Efficacy of levetiracetam in the treatment of restless legs syndrome (Keppra-RLS-Study)

The restless legs syndrome is a sleep disorder with an assumed central nervous disinhibition, involving the dopaminergic and GABAergic system. At present, most treatment used in RLS includes L-DOPA, dopamine agonists, benzodiazepines, and opiates. Potential disadvantages of these drugs are adverse effects, addiction potential as well as loss of efficacy with increasing treatment duration. Levetiracetam is an alternative drug with strong inhibitory activity and a suitable adverse effect profile.

Aim of the ongoing, open, prospective, uni-centered study is to investigate the acute effects of Levetiracetam on 10 drug-free patients (70% females; 60.80±8.48 years) diagnosed with idiopathic RLS utilizing polysomnography and psychometry. Preliminary short-term results of 7 patients having taken 500mg of Levetiracetam for 2 weeks and 1000mg for 1 week indicate that Levetiracetam is generally well tolerated, with no serious adverse effects. A significant decrease is observable in the severity of RLS after 3 weeks (measured with IRLS; p=.006). We assume that this reduction of RLS symptoms will be reflected in our secondary outcomes, measuring the quality of life, the daytime sleepiness, as well as polysomnographic measures.

Although these data have limited character and are preliminary, in sum, these results suggest that Levetiracetam can indeed effectively reduce symptoms of restless legs syndrome and improve overall sleep quality.

Final results of this pilot study are expected to come up in August 2005. In Octobre 2005, we will be able to present the final results.