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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01492699
First Posted: December 15, 2011
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
  Purpose
This is a clinical study for adult subjects with Post Traumatic Stress Disorder.

Condition Intervention
Post Traumatic Stress Disorder Drug: PRX-03140

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Nanotherapeutics, Inc.:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 7
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01492699


Locations
United States, Florida
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
Nanotherapeutics, Inc.
Investigators
Study Director: John Abernethy, MD Nanotherapeutics, Inc.
  More Information

Responsible Party: Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01492699     History of Changes
Other Study ID Numbers: 2010-PTSD-NT/001
First Submitted: December 9, 2011
First Posted: December 15, 2011
Last Update Posted: October 12, 2017
Last Verified: September 2014

Keywords provided by Nanotherapeutics, Inc.:
PTSD
Post Traumatic Stress Disorder

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders