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Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD (HONOR)

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ClinicalTrials.gov Identifier: NCT03062540
Recruitment Status : Terminated (Stopped early due to inadequate separation on primary efficacy endpoint at Week 12 according to Interim Analysis conducted on the first 274 (50%) patients.)
First Posted : February 23, 2017
Last Update Posted : July 31, 2018
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Brief Summary:
This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose study that will investigate the efficacy and safety of 5.6 mg TNX-102 SL (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.

Condition or disease Intervention/treatment Phase
PTSD Drug: TNX-102 SL Drug: Placebo SL Tablet Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 358 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients With Military-Related PTSD
Actual Study Start Date : March 27, 2017
Actual Primary Completion Date : July 27, 2018
Actual Study Completion Date : July 27, 2018

Arm Intervention/treatment
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.
Drug: TNX-102 SL
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Other Name: Low dose cyclobenzaprine sublingual tablets

Placebo Comparator: Placebo SL Tablet
2 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.
Drug: Placebo SL Tablet
Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
Other Name: Placebo sublingual tablets




Primary Outcome Measures :
  1. Mean change from baseline in the total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at Week 12. [ Time Frame: Day 0, Week 4, Week 8 and Week 12 ]
    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) (CAPS-5) total symptom severity score in a 12-week study.


Secondary Outcome Measures :
  1. Clinical Global Impression - Improvement from Initiation of Treatment (CGI-I) score after 12 weeks of treatment. [ Time Frame: 12 weeks ]
    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment.

  2. Change from baseline in the disruption of social life/leisure activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment. [ Time Frame: Day 0, Week 4, Week 8 and Week 12. ]
    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of social life/leisure activities assessed with the SDS after 12 weeks of treatment.

  3. Change from baseline in the disruption of work/school activities assessed using the Sheehan Disability Scale (SDS) after 12 weeks of treatment. [ Time Frame: Day 0, Week 4, Week 8 and Week 12. ]
    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in disruption of work/school activities assessed with the SDS after 12 weeks of treatment.

  4. Change from baseline in patients' quality of sleep using the Patient-Reported Outcome Measurement Information System (PROMIS) Sleep Disturbance scale after 12 weeks of treatment. [ Time Frame: Day 0, Week 4, Week 8 and Week 12. ]
    To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the change from baseline in quality of sleep using the PROMIS Sleep Disturbance scale after 12 weeks of treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between 18 and 75 years of age, who have served in any branch of the military.
  • Diagnosed with current PTSD as determined by the Clinician-Administered PTSD Scale (CAPS-5) for DSM-5.
  • Index trauma(s) resulting in PTSD must meet DSM-5 criterion A for PTSD as described in CAPS-5, have occurred in 2001 or later, be military service related.
  • Willing to refrain from use of all other formulations of cyclobenzaprine.
  • Willing and able to refrain from antidepressants and other excluded medications.
  • Capable of reading and understanding English and able to provide written informed consent.
  • If female, either not of childbearing potential or practicing a medically acceptable method of birth control throughout the study.
  • Willing and able to comply with all protocol-specified requirements.

Exclusion Criteria:

  • Increased risk of suicide, based on the investigator's judgment that is of a severity that is not appropriate for outpatient management, or that warrants additional therapy excluded by the protocol.
  • Significant (e.g., moderate or severe) comorbid traumatic brain injury (TBI) by history.
  • Severe depressive symptoms at screening or baseline.
  • Clinically significant laboratory abnormalities based on screening laboratory tests and/or medical history in the investigator's opinion.
  • Use of antidepressant medication within 2 months of baseline.
  • Female patients who are pregnant or lactating.
  • History of serotonin syndrome, severe allergic reaction or bronchospasm or known hypersensitivity to cyclobenzaprine or the excipients.
  • Seizure disorder.
  • Patients with a body mass index (BMI) > 45.
  • Has received any other investigational drug within 30 days before Screening.
  • Previous participation in any other study with TNX-102 SL.
  • Family member of investigative staff.

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): NCT03062540


  Show 43 Study Locations
Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Premier Research Group plc
Investigators
Study Director: Greg Sullivan, MD Tonix Pharmaceuticals

Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03062540     History of Changes
Other Study ID Numbers: TNX-CY-P301
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tonix Pharmaceuticals, Inc.:
PTSD
Military-related PTSD

Additional relevant MeSH terms:
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