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Keywords:

  • restless legs syndrome;
  • therapy;
  • levodopa;
  • benserazide;
  • extension;
  • time shift;
  • augmentation;
  • sleep;
  • quality of life

Abstract

To investigate the long-term efficacy and safety of sustained-release (SR) in combination with regular-release (RR) levodopa/benserazide in the treatment of restless legs syndrome (RLS), an open-label, prospective, extension study of a preceding double-blind crossover trial was performed for 12 months. Twenty-three severely disturbed RLS patients (7 men, 16 women) received a combination of RR and SR levodopa. Patients were treated on average for 10 months with a mean daily dose of 203 ± 101 mg of RR and of 185 ± 93 mg of SR levodopa. The mean daily total dose was 388 ± 162 mg levodopa. Efficacy was documented using patient's rating scales, sleep diaries, and investigator's global ratings with the Clinical Global Impressions (CGI). Ten of 23 patients completed the 1-year extension. Between baseline of the crossover trial and endpoint of the extension study (last-observation-carried-forward method, intention-to-treat population), quality of sleep improved (+3.5 ± 1.9, 7-point scale), sleep latency was shortened (−131 ± 152 minutes), and total sleep time lengthened (+ 190 ± 136 minutes). Severity of RLS at time of falling asleep (−6.5 ± 3.4, 11-point scale) and during the night (−6.0 ± 3.5) was markedly lower at the end of the extension but severity of RLS during the day (+1.9 ± 5.0) slightly increased. Of 13 dropouts, 8 patients discontinued therapy because of worsening RLS during the day. This trial shows that long-term treatment with the combination of RR and SR levodopa/benserazide in RLS patients with late-night problems was efficacious and not limited by tolerability problems in 40% of patients, whereas in the majority of patients, aggravating daytime problems required termination of the levodopa therapy within the 1-year treatment period. © 2003 Movement Disorder Society