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

NCT ID: NCT02733614

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2021-03-31

Brief Summary

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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

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Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SRX246

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

Group Type EXPERIMENTAL

SRX246

Intervention Type DRUG

novel V1a receptor antagonist

Placebo

oral administration, capsules, daily for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

Interventions

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SRX246

novel V1a receptor antagonist

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Medically stable, current diagnosis of PTSD

Exclusion Criteria

* Medically unstable
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role collaborator

United States Department of Defense

FED

Sponsor Role collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role collaborator

Azevan Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AVN010

Identifier Type: -

Identifier Source: org_study_id