Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Inv117-Kosten-CL01 |
Not provided
Not provided
Not provided
Houston site withdrew as a study site.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tuscaloosa Veterans Affairs Medical Center | FED |
| Ralph H. Johnson VA Medical Center | FED |
| Acorda Therapeutics | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assess the effect of nepicastat in the treatment of in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo.
The primary treatment objective is to assess the global efficacy of nepicastat in the treatment of hyper-arousal in Post Traumatic Stress Disorder (PTSD) in conflict or combat zone experienced veterans, in comparison to placebo. The secondary treatment objectives are to assess the ability of nepicastat to induce PTSD remission; treat PTSD and other PTSD symptom clusters and improve quality of life and overall functioning. A medical safety objective is to assess the tolerability and side effects of nepicastat in the treatment of PTSD in veterans who served in conflict zones at least one time between 1990 -2008 [includes Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF), Afghanistan, Gulf War, etc .
This is a 6-week study with the long-term objective is to define the best approach to treating PTSD and enhancing the quality of life in patients. Results from this pilot study will assist clinicians in treating active military service members or veterans with PTSD by developing new treatment algorithms for future larger studies.](streamdown:incomplete-link)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 (Medication arm - SYN117 aka Nepicastat) | Experimental | Veterans will be receiving the study medication Nepicastat initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily; During the 8 weeks (weeks: 7-14) extension phase, those from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed for an additional 8 weeks. Those who have a prior defined positive clinical response to the study medication, Nepicastat, will be continued on open label Nepicastat at 120mg once daily, in order to assess further improvement and safety; those who do not have a positive clinical response during the 6 weeks RCT will be offered the addition of the standard first-line PTSD pharmacotherapy, Paroxetine. Paroxetine is an allowed concomitant medication (i.e. "rescue medication") and is not considered a research medication or subject of a research question during the 8 weeks extension phase. |
|
| 2 (Placebo arm) | Placebo Comparator | During the 6 weeks ( weeks: 1-6) double- blind, randomized clinical trial (RCT) phase, the veterans who have been randomized to the placebo treatment group will be receiving placebo pills. During the 8 weeks (weeks: 7-14) extension phase, all veterans from both treatment groups of the RCT phase will start open-label, active Nepicastat (i.e. no chance of placebo) treatment and be followed by the study team for an additional 8 weeks. The veterans on the placebo during the RCT will receive the study medication at end of the study week 6, the medication will be initiated with a 3-day loading phase of 40 mg on day 1, 80 mg on day 2 and 120 mg on day 3 (orally) and be continued at 120 mg once daily for 8 weeks until the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN117 (nepicastat) | Drug | 120 mg per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in CAPS(D) hyperarousal scores as compared to placebo | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Structured Interview of Posttraumatic Stress Disorder (SIP) as compared to placebo | 6 weeeks | |
| Change from baseline in Montgomery Asberg Depression Rating Scale (MADRS)as compared to placebo | 6 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas Kosten, MD | Baylor College of Medicine, and DeBakey VAMC | Study Chair |
| Lori Davis, MD | Tuscaloosa VAMC | Study Director |
| Mark Hamner, MD | Ralph H Johnson VAMC | Principal Investigator |
| David P. Graham, MD | Michael E. DeBakey VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VAMC | Tuscaloosa | Alabama | 35404 | United States | ||
| Ralph H. Johnson VA Medical Center |
Not provided
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C109487 | nepicastat |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo comparator | Drug | once per day placebo capsules |
|
| Clinicians global impression of Severity and Improvement | 6 weeks |
| Quality of life assessment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). | 6 weeks |
| Change from baseline in Davidson Trauma Scale (DTS) as compared to placebo | 6 weeks |
| Change from baseline in Sheehan Disability Scale as compared to placebo | 6 weeks |
| Change from baseline in Clinician Administered PTSD Scale- Symptom (CAPS-SX) as compared to placebo | 6 weeks |
| Charleston |
| South Carolina |
| 29401 |
| United States |
| Michael E. Debakey VAMC | Houston | Texas | 77030 | United States |