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

Primary Purpose

Post Traumatic Stress Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PRX-03140

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects between ages 18-55
The subject has signed and dated the written informed consent to participate in the study
The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions
The subject meets criteria for PTSD as defined by the DSM-IV-TR
Stable use of clinically prescribed medications
Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation
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:

Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria
Patient actively suicidal within last 12-months or with current suicidal ideation
History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview
Participation in a clinical drug research study within the past 30 days
Subject currently taking any SSRI or anti-depressant medication.
Pregnant or breastfeeding females
Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.

Sites / Locations

Sarkis Clinical Trials

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PRX-03140

Arm Description

PRX-03140 for the treatment of PTSD

Outcomes

Primary Outcome Measures

Change in adverse events from baseline

adverse events will be evaluated at every visit

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01492699

First Posted

December 9, 2011

Last Updated

September 24, 2014

Sponsor

Ology Bioservices

1. Study Identification

Unique Protocol Identification Number

NCT01492699

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ology Bioservices

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Traumatic Stress Disorder

Keywords

PTSD, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PRX-03140

Arm Type

Experimental

Arm Description

PRX-03140 for the treatment of PTSD

Intervention Type

Drug

Intervention Name(s)

PRX-03140

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in adverse events from baseline

Description

adverse events will be evaluated at every visit

Time Frame

weekly for 4 weeks then every 4 weeks until week 14

Secondary Outcome Measure Information:

Title

Change from baseline in PTSD and mood related symptoms

Description

subjects will fill out PTSD and mood related symptoms questionnaires at each visit to show any changes in symptoms from baseline

Time Frame

weekly for 4 weeks then every 4 weeks until week 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects between ages 18-55 The subject has signed and dated the written informed consent to participate in the study The subject is able to understand and comply with written and verbal protocol requirements, instructions, and protocol-stated restrictions The subject meets criteria for PTSD as defined by the DSM-IV-TR Stable use of clinically prescribed medications Subject able to complete baseline, 4 weeks, and 12 week psychological and cognitive evaluation 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: Actively alcohol or drug dependent as defined by DSM-IV-TR Criteria Patient actively suicidal within last 12-months or with current suicidal ideation History of schizophrenia, bipolar disorder, attention deficit hyperactivity disorder, learning disability, stroke, multiple sclerosis or seizure disorder by interview Participation in a clinical drug research study within the past 30 days Subject currently taking any SSRI or anti-depressant medication. Pregnant or breastfeeding females Subjects will be excluded based on lab values, ECG findings, or physical findings that the Investigators deems exclusionary.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Abernethy, MD

Organizational Affiliation

Ology Bioservices

Official's Role

Study Director

Facility Information:

Facility Name

Sarkis Clinical Trials

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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