Post-Traumatic Stress DisordersPhase 2PTSDNCT02384369
Trial of Oral SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder
A Phase 2 study testing SNC-102 sustained release tablet in people with Post-Traumatic Stress Disorders and Posttraumatic Stress Disorders, run by Synchroneuron Inc..
Trial summary
This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs. Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Traumatic Stress Disorders, Posttraumatic Stress Disorders, Stress Disorders, Post-Traumatic
- What is being tested?
- SNC-102 sustained release tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2017
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of a diagnosis by a Board-Certified psychiatrist of combat-related posttraumatic stress disorder (cPTSD) according to Diagnostic and Statistical Manual (DSM-5) criteria for PTSD and a history linking the symptoms to combat exposure.
- Taking prazosin for treatment of cPTSD for a minimum of 4 weeks, on a stable dose for at least 2 weeks, and expected to remain on that dose for the duration of the study.
- Having sufficient residual symptoms of PTSD while on the current drug regimen that, in the opinion of the Principal Investigator, additional treatment of the disorder is clinically indicated.
- Body mass index of 18-38 kg/m2 inclusive.
Who cannot join
- Plans to initiate a new psychotropic medication (other than the study drug) during the period of the study.
- Plans to change the dose or discontinue prazosin or a psychotropic medication during the period of the study.
- Diagnosis of epilepsy or treatment with an antiepileptic drug.
- Use of alcohol or cannabis to the extent that, in the view of the Principal Investigator, it raises a significant risk of medication noncompliance, drinking alcohol after midnight on the days of study visits or missed study visits. Any use of non-prescribed opiates, cocaine, or other street drugs other than cannabis in the month prior to study entry.
- Any history of major medical complications of alcohol use including alcoholic hepatitis, cirrhosis of the liver, pancreatitis, alcohol withdrawal seizures, or delirium tremens.
- Patients taking moderate, stable doses of oral opiates for chronic pain may be admitted at the discretion of the Principal Investigator.
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- Current use of a drug other than prazosin with significant alpha-adrenergic blocking effects, if associated with symptomatic orthostatic hypotension.
- Current use of cocaine, amphetamine, phencyclidine, or ketamine, documented either by history or by urinary drug screening at Screening and Baseline Visits. Urinary drug screening for ketamine and phencyclidine will conducted off-site by the Study Sponsor if urinary drug screening available at the study site does not include these drugs. Any other drugs identified incidentally on drug screening will warrant exclusion only if the Principal Investigator, in consultation with the Sponsor, judges that their presence could interfere with the objectives of the trial.
- Pregnant or lactating female.
- Women of childbearing potential, unless the subject agrees to use dual contraceptive methods while on study drug and for 1 month afterward, which, in the opinion of the Principal Investigator, are effective and adequate for that subject's circumstances.
- Any severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that could increase the risk associated with study participation or study drug administration, could interfere with the informed consent process and/or with compliance with the requirements of the study, or could interfere with the interpretation of study results and which, in the Principal Investigator's opinion, would make the subject inappropriate for entry into this study.
- Use of any non-pharmacologic psychiatric somatic treatment within 4 weeks of baseline, or expected during the course of the study. Such treatments include but are not limited to electroconvulsive therapy, transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, light therapy, and acupuncture.
About this study
Official title: Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder Concomitantly Treated With Prazosin
This is a randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs.
Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo.
- Conditions
- Post-Traumatic Stress Disorders, Posttraumatic Stress Disorders, Stress Disorders, Post-Traumatic, Post-Traumatic Stress Disorders, Combat-related
- Being tested
- SNC-102 sustained release tablet
- 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.
