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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.

Tracking Information
First Submitted Date  ICMJE April 9, 2015
First Posted Date  ICMJE April 21, 2015
Last Update Posted Date October 31, 2017
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02421679 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2015)
  • 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
  • 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
  • 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)
  • Montgomery-Asberg Depression Rating Scale [ Time Frame: Week 12 ]
    Changes from baseline in lead-in study and since baseline in this study in MADRS
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Extension Safety and Efficacy Study of TNX-102 SL Tablets in Military Related PTSD and Related Conditions
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE Drug: TNX-102 SL
TNX-102 Sublingual tablets
Other Name: cyclobenzaprine HCI
Study Arms  ICMJE Experimental: TNX-102 SL
TNX-102 SL taken daily at bedtime for 12 weeks
Intervention: Drug: TNX-102 SL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
159
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2015)
200
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 66 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02421679
Other Study ID Numbers  ICMJE TNX-CY-P202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tonix Pharmaceuticals, Inc.
Study Sponsor  ICMJE Tonix Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Denise Bedoya Premier Research Group plc
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP