This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
161
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
GSK Investigational Site
Kassel, Hesse, Germany
Nocturnal polysomngraphy
Time frame: 6 weeks after start of treatment
Subjective sleep assessments as performed by Post-Sleep Questionnaires and subject -rated Insomnia Severity Index
Time frame: 4 weeks after start of treatment
Motor and cognitive functioning assessed by neurological tests (Romberg and Hee-to-toe) and Cognitive tests (Digit Symbol Substitution test and verbal Learning Memory test)
Time frame: 4 weeks after start of treatment
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GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
...and 3 more locations