Ignite Creation Date:
2024-05-05 @ 10:00 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01000493
Status:
COMPLETED
Last Update Posted:
2017-09-01
First Post:
2009-10-15
Brief Title:
Orvepitant GW823296 in Adult Post Traumatic Stress Disorder
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel-Group Fixed-Dose Study Evaluating the Efficacy and Safety of the Neurokinin-1 Receptor Antagonist Orvepitant GW823296 in Post Traumatic Stress Disorder PTSD
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mgday 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 60mgday or placebo 11 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 eg blood pressure heart rate temperature and heart function measurements electrocardiograms or ECGs
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 60mgday or placebo 11 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 eg blood pressure heart rate temperature and heart function measurements electrocardiograms or ECGs
Detailed Description:
The purpose of the current study is to test the safety and effects of orvepitant an investigational drug for the treatment of noncombat-related PTSD
Efficacy will be assessed using standard symptom and severity rating scales questionnaires The Clinicain Adminstered PTSD Scale CAPS will serve as the primary measure of efficacy Secondary efficacy endpoints include the CAPS subscale clusters Re-Experiencing Avoidance and Numbing and Hyperarousal the Davidson Trauma Scale DTS the Short PTSD Rating Interview SPRINT the Hamilton Depression Rating Scale HAM-D the Clinical Global Impression- Global Improvement and Severity of Illness Scale CGI-I and CGI-S respectively the Cognitive and Physical Functioning Questionnaire CPFQ and the Pittsburgh Sleep Quality Index PSQI
Safety and tolerability will be assessed by monitoring adverse events AEs or side effects physical examinations including vital signs such as blood pressure and heart rate clinical laboratory assessments blood tests electrical recordings of the heart electrocardiograms or ECGs the Columbia Suicidality Severity Rating Scale CSSRS Massachusetts Sexual Function Questionnaire MSFQ Discontinuation-Emergent Signs and Symptoms DESS scale and weight change
Blood samples will be taken at different time points to assess blood levels of orvepitant in patients allowing the relationship between amount of orvepitant in the body and efficacy to be studied
The primary objective of the study is to evaluate the efficacy of orvepitant 60mgday versus placebo a sugar pill with no active ingredients The secondary objectives include assessing the safety and tolerability of orvepitant assessing the profile of appearance and disappearance of orvepitant in the body blood following administration ie assessing how long the drug remains in the body and lastly to examine the relationship between blood levels of the drug and efficacy ie the change in CAPS score relative to what it was before starting the study medication
Following an initial screening visit subjects fulfilling the study entrance criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and electrocardiogram 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 Upon completion of the screening period eligible subjects will be randomly assigned at the baseline visit to one of two treatment regimens orvepitant 60mgday or placebo for a 12-week treatment phase The chances of receiving each of the two possible treatments will be equal Orvepitant will be administered as tablets Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant
During the treatment phase subjects will be required to return to the clinic at the end of Weeks 1 2 4 6 8 10 and 12 In addition all subjects will be required to return for a follow-up visit 14 days after the last dose of study medication In addition all subjects with ongoing adverse events at the 14-day follow-up visit will be required to return for a further follow-up visit 28 days after the last dose of study medication Women of child-bearing potential will also be required to attend the 28-Day follow-up visit for a pregnancy test A further test will be performed 42 Days following the end of treatment
Male and female outpatients between the ages of 18 to 64 years inclusive with a primary diagnosis of noncombat-related PTSD will be enrolled into this study A total of approximately 240 subjects are expected to be enrolled at approximately 25 different study sites in North America
Efficacy will be assessed using standard symptom and severity rating scales questionnaires The Clinicain Adminstered PTSD Scale CAPS will serve as the primary measure of efficacy Secondary efficacy endpoints include the CAPS subscale clusters Re-Experiencing Avoidance and Numbing and Hyperarousal the Davidson Trauma Scale DTS the Short PTSD Rating Interview SPRINT the Hamilton Depression Rating Scale HAM-D the Clinical Global Impression- Global Improvement and Severity of Illness Scale CGI-I and CGI-S respectively the Cognitive and Physical Functioning Questionnaire CPFQ and the Pittsburgh Sleep Quality Index PSQI
Safety and tolerability will be assessed by monitoring adverse events AEs or side effects physical examinations including vital signs such as blood pressure and heart rate clinical laboratory assessments blood tests electrical recordings of the heart electrocardiograms or ECGs the Columbia Suicidality Severity Rating Scale CSSRS Massachusetts Sexual Function Questionnaire MSFQ Discontinuation-Emergent Signs and Symptoms DESS scale and weight change
Blood samples will be taken at different time points to assess blood levels of orvepitant in patients allowing the relationship between amount of orvepitant in the body and efficacy to be studied
The primary objective of the study is to evaluate the efficacy of orvepitant 60mgday versus placebo a sugar pill with no active ingredients The secondary objectives include assessing the safety and tolerability of orvepitant assessing the profile of appearance and disappearance of orvepitant in the body blood following administration ie assessing how long the drug remains in the body and lastly to examine the relationship between blood levels of the drug and efficacy ie the change in CAPS score relative to what it was before starting the study medication
Following an initial screening visit subjects fulfilling the study entrance criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and electrocardiogram 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 Upon completion of the screening period eligible subjects will be randomly assigned at the baseline visit to one of two treatment regimens orvepitant 60mgday or placebo for a 12-week treatment phase The chances of receiving each of the two possible treatments will be equal Orvepitant will be administered as tablets Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant
During the treatment phase subjects will be required to return to the clinic at the end of Weeks 1 2 4 6 8 10 and 12 In addition all subjects will be required to return for a follow-up visit 14 days after the last dose of study medication In addition all subjects with ongoing adverse events at the 14-day follow-up visit will be required to return for a further follow-up visit 28 days after the last dose of study medication Women of child-bearing potential will also be required to attend the 28-Day follow-up visit for a pregnancy test A further test will be performed 42 Days following the end of treatment
Male and female outpatients between the ages of 18 to 64 years inclusive with a primary diagnosis of noncombat-related PTSD will be enrolled into this study A total of approximately 240 subjects are expected to be enrolled at approximately 25 different study sites in North America
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None