title: Tolerability and efficacy of the monoaminergic stabilizer (-)-OSU6162 (PNU-96391A) in Huntington's disease: a double-blind cross-over study.
abstract: OBJECTIVE
  To evaluate the safety (primary objective) and efficacy (secondary objective) of (-)-OSU6162 in Huntington's disease (HD).
  
  
  METHODS
  In a double-blind, cross-over trial, patients with HD were randomly assigned to start treatment on either (-)-OSU6162 or placebo. After 4 weeks, those patients who initially received active drug were switched to placebo for another 4 weeks, and vice versa. During the first week the (-)-OSU6162 dose was 15 mg twice daily, during the second week 30 mg twice daily, and during the last 2 weeks 45 mg twice daily. Motor, cognitive, mental and social functions were rated by the clinical investigator or by self-assessment, using established rating scales.
  
  
  RESULTS
  Fifteen patients fulfilling inclusion and exclusion criteria completed the study. (-)-OSU6162 was well tolerated by all patients and no adverse effects were observed. (-)-OSU6162 treatment significantly improved the Short Form 36 Vitality score, mainly due to an improvement of the individual item 'worn-out' (VT3). In addition, an improvement of depressive symptoms was found using Beck Depression Inventory. In contrast to a general trend of improvement in several non-motor variables only small and non-significant differences between (-)-OSU6162 and placebo were found regarding motor functions.
  
  
  CONCLUSIONS
  (-)-OSU6162 offers promise for the treatment of HD, as a drug with good tolerability, capable of improving the patients' experienced non-motor functions such as energy and mood and thus alleviating symptoms of great importance for their quality of life.
authors.affiliation: 1A Carlsson Research AB,Sahlgrenska Science Park,Gothenburg,Sweden.
authors.forename: Angelica
authors.initials: A
authors.lastname: Kloberg
authors.affiliation: 2Department of Neurology,Sahlgrenska University Hospital,Gothenburg,Sweden.
authors.forename: Radu
authors.initials: R
authors.lastname: Constantinescu
authors.affiliation: 3Institute of Neuroscience and Physiology,Sahlgrenska Academy,University of Gothenburg,Gothenburg,Sweden.
authors.forename: Marie Karin Lena
authors.initials: MK
authors.lastname: Nilsson
authors.affiliation: 3Institute of Neuroscience and Physiology,Sahlgrenska Academy,University of Gothenburg,Gothenburg,Sweden.
authors.forename: Maria Lizzie
authors.initials: ML
authors.lastname: Carlsson
authors.affiliation: 3Institute of Neuroscience and Physiology,Sahlgrenska Academy,University of Gothenburg,Gothenburg,Sweden.
authors.forename: Arvid
authors.initials: A
authors.lastname: Carlsson
authors.affiliation: 4Department of Medical and Clinical Genetics,Institute of Biomedicine,Sahlgrenska Academy at the University of Gothenburg,Gothenburg,Sweden.
authors.forename: Jan
authors.initials: J
authors.lastname: Wahlström
authors.affiliation: 5Department of Neurology,Sahlgrenska University Hospital,Gothenburg/Skaraborg Hospital,Skövde,Sweden.
authors.forename: Sara
authors.initials: S
authors.lastname: Haghighi
mesh_terms: D000328:Adult; D003071:Cognition / Q000187:drug effects; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D006816:Huntington Disease / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009043:Motor Activity / Q000187:drug effects; D010880:Piperidines / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D010880:Piperidines; C109513:OSU 6162