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

PTSD Clinical Trial

— HONOR  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03062540
• Other study ID #: TNX-CY-P301
• Status: Terminated
• Phase: Phase 3
• Start date: March 27, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: April 2024
• Source: Tonix Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 358
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Atlanta	Atlanta	Georgia
United States	Austin	Austin	Texas
United States	Berlin	Berlin	New Jersey
United States	Beverly hills	Beverly Hills	California
United States	Canton	Canton	Ohio
United States	Cedarhurst	Cedarhurst	New York
United States	Charleston	Charleston	South Carolina
United States	Chicago	Chicago	Illinois
United States	Cincinnati	Cincinnati	Ohio
United States	Colorado Springs	Colorado Springs	Colorado
United States	Cromwell	Cromwell	Connecticut
United States	Dallas	Dallas	Texas
United States	Dayton	Dayton	Ohio
United States	Downingtown	Downingtown	Pennsylvania
United States	Everett	Everett	Washington
United States	Flowood	Flowood	Mississippi
United States	Glendale	Glendale	California
United States	Houston	Houston	Texas
United States	Jacksonville	Jacksonville	Florida
United States	Lake City	Lake City	Florida
United States	Las Vegas	Las Vegas	Nevada
United States	Lauderhill	Lauderhill	Florida
United States	Little Rock	Little Rock	Arkansas
United States	Maitland	Maitland	Florida
United States	Media	Media	Pennsylvania
United States	Missoula	Missoula	Montana
United States	New Bedford	New Bedford	Massachusetts
United States	New York	New York	New York
United States	Norwich	Norwich	Connecticut
United States	Oakland	Oakland	California
United States	Oceanside	Oceanside	California
United States	Oklahoma City	Oklahoma City	Oklahoma
United States	Orange	Orange	California
United States	Phoenix	Phoenix	Arizona
United States	Riverside	Riverside	California
United States	Rogers	Rogers	Arkansas
United States	St. Louis	Saint Louis	Missouri
United States	Salem	Salem	Virginia
United States	San Antonio	San Antonio	Texas
United States	San Diego	San Diego	California
United States	San Diego	San Diego	California
United States	Tampa	Tampa	Florida
United States	Temecula	Temecula	California
United States	Washington, D.C.	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

References & Publications (1)

Parmenter ME, Lederman S, Weathers FW, Davis LL, Vaughn B, Engels J, Sullivan GM. A phase 3, randomized, placebo-controlled, trial to evaluate the efficacy and safety of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related posttraumatic str — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in the Total Clinician Administered PTSD Scale (CAPS-5) for DSM-5 at 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. Score ranges from 0 to 80 with lower scores indicating less severe PTSD symptoms.	Day 0 and Week 12
Secondary	Clinical Global Impression - Improvement From Initiation of Treatment (CGI-I) Score After 12 Weeks of Treatment.	To evaluate the efficacy of the TNX-102 SL (cyclobenzaprine HCl sublingual tablets) using the CGI-I score after 12 weeks of treatment. Score ranges from 1 to 7. 1 = Very much improved. 2 = Much improved. 3 = Minimally improved. 4 = No change. 5 = Minimally worse. 6 = Much worse. 7 = Very much worse.	Week 12
Secondary	Change From Baseline in the Disruption of Social Life/Leisure Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.	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. Score ranges from 0 to 10. Lower scores indicate less disruption to social life/leisure activities.	Day 0, Week 12.
Secondary	Change From Baseline in the Disruption of Work/School Activities Assessed Using the Sheehan Disability Scale (SDS) After 12 Weeks of Treatment.	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. Score ranges from 0 to 10. Lowers scores indicate less disruption to work/school activities.	Day 0, Week 12.
Secondary	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.	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. Raw score is transformed to T-scores using published conversions. T-score ranges from 30 to 80 with lower scores indicating better sleep quality.	Day 0, Week 12.