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

Sponsor
Tonix Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02277704
Collaborator
(none)
247
Enrollment
23
Locations
3
Arms
19
Duration (Months)
10.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: TNX-102 SL
  • Drug: Placebo
 Phase 2

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

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

Primary Outcome Measures

  1. Evaluate the efficacy of TNX-102 SL 2.8 mg using the DSM-5 total symptom severity score [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) [Continuously throughout the treatment period (total duration: about 3 months)]

  2. PTSD Checklist (Version 5) [Continuously throughout the treatment period (total duration: about 3 months)]

  3. Sheehan Disability Scale [Continuously throughout the treatment period (total duration: about 3 months)]

  4. Patient Global Impression of Change (Since Baseline) Scale [Continuously throughout the treatment period (total duration: about 3 months)]

  5. Number of Participants with Adverse Events [Continuously throughout the treatment period (total duration: about 3 months)]

  6. Change from baseline in ECG, lab results, vital signs and weight [Baseline and week 12]

  7. Changes from baseline in subject reported morning sedation [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) [Baseline, and weeks 1, 2, 4, 6, 8, and 12]

  9. Patient-Reported Outcome Measurement Information System- Sleep [Continuously throughout the treatment period (total duration: about 3 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Tuscaloosa VA Medical Center Tuscaloosa Alabama United States 35404
2 Noesis Pharma Phoenix Arizona United States 85032
3 Sun Valley Reserach Center Imperial California United States 92251
4 National City National City California United States 91950
5 Excell Research, Inc Oceanside California United States 92506
6 Neuropsychiatric Research Center of Orange County Orange California United States 92868
7 CITRIALS Riverside California United States 92506
8 Vetern Affairs, San Diego Health Care System San Diego California United States 92161
9 Cns, Inc. Torrance California United States 90502
10 Sarkis Clinical Trials Lake City Florida United States 32025
11 Compass Research North, LLC Leesburg Florida United States 34748
12 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
13 Atlanta Center For Medical Research Atlanta Georgia United States 30308
14 Great Lakes Clinical Trials Chicago Illinois United States 60640
15 Novex Clinical Research New Bedford Massachusetts United States 02740
16 Premier Psychiatric Research Instititute, Inc. Lincoln Nebraska United States 68526
17 Altea Research Las Vegas Nevada United States 89102
18 Cedarhurst Cedarhurst New York United States 11516
19 Cincinnati Cincinnati Ohio United States 45219
20 University Hospitals Case Medical Center Cleveland Ohio United States 44106
21 IPS Research Company Oklahoma City Oklahoma United States 73103
22 Clinical Trials of Texas San Antonio Texas United States 78229
23 Northwest Clinical Research Center Bellevue Washington United States 98007

Sponsors and Collaborators

  • Tonix Pharmaceuticals, Inc.

Investigators

  • Study Director: Denise Bedoya, Premier Research Group plc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tonix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02277704
Other Study ID Numbers:
  • TNX-CY-P201
First Posted:
Oct 29, 2014
Last Update Posted:
Oct 31, 2017
Last Verified:
Oct 1, 2017
Keywords provided by Tonix Pharmaceuticals, Inc.
PTSD
Military-related PTSD and other related conditions
Additional relevant MeSH terms:
Disease
Stress Disorders, Post-Traumatic

Study Results

No Results Posted as of Oct 31, 2017