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

• ClinicalTrials.gov Identifier: NCT01492699
• Recruitment Status: Completed
• First Posted: December 15, 2011
• Last Update Posted: September 25, 2014
• Sponsor: Ology Bioservices
• Information provided by (Responsible Party): Ology Bioservices

Tracking Information

• First Submitted Date: December 9, 2011
• First Posted Date: December 15, 2011
• Last Update Posted Date: September 25, 2014
• Study Start Date: June 2012
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 23, 2012)

Change in adverse events from baseline [ Time Frame: weekly for 4 weeks then every 4 weeks until week 14 ]

adverse events will be evaluated at every visit

Original Primary Outcome Measures (submitted: December 13, 2011)

Number of participants with adverse events [ Time Frame: weekly for 4 weeks then every 4 weeks until week 14 ]

adverse events will be evaluated at every visit

Current Secondary Outcome Measures (submitted: January 23, 2012)

Change from baseline in PTSD and mood related symptoms [ Time Frame: weekly for 4 weeks then every 4 weeks until week 14 ]

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

Original Secondary Outcome Measures (submitted: December 13, 2011)

Change from baseline in PTSD and mood related symptoms compared [ Time Frame: weekly for 4 weeks then every 4 weeks until week 14 ]

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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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.
• 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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Post Traumatic Stress Disorder

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.

Study Arms

Experimental: PRX-03140

PRX-03140 for the treatment of PTSD

Intervention: Drug: PRX-03140

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 24, 2014): 7
• Original Estimated Enrollment (submitted: December 13, 2011): 12
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01492699
• Other Study ID Numbers: 2010-PTSD-NT/001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Ology Bioservices
• Original Responsible Party: Same as current
• Current Study Sponsor: Ology Bioservices
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: John Abernethy, MD; Ology Bioservices

• PRS Account: Ology Bioservices
• Verification Date: September 2014