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

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03841773
Collaborator
(none)
192
Enrollment
30
Locations
2
Arms
13.6
Actual Duration (Months)
6.4
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.
Condition or Disease Intervention/Treatment Phase
  • Drug: TNX-102 SL
  • Drug: Placebo SL Tablets
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
192 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Mar 7, 2019
Actual Primary Completion Date :
Apr 24, 2020
Actual Study Completion Date :
Apr 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: TNX-102 SL Tablet 2.8 mg

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

Drug: TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
Other Names:
  • Low dose cyclobenzaprine sublingual tablets
  • Tonmya(R)

    		•
    Placebo Comparator: Placebo SL Tablet

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

    Drug: Placebo SL Tablets
    Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
    Other Names:
  • Placebo sublingual tablets
  • TNX-102 SL Placebo Tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. [Week 0, Week 4, Week 8 and Week 12]

    Secondary Outcome Measures

    1. Change from baseline in CGI-S score. [Week 0, Week 4, Week 8 and Week 12]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ashild Peters Phoenix Arizona United States 85012
    2 Ashild Peters Little Rock Arkansas United States 72211
    3 Ashild Peters Rogers Arkansas United States 72758
    4 Ashild Peters Beverly Hills California United States 90210
    5 Ashild Peters Oceanside California United States 92056
    6 Ashild Peters Orange California United States 92868
    7 Ashild Peters Panorama City California United States 91402
    8 Ashild Peters Riverside California United States 92506
    9 Ashild Peters San Diego California United States 92123
    10 Ashild Peters Temecula California United States 92591
    11 Ashild Peters Colorado Springs Colorado United States 80910
    12 Ashild Peters Norwich Connecticut United States 06360
    13 Ashild Peters Washington District of Columbia United States 20011
    14 Ashild Peters Jacksonville Florida United States 32256
    15 Ashild Peters North Miami Florida United States 33161
    16 Ashild Peters Orlando Florida United States 32801
    17 Ashild Peters Tampa Florida United States 33614
    18 Ashild Peters Alpharetta Georgia United States 30341
    19 Ashild Peters Lincolnwood Illinois United States 60712
    20 Ashild Peters Boston Massachusetts United States 02131
    21 Ashild Peters New Bedford Massachusetts United States 02740
    22 Ashild Peters Flowood Mississippi United States 39232
    23 Ashild Peters Saint Louis Missouri United States 63141
    24 Ashild Peters Las Vegas Nevada United States 89102
    25 Ashild Peters Oklahoma City Oklahoma United States 73106
    26 Ashild Peters Portland Oregon United States 97214
    27 Ashild Peters Salem Oregon United States 97301
    28 Ashild Peters Memphis Tennessee United States 38119
    29 Ashild Peters Austin Texas United States 78737
    30 Ashild Peters Dallas Texas United States 75231

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.

    Investigators

    • Study Director: Gregory M Sullivan, MD, Tonix Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03841773
    Other Study ID Numbers:
    • TNX-CY-P302
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tonix Pharmaceuticals, Inc.
    PTSD
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic
    Cyclobenzaprine

    Study Results

    No Results Posted as of Feb 11, 2021