. Saletu B, Gruber G, Saletu M, et al. 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 2000;41:181-9.
5. Abetz L, Allen RP, Follet A, et al. Evaluating the quality of life of patients with restless legs syndrome. Clin Ther 2004;26:925-35.
6. Partinen M, Hirvonen K, Jama L, et al. Efficacy and safety of pramipexole in idiopathic restless legs syndrome: a polysomnographic dose-finding study-the PRELUDE study. Sleep Med 2006;7:407-17.
7. Bliwise DL, Freeman A, Ingram CD, Rye DB, Chakravorty S, Watts RL. Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. Sleep Med 2005;6:141-7.
8. Allen RP, Becker PM, Bogan RK, et al, Ropinirole decreases periodic leg movements and improves sleep parameters in patients with restless legs syndrome. Sleep 2004;27:907-14.
9. Winkelman JW, Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med 2004;5:9-14.
10. Ondo W, Romanyshyn J, Vuong KD, Lai D. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol 2004;61:1393-7.
11. Rowbotham M, Harden N, Stacey B, Bernstein P, Magnus-Miller L. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA 1998;280:1837-42.
12. Rice AS, Maton S. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain 2001;94:215-24.
13. Pfizer Inc. Neurontin® Prescribing Information. [PDF] 2007 January 2007 [cited 2007 June 28]; Currently available from: http:// www.pfizer.com/files/products/uspi-neurontin.pdf
14. McLean MJ. Gabapentin in the management of convulsive disorders. Epilepsia 1999;40 Suppl 6:S39-50; discussion S73-4.
15. Anhut H, Ashman P, Feuerstein TJ, Sauermann W, Saunders M, Schmidt B. Gabapentin (Neurontin) as add-on therapy in patients with partial seizures: a double-blind, placebo-controlled study. The International Gabapentin Study Group. Epilepsia 1994;35:795-801.
16. Mellick GA, Mellick LB. Management of restless legs syndrome with gabapentin (Neurontin), Sleep 1996;19:224-6.
17. Thorp ML, Morris CD, Bagby SP. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. Am J Kidney Dis 2001;38:104-8.
18. Micozkadioglu H, Ozdemir FN, Kut A, Sezer S, Saatci U, Hab-eral M. Gabapentin versus levodopa for the treatment of Restless Legs Syndrome in hemodialysis patients: an open-label study. Ren Fail 2004;26:393-7.
19. Mellick LB, Mellick GA. Successful treatment of reflex sympathetic dystrophy with gabapentin. Am J Emerg Med 1995;13:96.
20. Adler CH. Treatment of restless legs syndrome with gabapentin. Clin Neuropharmacol 1997;20:148-51.
21. Happe S, Klosch G, Saletu B, Zeitlhofer J. Treatment of idiopathic restless legs syndrome (RLS) with gabapentin. Neurology 2001;57:1717-9.
22. Happe S, Sauter C, Klosch G, Saletu B, Zeitlhofer J. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology 2003;48:82-6.
23. Garcia-Borreguero D, Larrosa O, de la Llave Y, Verger K, Mas-ramon X, Hernandez G. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002;59:1573-9.
24. Gidal BE, Radulovic LL, Kruger S, Rutecki P, Pitterle M, Bockbrader HN. Inter- and intra-subject variability in gabapentin absorption and absolute bioavailability. Epilepsy Res 2000;40:123-7.
25. Cundy KC, Annamalai T, Bu L, et al. XP13512 [(+/-)-1-([(alpha- isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: II. Improved oral bioavailability, dose proportionality, and colonic absorption compared with gabapentin in rats and monkeys. J Pharmacol Exp Ther 2004;311:324-33.
26. Cundy KC SS, Luo W, Zou J, Moors TL, Canafax DM. Clinical pharmacokinetics of XP13512, anovel transported prodrug of gabapentin. J Clin Pharmacol 2008;In press.
27. 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;4:101-19.
28. Walters AS, LeBrocq C, Dhar A, et al. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med 2003;4:121-32.
29. Montplaisir J, Boucher S, Nicolas A, et al. Immobilization tests and periodic leg movements in sleep for the diagnosis of restless leg syndrome. Mov Disord 1998;13:324-9.
30. Holm S. A simple sequentially rejective multiple test procedure. Scand J Statis 1979;6:65-70.
31. Adler CH, Hauser RA, Sethi K, et al. Ropinirole for restless legs syndrome: a placebo-controlled crossover trial. Neurology 2004;62:1405-7.
32. Trenkwalder C, Garcia-Borreguero D, Montagna P, et al. 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 2004;75:92-7.
33. Walters AS, Ondo WG, Dreykluft T, Grunstein R, Lee D, Sethi K. 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 2004;19:1414-23.
34. Winkelman JW, Sethi KD, Kushida CA, et al. Efficacy and safety of pramipexole in restless legs syndrome. Neurology 2006;67:1034-9.
35. Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia 2002;43:1493-7.
36. Saletu M, Anderer P, Saletu-Zyhlarz G, Hauer C, Saletu B. Acute placebo-controlled sleep laboratory studies and clinical follow-up with pramipexole in restless legs syndrome. Eur Arch Psychiatry Clin Neurosci 2002;252:185-94.