메뉴 건너뛰기




Volumn 29, Issue 1, 2013, Pages 13-21

Gabapentin enacarbil in Japanese patients with restless legs syndrome: A 12-week, randomized, double-blind, placebo-controlled, parallel-group study

Author keywords

Gabapentin enacarbil; International Restless Legs Syndrome Rating Scale; Japan; Restless Legs Syndrome; Tolerability

Indexed keywords

CLONAZEPAM; GABAPENTIN; GABAPENTIN ENACARBIL; PLACEBO; PRAMIPEXOLE;

EID: 84871389240     PISSN: 03007995     EISSN: 14734877     Source Type: Journal    
DOI: 10.1185/03007995.2012.746217     Document Type: Article
Times cited : (32)

References (41)
  • 1
    • 0036344976 scopus 로고    scopus 로고
    • Prevalence of restless legs syndrome and periodic limb movement disorder in the general population
    • Ohayon MM, Roth T. Prevalence of restless legs syndrome and periodic limb movement disorder in the general population. J Psychosom Res 2002;53:547-54
    • (2002) J Psychosom Res , vol.53 , pp. 547-554
    • Ohayon, M.M.1    Roth, T.2
  • 2
    • 33749245492 scopus 로고    scopus 로고
    • Prevalence and correlates of restless legs syndrome symptoms in the Wisconsin Sleep Cohort
    • Winkelman JW, Finn L, Young T. Prevalence and correlates of restless legs syndrome symptoms in the Wisconsin Sleep Cohort. Sleep Med 2006;7:545-52
    • (2006) Sleep Med , vol.7 , pp. 545-552
    • Winkelman, J.W.1    Finn, L.2    Young, T.3
  • 3
    • 61449084770 scopus 로고    scopus 로고
    • Prevalence of restless legs syndrome in a rural community in Japan
    • Nomura T, Inoue Y, Kusumi M, et al. Prevalence of restless legs syndrome in a rural community in Japan. Mov Disord 2008;23:2363-9
    • (2008) Mov Disord , vol.23 , pp. 2363-2369
    • Nomura, T.1    Inoue, Y.2    Kusumi, M.3
  • 4
    • 47649104696 scopus 로고    scopus 로고
    • Email-based epidemiological surveys on restless legs syndrome in Japan
    • Nomura T, Inoue Y, Kusumi M, et al. Email-based epidemiological surveys on restless legs syndrome in Japan. Sleep Biol Rhythm 2008;6:139-45
    • (2008) Sleep Biol Rhythm , vol.6 , pp. 139-145
    • Nomura, T.1    Inoue, Y.2    Kusumi, M.3
  • 5
    • 21744445935 scopus 로고    scopus 로고
    • Restless legs syndrome prevalence and impact: REST general population study
    • 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
    • (2005) Arch Intern Med , vol.165 , pp. 1286-1292
    • Allen, R.P.1    Walters, A.S.2    Montplaisir, J.3
  • 6
    • 33947521578 scopus 로고    scopus 로고
    • Burden of restless legs syndrome on health-related quality of life
    • Kushida C, Martin M, Nikam P, et al. Burden of restless legs syndrome on health-related quality of life. Qual Life Res 2007;16:617-24
    • (2007) Qual Life Res , vol.16 , pp. 617-624
    • Kushida, C.1    Martin, M.2    Nikam, P.3
  • 7
    • 0034646434 scopus 로고    scopus 로고
    • Prevalence and risk factors of RLS in an elderly population: The MEMO study. Memory and Morbidity in Augsburg Elderly
    • Rothdach AJ, Trenkwalder C, Haberstock J, et al. Prevalence and risk factors of RLS in an elderly population: the MEMO study. Memory and Morbidity in Augsburg Elderly. Neurology 2000;54:1064-8
    • (2000) Neurology , vol.54 , pp. 1064-1068
    • Rothdach, A.J.1    Trenkwalder, C.2    Haberstock, J.3
  • 8
    • 79951960273 scopus 로고    scopus 로고
    • Algorithms for the diagnosis and treatment of restless legs syndrome in primary care