SNC-102 sustained release tabletDrug
Also called SNC-102, SNC102
Sustained release oral tablet of SNC-102
| Study group | Role | What they receive |
|---|---|---|
| SNC-102 sustained release tablet | Experimental | SNC-102 sustained release tablet for oral administration, 1600 mg BID for 8 weeks Receives: Drug: SNC-102 sustained release tablet |
| Placebo | Placebo comparator | Placebo tablet for oral administration, BID for 8 weeks Receives: Drug: SNC-102 sustained release tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5)
Determine whether SNC-102 at a dose of 1600 mg twice daily (BID), added to pre-existing treatment that includes prazosin, will decrease the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the CAPS-5, compared with the response to placebo.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: Insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synchroneuron Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384369
- Sponsor's protocol ID
- SNC-102-221 PT
- Acronym
- PTSD
- Status last verified
- Apr 2016
- First submitted
- 4 Mar 2015
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Efficacy, Safety, and Pharmacokinetics of Orally Administered SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder Concomitantly Treated With Prazosin
- ClinicalTrials.gov ID
- NCT02384369
- Acronym / sponsor ID
- PTSD / SNC-102-221 PT
- Conditions
- Post-Traumatic Stress Disorders, Posttraumatic Stress Disorders, Stress Disorders, Post-Traumatic, Post-Traumatic Stress Disorders, Combat-related
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synchroneuron Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 10 Mar 2015 (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 randomized, double-blind, placebo-controlled study of SNC-102 in adult subjects with cPTSD, added to pre-existing treatment that includes prazosin with or without other psychotropic drugs.
Subjects will be treated with SNC-102 tablets or matching placebo on a BID basis for 8 weeks. Subjects will be evaluated for the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the Clinician Administered PTSD Scale (CAPS-5), compared with the response to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNC-102 sustained release tablet | Experimental | Drug: SNC-102 sustained release tabletSNC-102 sustained release tablet for oral administration, 1600 mg BID for 8 weeks |
| Placebo | Placebo comparator | Drug: SNC-102 sustained release tabletPlacebo tablet for oral administration, BID for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmation of a diagnosis by a Board-Certified psychiatrist of combat-related posttraumatic stress disorder (cPTSD) according to Diagnostic and Statistical Manual (DSM-5) criteria for PTSD and a history linking the symptoms to combat exposure.
- Taking prazosin for treatment of cPTSD for a minimum of 4 weeks, on a stable dose for at least 2 weeks, and expected to remain on that dose for the duration of the study.
- Having sufficient residual symptoms of PTSD while on the current drug regimen that, in the opinion of the Principal Investigator, additional treatment of the disorder is clinically indicated.
- Body mass index of 18-38 kg/m2 inclusive.
Key exclusion criteria (12 listed)
- Plans to initiate a new psychotropic medication (other than the study drug) during the period of the study.
- Plans to change the dose or discontinue prazosin or a psychotropic medication during the period of the study.
- Diagnosis of epilepsy or treatment with an antiepileptic drug.
- Use of alcohol or cannabis to the extent that, in the view of the Principal Investigator, it raises a significant risk of medication noncompliance, drinking alcohol after midnight on the days of study visits or missed study visits. Any use of non-prescribed opiates, cocaine, or other street drugs other than cannabis in the month prior to study entry.
- Any history of major medical complications of alcohol use including alcoholic hepatitis, cirrhosis of the liver, pancreatitis, alcohol withdrawal seizures, or delirium tremens.
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 |
|---|---|---|
| SNC-102 sustained release tabletAlso: SNC-102, SNC102Sustained release oral tablet of SNC-102 | Drug | Placebo, SNC-102 sustained release tablet |
Primary outcome
PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5)
Time frame: 8 weeks
Determine whether SNC-102 at a dose of 1600 mg twice daily (BID), added to pre-existing treatment that includes prazosin, will decrease the symptoms of combat-related posttraumatic stress disorder (cPTSD) as measured by the CAPS-5, compared with the response to placebo.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNC-102 sustained release tablet in people with Post-Traumatic Stress Disorders and Posttraumatic Stress Disorders, run by Synchroneuron Inc..
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 4 inclusion and 12 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: withdrawn, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
PTSD symptoms as measured by Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual-5 (CAPS-5) (time frame: 8 weeks). 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 18 Apr 2016.