Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study

Arthur S. Walters, William G. Ondo, Tilman Dreykluft, Ron Grunstein, Daniel Lee, Kapil Dev Sethi, A. Ambrogetti, K. Boundy, P. Gates, P. Hackney, J. Karrasch, J. Swieca, K. Buttoo, A. Douglass, E. Giannouli, D. B. King, P. Lesperance, J. J. Lipsitz, T. Mendis, R. MorehouseE. Pourcher, M. Rajda, G. Sridhar, D. Stewart, B. Bergtholdt, M. Deuschle, T. Dreykluft, C. Oehlwein, H. Schulz, H. Sommer, H. D. Stahl, M. Lossius, W. Telstad, N. Hyman, P. Tidswell, A. Young, M. J. Buchfuhrer, A. A. DeMaria, K. Doghramji, T. Freedom, R. A. Hauser, A. S. Kloman, S. Lesage, R. Pahwa, K. Ruggles, P. K. Sahota, M. Scharf, L. Scrima, D. J. Seiden, R. A. Shubin, T. Simuni, R. M. Trosch, R. D. Vorona

Research output: Contribution to journalArticle

207 Citations (Scopus)

Abstract

Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.

Original languageEnglish (US)
Pages (from-to)1414-1423
Number of pages10
JournalMovement Disorders
Volume19
Issue number12
DOIs
StatePublished - Jul 21 2004

Fingerprint

Restless Legs Syndrome
compound A 12
Placebos
Sleep
Quality of Life
Therapeutics
ropinirole
Restless legs syndrome 2
Dopamine Agonists
Outpatients
Outcome Assessment (Health Care)
Confidence Intervals
Safety

Keywords

  • Quality of life
  • RLS
  • Ropinirole
  • Sleep

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

Cite this

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2 : A 12-week, double-blind, randomized, parallel-group, placebo-controlled study. / Walters, Arthur S.; Ondo, William G.; Dreykluft, Tilman; Grunstein, Ron; Lee, Daniel; Sethi, Kapil Dev; Ambrogetti, A.; Boundy, K.; Gates, P.; Hackney, P.; Karrasch, J.; Swieca, J.; Buttoo, K.; Douglass, A.; Giannouli, E.; King, D. B.; Lesperance, P.; Lipsitz, J. J.; Mendis, T.; Morehouse, R.; Pourcher, E.; Rajda, M.; Sridhar, G.; Stewart, D.; Bergtholdt, B.; Deuschle, M.; Dreykluft, T.; Oehlwein, C.; Schulz, H.; Sommer, H.; Stahl, H. D.; Lossius, M.; Telstad, W.; Hyman, N.; Tidswell, P.; Young, A.; Buchfuhrer, M. J.; DeMaria, A. A.; Doghramji, K.; Freedom, T.; Hauser, R. A.; Kloman, A. S.; Lesage, S.; Pahwa, R.; Ruggles, K.; Sahota, P. K.; Scharf, M.; Scrima, L.; Seiden, D. J.; Shubin, R. A.; Simuni, T.; Trosch, R. M.; Vorona, R. D.

In: Movement Disorders, Vol. 19, No. 12, 21.07.2004, p. 1414-1423.

