Trial of Oral SNC-102 in Subjects With Combat-Related Posttraumatic Stress Disorder

NCT02384369 | Withdrawn Phase 2

• 1 other identifier: SNC-102-221 PT
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Posttraumatic Stress Disorders; Stress Disorders, Post-Traumatic; Post-Traumatic Stress Disorders, Combat-related

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

SNC-102 sustained release tablet

EXPERIMENTAL

SNC-102 sustained release tablet for oral administration, 1600 mg BID for 8 weeks

Drug: SNC-102 sustained release tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet for oral administration, BID for 8 weeks

Drug: SNC-102 sustained release tablet

Interventions

SNC-102 sustained release tablet DRUG

Sustained release oral tablet of SNC-102

Also known as: SNC-102, SNC102

Placebo; SNC-102 sustained release tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Current use of a drug other than prazosin with significant alpha-adrenergic blocking effects, if associated with symptomatic orthostatic hypotension.
• 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.

Sponsors & Collaborators

• Synchroneuron Inc.: lead

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 10, 2015
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 18, 2016

Record last verified: 2016-04