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"
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- PTSD
- Sponsor
- Tonix Pharmaceuticals, Inc.
- Enrollment
- 245
- Locations
- 23
- Primary Endpoint
- The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
Intervention: Placebo
TNX-102 SL, 2.8 mg
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.
Intervention: TNX-102 SL
TNX-102 SL, 2.8 mg
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.
Intervention: Placebo
TNX-102 SL, 5.6 mg
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
Intervention: TNX-102 SL
Outcomes
Primary Outcomes
The Mean Change From Baseline (Visit 2) in the Total CAPS-5 Score After 12 Weeks of Treatment Evaluated at Visit 9 (Week 12).
Time Frame: 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 Outcomes
- Clinician Global Impression - Improvement Scale Responder Rate at Week 12(Week 12)
- Change From Baseline in Patients' Quality of Sleep Using the PROMIS Sleep Disturbance Scale After 12 Weeks of Treatment(Day 1, Week 12)
- Mean Change From Baseline in Sheehan Disability Scale (SDS) Total Score(Day 1, Week 12)