Proof-of-concept Study to Assess the Efficacy and Safety... | NCT02733614

Studies
Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD

NCT02733614

Sponsor

Azevan Pharmaceuticals

Status

Terminated

Last Update Posted

Nov 1, 2021Actual

Enrollment

33Actual

Phase

Phase 2

Conditions

PTSD

Interventions

SRX246
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

funding

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Oct 2020Actual

Completion Date

Mar 31, 2021Actual

First Submitted Date

Mar 29, 2016

First Submission Date that Met QC Criteria

Apr 5, 2016

First Posted Date

Apr 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2021

Last Update Posted Date

Nov 1, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Azevan PharmaceuticalsINDUSTRY

Collaborators

Name	Class
Weill Medical College of Cornell University	OTHER
United States Department of Defense	FED
U.S. Army Medical Research and Development Command	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SRX246	Experimental	SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks	Drug: SRX246
Placebo	Placebo Comparator	oral administration, capsules, daily for 8 weeks	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SRX246	Drug	novel V1a receptor antagonist	SRX246
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of overall clinical improvement	Measured using the Clinician Administered PTSD Scale (CAPS)	18 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with treatment-related adverse events	Assessments of adverse events (AEs), dose reductions and dropouts due to AEs	18 weeks
Reduction in depressive symptoms	Measured using the Beck Depression Inventory (BDI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Medically stable, current diagnosis of PTSD

Exclusion Criteria:

Medically unstable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Weill Cornell Medical College		New York	New York	10065	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Nov 17, 2021
Reset	Dec 15, 2021
Release	Jul 18, 2023
Reset	Aug 3, 2023

Submission Tracking

Estimated Results First Submitted Date

Nov 17, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 17, 2021			Dec 15, 2021
Jul 18, 2023

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C584649	SRX246

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided