Post Traumatic Stress DisorderNCT01492699
Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder
A study testing PRX-03140 in people with Post Traumatic Stress Disorder, run by Alachua Government Services, Inc. at 1 site in United States.
Trial summary
This is a clinical study for adult subjects with Post Traumatic Stress Disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- PRX-03140
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Open label clinical study to evaluate the efficacy of PRX-03140 in reducing PTSD symptoms
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- PRX-03140
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRX-03140Drug
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 group | Role | What they receive |
|---|---|---|
| PRX-03140 | Experimental | PRX-03140 for the treatment of PTSD Receives: Drug: PRX-03140 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adverse events from baseline
adverse events will be evaluated at every visit
Measured: weekly for 4 weeks then every 4 weeks until week 14
Secondary outcomes (1)
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
Measured: weekly for 4 weeks then every 4 weeks until week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alachua Government Services, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Abernethy, MD, Study director, Alachua Government Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492699
- Sponsor's protocol ID
- 2010-PTSD-NT/001
- Status last verified
- Sep 2014
- First submitted
- 9 Dec 2011
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Site, Open Label Pilot Study of PRX-03140 to Assess Safety for Use in Adult Subjects With Post Traumatic Stress Disorder.
- ClinicalTrials.gov ID
- NCT01492699
- Acronym / sponsor ID
- 2010-PTSD-NT/001
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alachua Government Services, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRX-03140 | Experimental | Drug: PRX-03140PRX-03140 for the treatment of PTSD |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRX-0314050 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. | Drug | PRX-03140 |
Primary outcome
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
1 secondary outcome
Change from baseline in PTSD and mood related symptoms
Time frame: weekly for 4 weeks then every 4 weeks until week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Abernethy, MD study director
Alachua Government Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRX-03140 in people with Post Traumatic Stress Disorder, run by Alachua Government Services, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adverse events from baseline (time frame: weekly for 4 weeks then every 4 weeks until week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.