    • Garcia-Borreguero D, Stillman P, Benes H, et al. Algorithms for the diagnosis and treatment of restless legs syndrome in primary care. BMC Neurol 2011;11:28
    • (2011) BMC Neurol , vol.11 , pp. 28
    • Garcia-Borreguero, D.1    Stillman, P.2    Benes, H.3
  • 9
    • 3042776491 scopus 로고    scopus 로고
    • An algorithm for the management of restless legs syndrome
    • Silber MH, Ehrenberg BL, Allen RP, et al. An algorithm for the management of restless legs syndrome. Mayo Clin Proc 2004;79:916-22
    • (2004) Mayo Clin Proc , vol.79 , pp. 916-922
    • Silber, M.H.1    Ehrenberg, B.L.2    Allen, R.P.3
  • 10
    • 61449256613 scopus 로고    scopus 로고
    • Treatment of restless legs syndrome: An evidence-based review and implications for clinical practice
    • Trenkwalder C, Hening WA, Montagna P, et al. Treatment of restless legs syndrome: an evidence-based review and implications for clinical practice. Mov Disord 2008;23:2267-302
    • (2008) Mov Disord , vol.23 , pp. 2267-2302
    • Trenkwalder, C.1    Hening, W.A.2    Montagna, P.3
  • 11
    • 84856960608 scopus 로고    scopus 로고
    • Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (willis-ekbom disease): Results from a prospective multicenter study over 66 weeks
    • García-Borreguero D, Hogl B, Ferini-Strambi L, et al. Systematic evaluation of augmentation during treatment with ropinirole in restless legs syndrome (Willis-Ekbom disease): results from a prospective, multicenter study over 66 weeks. Mov Disord 2012;27:277-83
    • (2012) Mov Disord , vol.27 , pp. 277-283
    • García-Borreguero, D.1    Hogl, B.2    Ferini-Strambi, L.3
  • 12
    • 79955114643 scopus 로고    scopus 로고
    • A 10-year, longitudinal assessment of dopamine agonists and methadone in the treatment of restless legs syndrome
    • Silver N, Allen RP, Senerth J, et al. A 10-year, longitudinal assessment of dopamine agonists and methadone in the treatment of restless legs syndrome. Sleep Med. 2011;12:440-4
    • (2011) Sleep Med. , vol.12 , pp. 440-444
    • Silver, N.1    Allen, R.P.2    Senerth, J.3
  • 13
    • 79955117203 scopus 로고    scopus 로고
    • Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample
    • Allen RP, Ondo WG, Ball E, et al. Restless legs syndrome (RLS) augmentation associated with dopamine agonist and levodopa usage in a community sample. Sleep Med 2011;12:431-9
    • (2011) Sleep Med , vol.12 , pp. 431-439
    • Allen, R.P.1    Ondo, W.G.2    Ball, E.3
  • 14
    • 77749340689 scopus 로고    scopus 로고
    • Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: Results of a prospective multi-center study
    • Hogl B, Garcia-Borreguero D, Kohnen R, et al. Progressive development of augmentation during long-term treatment with levodopa in restless legs syndrome: results of a prospective multi-center study. J Neurol 2010;257:230-7
    • (2010) J Neurol , vol.257 , pp. 230-337
    • Hogl, B.1    Garcia-Borreguero, D.2    Kohnen, R.3
  • 15
    • 4444354362 scopus 로고    scopus 로고
    • Long-term treatment of restless legs syndrome with dopamine agonists
    • Ondo W, Romanyshyn J, Vuong KD, et al. Long-term treatment of restless legs syndrome with dopamine agonists. Arch Neurol 2004;61:1393-7
    • (2004) Arch Neurol , vol.61 , pp. 1393-1397
    • Ondo, W.1    Romanyshyn, J.2    Vuong, K.D.3
