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Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome.
Sleep Med. 2005 Mar; 6(2):141-7.SM

Abstract

BACKGROUND AND PURPOSE

Restless legs syndrome (RLS) is a condition characterized by an urge to move the legs, usually accompanied by lower limb paresthesias. These symptoms worsen at rest, are relieved by activity, and are worse at night. Previous studies have suggested that dopaminergic drugs such as L-dopa and dopamine agonists, as well as benzodiazepines and opioids, can treat RLS successfully. The purpose of this study was to test the clinical efficacy of ropinirole, a D2/D3 agonist, in the treatment of RLS in a double-blind, short-term, placebo-controlled clinical trial.

PATIENTS AND METHODS

After undergoing successful open-label titration and dose adjustments with ropinirole for RLS symptoms over a period of 4 weeks, 22 RLS patients (mean age=50.8; mean duration of symptoms=26.1 years) were randomized to receive either placebo (n=13) or ropinirole (n=9) for 2 additional weeks. Outcome measures included assessment of periodic leg movements in sleep (PLMS) recorded with nocturnal polysomnography and RLS symptoms as assessed with the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Secondary outcomes included sleep macroarchitecture.

RESULTS

Results indicated that relative to placebo, ropinirole, at a mean dose of 1.4mg HS significantly decreased PLMS and RLS symptoms. Sleep macroarchitecture did not change. Side effects were typical of all dopamine agonists and were dose related. The majority of patients elected to continue treatment with ropinirole upon study completion.

CONCLUSIONS

Ropinirole successfully treated long-standing RLS and can be considered a viable short-term treatment for this condition.

Authors+Show Affiliations

Department of Neurology, Emory University Medical School, WMRB, Suite 6000, 1639 Pierce Drive, Atlanta, GA 30322, USA. dbliwis@emory.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

15716217

Citation

Bliwise, D L., et al. "Randomized, Double-blind, Placebo-controlled, Short-term Trial of Ropinirole in Restless Legs Syndrome." Sleep Medicine, vol. 6, no. 2, 2005, pp. 141-7.
Bliwise DL, Freeman A, Ingram CD, et al. Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. Sleep Med. 2005;6(2):141-7.
Bliwise, D. L., Freeman, A., Ingram, C. D., Rye, D. B., Chakravorty, S., & Watts, R. L. (2005). Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. Sleep Medicine, 6(2), 141-7.
Bliwise DL, et al. Randomized, Double-blind, Placebo-controlled, Short-term Trial of Ropinirole in Restless Legs Syndrome. Sleep Med. 2005;6(2):141-7. PubMed PMID: 15716217.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, placebo-controlled, short-term trial of ropinirole in restless legs syndrome. AU - Bliwise,D L, AU - Freeman,A, AU - Ingram,C D, AU - Rye,D B, AU - Chakravorty,S, AU - Watts,R L, PY - 2004/02/16/received PY - 2004/10/20/revised PY - 2004/12/01/accepted PY - 2005/2/18/pubmed PY - 2005/7/16/medline PY - 2005/2/18/entrez SP - 141 EP - 7 JF - Sleep medicine JO - Sleep Med. VL - 6 IS - 2 N2 - BACKGROUND AND PURPOSE: Restless legs syndrome (RLS) is a condition characterized by an urge to move the legs, usually accompanied by lower limb paresthesias. These symptoms worsen at rest, are relieved by activity, and are worse at night. Previous studies have suggested that dopaminergic drugs such as L-dopa and dopamine agonists, as well as benzodiazepines and opioids, can treat RLS successfully. The purpose of this study was to test the clinical efficacy of ropinirole, a D2/D3 agonist, in the treatment of RLS in a double-blind, short-term, placebo-controlled clinical trial. PATIENTS AND METHODS: After undergoing successful open-label titration and dose adjustments with ropinirole for RLS symptoms over a period of 4 weeks, 22 RLS patients (mean age=50.8; mean duration of symptoms=26.1 years) were randomized to receive either placebo (n=13) or ropinirole (n=9) for 2 additional weeks. Outcome measures included assessment of periodic leg movements in sleep (PLMS) recorded with nocturnal polysomnography and RLS symptoms as assessed with the International Restless Legs Syndrome Study Group (IRLSSG) Rating Scale. Secondary outcomes included sleep macroarchitecture. RESULTS: Results indicated that relative to placebo, ropinirole, at a mean dose of 1.4mg HS significantly decreased PLMS and RLS symptoms. Sleep macroarchitecture did not change. Side effects were typical of all dopamine agonists and were dose related. The majority of patients elected to continue treatment with ropinirole upon study completion. CONCLUSIONS: Ropinirole successfully treated long-standing RLS and can be considered a viable short-term treatment for this condition. SN - 1389-9457 UR - https://www.unboundmedicine.com/medline/citation/15716217/Randomized_double_blind_placebo_controlled_short_term_trial_of_ropinirole_in_restless_legs_syndrome_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1389-9457(04)00220-5 DB - PRIME DP - Unbound Medicine ER -