A phase II,open-label,non-comparative study of Botulinum toxin in Restless Legs Syndrome |
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Authors: | Imad Ghorayeb Antoine Bénard Alexandre Vivot François Tison Pierre Burbaud |
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Institution: | 1. Service des Explorations Fonctionnelles du Système Nerveux, Hôpital Pellegrin, Place Amélie Raba-Léon, 33076 Bordeaux cedex, France;2. Unité de soutien méthodologique à la recherche clinique et épidémiologique, Service d’Information Médicale, CHU de Bordeaux, Bordeaux, France;3. Department of Neurology, University Hospital Bordeaux, Bordeaux, France |
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Abstract: | ObjectiveTo assess the efficacy of intradermally injected botulinum neurotoxin type A (BoNT/A) in patients with Restless Legs Syndrome (RLS).MethodsWe conducted an optimal two-stage, phase II exploratory, open label, non-comparative clinical trial. The primary outcome measure was the efficacy of BoNT/A defined by the proportion of patients (responders) with ?50% improvement of their RLS severity score at week 2 following injections compared to baseline score at inclusion. Twenty-seven patients were to be included in the first stage of the trial, which was to be stopped if less than nine responders were documented. Selected patients had a minimum score of 21 on the International RLS Rating Scale. They all received a series of 20 intradermal injections of 0.05 ml of BoNT/A in symptomatic areas in their lower limbs. Change of RLS severity was evaluated over a 6 months period.ResultsOf the 27 selected patients, only six achieved the primary endpoint at week 2. In these six patients, the median duration (Inter-Quartile Range) of the IRLSRS score improvement of at least 50% was 46 days (42–126).ConclusionsConsidering the proportion of responders as the primary endpoint of this trial, BoNT/A showed no efficacy in alleviating RLS sensory symptoms. |
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