Research output: Contribution to journalArticle

Walters, AS, Ondo, WG, Dreykluft, T, Grunstein, R, Lee, D, Sethi, KD, Ambrogetti, A, Boundy, K, Gates, P, Hackney, P, Karrasch, J, Swieca, J, Buttoo, K, Douglass, A, Giannouli, E, King, DB, Lesperance, P, Lipsitz, JJ, Mendis, T, Morehouse, R, Pourcher, E, Rajda, M, Sridhar, G, Stewart, D, Bergtholdt, B, Deuschle, M, Dreykluft, T, Oehlwein, C, Schulz, H, Sommer, H, Stahl, HD, Lossius, M, Telstad, W, Hyman, N, Tidswell, P, Young, A, Buchfuhrer, MJ, DeMaria, AA, Doghramji, K, Freedom, T, Hauser, RA, Kloman, AS, Lesage, S, Pahwa, R, Ruggles, K, Sahota, PK, Scharf, M, Scrima, L, Seiden, DJ, Shubin, RA, Simuni, T, Trosch, RM & Vorona, RD 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', Movement Disorders, vol. 19, no. 12, pp. 1414-1423. https://doi.org/10.1002/mds.20257
Walters, Arthur S. ; Ondo, William G. ; Dreykluft, Tilman ; Grunstein, Ron ; Lee, Daniel ; Sethi, Kapil Dev ; Ambrogetti, A. ; Boundy, K. ; Gates, P. ; Hackney, P. ; Karrasch, J. ; Swieca, J. ; Buttoo, K. ; Douglass, A. ; Giannouli, E. ; King, D. B. ; Lesperance, P. ; Lipsitz, J. J. ; Mendis, T. ; Morehouse, R. ; Pourcher, E. ; Rajda, M. ; Sridhar, G. ; Stewart, D. ; Bergtholdt, B. ; Deuschle, M. ; Dreykluft, T. ; Oehlwein, C. ; Schulz, H. ; Sommer, H. ; Stahl, H. D. ; Lossius, M. ; Telstad, W. ; Hyman, N. ; Tidswell, P. ; Young, A. ; Buchfuhrer, M. J. ; DeMaria, A. A. ; Doghramji, K. ; Freedom, T. ; Hauser, R. A. ; Kloman, A. S. ; Lesage, S. ; Pahwa, R. ; Ruggles, K. ; Sahota, P. K. ; Scharf, M. ; Scrima, L. ; Seiden, D. J. ; Shubin, R. A. ; Simuni, T. ; Trosch, R. M. ; Vorona, R. D. / Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2 : A 12-week, double-blind, randomized, parallel-group, placebo-controlled study. In: Movement Disorders. 2004 ; Vol. 19, No. 12. pp. 1414-1423.
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title = "Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study",
abstract = "Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95{\%} confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.",
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T1 - Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2

T2 - A 12-week, double-blind, randomized, parallel-group, placebo-controlled study

AU - Walters, Arthur S.

AU - Ondo, William G.

AU - Dreykluft, Tilman

AU - Grunstein, Ron

AU - Lee, Daniel

AU - Sethi, Kapil Dev

AU - Ambrogetti, A.

AU - Boundy, K.

AU - Gates, P.

AU - Hackney, P.

AU - Karrasch, J.

AU - Swieca, J.

AU - Buttoo, K.

AU - Douglass, A.

AU - Giannouli, E.

AU - King, D. B.

AU - Lesperance, P.

AU - Lipsitz, J. J.

AU - Mendis, T.

AU - Morehouse, R.

AU - Pourcher, E.

AU - Rajda, M.

AU - Sridhar, G.

AU - Stewart, D.

AU - Bergtholdt, B.

AU - Deuschle, M.

AU - Dreykluft, T.

AU - Oehlwein, C.

AU - Schulz, H.

AU - Sommer, H.

AU - Stahl, H. D.

AU - Lossius, M.

AU - Telstad, W.

AU - Hyman, N.

AU - Tidswell, P.

AU - Young, A.

AU - Buchfuhrer, M. J.

AU - DeMaria, A. A.

AU - Doghramji, K.

AU - Freedom, T.

AU - Hauser, R. A.

AU - Kloman, A. S.

AU - Lesage, S.

AU - Pahwa, R.

AU - Ruggles, K.

AU - Sahota, P. K.

AU - Scharf, M.

AU - Scrima, L.

AU - Seiden, D. J.

AU - Shubin, R. A.

AU - Simuni, T.

AU - Trosch, R. M.

AU - Vorona, R. D.

PY - 2004/7/21

Y1 - 2004/7/21

N2 - Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.

AB - Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.

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KW - RLS

KW - Ropinirole

KW - Sleep

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