Overview

This trial is active, not recruiting.

Condition ptsd
Treatments tnx-102 sl, placebo
Phase phase 2
Sponsor Tonix Pharmaceuticals, Inc.
Start date October 2014
End date June 2016
Trial size 247 participants
Trial identifier NCT02277704, TNX-CY-P201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
placebo
(Active Comparator)
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
placebo
(Active Comparator)
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
tnx-102 sl

Primary Outcomes

Measure
Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score
time frame: 12 weeks

Secondary Outcomes

Measure
Clinician Administered PTSD Scale (for DSM-5)
time frame: Continuously throughout the treatment period (total duration: about 3 months)
PTSD Checklist (Version 5)
time frame: Continuously throughout the treatment period (total duration: about 3 months)
Sheehan Disability Scale
time frame: Continuously throughout the treatment period (total duration: about 3 months)
Patient Global Impression of Change (Since Baseline) Scale
time frame: Continuously throughout the treatment period (total duration: about 3 months)
Number of Participants with Adverse Events
time frame: Continuously throughout the treatment period (total duration: about 3 months)
Change from baseline in ECG, lab results, vital signs and weight
time frame: Baseline and week 12
Changes from baseline in subject reported morning sedation
time frame: Baseline, and weeks 2, 4, 8, and 12
Changes from baseline indicative of increased suicidal ideation or behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline, and weeks 1, 2, 4, 6, 8, and 12
Patient-Reported Outcome Measurement Information System- Sleep
time frame: Continuously throughout the treatment period (total duration: about 3 months)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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"
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Tonix Pharmaceuticals, Inc..