  • 16
    • 0742306162 scopus 로고    scopus 로고
    • Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS)
    • Winkelman JW, Johnston L. Augmentation and tolerance with long-term pramipexole treatment of restless legs syndrome (RLS). Sleep Med 2004;5:9-14
    • (2004) Sleep Med , vol.5 , pp. 9-14
    • Winkelman, J.W.1    Johnston, L.2
  • 18
    • 0037180403 scopus 로고    scopus 로고
    • Treatment of restless legs syndrome with gabapentin: A double-blind, cross-over study
    • Garcia-Borreguero D, Larrosa O, de la Llave Y, et al. Treatment of restless legs syndrome with gabapentin: a double-blind, cross-over study. Neurology 2002;59:1573-9
    • (2002) Neurology , vol.59 , pp. 1573-1579
    • Garcia-Borreguero, D.1    Larrosa, O.2    De La Llave, Y.3
  • 19
    • 0141867890 scopus 로고    scopus 로고
    • Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome
    • Happe S, Sauter C, Klosch G, et al. Gabapentin versus ropinirole in the treatment of idiopathic restless legs syndrome. Neuropsychobiology 2003;48:82-6
    • (2003) Neuropsychobiology , vol.48 , pp. 82-86
    • Happe, S.1    Sauter, C.2    Klosch, G.3
  • 20
    • 0034129145 scopus 로고    scopus 로고
    • Inter-And intra-subject variability in gabapentin absorption and absolute bioavailability
    • Gidal BE, Radulovic LL, Kruger S, et al. Inter-And intra-subject variability in gabapentin absorption and absolute bioavailability. Epilepsy Res 2000;40:123-7
    • (2000) Epilepsy Res , vol.40 , pp. 123-127
    • Gidal, B.E.1    Radulovic, L.L.2    Kruger, S.3
  • 21
    • 4644328982 scopus 로고    scopus 로고
    • XP13512 [(+/-)-1-([(a-isobutanoyloxyethoxy)carbonyl] aminomethyl)-1- cyclohexane acetic acid], a novel gabapentin prodrug: I. Design, synthesis, enzymatic conversion to gabapentin, and transport by intestinal solute transporters
    • Cundy KC, Branch R, Chernov-Rogan T, et al. XP13512 [(+/-)-1-([(a- isobutanoyloxyethoxy)carbonyl] aminomethyl)-1-cyclohexane acetic acid], a novel gabapentin prodrug: I. Design, synthesis, enzymatic conversion to gabapentin, and transport by intestinal solute transporters. J Pharmacol Exp Ther 2004;311:315-23
    • (2004) J Pharmacol Exp Ther , vol.311 , pp. 315-323
    • Cundy, K.C.1    Branch, R.2    Chernov-Rogan, T.3
  • 22
    • 4644251930 scopus 로고    scopus 로고
    • XP13512 [(+/-)-1-([(a-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
    • Cundy KC, Annamalai T, Bu L, et al. XP13512 [(+/-)-1-([(a- 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
    • (2004) J Pharmacol Exp Ther , vol.311 , pp. 324-333
    • Cundy, K.C.1    Annamalai, T.2    Bu, L.3
  • 23
    • 57449097189 scopus 로고    scopus 로고
    • Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin
    • Cundy KC, Sastry S, Luo W, et al. Clinical pharmacokinetics of XP13512, a novel transported prodrug of gabapentin. J Clin Pharmacol 2008;48:1378-88
    • (2008) J Clin Pharmacol , vol.48 , pp. 1378-1388
    • Cundy, K.C.1    Sastry, S.2    Luo, W.3
  • 24
    • 72149086940 scopus 로고    scopus 로고
    • Pharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: A randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteers
    • Lal R, Sukbuntherng J, Luo W, et al. Pharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteers. Clin Ther 2009;31:1776-86
    • (2009) Clin Ther , vol.31 , pp. 1776-1786
