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

Post Traumatic Stress Disorder Clinical Trial

Official title:

Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492699
• Other study ID #: 2010-PTSD-NT/001
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: September 24, 2014
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: September 2014
• Source: Nanotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Sarkis Clinical Trials	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nanotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from baseline in PTSD and mood related symptoms	subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline	weekly for 4 weeks then every 4 weeks until week 14