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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492699
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : September 25, 2014
Information provided by (Responsible Party):
Ology Bioservices

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

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: PRX-03140 Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PRX-03140
PRX-03140 for the treatment of PTSD
Drug: PRX-03140
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.

Primary Outcome Measures :
  1. Change in adverse events from baseline [ Time Frame: weekly for 4 weeks then every 4 weeks until week 14 ]
    adverse events will be evaluated at every visit

Secondary Outcome Measures :
  1. Change from baseline in PTSD and mood related symptoms [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492699

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United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
Ology Bioservices
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Study Director: John Abernethy, MD Ology Bioservices
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Responsible Party: Ology Bioservices Identifier: NCT01492699    
Other Study ID Numbers: 2010-PTSD-NT/001
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: September 25, 2014
Last Verified: September 2014
Keywords provided by Ology Bioservices:
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders