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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)

Primary Purpose

PTSD

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNX-102 SL
Placebo SL Tablets
Sponsored by
Tonix Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
  • Index trauma must have occurred within 9 years of Screening Visit
  • Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

  • Use of antidepressant medication within 2 months of Baseline

Sites / Locations

  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters
  • Ashild Peters

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TNX-102 SL Tablet 2.8 mg

Placebo SL Tablet

Arm Description

2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.

2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.

Outcomes

Primary Outcome Measures

The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit.

Secondary Outcome Measures

Change from baseline in CGI-S score.

Full Information

First Posted
February 12, 2019
Last Updated
February 8, 2021
Sponsor
Tonix Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03841773
Brief Title
A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Acronym
RECOVERY
Official Title
A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Interim Analysis results
Study Start Date
March 7, 2019 (Actual)
Primary Completion Date
April 24, 2020 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tonix Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) - a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible patients will have a telephonic visit at week 2 and then return regularly to the study clinic for monthly visits for assessments of efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNX-102 SL Tablet 2.8 mg
Arm Type
Experimental
Arm Description
2 x TNX-102 SL, 2.8 mg Tablets taken sublingually each day at bedtime for 12 weeks.
Arm Title
Placebo SL Tablet
Arm Type
Placebo Comparator
Arm Description
2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
TNX-102 SL
Other Intervention Name(s)
Low dose cyclobenzaprine sublingual tablets, Tonmya(R)
Intervention Description
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo SL Tablets
Other Intervention Name(s)
Placebo sublingual tablets, TNX-102 SL Placebo Tablets
Intervention Description
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Primary Outcome Measure Information:
Title
The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit.
Time Frame
Week 0, Week 4, Week 8 and Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in CGI-S score.
Time Frame
Week 0, Week 4, Week 8 and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening) Index trauma must have occurred within 9 years of Screening Visit Must have occurred when the patient was ≥18 years of age Exclusion Criteria: Use of antidepressant medication within 2 months of Baseline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory M Sullivan, MD
Organizational Affiliation
Tonix Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Ashild Peters
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Ashild Peters
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Ashild Peters
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
Ashild Peters
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Ashild Peters
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Ashild Peters
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ashild Peters
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Ashild Peters
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Ashild Peters
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ashild Peters
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Ashild Peters
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Ashild Peters
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Ashild Peters
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20011
Country
United States
Facility Name
Ashild Peters
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Ashild Peters
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Ashild Peters
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Ashild Peters
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Ashild Peters
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
Ashild Peters
City
Lincolnwood
State/Province
Illinois
ZIP/Postal Code
60712
Country
United States
Facility Name
Ashild Peters
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Ashild Peters
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Ashild Peters
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Ashild Peters
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Ashild Peters
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Ashild Peters
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Facility Name
Ashild Peters
City
Portland
State/Province
Oregon
ZIP/Postal Code
97214
Country
United States
Facility Name
Ashild Peters
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Ashild Peters
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Ashild Peters
City
Austin
State/Province
Texas
ZIP/Postal Code
78737
Country
United States
Facility Name
Ashild Peters
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

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