title: Clinical trials in restless legs syndrome--recommendations of the European RLS Study Group (EURLSSG).
abstract: The European Restless Legs Syndrome (RLS) Study Group (EURLSSG) is an association of European RLS experts who are actively involved in RLS research. A major aim of the Study Group is the development and continuous improvement of standards for diagnosis and treatment of RLS. Several members developed study designs and evaluation methods in investigator-initiated trials early in the 1990s, and all members have since contributed to many pivotal and nonpivotal drug trials for the treatment of RLS. The recommendations on clinical investigations of pharmacological treatment of RLS patients summarize the group's expertise and knowledge acquired through clinical trials. The recommendations primarily address how to plan and conduct confirmatory, randomized clinical studies in patients with idiopathic RLS. Advice is presented for the diagnosis of RLS and clinical and polysomnographic inclusion and exclusion criteria. Primary and secondary endpoints for an evaluation of efficacy are based on a critical description of validated methods for both short- and long-term trials, also in special populations (children, pregnant women, elderly patients). The recommendations include the assessment of augmentation. Finally, general issues including the evaluation of safety and tolerability, as well as specific neurological and cardiovascular risks and sleep attacks/daytime somnolence, are discussed. The aim of these recommendations is to support research groups or pharmaceutical companies in the design of optimized study protocols.
authors.affiliation: Paracelsus-Elena Hospital, Center of Parkinsonism and Movement Disorders, Klinikstr. 16, 34128 Kassel, Germany. ctrenkwalder@gmx.de
authors.forename: Claudia
authors.initials: C
authors.lastname: Trenkwalder
authors.forename: Ralf
authors.initials: R
authors.lastname: Kohnen
authors.forename: Richard P
authors.initials: RP
authors.lastname: Allen
authors.forename: Heike
authors.initials: H
authors.lastname: Benes
authors.forename: Luigi
authors.initials: L
authors.lastname: Ferini-Strambi
authors.forename: Diego
authors.initials: D
authors.lastname: Garcia-Borreguero
authors.forename: Georgios M
authors.initials: GM
authors.lastname: Hadjigeorgiou
authors.forename: Svenja
authors.initials: S
authors.lastname: Happe
authors.forename: Birgit
authors.initials: B
authors.lastname: Högl
authors.forename: Magdolna
authors.initials: M
authors.lastname: Hornyak
authors.forename: Christine
authors.initials: C
authors.lastname: Klein
authors.forename: Alexander
authors.initials: A
authors.lastname: Nass
authors.forename: Pasquale
authors.initials: P
authors.lastname: Montagna
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.forename: Shaun
authors.initials: S
authors.lastname: O'Keeffe
authors.forename: Walter
authors.initials: W
authors.lastname: Paulus
authors.forename: Werner
authors.initials: W
authors.lastname: Poewe
authors.forename: Federica
authors.initials: F
authors.lastname: Provini
authors.forename: Peter P
authors.initials: PP
authors.lastname: Pramstaller
authors.forename: Mariusz
authors.initials: M
authors.lastname: Sieminski
authors.forename: Karel
authors.initials: K
authors.lastname: Sonka
authors.forename: Karin
authors.initials: K
authors.lastname: Stiasny-Kolster
authors.forename: Al
authors.initials: A
authors.lastname: de Weerd
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Wetter
authors.forename: Juliane
authors.initials: J
authors.lastname: Winkelmann
authors.forename: Marco
authors.initials: M
authors.lastname: Zucconi
mesh_terms: D023381:Endpoint Determination; D005060:Europe; D006801:Humans; D018579:Patient Selection; D017286:Polysomnography; D016032:Randomized Controlled Trials as Topic; D012148:Restless Legs Syndrome / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy*; D016896:Treatment Outcome