Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

PTSD Clinical Trial

— AtEase  

Official title:

A Phase 2, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken at Bedtime in Subjects With Military-Related PTSD and Related Conditions (Protocol No. TNX-CY-P201) -"AtEase STUDY"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277704
• Other study ID #: TNX-CY-P201
• Status: Completed
• Phase: Phase 2
• Start date: October 2014
• Est. completion date: May 2016

Study information

• Verified date: May 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, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female between 18 and 65 years of age
• Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
• For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
• Willing and able to withdraw and refrain from specific therapies (ask PI)
• Use medically acceptable form of contraception (female only)
• Signed informed consent

Exclusion Criteria:

• Significant traumatic brain injury
• Severe depression
• Bipolar and psychotic disorders
• Increase risk of suicide
• Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
• Unable to wash-out specific medications (ask PI)
• History of violent behavior within past 2 years, unrelated to work duties
• History of drug or alcohol abuse within past 6 months
• Positive illegal substance test
• Known hypersensitivity to cyclobenzaprine
• Others: seizure disorders, uncontrolled sleep apnea, BMI>40
• Participation in an investigational study in past 30 days
• In the process of litigating for compensation for a psychiatric disorder
• Females that are pregnant or breastfeeding

Related Conditions & MeSH terms

• Disease
• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Drug:
• TNX-102 SL

• Placebo

Locations

Country	Name	City	State
United States	Atlanta Center For Medical Research	Atlanta	Georgia
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Cedarhurst	Cedarhurst	New York
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Cincinnati	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Sun Valley Research Center	Imperial	California
United States	Sarkis Clinical Trials	Lake City	Florida
United States	Altea Research	Las Vegas	Nevada
United States	Compass Research North, LLC	Leesburg	Florida
United States	Premier Psychiatric Research Institute, Inc.	Lincoln	Nebraska
United States	National City	National City	California
United States	Novex Clinical Research	New Bedford	Massachusetts
United States	Excell Research, Inc	Oceanside	California
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center of Orange County	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Noesis Pharma	Phoenix	Arizona
United States	CITRIALS	Riverside	California
United States	Clinical Trials of Texas	San Antonio	Texas
United States	Veteran Affairs, San Diego Health Care System	San Diego	California
United States	Cns, Inc.	Torrance	California
United States	Tuscaloosa VA Medical Center	Tuscaloosa	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Tonix Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sullivan GM, Gendreau RM, Gendreau J, Peters P, Peters A, Engels J, Daugherty BL, Vaughn B, Weathers FW, Lederman S. Randomized clinical trial of bedtime sublingual cyclobenzaprine (TNX-102 SL) in military-related PTSD and the role of sleep quality in tre — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).	The mean change from baseline (Visit 2) in the Total CAPS-5 score after 12 weeks of treatment evaluated at Visit 9 (Week 12). The primary efficacy comparison will be the change from baseline in total CAPS-5 score for the 2.8 mg treatment arm compared to placebo. CAPS-5 score ranges from 0-80 with lower scores indicating less severe PTSD symptoms.	Day 1, Week 12
Secondary	Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment	Change from baseline in patients' quality of sleep using the PROMIS (Patient -Reported Outcome Measurement Information System) Sleep Disturbance scale after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Raw scores are converted to T-scores using published conversion tables. Sleep Disturbance T-score ranges from 28.9 to 76.5. Lower scores indicate less sleep disturbance	Day 1, Week 12
Secondary	Clinician Global Impression - Improvement Scale Responder Rate at Week 12	Responder rates in CGI-I (Clinician Global Impression - Improvement Scale) after 12 weeks of treatment comparing the 2.8 mg treatment arm to placebo. Responder rate is defined as the number of patients scored as either a 1 or 2 on CGI-I at Week 12. The score ranges from 1 to 7 with the following anchors for each score: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	Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score	Mean Change from Baseline in SDS Total Score at Week 12. Score ranges from 0 to 30. A score of 0 means the patient is unimpaired, and a score of 30 means the patient is highly impaired.	Day 1, Week 12