A Phase 2 interventional study of GW597599 and Placebo in Sleep Disorders, sponsored by GlaxoSmithKline. Completed at 13 sites in Germany. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2016-10-28.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This study is a 28-day polysomnographic and subjective assessment of oral Vestipitant 15mg/day for treatment of Primary Insomnia in adults outpatients.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 161 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vestipitant 15mg once daily
Drug: GW597599
Placebo
Drug: Placebo
GW597599 15mg tablet
Placebo to match GW597599 15mg tablet
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
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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