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Trial record 1 of 1 for:    NCT03841773
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A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD (RECOVERY)

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: NCT03841773
Recruitment Status : Active, not recruiting
First Posted : February 15, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 12, 2019
First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 10, 2020
Actual Study Start Date  ICMJE March 7, 2019
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
The mean change from baseline (Visit 2) in the Total CAPS-5 score evaluated at the landmark visit. [ Time Frame: Week 0, Week 4, Week 8, Week 12 and Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2019)
Change from baseline in CGI-S score. [ Time Frame: Week 0, Week 4, Week 8 and Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2019)
Change from baseline in CGI-S score. [ Time Frame: Week 0, Week 4, Week 8, Week 12 and Week 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD
Official Title  ICMJE A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD Taken Daily at Bedtime (Protocol No. TNX-CY-P302)
Brief Summary This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of TNX-102 SL 5.6 mg (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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE PTSD
Intervention  ICMJE
  • Drug: TNX-102 SL
    Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
    Other Names:
    • Low dose cyclobenzaprine sublingual tablets
    • Tonmya(R)
  • Drug: Placebo SL Tablets
    Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
    Other Names:
    • Placebo sublingual tablets
    • TNX-102 SL Placebo Tablets
Study Arms  ICMJE
  • 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.
    Intervention: Drug: TNX-102 SL
  • Placebo Comparator: Placebo SL Tablet
    2 x Placebo Tablets taken sublingually each day at bedtime for 12 weeks.
    Intervention: Drug: Placebo SL Tablets
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 6, 2020)
192
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2019)
250
Estimated Study Completion Date  ICMJE March 15, 2020
Estimated Primary Completion Date March 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male and Female subjects between the years of 18-75 with a diagnosis of PTSD (diagnosis can be made at screening)
  • Index trauma must have occurred within 9 years of Screening Visit
  • Must have occurred when the patient was ≥18 years of age

Exclusion Criteria:

  • Use of antidepressant medication within 2 months of Baseline
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 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 NCT03841773
Other Study ID Numbers  ICMJE TNX-CY-P302
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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: Gregory M Sullivan, MD Tonix Pharmaceuticals
PRS Account Tonix Pharmaceuticals, Inc.
Verification Date February 2020

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