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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.
 
ClinicalTrials.gov Identifier: NCT02421679
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : October 31, 2017
Sponsor:
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02421679


Locations
Show Show 22 study locations
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Denise Bedoya Premier Research Group plc

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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02421679    
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.:
PTSD
Military-related PTSD and other related conditions
open-label extension
Additional relevant MeSH terms:
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Disease
Stress Disorders, Post-Traumatic
Pathologic Processes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Cyclobenzaprine
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