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

NCT ID: NCT01492699

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

Brief Summary

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

Detailed Description

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

Conditions

Post Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PRX-03140

PRX-03140 for the treatment of PTSD

Group Type: EXPERIMENTAL

PRX-03140

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Abernethy, MD

Role: STUDY_DIRECTOR

Alachua Government Services, Inc.

Locations

Sarkis Clinical Trials

Gainesville, Florida, United States

Countries

United States

Other Identifiers

2010-PTSD-NT/001

Identifier Type: -

Identifier Source: org_study_id