Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions
- Conditions
- PTSD
- Interventions
- Drug: PlaceboDrug: TNX-102 SL
- Registration Number
- NCT02277704
- Lead Sponsor
- Tonix Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 245
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL, 2.8 mg TNX-102 SL 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL, 2.8 mg Placebo 1 x TNX-102 SL 2.8mg tablet ("TNX-102 SL") and 1 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime. TNX-102 SL, 5.6 mg TNX-102 SL 2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
- Primary Outcome Measures
Name Time Method The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12). Day 1, 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.
- Secondary Outcome Measures
Name Time Method Clinician Global Impression - Improvement Scale Responder Rate at Week 12 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
Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment Day 1, Week 12 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
Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score Day 1, Week 12 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.
Trial Locations
- Locations (23)
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Altea Research
🇺🇸Las Vegas, Nevada, United States
Cincinnati
🇺🇸Cincinnati, Ohio, United States
Veteran Affairs, San Diego Health Care System
🇺🇸San Diego, California, United States
Sun Valley Research Center
🇺🇸Imperial, California, United States
Cedarhurst
🇺🇸Cedarhurst, New York, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Orange, California, United States
Compass Research North, LLC
🇺🇸Leesburg, Florida, United States
CITRIALS
🇺🇸Riverside, California, United States
Tuscaloosa VA Medical Center
🇺🇸Tuscaloosa, Alabama, United States
Cns, Inc.
🇺🇸Torrance, California, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Premier Psychiatric Research Institute, Inc.
🇺🇸Lincoln, Nebraska, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Noesis Pharma
🇺🇸Phoenix, Arizona, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Novex Clinical Research
🇺🇸New Bedford, Massachusetts, United States
Excell Research, Inc
🇺🇸Oceanside, California, United States
National City
🇺🇸National City, California, United States
Sarkis Clinical Trials
🇺🇸Lake City, Florida, United States
Atlanta Center For Medical Research
🇺🇸Atlanta, Georgia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States