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P202: Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02421679
Collaborator
(none)
159
Enrollment
22
Locations
1
Arm
16
Actual Duration (Months)
7.2
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a 12-week, multicenter, open-label extension study to evaluate the safety and efficacy of TNX-102 SL tablet taken daily at bedtime in patients with Military-Related PTSD or related condition. Patients recruited into this trial are those who have successfully completed the double-blind study, TNX-CY-P201 (AtEase Study). Patients will not be made aware of the therapy they received during the double-blind study.

Condition or Disease Intervention/Treatment Phase
  • Drug: TNX-102 SL
 Phase 2

Detailed Description

The study will consist of 4 clinic visits, including Screening/Baseline Visit 1 (Day 0, which is anticipated to be the same date as the final visit in the lead-in P201 study) and visits after 2, 6 and 12 weeks of treatment. The previous requirements in the lead-in study for refraining from the use of certain concomitant medications and trauma-focused psychotherapies will be relaxed. Patients may continue to take rescue therapy for sleep, as appropriate, or they may utilize other medications as needed to help them sleep, per the judgment of the investigator.

Eligible patients who provide written informed consent will take one TNX-102 SL tablet daily at bedtime sublingually (under the tongue) for 12 weeks. All patients will be assigned to receive tthe same dosage of TNX-102 SL, regardless of their treatment assignment in the lead-in study. No patients, investigators, or study staff will know the assigned study treatment from the lead-in study, P201, at the time of entry into the extension study. Patient data collected at the Week 12 visit (Visit 9) in the lead-in P201 study will be used as one of the baseline values for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 12-Week, Open-Label, Multicenter, Extension Study To TNX-CY-P201 To Evaluate The Safety And Efficacy Of TNX-102 SL Taken Daily At Bedtime In Patients With Military-Related PTSD And Related Conditions
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: TNX-102 SL

TNX-102 SL taken daily at bedtime for 12 weeks

Drug: TNX-102 SL
TNX-102 Sublingual tablets
Other Names:
  • cyclobenzaprine HCI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety (Adverse events, change in lab test results and vital signs) [Week 12]

      To evaluate the safety of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) as new treatment emergent AEs since lead-in study, change in clinical laboratory test results and vital signs

    Secondary Outcome Measures

    1. Total CAPS-5 (Clinician Administered PTSD Scale (for Diagnostic and Statistical Manual of Mental Disorders Version 5) [Weeks 2, 6 and 12]

      Changes in total CAPS-5 score from baseline in lead-in study and since baseline in this study

    2. Response rates a in Total CAPS-5 score [Weeks 2, 6 and 12]

      ≥30% decrease in Total CAPS-5 score at weeks from baseline in lead-in study and since baseline in this study

    3. CAPS-5 cluster score items [Weeks 2, 6 and 12]

      Changes from baseline in lead-in study and since baseline in this study in item scores, including intrusion symptoms (Criterion B) CAPS-5 item 2. (B-2) (unpleasant dreams related to the trauma) persistent avoidance (Criterion C), negative cognitions and mood (Criterion D) arousal and reactivity (Criterion E)

    4. Montgomery-Asberg Depression Rating Scale [Week 12]

      Changes from baseline in lead-in study and since baseline in this study in MADRS

    5. PROMIS (Patient -Reported Outcome Measurement Information System) [Week 12]

      Changes from baseline in lead-in study and since baseline in this study in PROMIS scores

    6. MTRSS (Morning Treatment-Related Sedation Scale) [Week 12]

      Changes from baseline in lead-in study and since baseline in this study in MTRSS scores

    7. PGIC (Patient Global Impression of Change Scale) [Week 12]

      Changes from baseline in lead-in study and since baseline in this study in PGIC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 66 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Completed the lead-in study and is judged as reasonably compliant, with at least 60% compliance

    • Signed informed consent

    • Met all prior inclusion and exclusion requirements for lead-in study

    • No new or worsening medical conditions since starting the lead-in study that could pose a safety risk or interfere with participation in the study

    • Willing to refrain from use of specific medication (ask PI)

    • Female patients of childbearing potential continue to practice medically acceptable methods of birth control

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tuscaloosa VA Medical Center Tuscaloosa Alabama United States 35404
    2 Noesis Pharma Phoenix Arizona United States 85032
    3 Sun Valley Reserach Center Imperial California United States 92251
    4 Synergy Clinical Research National City California United States 91950
    5 Excell Research, Inc Oceanside California United States 92506
    6 Neuropsychiatric Research Center of Orange County Orange California United States 92868
    7 CITRIALS Riverside California United States 92506
    8 CESAMH San Diego California United States 92103
    9 Cns, Inc. Torrance California United States 90502
    10 Sarkis Clinical Trials Lake City Florida United States 32025
    11 Compass Research North, LLC Leesburg Florida United States 34748
    12 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
    13 Atlanta Center For Medical Research Atlanta Georgia United States 30308
    14 Great Lakes Clinical Trials Chicago Illinois United States 60640
    15 Novex Clinical Research New Bedford Massachusetts United States 02740
    16 Premier Psychiatric Research Instititute, Inc. Lincoln Nebraska United States 68526
    17 Altea Research Las Vegas Nevada United States 89102
    18 Neurobehavioral Research, Inc. Cedarhurst New York United States 11516
    19 University of Cincinnati College of Medicine Cincinnati Ohio United States 45219
    20 University Hospitals Case Medical Center Cleveland Ohio United States 44106
    21 Clinical Trials of Texas San Antonio Texas United States 78229
    22 Northwest Clinical Research Center Bellevue Washington United States 98007

    Sponsors and Collaborators

    • Tonix Pharmaceuticals, Inc.

    Investigators

    • Study Director: Denise Bedoya, Premier Research Group plc

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tonix Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02421679
    Other Study ID Numbers:
    • TNX-CY-P202
    First Posted:
    Apr 21, 2015
    Last Update Posted:
    Oct 31, 2017
    Last Verified:
    Oct 1, 2017
    Keywords provided by Tonix Pharmaceuticals, Inc.
    PTSD
    Military-related PTSD and other related conditions
    open-label extension
    Additional relevant MeSH terms:
    Disease
    Stress Disorders, Post-Traumatic
    Cyclobenzaprine

    Study Results

    No Results Posted as of Oct 31, 2017