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HONOR: Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT03062540
Collaborator
Premier Research Group plc (Industry)
358
Enrollment
43
Locations
2
Arms
16
Actual Duration (Months)
8.3
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 5.6 mg TNX-102 SL (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 Tablet
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
358 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 Taken Daily at Bedtime in Patients With Military-Related PTSD
Actual Study Start Date :
Mar 27, 2017
Actual Primary Completion Date :
Jul 27, 2018
Actual Study Completion Date :
Jul 27, 2018

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 each day at bedtime starting on Day 0 for 12 weeks
Other Names:
  • Low dose cyclobenzaprine sublingual tablets

    		•
    Placebo Comparator: Placebo SL Tablet

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

    Drug: Placebo SL Tablet
    Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
    Other Names:
  • Placebo sublingual tablets

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. [Day 0, Week 4, Week 8 and Week 12]

      To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study.

    Secondary Outcome Measures

    1. Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment. [12 weeks]

      To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment.

    2. Change from baseline in the disruption of social life/leisure activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment. [Day 0, Week 4, Week 8 and Week 12.]

      To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment.

    3. Change from baseline in the disruption of work/school activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment. [Day 0, Week 4, Week 8 and Week 12.]

      To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment.

    4. Change from baseline in patients' quality of sleep using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance scale after 12 weeks of treatment. [Day 0, Week 4, Week 8 and Week 12.]

      To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment.

    Eligibility Criteria

    Criteria

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

    • Male or female between 18 and 75 years of age, who have served in any branch of the military.

    • Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.

    • Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.

    • Willing to refrain from use of all other formulations of cyclobenzaprine.

    • Willing and able to refrain from antidepressants and other excluded medications.

    • Capable of reading and understanding English and able to provide written informed consent.

    • If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.

    • Willing and able to comply with all protocol-specified requirements.

    Exclusion Criteria:

    • Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.

    • Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.

    • Severe depressive symptoms at screening or baseline.

    • Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.

    • Use of antidepressant medication within 2 months of baseline.

    • Female patients who are pregnant or lactating.

    • History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.

    • Seizure disorder.

    • Patients with a body mass index (BMI) > 45.

    • Has received any other investigational drug within 30 days before Screening.

    • Previous participation in any other study with TNX-102 SL.

    • Family member of investigative staff.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Phoenix Arizona United States 85032
    2 Little Rock Little Rock Arkansas United States 72211
    3 Rogers Rogers Arkansas United States 72758
    4 Beverly hills Beverly Hills California United States 90210
    5 Glendale Glendale California United States 91206
    6 Oakland Oakland California United States 94607
    7 Oceanside Oceanside California United States 92056
    8 Orange Orange California United States 92868
    9 Riverside Riverside California United States 92506
    10 San Diego San Diego California United States 92123
    11 San Diego San Diego California United States 92161
    12 Temecula Temecula California United States 92591
    13 Colorado Springs Colorado Springs Colorado United States 80910
    14 Cromwell Cromwell Connecticut United States 06416
    15 Norwich Norwich Connecticut United States 06360
    16 Washington, D.C. Washington District of Columbia United States 20018
    17 Jacksonville Jacksonville Florida United States 32256
    18 Lake City Lake City Florida United States 32607
    19 Lauderhill Lauderhill Florida United States 33319
    20 Maitland Maitland Florida United States 32751
    21 Tampa Tampa Florida United States 33609
    22 Atlanta Atlanta Georgia United States 30341
    23 Chicago Chicago Illinois United States 60640
    24 New Bedford New Bedford Massachusetts United States 02740
    25 Flowood Flowood Mississippi United States 39232
    26 St. Louis Saint Louis Missouri United States 63141
    27 Missoula Missoula Montana United States 59812
    28 Las Vegas Las Vegas Nevada United States 89102
    29 Berlin Berlin New Jersey United States 08009
    30 Cedarhurst Cedarhurst New York United States 11516
    31 New York New York New York United States 10128
    32 Canton Canton Ohio United States 44718
    33 Cincinnati Cincinnati Ohio United States 45219
    34 Dayton Dayton Ohio United States 45417
    35 Oklahoma City Oklahoma City Oklahoma United States 73103
    36 Downingtown Downingtown Pennsylvania United States 19335
    37 Media Media Pennsylvania United States 19063
    38 Charleston Charleston South Carolina United States 29407
    39 Austin Austin Texas United States 78754
    40 Dallas Dallas Texas United States 75231
    41 Houston Houston Texas United States 77098
    42 Salem Salem Virginia United States 24153
    43 Everett Everett Washington United States 98201

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.
    • Premier Research Group plc

    Investigators

    • Study Director: Greg Sullivan, MD, Tonix Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT03062540
    Other Study ID Numbers:
    • TNX-CY-P301
    First Posted:
    Feb 23, 2017
    Last Update Posted:
    Sep 17, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Military-related PTSD
    Additional relevant MeSH terms:
    Stress Disorders, Post-Traumatic
    Cyclobenzaprine

    Study Results

    No Results Posted as of Sep 17, 2019