Transdermal lisuride: short-term efficacy and tolerability study in patients with severe restless legs syndrome.

Abstract

BACKGROUND AND PURPOSE:

Restless legs syndrome (RLS) patients suffer from symptoms not only at bedtime but also with variable circadian patterns. Transdermal application forms of dopamine agonists are expected to lead to a stable plasma concentration of the active drug which could ease treatment for RLS patients with daytime symptoms and avoid side effects of oral dopaminergic therapies.

PATIENTS AND METHODS:

In this controlled pilot study, 10 patients (six females, four males, mean age 58 years) with severe and long-lasting idiopathic RLS were treated during an initial open-label phase for 2 weeks either with one (n=3 patients) or, if required, two patches of lisuride every other day (dose per patch: 3mg lisuride, nominal effective release rate 7.0 microg lisuride/h). Patients were then randomized to double-blind treatment with lisuride (n=5) or placebo (n=4) for 1 week.

RESULTS:

Severity of RLS clearly improved during open-label and double-blind treatment with lisuride but became worse under placebo according to the International Restless Legs Syndrome Study Group Rating Scale (IRLS), RLS-6, and Clinical Global Impressions (CGIs) scales, and actigraphy assessments (periodic leg movement index) in the 1-week double-blind period.

CONCLUSION:

The explorative findings of this small controlled study suggest that lisuride patches might be an efficacious treatment for RLS patients without clinically relevant tolerability problems.

• Authors: Heike Benes
• Journal: Sleep medicine (Sleep Med) Vol. 7 Issue 1 Pg. 31-5 (Jan 2006) ISSN: 1389-9457 [Print] Netherlands
• PMID: 16194624 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Lisuride

Topics

• Administration, Cutaneous
• Double-Blind Method
• Female
• Humans
• Lisuride (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Polysomnography
• Restless Legs Syndrome (diagnosis, drug therapy, physiopathology)
• Severity of Illness Index
• Time Factors
• Treatment Outcome