C H Schenck, J Y Montplaisir, B Frauscher, B Hogl, J-F Gagnon, R Postuma, K Sonka, P Jennum, M Partinen, I Arnulf, V Cochen de Cock, Y Dauvilliers, P-H Luppi, A Heidbreder, G Mayer, F Sixel-Döring, C Trenkwalder, M Unger, P Young, Y K Wing, L Ferini-Strambi, R Ferri, G Plazzi, M Zucconi, Y Inoue, A Iranzo, J Santamaria, C Bassetti, J C Möller, B F Boeve, Y Y Lai, M Pavlova, C Saper, P Schmidt, J M Siegel, C Singer, E St Louis, A Videnovic, W Oertel
OBJECTIVES: We aimed to provide a consensus statement by the International Rapid Eye Movement Sleep Behavior Disorder Study Group (IRBD-SG) on devising controlled active treatment studies in rapid eye movement sleep behavior disorder (RBD) and devising studies of neuroprotection against Parkinson disease (PD) and related neurodegeneration in RBD. METHODS: The consensus statement was generated during the fourth IRBD-SG symposium in Marburg, Germany in 2011. The IRBD-SG identified essential methodologic components for a randomized trial in RBD, including potential screening and diagnostic criteria, inclusion and exclusion criteria, primary and secondary outcomes for symptomatic therapy trials (particularly for melatonin and clonazepam), and potential primary and secondary outcomes for eventual trials with disease-modifying and neuroprotective agents...
August 2013: Sleep Medicine