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

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ClinicalTrials.gov Identifier: NCT02277704
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Tonix Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
PTSD Drug: TNX-102 SL Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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"
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Treatment A
2 x placebo tablet ("placebo") to be taken sublingually once daily at bedtime.
 Drug: Placebo
Active Comparator: Treatment B
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.
 Drug: TNX-102 SL
Drug: Placebo
Active Comparator: Treatment C
2 x TNX-102 SL 2.8mg tablets ("TNX-102 SL") to be taken sublingually once daily at bedtime.
 Drug: TNX-102 SL


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Clinician Administered PTSD Scale (for DSM-5) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
  2. PTSD Checklist (Version 5) [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
  3. Sheehan Disability Scale [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
  4. Patient Global Impression of Change (Since Baseline) Scale [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
  5. Number of Participants with Adverse Events [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]
  6. Change from baseline in ECG, lab results, vital signs and weight [ Time Frame: Baseline and week 12 ]
  7. Changes from baseline in subject reported morning sedation [ Time Frame: Baseline, and weeks 2, 4, 8, and 12 ]
  8. 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 ]
  9. Patient-Reported Outcome Measurement Information System- Sleep [ Time Frame: Continuously throughout the treatment period (total duration: about 3 months) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277704


Locations
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Sponsors and Collaborators
Tonix Pharmaceuticals, Inc.
Investigators
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Study Director: Denise Bedoya Premier Research Group plc
More Information
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Responsible Party: Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02277704    
Other Study ID Numbers: TNX-CY-P201
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Keywords provided by Tonix Pharmaceuticals, Inc.:
PTSD
Military-related PTSD and other related conditions
Additional relevant MeSH terms:
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Disease
Stress Disorders, Post-Traumatic
Pathologic Processes
 Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders