Clinical trials in restless legs syndrome--recommendations of the European RLS Study Group (EURLSSG).
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.
Trenkwalder
Claudia
C
Paracelsus-Elena Hospital, Center of Parkinsonism and Movement Disorders, Klinikstr. 16, 34128 Kassel, Germany. ctrenkwalder@gmx.de
Kohnen
Ralf
R
Allen
Richard P
RP
Benes
Heike
H
Ferini-Strambi
Luigi
L
Garcia-Borreguero
Diego
D
Hadjigeorgiou
Georgios M
GM
Happe
Svenja
S
Högl
Birgit
B
Hornyak
Magdolna
M
Klein
Christine
C
Nass
Alexander
A
Montagna
Pasquale
P
Oertel
Wolfgang H
WH
O'Keeffe
Shaun
S
Paulus
Walter
W
Poewe
Werner
W
Provini
Federica
F
Pramstaller
Peter P
PP
Sieminski
Mariusz
M
Sonka
Karel
K
Stiasny-Kolster
Karin
K
de Weerd
Al
A
Wetter
Thomas C
TC
Winkelmann
Juliane
J
Zucconi
Marco
M
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