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

NCT01492699 | Completed

• 1 other identifier: 2010-PTSD-NT/001
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Traumatic Stress Disorder

Keywords

PTSD; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline in PTSD and mood related symptoms

  weekly for 4 weeks then every 4 weeks until week 14

Study Arms (1)

PRX-03140

EXPERIMENTAL

PRX-03140 for the treatment of PTSD

Drug: PRX-03140

Interventions

PRX-03140 DRUG

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.

PRX-03140

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead

Study Sites (1)

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• John Abernethy, MD

  Alachua Government Services, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2011
• First Posted: December 15, 2011
• Study Start: June 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

US (1)