Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder

Study Overview
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Brief Summary
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This is a clinical study for adult subjects with Post Traumatic Stress Disorder.

Detailed Description
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Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms

Official Title
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Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: PRX-03140


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects between ages 18-55 The subject has signed and dated the written informed consent to participate in the study The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions The subject meets criteria for PTSD as defined by the DSM-IV-TR Stable use of clinically prescribed medications Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation Female subjects - not surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) for at least 6 months or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal, vaginal, or injection) in use at least 3 consecutive months prior to the first dose of study medication, double barrier (condom with spermicide; diaphragm with spermicide), intrauterine device (IUD), or vasectomized partner (6 months minimum since vasectomy). Exclusion Criteria: Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria Patient actively suicidal within last 12-months or with current suicidal ideation History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview Participation in a clinical drug research study within the past 30 days Subject currently taking any SSRI or anti-depressant medication. Pregnant or breastfeeding females Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRX-03140<br>PRX-03140 for the treatment of PTSD | Drug: PRX-03140<br>* 50 mg PRX-03140 capsules once daily for 2 weeks. After 2 weeks, the dose will increase to 100mg PRX-03140 once daily for 10 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in adverse events from baseline | adverse events will be evaluated at every visit | weekly for 4 weeks then every 4 weeks until week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in PTSD and mood related symptoms | subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline | weekly for 4 weeks then every 4 weeks until week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Post Traumatic Stress Disorder