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Trial record 26 of 49 for:    CYCLOBENZAPRINE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02421679
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

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
PTSD 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 159 participants
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 : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

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 Name: cyclobenzaprine HCI

Primary Outcome Measures :
  1. Safety (Adverse events, change in lab test results and vital signs) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Week 12 ]
    Changes from baseline in lead-in study and since baseline in this study in PGIC

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02421679

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United States, Alabama
Tuscaloosa VA Medical Center
Tuscaloosa, Alabama, United States, 35404
United States, Arizona
Noesis Pharma
Phoenix, Arizona, United States, 85032
United States, California
Sun Valley Reserach Center
Imperial, California, United States, 92251
Synergy Clinical Research
National City, California, United States, 91950
Excell Research, Inc
Oceanside, California, United States, 92506
Neuropsychiatric Research Center of Orange County
Orange, California, United States, 92868
Riverside, California, United States, 92506
San Diego, California, United States, 92103
Cns, Inc.
Torrance, California, United States, 90502
United States, Florida
Sarkis Clinical Trials
Lake City, Florida, United States, 32025
Compass Research North, LLC
Leesburg, Florida, United States, 34748
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
United States, Georgia
Atlanta Center For Medical Research
Atlanta, Georgia, United States, 30308
United States, Illinois
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Massachusetts
Novex Clinical Research
New Bedford, Massachusetts, United States, 02740
United States, Nebraska
Premier Psychiatric Research Instititute, Inc.
Lincoln, Nebraska, United States, 68526
United States, Nevada
Altea Research
Las Vegas, Nevada, United States, 89102
United States, New York
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States, 11516
United States, Ohio
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States, 45219
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Texas
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
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Study Director: Denise Bedoya Premier Research Group plc

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Responsible Party: Tonix Pharmaceuticals, Inc. Identifier: NCT02421679     History of Changes
Other Study ID Numbers: TNX-CY-P202
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Keywords provided by Tonix Pharmaceuticals, Inc.:
Military-related PTSD and other related conditions
open-label extension
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Tranquilizing Agents
Central Nervous System Depressants