' '
Deutsch | English    

Forschungsdatenbank PMU-SQQUID

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.
Saletu, M; Anderer, P; Högl, B; Saletu-Zyhlarz, G; Kunz, A; Poewe, W; Saletu, B;
J Neural Transm (Vienna). 2003; 110(6): 611-626.
Originalarbeiten (Zeitschrift)


Kunz Alexander


In a double-blind, placebo-controlled randomized crossover trial, the acute efficacy of a combination treatment of 100 mg regular-release (rr) and 100 mg sustained-release (sr) L-dopa/benserazide in RLS was investigated by means of sleep laboratory methods, with a subsequent open clinical follow-up for 4 weeks. 21 RLS patients classified according to ICSD and IRLSSG criteria were included; 18 completed the study. Objective sleep quality was determined by polysomnography (PSG) in 3 subsequent nights (adaptation/screening, placebo and drug night), subjective sleep and awakening quality was evaluated by rating scales, objective awakening quality by psychometric tests. Clinical follow-up consisted of daily ratings of subjective sleep and awakening quality (SSA) and VAS for RLS symptomatology ratings, completion of the RLS (IRLSSG) Scale weekly and the Zung Depression (SDS) and Anxiety (SAS) Scale, Quality of Life Index, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale before and after therapy. Acute L-dopa/benserazide significantly (p < 0.001) and markedly (75%) decreased the target variable PLM/h of sleep as well as all other RLS/PLM variables, but failed to improve objective sleep efficiency and subjective sleep quality in comparison to placebo. After 4 weeks of therapy, however, subjective sleep and awakening quality also improved significantly. While RLS/PLM measures showed an immediate significant and marked response to the combination therapy subjective sleep quality only improved after chronic treatment.

Useful keywords (using NLM MeSH Indexing)



Aged, 80 and over


Benserazide/therapeutic use

Cross-Over Studies

Delayed-Action Preparations/pharmacology

Delayed-Action Preparations/therapeutic use

Double-Blind Method

Drug Administration Schedule

Drug Combinations


Follow-Up Studies



Levodopa/therapeutic use


Middle Aged

Restless Legs Syndrome/drug therapy*

Sleep/drug effects*


Treatment Outcome

Find related publications in this database (Keywords)

restless legs syndrome
sleep quality
regular-release levodopa (rr-L-dopa)
sustained-release levodopa (sr-L-dopa)