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

This study is currently recruiting participants.
Verified January 2013 by Nanotherapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01492699
First received: December 9, 2011
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline


Estimated Enrollment: 12
Study Start Date: June 2012
Estimated 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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492699

Contacts
Contact: John Abernethy, MD jabernethy@nanotherapeutics.com
Contact: Angie Kimbler akimbler@nanotherapeutics.com

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

No publications provided

Responsible Party: Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01492699     History of Changes
Other Study ID Numbers: 2010-PTSD-NT/001
Study First Received: December 9, 2011
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013