Orvepitant (GW823296) in Adult Post Traumatic Stress Disorder
Status:
Completed
Trial end date:
2010-06-28
Target enrollment:
Participant gender:
Summary
This is a 12-week, randomized, multicenter, double-blind, placebo controlled, fixed-dose
parallel group study to assess the efficacy and safety of orvepitant (60 mg/day) versus
placebo in subjects with a diagnosis of noncombat-related Posttraumatic Stress Disorder
(PTSD), whose symptoms are considered moderate or severe.
Following an initial screening visit, subjects fulfilling the study inclusion and exclusion
criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory
and ECG assessments and to confirm eligibility for inclusion into the study. This screening
phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the
screening period, eligible subjects will be randomized at the baseline visit to receive
either orvepitant 60mg/day or placebo (1:1 ratio). Those subjects randomized to receive
placebo will receive study medication identical in appearance to that received by subjects
assigned to receive orvepitant.
Efficacy will be assessed using the Clinician Administered PTSD Scale (CAPS) as the primary
efficacy measure. Key secondary efficacy endpoints will be based on the Davidson Trauma Scale
(DTS), the Short PTSD Rating Interview (SPRINT), the Clinical Global Impression- Global
Improvement and Severity of Illness Scales (CGI-I and CGI-S, respectively), the Hamilton
Depression Rating Scale (HAM-D), the Cognitive and Physical Functioning Questionnaire (CPFQ)
and the Pittsburgh Sleep Quality Index (PSQI).
Safety will be assessed by monitoring for adverse events (side effects) and through periodic
laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart
rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
Phase:
Phase 2
Details
Lead Sponsor:
GlaxoSmithKline
Treatments:
Neurokinin A Neurokinin-1 Receptor Antagonists Substance P