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

Not Applicable

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: PRX-03140

• Registration Number: NCT01492699
• Lead Sponsor: Resilience Government Services, Inc.

Brief Summary

This is a clinical study for adult subjects with Post Traumatic Stress Disorder.

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Study Start: 2012-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-24
• Last Update Posted: 2014-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

1. Male and female subjects between ages 18-55
2. The subject has signed and dated the written informed consent to participate in the study
3. The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
4. The subject meets criteria for PTSD as defined by the DSM-IV-TR
5. Stable use of clinically prescribed medications
6. Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
7. 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

1. Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria
2. Patient actively suicidal within last 12-months or with current suicidal ideation
3. History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview
4. Participation in a clinical drug research study within the past 30 days
5. Subject currently taking any SSRI or anti-depressant medication.
6. Pregnant or breastfeeding females
7. Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PRX-03140	PRX-03140	PRX-03140 for the treatment of PTSD

Primary Outcome Measures

Name	Time	Method
Change in adverse events from baseline	weekly for 4 weeks then every 4 weeks until week 14	adverse events will be evaluated at every visit

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PTSD and mood related symptoms	weekly for 4 weeks then every 4 weeks until week 14	subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline

Trial Locations

Locations (1)

Sarkis Clinical Trials; 🇺🇸 Gainesville, Florida, United States