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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanotherapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01492699
First received: December 9, 2011
Last updated: June 17, 2013
Last verified: June 2013

December 9, 2011
June 17, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
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
Number of participants with adverse events [ 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
Complete list of historical versions of study NCT01492699 on ClinicalTrials.gov Archive Site
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
Change from baseline in PTSD and mood related symptoms compared [ 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 vist to show any changes in symptoms from baseline
Not Provided
Not Provided
 
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.

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

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

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Post Traumatic Stress Disorder
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.
Experimental: PRX-03140
PRX-03140 for the treatment of PTSD
Intervention: Drug: PRX-03140
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01492699
2010-PTSD-NT/001
No
Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
Not Provided
Study Director: John Abernethy, MD Nanotherapeutics, Inc.
Nanotherapeutics, Inc.
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP