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

Sponsor

Azevan Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT02733614

Collaborator

Weill Medical College of Cornell University (Other), United States Department of Defense (U.S. Fed), U.S. Army Medical Research and Development Command (U.S. Fed)

Enrollment

Location

Arms

51.9

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Drug: SRX246 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Oct 1, 2020

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SRX246 SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks	Drug: SRX246 novel V1a receptor antagonist
Placebo Comparator: Placebo oral administration, capsules, daily for 8 weeks	Drug: Placebo matching placebo

Arm

Intervention/Treatment

Experimental: SRX246

SRX246 160 mg BID, oral administration, capsules, daily for 8 weeks

Drug: SRX246

novel V1a receptor antagonist

Placebo Comparator: Placebo

oral administration, capsules, daily for 8 weeks

Drug: Placebo

matching placebo

Outcome Measures

Primary Outcome Measures

Assessment of overall clinical improvement [18 weeks]
Measured using the Clinician Administered PTSD Scale (CAPS)

Secondary Outcome Measures

Number of participants with treatment-related adverse events [18 weeks]
Assessments of adverse events (AEs), dose reductions and dropouts due to AEs
Reduction in depressive symptoms [18 weeks]
Measured using the Beck Depression Inventory (BDI)
Reduction in anger and aggression [18 weeks]
Measured using the Overt Aggression Scale-Modified (OAS-M)
Reduction in irritability [18 weeks]
Measured using the Sheehan Irritability Scale (SIS)
Improvement in overall functioning [18 weeks]
Measured using the Medical Outcomes Study Short-Form 12-Item Health Survey (SF-12)
Improvement in quality of life [18 weeks]
Measured using the Sheehan Disability Scale (SDS)
Improvement in sleep quality [18 weeks]
Measured using the Pittsburgh Sleep Quality Index (PSQI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Medically stable, current diagnosis of PTSD

Exclusion Criteria:

Medically unstable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10065

Sponsors and Collaborators

Azevan Pharmaceuticals
Weill Medical College of Cornell University
United States Department of Defense
U.S. Army Medical Research and Development Command

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Azevan Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT02733614

Other Study ID Numbers:

AVN010

First Posted:

Apr 11, 2016

Last Update Posted:

Nov 1, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

SRX246

Study Results

No Results Posted as of Nov 1, 2021