    • Lal, R.1    Sukbuntherng, J.2    Luo, W.3
  • 25
    • 77950672531 scopus 로고    scopus 로고
    • Clinical pharmacokinetic drug interaction studies of gabapentin enacarbil, a novel transported prodrug of gabapentin, with naproxen and cimetidine
    • Lal R, Sukbuntherng J, Luo W, et al. Clinical pharmacokinetic drug interaction studies of gabapentin enacarbil, a novel transported prodrug of gabapentin, with naproxen and cimetidine. Br J Clin Pharmacol 2010;69:498-507
    • (2010) Br J Clin Pharmacol , vol.69 , pp. 498-507
    • Lal, R.1    Sukbuntherng, J.2    Luo, W.3
  • 26
    • 76749099240 scopus 로고    scopus 로고
    • The effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbil
    • Lal R, Sukbuntherng J, Luo W, et al. The effect of food with varying fat content on the clinical pharmacokinetics of gabapentin after oral administration of gabapentin enacarbil. Int J Clin Pharmacol Ther 2010;48:120-8
    • (2010) Int J Clin Pharmacol Ther , vol.48 , pp. 120-2228
    • Lal, R.1    Sukbuntherng, J.2    Luo, W.3
  • 27
    • 77952909928 scopus 로고    scopus 로고
    • Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: A randomized controlled study
    • Bogan RK, Bornemann MA, Kushida CA, et al. Long-term maintenance treatment of restless legs syndrome with gabapentin enacarbil: a randomized controlled study. Mayo Clin Proc 2010;85:512-21
    • (2010) Mayo Clin Proc , vol.85 , pp. 512-521
    • Bogan, R.K.1    Bornemann, M.A.2    Kushida, C.A.3
  • 28
    • 79551574731 scopus 로고    scopus 로고
    • A 52-week study of gabapentin enacarbil in restless legs syndrome
    • Ellenbogen AL, Thein SG, Winslow DH, et al. A 52-week study of gabapentin enacarbil in restless legs syndrome. Clin Neuropharmacol 2011;34:8-16
    • (2011) Clin Neuropharmacol , vol.34 , pp. 8-16
    • Ellenbogen, A.L.1    Thein, S.G.2    Winslow, D.H.3
  • 29
    • 61549121079 scopus 로고    scopus 로고
    • Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS
    • Kushida CA, Becker PM, Ellenbogen AL, et al. Randomized, double-blind, placebo-controlled study of XP13512/GSK1838262 in patients with RLS. Neurology 2009;72:439-46
    • (2009) Neurology , vol.72 , pp. 439-446
    • Kushida, C.A.1    Becker, P.M.2    Ellenbogen, A.L.3
  • 30
    • 62549108197 scopus 로고    scopus 로고
    • A randomized, double-blind, placebo-controlled, crossover study of XP13512/GSK1838262 in the treatment of patients with primary restless legs syndrome
    • 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;32:159-68
    • (2009) Sleep , vol.32 , pp. 159-168
    • Kushida, C.A.1    Walters, A.S.2    Becker, P.3
  • 31
    • 74249093154 scopus 로고    scopus 로고
    • Gabapentin enacarbil in restless legs syndrome: A phase 2b, 2-week, randomized, double-blind, placebo-controlled trial
    • Walters AS, Ondo WG, Kushida CA, et al. Gabapentin enacarbil in restless legs syndrome: a phase 2b, 2-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol 2009;32:311-20
    • (2009) Clin Neuropharmacol , vol.32 , pp. 311-320
    • Walters, A.S.1    Ondo, W.G.2    Kushida, C.A.3
  • 32
    • 79959302556 scopus 로고    scopus 로고
    • A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome
    • Lee DO, Ziman RB, Perkins AT, et al. A randomized, double-blind, placebo-controlled study to assess the efficacy and tolerability of gabapentin enacarbil in subjects with restless legs syndrome. J Clin Sleep Med 2011;7:282-92
    • (2011) J Clin Sleep Med , vol.7 , pp. 282-892
    • Lee, D.O.1    Ziman, R.B.2    Perkins, A.T.3
  • 33
    • 0015025451 scopus 로고
    • A test for differences between treatment means when several dose levels are compared with a zero dose control
    • Williams DA. A test for differences between treatment means when several dose levels are compared with a zero dose control. Biometrics 1971;27:103-17
    • (1971) Biometrics , vol.27 , pp. 103-117
    • Williams, D.A.1
  • 34
    • 0015357959 scopus 로고
    • The comparison of several dose levels with a zero dose control
    • Williams DA. The comparison of several dose levels with a zero dose control. Biometrics 1972;28:519-31
    • (1972) Biometrics , vol.28 , pp. 519-531
    • Williams, D.A.1
  • 35
    • 33748996775 scopus 로고    scopus 로고
    • Efficacy and safety of pramipex-ole in restless legs syndrome
    • Winkelman JW, Sethi KD, Kushida CA, et al. Efficacy and safety of pramipex-ole in restless legs syndrome. Neurology 2006;67:1034-9
    • (2006) Neurology , vol.67 , pp. 1034-1039
    • Winkelman, J.W.1    Sethi, K.D.2    Kushida, C.A.3
  • 36
    • 49849083845 scopus 로고    scopus 로고
    • Efficacy of rotigotine for treatment of moderate-to-severe restless legs syndrome: A randomised, double-blind, placebo-controlled trial
    • 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
    • (2008) Lancet Neurol , vol.7 , pp. 595-604
    • Trenkwalder, C.1    Benes, H.2    Poewe, W.3
  • 37
    • 40849113591 scopus 로고    scopus 로고
    • Efficacy of rotigotine trans-dermal system in severe restless legs syndrome: A randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe
    • Oertel WH, Benes H, Garcia-Borreguero D, et al. Efficacy of rotigotine trans-dermal system in severe restless legs syndrome: a randomized, double-blind, placebo-controlled, six-week dose-finding trial in Europe. Sleep Med 2008;9:228-39
    • (2008) Sleep Med , vol.9 , pp. 228-239
    • Oertel, W.H.1    Benes, H.2    Garcia-Borreguero, D.3
  • 38
    • 41849091473 scopus 로고    scopus 로고
    • Where dopamine meets opioids: A meta-Analysis of the placebo effect in restless legs syndrome treatment studies
    • Fulda S, Wetter TC. Where dopamine meets opioids: a meta-Analysis of the placebo effect in restless legs syndrome treatment studies. Brain 2008;131:902-17
    • (2008) Brain , vol.131 , pp. 902-917
    • Fulda, S.1    Wetter, T.C.2
  • 40
    • 60749108941 scopus 로고    scopus 로고
    • MMRM vs. LOCF: A comprehensive comparison based on simulation study and 25 NDA datasets
    • Siddiqui O, Hung HMJ, O'Neill Robert. MMRM vs. LOCF: A comprehensive comparison based on simulation study and 25 NDA datasets. J Biopharm Stat 2009;19:227-246
    • (2009) J Biopharm Stat , vol.19 , pp. 227-246
    • Siddiqui, O.1    Hmj, H.2    O'Neill, R.3
  • 41
    • 84940615775 scopus 로고    scopus 로고
    • Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome
    • Winkelman JW, Bogan RK, Schmidt MH, et al. Randomized polysomnography study of gabapentin enacarbil in subjects with restless legs syndrome. Mov Disord 2011;26:2065-72
    • (2011) Mov Disord , vol.26 , pp. 2065-2072
    • Winkelman, J.W.1    Bogan, R.K.2    Schmidt, M.H.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.